Physical Function In Patients Research Articles

Association between ankle torque and performance-based tests, self-reported pain, and physical function in patients with knee osteoarthritis.

This study aimed to investigate the association between ankle torque and performance-based tests, self-reported pain, and physical function in patients with knee osteoarthritis (OA). The cross-sectional study was conducted with 39 individuals (24 females, 15 males; mean age: 57.3±6.2 years; range, 40 to 65 years) with knee OA between January 2014 and July 2015. Ankle torque was determined using an isokinetic dynamometer. The 40-m fast-paced walk test and a stair climb test were used to assess functional performance. Self-reported pain and physical function were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Pearson's correlation coefficients were calculated to test correlations between the dependent variables (40-m fast-paced walk test, stair climb test, WOMAC pain and physical function domains, sex, age, body mass index, and radiologic evidence of OA) and the independent variables (mean plantar flexor torque and dorsiflexor peak torque). A multiple linear regression analysis was applied to quantify the association between the dependent and independent variables. Dorsiflexor and plantar flexor peak torques in the concentric and eccentric modes were negatively correlated with the 40-m fast-paced walk and stair climb tests (r=-0.33 to -0.51, p≤0.05). A negative correlation was found between concentric plantar flexor torque and the WOMAC physical function score (r=-0.35, p=0.03). No correlation was found between ankle torques and the WOMAC pain score (p>0.05). The multiple linear regression analysis showed that the eccentric plantar flexor and dorsiflexor torques were significantly associated with the stair climb test (β=-0.001, 95% confidence interval [CI]: -0.001 to 0.000, p=0.03, and β=-0.002, 95% CI: -0.004 to 0.000, p=0.05, respectively). No significant associations were found between concentric plantar flexor and dorsiflexor torques and the stair climb test (p>0.05). No significant associations were found between the ankle torques and the 40-m fast-paced walk test and WOMAC physical function (p>0.05). Ankle torque plays an important role in functional performance. Thus, ankle torque deficit, especially eccentric plantar flexor and dorsiflexor torques, may exert a negative influence on stair climbing performance in patients with knee osteoarthritis.

The relationship between CT-derived sarcopenia, systemic inflammation, physical function and survival in patients with advanced cancer.

804 Background: The CT-derived sarcopenia score (CT-SS) is thought to capture the nutritional and functional reserve of the cancer patient. However, it is unknown whether the CT-SS is associated with measures of physical function in patients with advanced cancer. Furthermore, has complimentary prognostic value when utilised as a phenotypic criterion in the GLIM cachexia framework. Methods: Prospectively collected data from patients with advanced cancer, undergoing anti-cancer therapy with palliative intent, across nine sites in the UK and Ireland between 2011–2016, was retrospectively analysed. Relationships between the CT-SS, ECOG-PS, measures of physical function and aetiological GLIM criterion (mGPS and metastatic disease) were examined using χ2 test for linear-by-linear association. Results: 518 patients met the inclusion criteria. 55 % (n=286) were male and 51% (n=266) were 65 years of age. The majority of patients had either GI (47%, n=242) or lung (25%, n=129) tumours. 46% (n=241) were CT-SS ≥1. 53% (n=274) of patients were inflamed (mGPS≥1). 63% (n=325) had an ECOG-PS>0/1. Of the 192 patients who underwent timed up-and-go testing and two-minute walk testing, 72% (n=138) and 96% (n=185) were categorised as a failure, respectively. Median survival from entry to the study was 8.7 months (4.2-18.3). 84% (n=433), 64% (n=339) and 38% (n=194) of patients were alive at 3-, 6- and 12-months, respectively. The CT-SS was significantly associated with ECOG-PS (p<0.001), timed up-and-go test failure (p<0.05), two-minute walk test failure (p<0.05), 3-month survival (p<0.05), 6-month survival (p<0.05) and 12-month survival (p<0.05). Furthermore, was significantly associated with 3-, 6- and 12-month survival in patients who were mGPS 0 and did not have metastatic disease (p<0.05 and p<0.05, respectively). Conclusions: The CT-SS is associated with physical function and survival in patients with advanced cancer. Furthermore, has complementary prognostic value to the aetiological criterion of the GLIM framework.

Six pills less: no benefit for bicarbonate supplementation in renal allograft recipients

Metabolic acidosis (defined as serum bicarbonate <22 mmol/L) is frequent in patients with chronic kidney disease and is associated with disease progression. 1 Chapter 3: management of progression and complications of CKD. Kidney Int Suppl (2011). 2013; 3 (No authors listed): 73-90 Summary Full Text Full Text PDF PubMed Scopus (90) Google Scholar Several prospective trials and meta-analyses 2 Hultin S Hood C Campbell KL Toussaint ND Johnson DW Badve SV A systematic review and meta-analysis on effects of bicarbonate therapy on kidney outcomes. Kidney Int Rep. 2020; 6: 695-705 Summary Full Text Full Text PDF PubMed Scopus (8) Google Scholar , 3 Witham MD Band M Chong H et al. Sodium bicarbonate to improve physical function in patients over 60 years with advanced chronic kidney disease: the BiCARB RCT. Health Technol Assess. 2020; 24: 1-90 Crossref PubMed Scopus (8) Google Scholar , 4 Di Iorio BR Bellasi A Raphael KL et al. Treatment of metabolic acidosis with sodium bicarbonate delays progression of chronic kidney disease: the UBI study. J Nephrol. 2019; 32: 989-1001 Crossref PubMed Scopus (70) Google Scholar , 5 Dubey AK Sahoo J Vairappan B Haridasan S Parameswaran S Priyamvada PS Correction of metabolic acidosis improves muscle mass and renal function in chronic kidney disease stages 3 and 4: a randomized controlled trial. Nephrol Dial Transplant. 2020; 35: 121-129 PubMed Google Scholar , 6 Navaneethan SD Shao J Buysse J Bushinsky DA Effects of treatment of metabolic acidosis in CKD: a systematic review and meta-analysis. Clin J Am Soc Nephrol. 2019; 14: 1011-1020 Crossref PubMed Scopus (60) Google Scholar have suggested potential positive effects (of low certainty) of sodium bicarbonate treatment on chronic kidney disease progression, and bicarbonate supplementation is recommended in patients with chronic kidney disease with serum bicarbonate less than 22 mmol/L. 1 Chapter 3: management of progression and complications of CKD. Kidney Int Suppl (2011). 2013; 3 (No authors listed): 73-90 Summary Full Text Full Text PDF PubMed Scopus (90) Google Scholar However, protective mechanisms are not fully understood and it is difficult to determine whether acidosis is a cause or consequence of renal function decline. Sodium bicarbonate for kidney transplant recipients with metabolic acidosis in Switzerland: a multicentre, randomised, single-blind, placebo-controlled, phase 3 trialIn adult kidney transplant recipients, correction of metabolic acidosis by treatment with sodium bicarbonate over 2 years did not affect the decline in estimated GFR. Thus, treatment with sodium bicarbonate should not be generally recommended to preserve estimated GFR (a surrogate marker for graft function) in kidney transplant recipients with chronic kidney disease who have metabolic acidosis. Full-Text PDF

Piloting HealthScore: Feasibility and acceptability of a clinically integrated health coaching program for people living with cancer.

Cancer supportive care interventions often have limited generalizability, goal misalignment, and high costs. We developed and piloted a health coaching intervention, UNC HealthScore, in patients undergoing cancer treatment (ClinicalTrials.gov identifier NCT04923997). We present feasibility, acceptability, and preliminary outcome data. HealthScore is a six-month, theory-based, multicomponent intervention delivered through participant-driven coaching sessions. For the pilot study, participants were provided a Fitbit, responded to weekly symptom and physical function digital surveys, and met with a health coach weekly to develop and monitor goals. Coaching notes were discussed in weekly interdisciplinary team meetings and provided back to the treating oncology team. Symptom alerts were monitored and triaged through a study resource nurse to relevant supportive care services. Feasibility was determined based on intervention enrollment and completion. Acceptability was based on satisfaction with coaching and Fitbit-wearing and was informed by semistructured exit interviews. Outcomes evaluated for signs of improvement included several PROMIS (Patient-Reported Outcomes Measurement Information System) measures, including the primary intervention target, physical function. From May 2020 to March 2022, 50 participants completed the single-arm pilot. Feasibility was high: 66% enrolled and 71% completed the full intervention. Participants reported an average of 4.8 and 4.7 (out of 5) on the acceptability of coaching calls and using the Fitbit, respectively. Physical function scores rose 3.1 points (SE=1.1) from baseline to 3months, and 4.3 (SE=1.0) from baseline to 6 months, above established minimal clinically important difference (MCID). Improvements above MCID were also evident in anxiety and depression, and smaller improvements were demonstrated for emotional support, social isolation, cognitive function, symptom burden, and self-efficacy. HealthScore shows feasibility, acceptability, and promising preliminary outcomes. Randomized studies are underway to determine the efficacy of preserving physical function in patients with advanced cancer.

Patient-reported Anxiety Scores Are Associated With Lower Physical Function in Patients Experiencing Orthopaedic Trauma.

The outcomes of orthopaedic trauma are not solely determined by injury severity or surgical treatment. Studies of numerous orthopaedic outcomes have found that psychosocial factors are also important. Symptoms of anxiety have been linked to long-term pain and disability. Although the existence of a relationship between psychosocial factors and functional outcomes is accepted across multiple disciplines, quantification of this association in patients who have experienced orthopaedic trauma has remained limited. Measuring the anxiety experienced by these individuals and the association with long-term functional outcomes remain poorly understood. (1) Is there an association between early postoperative anxiety symptoms and late recovery of self-reported physical function in patients with orthopaedic trauma? (2) What was the impact of other factors such as demographic variables and comorbidities on late recovery physical function scores, and how did the magnitude of these factors compare with the association with anxiety score? (3) Did patients who presented as trauma activations differ regarding their anxiety symptoms and late-recovery self-reported physical function? A total of 1550 patients with lower extremity fractures and postoperative Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety and physical function scores treated between January 1, 2014, and January 1, 2021, at an academic Level I trauma center in North America were assessed. We performed a bivariate regression between the initial PROMIS anxiety and physical function, as well as a multivariate regression including age, gender, BMI, and American Society of Anesthesiologists class to control for potential confounding variables. In a subgroup of 787 patients presenting as trauma activations, we performed a separate regression including Injury Severity Score. PROMIS anxiety was associated with decreased late-recovery physical function (β = -2.64 [95% CI -3.006 to -2.205]; p < 0.001). The relationship between PROMIS anxiety and physical function remained after controlling for confounding variables in our overall cohort (β = -2.54 [95% CI -2.93 to -2.15]; p < 0.001) and in the trauma activation cohort (β = -2.71 [95% CI -3.19 to -2.23]; p < 0.001). Age and American Society of Anesthesiologists score were associated with worse PROMIS physical function scores, while being a man was associated with better PROMIS physical function scores (age: β= -1.26 [95% CI -1.50 to -1.02]; American Society of Anesthesiologists class: β=-2.99 [95% CI -3.52 to -2.46]; men: β = 0.95 [95% CI 0.16 to 1.75]). There were no differences in initial anxiety symptoms or late-recovery physical function between patients who presented as trauma activations and those who did not. Injury Severity Scores were independently associated with worse function (β = -1.45 [95% CI -2.11 to -0.79]. Initial patient self-reported anxiety is negatively associated with patient-reported physical function at the final follow-up interval in a broad cohort of patients with orthopaedic lower extremity injuries undergoing surgery. Identifying patients with high initial PROMIS anxiety scores may allow us to determine which patients will report lower functional scores at the final follow-up. Future investigations could focus on the effect of psychosocial interventions such as cognitive behavioral therapy and mindfulness on functional scores. Level III, therapeutic study.

Effectiveness of active occupational therapy in patients with acute stroke: A propensity score-weighted retrospective study.

The effects of therapy and patient characteristics on rehabilitation outcomes in patients with acute stroke are unclear. We investigated the effects of intensive occupational therapy (OT) on patients with acute stroke. We performed a retrospective cohort study using the 2005-2016 Japan Rehabilitation Database, from which we identified patients with stroke (n = 10,270) who were admitted to acute care hospitals (n = 37). We defined active OT (AOT) and non-AOT as OT intervention times (total intervention time/length of hospital stay) longer or shorter than the daily physical therapy intervention time, respectively. The outcomes assessed were the Functional Independence Measure (FIM) and National Institutes of Health Stroke Scale (NIHSS) scores, duration of hospitalization, and rate of discharge. Propensity scores and inverse probability of treatment weighting analyses adjusted for patient characteristics were performed to investigate the effects of AOT on patient outcomes. We enrolled 3,501 patients (1,938 and 1,563 patients in the AOT and non-AOT groups, respectively) in the study. After inverse probability of treatment weighting, the AOT group had a shorter length of hospitalization (95% confidence interval: -3.7, -1.3, p < 0.001), and the FIM (95% confidence interval: 2.0, 5.7, p < 0.001) and NIHSS (95% confidence interval; 0.3, 1.1, p < 0.001) scores improved significantly. Subgroup analysis showed that lower NHISS scores for aphasia, gaze, and neglect and lower overall NIHSS and FIM scores on admission led to a greater increase in FIM scores in the AOT group. AOT improved the limitations in performing activities of daily living (ADL) and physical function in patients with acute stroke and reduced the length of hospitalization. Additionally, subgroup analysis suggested that the increase in FIM score was greater in patients with severe limitations in performing ADLs and worse cognitive impairment, such as neglect, on admission.

Thick shells and medially wedged posts increase foot orthoses medial longitudinal arch stiffness: an experimental study

BackgroundFoot orthoses (FOs) are commonly prescribed devices to attenuate biomechanical deficits and improve physical function in patients with musculoskeletal disorders. It is postulated that FOs provide their effects through the production of reaction forces at the foot-FOs interface. An important parameter to provide these reaction forces is their medial arch stiffness. Preliminary results suggest that adding extrinsic additions to FOs (e.g., rearfoot posts) increases their medial arch stiffness. A better understanding of how FOs medial arch stiffness can be modulated by changing structural factors is necessary to better customise FOs for patients. The objectives of this study were to compare FOs stiffness and force required to lower the FOs medial arch in three thicknesses and two models (with and without medially wedged forefoot-rearfoot posts).MethodsTwo models of FOs, 3D printed in Polynylon-11, were used: (1) without extrinsic additions (mFO), and (2) with forefoot-rearfoot posts and a 6o medial wedge (FO6MW). For each model, three thicknesses (2.6 mm, 3.0 mm, and 3.4 mm) were manufactured. FOs were fixed to a compression plate and vertically loaded over the medial arch at a rate of 10 mm/minute. Two-way ANOVAs and Tukey post-hoc tests with Bonferroni corrections were used to compare medial arch stiffness and force required to lower the arch across conditions.ResultsRegardless of the differing shell thicknesses, the overall stiffness was 3.4 times greater for FO6MW compared to mFO (p < 0.001). FOs with 3.4 mm and 3.0 mm thicknesses displayed 1.3- and 1.1- times greater stiffness than FOs with a thickness of 2.6 mm. FOs with a thickness of 3.4 mm also exhibited 1.1 times greater stiffness than FOs with a thickness of 3.0 mm. Overall, the force to lower the medial arch was up to 3.3 times greater for FO6MW than mFO and thicker FOs required greater force (p < 0.001).ConclusionsAn increased medial longitudinal arch stiffness is seen in FOs following the addition of 6o medially inclined forefoot-rearfoot posts, and when the shell is thicker. Overall, adding forefoot-rearfoot posts to FOs is significantly more efficient than increasing shell thickness to enhance these variables should that be the therapeutic aim.

Physical function of patients with severe COVID-19 pneumonia requiring invasive mechanical ventilation: an observational study.

Physical function of patients with severe COVID-19 pneumonia requiring invasive mechanical ventilation: an observational study.

Serum and synovial fluid 14-3-3η protein in patients with primary knee osteoarthritis compared with rheumatoid arthritis: relation to functional status and radiographic damage

Aim of the workThe aim of the present work was to examine the association between 14-3-3η protein levels in both serum and synovial fluid (SF) with radiographic damage and physical function in patients with primary knee osteoarthritis (OA) compared with rheumatoid arthritis (RA) patients.Patients and methodsThis is a cross-sectional study that involved two groups: group 1 included 50 primary knee OA patients, and group 2 included 50 RA patients. All study patients were assessed for serum and SF levels of 14-3-3η protein that was measured through ELISA technique. Functional assessment of OA patients was done using Western Ontario and McMaster Osteoarthritis index (WOMAC). Radiological assessment was evaluated using Kellgren–Lawrence (KL) grading scale.ResultsThe mean age of OA patients was 51.7 ± 10.4 years, disease duration was 24.8 ± 5.2 months, and mean WOMAC and KL grading scores were 18.5 ± 6.5 and 2.0 ± 0.99, respectively. Serum and SF 14-3-3η protein was significantly higher among RA compared with OA (1.5 ± 0.51 and 3.6 ± 1.1 ng/ml vs. 0.24 ± 0.03 and 0.24 ± 0.03, P = 0.004 and 0.018, respectively). There were no significant differences in serum and SF 14-3-3η protein between male and female OA patients (P = 0.99 and 0.87, respectively). A significant correlation was found between serum levels of 14-3-3η and erythrocyte sedimentation rate (r = 0.49, P = 0.014). The correlations between 14-3-3η protein in OA patients with WOMAC and KL grading scale were weak and not significant (P > 0.05).Conclusions14-3-3η protein levels were significantly lower in OA patients compared with RA patients. Although 14-3-3η levels were significantly correlated with inflammation, there was no correlation with functional status or radiological damage in knee OA patients.

Occurrence of Urinary Tract Infections and Physical Functioning in Patients After Stroke

Introduction: The majority of brain strokes result in a reduction of physical functioning and remain a major cause of disability. Post-stroke rehabilitation aims to improve physical functioning of patients who have suffered from stroke. Infections, including those of the urinary tract (UTI), are complications of stroke that occur in patients who undergo physical therapy at stationary departments of neurological rehabilitation and may significantly influence its effectiveness. Study aim: The main objective of the study is to assess the relationship between the UTI and physical functioning in patients after stroke, and the relationship between prevalence of UTIs and the results of rehabilitation in post-stroke patients. Material and methods: An observational case-control study was conducted, with a natural selection into the study groups according to the prevalence of UTI. Data was collected from the medical records of all stroke patients rehabilitated at the inpatient Neurological Rehabilitation Department of ORNR “Krzeszowice” in Krzeszowice during the period from 01 Jan. 2012 to 31 Dec. 2014. The study included 400 patients. Physical functioning was assessed using the Barthel and Rankin scales. Results. UTI occurred in 37.5% of patients. In the univariate analysis, the occurrence of UTIs was associated with worse physical functioning at admission and discharge. After adjustment to the influence of gender, age, side and type of stroke, the time since discharge from the stroke unit, the presence of diabetes and use urinary catheter, better physical functioning at admission to the neurological rehabilitation unit was inversely related to the occurrence of UTI (according to the Barthel scale: OR = 0.89, 95% CI: 0.85-0.94); according to the Rankin scale: OR = 1.75; 95% CI: 1.33-2.32). At discharge, after adjustment for: influence of physical functioning at admission to the ward and other confounding factors, the occurrence of UTI was not significantly correlated with the physical functioning of patients. During hospitalisation, physical functioning improved in both groups, but among the group of patients with UTI, the dynamics of the change was significantly greater than in patients without UTI. Conclusions. In stroke patients referred to inpatient neurological rehabilitation, UTIs are a common complication. The occurrence of UTI was associated with decreased physical functioning at admission to the department, but in patients with UTI, more dynamic improvement in physical functioning was found during rehabilitation. The incidence of UTI was not related to physical functioning at discharge from the ward.

Implemetasi Evidence Based Nursing: Efek Mobilsasi Dini pada Peningkatan Fungsi Fisik pada Pasien Paska Bedah Jantung (CABG)

This study aims to apply the effect of early mobilization on improving physical function in patients after CABG cardiac surgery based on the latest research results (Evidence-Based Nursing Practice). The method used was an experiment through the application of intervention for five days and continued with measurements on day 6 in the intervention group before the patient was sent home with the target being able to run (6'WMT). The research results show that the application of EBPN obtains a p-value of 0.005. In conclusion, there is a relationship between giving early mobilization interventions and functional ability with the 6 MWT test. &#x0D; Keywords: Evidence-Based Nursing, Physical Ability (6'WMT), Early Mobilization, Post Cardiac Surgery (CABG)

Functional Outcomes Following a Telehealth Interdisciplinary Program During COVID

<h3>Research Objectives</h3> To investigate the effectiveness of a telehealth (TH) program on the physical function of patients with chronic pain, and to compare TH to historical in-person treatment outcomes. <h3>Design</h3> A retrospective chart review of outcome data obtained pre-post week treatment duration. <h3>Setting</h3> Academic rehabilitation hospital, outpatient pain management center. <h3>Participants</h3> A sample of 51 consecutive adult patients with chronic pain (n=51) who participated in the TH program and historical data was obtained from a similar group of patients (n=51) who previously completed a comparable in-person pain program. <h3>Interventions</h3> The TH treatment included 1-2 weekly sessions from occupational therapists, psychologists and physical therapists, physical therapy group, for 6 weeks. The in-person program included individual occupational and physical therapy, individual psychology, and group sessions in each discipline, for 6 weeks. <h3>Main Outcome Measures</h3> The following pain region specific outcomes measures were used: Disabilities of the Arm, Shoulder and Hand (DASH), Oswestry Disability Index (ODI), Neck Disability Index (NDI), Lower Extremity Function Scale (LEFS), Tampa Scale for Kinesiophobia (TSK), and Patient Specific Functional Scale (PSFS). All measures were administered at the start of the program and again at discharge. <h3>Results</h3> Paired-samples t-tests showed significant changes on all outcome measures (t's = 2.320 - 12.082, P's = .001 - .045). Cohen's d indicated medium effects for the LEFS, TSK, ODI, NDI, and DASH (d's = .35 - .61), and a large effect for the PSFS (d = 1.79). Independent-samples t-tests were used to compare outcomes (difference scores) between those receiving the TH invention and those who participated in an in-person program. There were no statistically significant group differences on any of the outcomes: LEFS (Mdiff= -0.03, 95%CI [-5.95,5.89], t(53)= -0.010, p=.992), TSK (Mdiff= -1.77, CI [1.54,-4.85], t(70)= -1.161, p=.250), ODI (Mdiff=0.72, CI [-2.80,4.25], t(45)=0.413, p=.681), NDI (Mdiff= -0.40, CI [-6.73,5.93], t(13)= -.136, p=.894), DASH (Mdiff=3.98, CI [-6.38,14.34], t(28)=0.786, p=.438), and PSFS (Mdiff= -0.62, 95%CI [-1.33,0.10], t(91)= -1.714, p=.090). <h3>Conclusions</h3> Findings show preliminary support for the effectiveness of an interdisciplinary pain management telehealth intervention. <h3>Author(s) Disclosures</h3> None

Efficacy of Efanesoctocog Alfa on Physical Functioning: Results from the XTEND-1 Phase 3 Clinical Trial in Previously Treated Patients with Hemophilia A

Background: Adults with severe hemophilia A may have reduced levels of physical functioning significantly impacting their health-related quality of life (HRQoL). Results from the Phase 3 XTEND-1 study demonstrated that once-weekly efanesoctocog alfa prophylaxis was well-tolerated and provided superior bleed protection compared with prior factor VIII (FVIII) prophylaxis. Objective: To evaluate the efficacy of once-weekly efanesoctocog alfa prophylaxis on physical functioning in adults and adolescents (≥12 years of age) with severe hemophilia A who were previously treated with standard of care FVIII prophylaxis. Methods: XTEND-1 (NCT04161495) was a phase 3, open-label, multicenter trial in previously treated patients (≥12 years of age) with severe hemophilia A. Patients received once-weekly prophylactic efanesoctocog alfa, 50 IU/kg for 52 weeks (Arm A) or on-demand efanesoctocog alfa, 50 IU/kg for 26 weeks followed by 26 weeks of once-weekly prophylaxis ([50 IU/kg]; Arm B). Physical functioning was assessed as a secondary endpoint using hemophilia-specific HRQoL questionnaire for adults (Haem-A-QoL; in patients ≥17 years of age), Patient-Reported Outcomes Measurement Information System (PROMIS)-Short Form v2.0 physical function (PF; in patients ≥18 years of age), and as exploratory endpoints using Hemophilia Activities List (HAL; in patients ≥18 years of age), and EuroQol- 5 Dimension-5 Level (EQ-5D-5L; mobility and usual activities domains). Exit interviews, ActiGraph Activity Monitors (worn for 8 consecutive days at intervals throughout the study period), and post-hoc analysis (including psychometric analyses) were also used to evaluate physical functioning. The mean change from baseline to Week 52 in Haem-A-QoL Physical Health (PH) score, PROMIS PF 6b T-score, and HAL overall score, along with 95% confidence interval (CI) were estimated by a mixed-effect model with repeated measures. Here we report results for patients in Arm A. Results of the exit interviews and Actigraphy were evaluated in the overall patients included in the trial (Arms A and B). Results: A total of 159 patients (Arm A, N=133; Arm B, N=26) were included in the XTEND-1 trial. At baseline, the Haem-A-QoL PH score (mean [standard deviation, SD]) was 37.02 (23.83), while the overall HAL score was 76.11 [20.73]. A total of 18% (22/122) and 9% (11/122) patients reported moderate to severe problems with mobility and usual activities, respectively, at baseline, as per EQ-5D-5L. Prophylactic treatment with efanesoctocog alfa resulted in significant improvement in physical health: least square (LS) mean change in the Haem-A-QoL PH score from baseline to Week 52 was -6.74 (95% CI: -10.13 to -3.36; P=0.0001). Psychometric analyses reported meaningful within-group change for Haem-A-QoL PH score of 6.8 (range: 4.8-6.8) defined in the context used in the study. Numerical improvement was observed in PROMIS PF 6b T-score (LS mean change from baseline: 0.56 [95% CI: -0.38 to 1.50] and in HAL overall score at Week 52 (LS mean change: 0.67 [95% CI: -2.03 to 3.38]). A total of 23.5% (27/115) patients reported an improvement in at least 1 category in mobility at Week 52, while usual activities improved in 19.1% (22/115) patients in the EQ-5D-5L scale. These improvements in physical functioning on various instruments were aligned with the results from the exit interviews (N=29, including 17 patients in Arm A) reporting improvement in physical functioning in most patients (26/29). In addition, trends of improved physical activity were also observed in the Actigraphy data (mean [SD]: 5376 [3796] steps/day at baseline versus 5758 [4472] steps/day at Week 52; overall patients, N=158, including 132 patients in Arm A). Conclusions: Once-weekly prophylaxis with efanesoctocog alfa resulted in improvement in physical functioning in patients with hemophilia A, positively impacting daily living activities, in patients who were on prior standard of care FVIII prophylaxis.

Patient-Reported Outcomes from a Phase 2, Randomized Trial Evaluating the Safety and Efficacy of Pozelimab and Cemdisiran in Patients with Paroxysmal Nocturnal Hemoglobinuria

Background: Paroxysmal nocturnal hemoglobinuria (PNH) is an ultra-rare acquired genetic disease characterized by uncontrolled complement activation, which results in intravascular hemolysis and an increased tendency to develop thrombosis. PNH causes symptoms such as severe fatigue, which can negatively impact a patient's physical functioning and health-related quality of life (QoL). Cemdisiran is an investigational N-acetylgalactosamine-conjugated small interfering RNA (siRNA) that suppresses liver production of complement component C5, while pozelimab is an investigational fully human monoclonal antibody inhibitor of C5. The combination of pozelimab and cemdisiran is being evaluated in an ongoing phase 2, randomized, open-label, two-arm study that is designed to evaluate the safety and efficacy of combination therapy in patients with PNH who were transitioning from pozelimab monotherapy (NCT04811716). Interim patient-reported outcomes data are presented here. Methods: Twenty-two patients were randomized (1:1) to two treatment regimens; both arms received subcutaneous (SC) cemdisiran 200 mg every 4 weeks (Q4W) plus pozelimab 400 mg SC at a frequency of either Q4W (arm 1) or every 2 weeks (arm 2). Patients completed the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) scale (score range 0-52), and the European Organization for Research and Treatment of Cancer: Quality-of-Life Questionnaire global health status (GHS)/QoL and physical function assessments (score range 0-100). Higher scores indicate a better level of functioning or GHS/QoL, or less fatigue. Results: Prior to receiving pozelimab monotherapy, mean (standard deviation [SD]) pre-treatment values were 32.3 (15.2) for FACIT-Fatigue scores, 60.6 (22.4) for GHS/QoL scores, and 70.9 (22.5) for physical functioning scores (Table 1). For the current trial, baseline values were representative of the pozelimab monotherapy that the patients were receiving prior to transitioning to the combination therapy. The mean (SD) FACIT-Fatigue score at baseline was 45.4 (5.5) for arm 1 and 45.0 (3.4) for arm 2 (Table 1). Over Weeks 2-16, the mean FACIT-Fatigue scores were 40.1-45.6 for arm 1 and 39.2-41.4 for arm 2. The mean (SD) GHS/QoL scores were well controlled and similar for both treatment arms at baseline (77.8 [14.4] for arm 1 and 77.4 [20.8] for arm 2). Over Weeks 2-16, the mean GHS/QoL scores were 68.1-77.8 for arm 1 and 54.2-78.6 for arm 2. The mean physical functioning score at baseline was 93.3 for both treatment groups (SD: 8.8 for arm 1 and 9.4 for arm 2). Over Weeks 2-16, the mean physical functioning scores were 89.6-95.6 for arm 1 and 81.0-83.3 for arm 2 (Table 1). Conclusions: Patients with PNH who transitioned from pozelimab monotherapy had improved baseline scores compared with pre-treatment for their GHS/QoL, physical functioning, and fatigue scores. Improvements in these scores were maintained by the combination treatment through to Week 16, particularly with the pozelimab Q4W and cemdisiran dose regimen. This preliminary evidence, with limited sample size, suggests that pozelimab and cemdisiran combination therapy, particularly the Q4W regimen, maintains improvements in patient fatigue, GHS/QoL, and physical functioning. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Effects of High and Low-To-Moderate Intensity Exercise During (Neo-) Adjuvant Chemotherapy on Muscle Cells, Cardiorespiratory Fitness, and Muscle Function in Women With Breast Cancer: Protocol for a Randomized Controlled Trial.

(Neo-)adjuvant chemotherapy for breast cancer is effective but has deleterious side effects on muscle tissue, resulting in reduced skeletal muscle mass, muscle function, and cardiorespiratory fitness. Various exercise regimens during cancer treatment have been shown to counteract some of these side effects. However, no study has compared the effect of high-intensity training versus low-to-moderate intensity training on muscle tissue cellular outcomes and physical function in patients with breast cancer during chemotherapy. The aim of this substudy within the Physical Training in Cancer (Phys-Can) consortium is to evaluate and compare the effects of high and low-to-moderate intensity exercise on muscle cellular outcomes, muscle function, and cardiorespiratory fitness in women with breast cancer undergoing (neo-)adjuvant chemotherapy. We further aim to investigate if the effects of chemotherapy including taxanes on muscles will be different from those of taxane-free chemotherapy. Eighty women recently diagnosed with breast cancer scheduled to start (neo-)adjuvant chemotherapy will be randomized to a combination of strength and endurance training, either at high intensity or at low-to-moderate intensity. Testing of muscle function and cardiorespiratory fitness and collection of muscle biopsies from the vastus lateralis muscle will be performed before the first cycle of chemotherapy (or after 1 week, when not possible) (T0), halfway through chemotherapy (T1), and after completion of chemotherapy (T2). It is estimated that approximately 50% of the participants will be willing to undergo muscle biopsies. To separate the effect of the treatment itself, a usual care group with no supervised training will also be included, and in this group, testing and collection of muscle biopsies will be performed at T0 and T2 only. This study is funded by Active Against Cancer (Aktiv mot kreft) (May 2013) and the Norwegian Cancer Society (December 2018). Inclusion started in December 2016 and the last participant is expected to be recruited in December 2022. As of June 2022, we enrolled 38 (19 with biopsies) participants to the high-intensity training group, 36 (19 with biopsies) participants to the low-to-moderate intensity training group, and 17 (16 with biopsies) participants to the usual care group. Data analyses will start in fall 2022. The first results are expected to be published in spring 2024. This study will generate new knowledge about the effects of different training intensities for women with breast cancer during chemotherapy treatment. It will give further insight into how chemotherapy affects the muscle tissue and how physical training at different intensities may counteract the treatment side effects in muscles. The results of this study will inform the development and refinement of exercise programs that are effective and compatible with the multidisciplinary management of breast cancer. ClinicalTrials.gov NCT05218876; https://tinyurl.com/ysaj9dhm. DERR1-10.2196/40811.

The effectiveness of visceral osteopathy in pain, disability, and physical function in patients with low-back pain. A systematic review and meta-analysis

Background and purposeSystematic review and meta-analysis to assess the effectiveness of visceral osteopathy in improving pain intensity, disability and physical function in patients with low-back pain (LBP). Materials and methodsMEDLINE (Pubmed), PEDro, SCOPUS, Cochrane Library and Web of Science databases were searched from inception to February 2022. PICO search strategy was used to identify randomized controlled trials applying visceral techniques in patients with LBP. Eligible studies and data extraction were conducted independently by two reviewers. Quality of the studies was assessed with the Physiotherapy Evidence Database scale, and the risk of bias with Cochrane Collaboration tool. Meta-analyses were conducted using random effects models according to heterogeneity assessed with I2 coefficient. Data on outcomes of interest were extracted by a researcher using RevMan 5.4 software. ResultsFive studies were included in the systematic review involving 268 patients with LBP. The methodological quality of the included ranged from high to low and the risk of bias was high. Visceral osteopathy techniques have shown no improvements in pain intensity (Standardized mean difference (SMD) = -0.53; 95% CI; -1.09, 0.03; I2: 78%), disability (SMD = -0.08; 95% CI; -0.44, 0.27; I2: 0%) and physical function (SMD = -0.26; 95% CI; -0.62, 0.10; I2: 0%) in patients with LBP. ConclusionsThis systematic review and meta-analysis showed a lack of high-quality studies showing the effectiveness of visceral osteopathy in pain, disability, and physical function in patients with LBP.

Case–control study of the correlation between the five times sit to stand and 6-min walk distance in patients with pancreatic cancer

PurposeCases of pancreatic cancer are increasing, and the risk of developing this disease reportedly increases with age. In recent years, there has been an increasing number of reports on physical function in patients with pancreatic cancer. Methods such as the 6-min walk distance (6 MWD) should be established to evaluate physical function, as a decline in exercise capacity is an important index in these patients. Recently, the 6 MWD has also been used to evaluate physical function in patients with pancreatic cancer. In healthy older adults, a decrease in 6 MWD is reportedly associated with intrinsic capacity and health status. Such factors make assessing 6 MWD important. However, the measurement of 6 MWD requires a sizable measurement environment. The five times sit to stand (FTSTS) test is a simple method that can be performed using a chair. FTSTS is hypothesized to be a useful assessment scale in patients with pancreatic cancer because it is easy to estimate the decline in physical function in clinical practice if the decline in 6 MWD can be estimated by evaluating FTSTS. The study’s purpose was to clarify this hypothesis and ascertain the cutoff required to determine the decrease in 6 MWD in clinical practice.MethodsSixty consecutive patients with preoperative pancreatic cancer who were assessed for physical function were studied. 6 MWD (< 400 m) was the objective variable, and binary logistic regression analysis was performed, with age, BMI, sex, FTSTS, and HGS as explanatory variables. Receiver-operating characteristic (ROC) curve analysis was performed for the explanatory variables, which were found to be significant based on logistic regression analysis. The area under the curve (AUC) was also calculated. Sensitivity, specificity, negative predictive value (NPV), and positive predictive value (PPV) were evaluated. This study was approved by Hiroshima University Hospital’s ethics committee (approval number: E808-1).ResultsFifty-seven of the 60 patients were included in the analysis. Logistic regression analysis showed that FTSTS was a significant explanatory variable; ROC curve analysis showed an AUC of 0.872 and a cutoff value of 8.98 s. The sensitivity, specificity, PPV, and NPV were 82.4%, 80.0%, 63.6%, and 91.4%, respectively.ConclusionsA decrease in 6 MWD in preoperative pancreatic cancer patients can be identified by performing FTSTS.

Functional Outcomes Following Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy: A Prospective Cohort Study

BackgroundPre-operative physical status and its association with post-operative surgical outcomes is poorly understood in patients with peritoneal malignancy who undergo cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC). The aims of this study were to determine the pre-operative physical function in patients having CRS-HIPEC and investigate the association between physical function and post-operative outcomes.Patients and MethodsPatients undergoing CRS-HIPEC between 2017 and 2021 were recruited at a single quaternary referral hospital in Sydney, Australia. The primary physical function measures were the 6-min walk test (6MWT) and the five-times sit to stand test (5STS). Data were collected pre-operatively and at post-operative day 10, and were analysed according to pre-operative patient characteristics and post-operative outcomes such as length of hospital stay (LOS) and complications.ResultsThe cohort of patients that participated in functional assessments consisted of 234 patients, with a median age of 56 years. Patients having CRS-HIPEC performed worse on the 6MWT pre-operatively compared with the general Australian population (p < 0.001). Post-operatively, these patients experienced a further deterioration in 6MWT and 5STS performance and the degree of the post-operative decline in function was associated with post-operative morbidity. A higher level of pre-operative physical function was associated with shorter LOS and minor post-operative complications.ConclusionsPatients who have undergone CRS-HIPEC were functionally impaired pre-operatively compared with the general population and experience a further deterioration of physical function post-operatively. A higher level of pre-operative physical function is associated with minor post-operative morbidity, which is highly relevant for pre-operative optimisation of patients with cancer.

Science slowly accepts the matrix of consciousness

Systematic review and meta-analysis to assess the effectiveness of visceral osteopathy in improving pain intensity, disability and physical function in patients with low-back pain (LBP).MEDLINE (Pubmed), PEDro, SCOPUS, Cochrane Library and Web of Science databases were searched from inception to February 2022. PICO search strategy was used to identify randomized controlled trials applying visceral techniques in patients with LBP. Eligible studies and data extraction were conducted independently by two reviewers. Quality of the studies was assessed with the Physiotherapy Evidence Database scale, and the risk of bias with Cochrane Collaboration tool. Meta-analyses were conducted using random effects models according to heterogeneity assessed with I2 coefficient. Data on outcomes of interest were extracted by a researcher using RevMan 5.4 software.Five studies were included in the systematic review involving 268 patients with LBP. The methodological quality of the included ranged from high to low and the risk of bias was high. Visceral osteopathy techniques have shown no improvements in pain intensity (Standardized mean difference (SMD) = -0.53; 95% CI; -1.09, 0.03; I2: 78%), disability (SMD = -0.08; 95% CI; -0.44, 0.27; I2: 0%) and physical function (SMD = -0.26; 95% CI; -0.62, 0.10; I2: 0%) in patients with LBP.This systematic review and meta-analysis showed a lack of high-quality studies showing the effectiveness of visceral osteopathy in pain, disability, and physical function in patients with LBP.

Prehabilitation in Locally Advanced Cervical Cancer Patients Receiving Radiotherapy

<h3>Purpose/Objective(s)</h3> Cervical Cancer is one of the leading malignancies in women, and concurrent chemoradiation followed by brachytherapy is the current standard of care for locally advanced carcinoma cervix. Prehabilitation involves physical and psychological assessments to ensure a functional baseline, identify problems, and give focused interventions to enhance patient health and reduce the occurrence and severity of current and future treatment related impairments. This study was done to assess the impact of prehabilitation in cervical cancer patients receiving radiotherapy with or without chemotherapy on overall treatment time, health related quality of life and to assess the treatment related morbidity requiring hospital admissions. <h3>Materials/Methods</h3> A single institution, prospective interventional study was conducted from July 2020 to July 2021. All patients with biopsy-proven locally advanced cervical cancer scheduled for chemoradiation followed by brachytherapy after getting informed consent were enrolled in the study. Patients were assessed for baseline functional status following which they went through 5 sessions of physiotherapy, 7 visits for nutritional advice, and 7 visits for psychological counselling under supervision beginning 2 weeks prior to the initiation of treatment to the end of treatment. HRQOL was assessed according to EORTC CX QLQ 30 and QLQ 24 questionnaire at the baseline and end of treatment. <h3>Results</h3> The mean age of patients was 50 years with a range of 37-65 years; and the commonest stage at presentation was FIGO stage IIIC1.The mean albumin of our study population was 4.2g/dl,15 patients (71.4%) achieved OTT of less than 56 days, only 4 patients (19%) required hospital admissions for treatment related toxicities. All patients (100%) completed entire radiation treatment. There was improvement in the quality of life in the domains of physical functioning, pain, symptoms, and appetite at the end of treatment when compared to baseline. It was found to be statistically significant in patient's physical functioning (p-value 0.004) and improvement in symptom experience (p-value 0.001), pain (p-value 0.038) and appetite loss (p-value 0.046). <h3>Conclusion</h3> Prehabilitation is a promising pre-emptive interventional paradigm, conceptually intuitive and based on sound theoretical principles. This intervention is recommended to improve the outcomes and reduction in treatment related toxicities. In spite of the emerging encouraging data, the effective combination of intervention needs to be further evaluated and established.