Usual Therapy Research Articles

Catheter ablation in atrial fibrillation and heart failure with preserved ejection fraction improves peak pulmonary capillary wedge pressure, exercise capacity and quality of life: RCT STALL HFpEF

Abstract Introduction Atrial fibrillation (AF) frequently accompanies heart failure with preserved ejection fraction (HFpEF). AF exacerbates HFpEF through adverse haemodynamic effects. In turn, HFpEF promotes AF through adverse left atrial remodelling. Observational data suggest sinus rhythm restoration improves outcomes in patients with AF and HFpEF. However, there are no randomised data examining the effects of rhythm control with catheter-based AF ablation on HFpEF outcomes. Purpose To compare the effects of AF ablation versus usual medical therapy on markers of HFpEF severity, including exercise haemodynamics, natriuretic peptide levels and patient symptoms. Methods Patients with symptomatic AF and HFpEF underwent exercise right heart catheterization (RHC) and cardiopulmonary exercise testing (CPET). HFpEF diagnosis was based on left ventricular ejection fraction (LVEF) ≥50%, elevated natriuretic peptide and echocardiographic diastolic impairment. HFpEF was confirmed on exercise RHC based on peak exercise pulmonary capillary wedge pressure (PCWP) of ≥25mmHg. Patients were randomised to AF ablation versus medical therapy, with investigations repeated at 6 months. The primary outcome was change in PCWP on follow-up. Results 31 patients aged 66.1±7.5 years were randomized to AF ablation (16) versus medical therapy (15), with 51.6% female and 80.6% persistent AF. Baseline characteristics were comparable across groups. Paired analyses of ablation cohort showed significant reductions in peak PCWP (29.6±3.7 vs 25.9±4.6 mmHg, p<0.01), PCWP indexed for workload (39.0±57.9 vs 33.0±50.5 mmHg/W/kg, p<0.01), and BNP (146.2±80.5 vs 82.2±75.4 pg/mL, p=0.01); and increased resting cardiac output (4.6±0.9 vs 5.6±1.2 L/min, p=0.01), peak cardiac output (9.6±4.2 vs 10.4±3.7 L/min, p=0.02), peak (30s averaged) VO2 (1875.1±759.2 vs 2193.7±878.1 mL/min, p<0.01), peak absolute VO2 (1937.3±739.3 vs 2216.3±861.9 mL/min, p<0.01), peak (30s averaged) relative VO2 (19.4±5.9 vs 22.9±7.4 ml/kg/min) and peak workload (162.0±81.1 vs 184.4±83.4 W, p<0.01). Quality of life scores improved: AFEQT (45.3±20.9 vs 75±20.7, p<0.01) and MLHF (53±23.3 vs 17.5±22.8, p<0.01). Reversal of HFpEF by PCWP criteria occurred in 31.2% following AF ablation, and 50% among those free from arrhythmia recurrence. In the medical arm, there were no significant differences in RHC, CPET, and natriuretic peptide outcomes on follow-up versus baseline. Repeated measures mixed ANOVA testing showed significant time-randomisation interaction on peak VO2, absolute peak VO2, peak relative VO2, AFEQT/ MLHF scores, suggesting that significant improvements in these parameters were related to AF ablation. Conclusion In patients with concomitant AF and HFpEF, AF ablation improves invasive exercise haemodynamic parameters, increases exercise capacity, and enhances quality of life. Successful AF ablation may reverse the clinical syndrome of HFpEF in a subset of cases. Funding Acknowledgement Type of funding sources: None.

USE OF PLASMA EXCHANGE TO TREAT REFRACTORY DIFFUSE ALVEOLAR HEMORRHAGE FROM ANTINEUTROPHIL CYTOPLASMIC ANTIBODY-ASSOCIATED VASCULITIS

USE OF PLASMA EXCHANGE TO TREAT REFRACTORY DIFFUSE ALVEOLAR HEMORRHAGE FROM ANTINEUTROPHIL CYTOPLASMIC ANTIBODY-ASSOCIATED VASCULITIS

Aldosterone, Renin, and Aldosterone-to-Renin Ratio Variability in Screening for Primary Aldosteronism.

The plasma aldosterone concentration (PAC), renin, and aldosterone-to-renin ratio (ARR) are used to screen for primary aldosteronism (PA). Substantial intra-individual variability of PAC and ARR using plasma renin activity in the context of usual antihypertensive therapy has been described, but there is no data on ARR variability calculated using direct renin concentration (DRC). To describe the intra-individual variability of PAC, DRC, and ARR in the absence of interfering medications in patients with and without PA. Retrospective cohort study. Hypertensive patients referred for investigation of PA, with at least 2 ARR measurements while off interfering medications. Endocrine hypertension service of a tertiary center, from May 2017 to July 2021. PAC, DRC, and ARR variability was calculated as coefficient of variation (CV) and percent difference (PD). Analysis of 223 patients (55% female, median age 52 years), including 162 with confirmed PA, demonstrated high variability with a sample CV of 22-25% in the PAC and sample CV of 41% to 42% in the DRC and ARR in both the PA and non-PA groups. The degree of variability was substantially higher than the assays' analytical CV. Sixty-two patients (38%) with PA had at least one ARR below 70 pmol/L:mU/L (2.4 ng/dL:mU/L), a cut-off for first-line screening of PA. Significant intra-individual variability in PAC, DRC, and hence ARR occurs in a large proportion of patients being investigated for PA. These findings support the need for at least 2 ARR before PA is excluded or further investigated.

Dapagliflozin in Heart Failure with Mildly Reduced or Preserved Ejection Fraction

BackgroundSodium–glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of hospitalization for heart failure and cardiovascular death among patients with chronic heart failure and a left ventricular ejection fraction of 40% or less. Whether SGLT2 inhibitors are effective in patients with a higher left ventricular ejection fraction remains less certain.MethodsWe randomly assigned 6263 patients with heart failure and a left ventricular ejection fraction of more than 40% to receive dapagliflozin (at a dose of 10 mg once daily) or matching placebo, in addition to usual therapy. The primary outcome was a composite of worsening heart failure (which was defined as either an unplanned hospitalization for heart failure or an urgent visit for heart failure) or cardiovascular death, as assessed in a time-to-event analysis.ResultsOver a median of 2.3 years, the primary outcome occurred in 512 of 3131 patients (16.4%) in the dapagliflozin group and in 610 of 3132 patients (19.5%) in the placebo group (hazard ratio, 0.82; 95% confidence interval [CI], 0.73 to 0.92; P<0.001). Worsening heart failure occurred in 368 patients (11.8%) in the dapagliflozin group and in 455 patients (14.5%) in the placebo group (hazard ratio, 0.79; 95% CI, 0.69 to 0.91); cardiovascular death occurred in 231 patients (7.4%) and 261 patients (8.3%), respectively (hazard ratio, 0.88; 95% CI, 0.74 to 1.05). Total events and symptom burden were lower in the dapagliflozin group than in the placebo group. Results were similar among patients with a left ventricular ejection fraction of 60% or more and those with a left ventricular ejection fraction of less than 60%, and results were similar in prespecified subgroups, including patients with or without diabetes. The incidence of adverse events was similar in the two groups.ConclusionsDapagliflozin reduced the combined risk of worsening heart failure or cardiovascular death among patients with heart failure and a mildly reduced or preserved ejection fraction. (Funded by AstraZeneca; DELIVER ClinicalTrials.gov number, NCT03619213.)

Effect of innovative vs. usual care physical therapy in subacute rehabilitation after stroke. A multicenter randomized controlled trial

Research on stroke rehabilitation often addresses common difficulties such as gait, balance or physical activity separately, a fragmentation contrasting the complexity in clinical practice. Interventions aiming for recovery are needed. The purpose of this study was to investigate effects of a comprehensive low-cost physical therapy intervention, I-CoreDIST, vs. usual care on postural control, balance, physical activity, gait and health related quality of life during the first 12 weeks post-stroke. This prospective, assessor-masked randomized controlled trial included 60 participants from two stroke units in Norway. Participants, who were randomized to I-CoreDIST (n = 29) or usual care physical therapy (n = 31), received 5 sessions/week when in-patients or 3 sessions/week as out-patients. Primary outcomes were the Trunk Impairment Scale-modified Norwegian version (TISmodNV) and activity monitoring (ActiGraphsWgt3X-BT). Secondary outcomes were the Postural Assessment Scale for Stroke, MiniBesTEST, 10-meter walk test, 2-minute walk test, force-platform measurements and EQ5D-3L. Stroke specific quality of life scale was administered at 12 weeks. Linear regression and non-parametric tests were used for statistical analysis. Five participants were excluded and seven lost to follow-up, leaving 48 participants in the intention-to-treat analysis. There were no significant between-group effects for primary outcomes: TIS-modNV (p = 0,857); daily average minutes of sedative (p = 0.662), light (p = 0.544) or moderate activity (p = 0.239) and steps (p = 0.288), or secondary outcomes at 12 weeks except for significant improvements on EQ5D-3L in the usual care group. Within-group changes were significant for all outcomes in both groups except for activity levels that were low, EQ5D-3L favoring the usual care group, and force-platform data favoring the intervention group. Physical therapy treatment with I-CoreDIST improved postural control, balance, physical activity and gait during the first 12 weeks after a stroke but is not superior to usual care.

Subacute stent thrombosis with spontaneously resolved secondary thrombi in paroxysmal nocturnal hemoglobinuria: a case report

BackgroundStent thrombosis (ST) is a serious complication; however, a method to prevent ST in patients with thrombophilic diseases has not been established.Case presentationWe report a case of subacute ST in a patient with paroxysmal nocturnal hemoglobinuria (PNH) who was receiving continuous heparin treatment in addition to the usual dual antiplatelet therapy for contrast defects at the proximal site of the occluded right coronary artery and the proximal site of the left circumflex artery. Despite the resolution of thrombi in secondary lesions, subacute ST occurred. After percutaneous coronary intervention for ST, triple therapy, including oral anticoagulation for PNH-related thrombosis, was initiated. The patient subsequently underwent craniotomy hematoma removal for hemorrhagic cerebral infarction.ConclusionsReported cases of ST in patients with PNH are very few, and this case adds evidence with respect to antithrombotic therapy in patients with thrombotic tendencies. Both thrombosis and bleeding should be considered when administering antithrombotic therapy to patients with thrombotic diseases. If there are specific treatments for thrombophilic diseases, they should be initiated early.

Factor XIa inhibition with asundexian after acute non-cardioembolic ischaemic stroke (PACIFIC-Stroke): an international, randomised, double-blind, placebo-controlled, phase 2b trial

Asundexian (Bayer AG, Leverkusen, Germany), an oral small molecule factor XIa (FXIa) inhibitor, might prevent thrombosis without increasing bleeding. Asundexian's effect for secondary prevention of recurrent stroke is unknown. In this randomised, double-blind, placebo-controlled, phase 2b dose-finding trial (PACIFIC-Stroke), patients with acute (within 48 h) non-cardioembolic ischaemic stroke were recruited from 196 hospitals in 23 countries. Patients were eligible if they were aged 45 years or older, to be treated with antiplatelet therapy, and able to have a baseline MRI (either before or within 72 h of randomisation). Eligible participants were randomly assigned (1:1:1:1), using an interactive web-based response system and stratified according to anticipated antiplatelet therapy (single vs dual), to once daily oral asundexian (BAY 2433334) 10 mg, 20 mg, or 50 mg, or placebo in addition to usual antiplatelet therapy, and were followed up during treatment for 26-52 weeks. Brain MRIs were obtained at study entry and at 26 weeks or as soon as possible after treatment discontinuation. The primary efficacy outcome was the dose-response effect on the composite of incident MRI-detected covert brain infarcts and recurrent symptomatic ischaemic stroke at or before 26 weeks after randomisation. The primary safety outcome was major or clinically relevant non-major bleeding as defined by International Society on Thrombosis and Haemostasis criteria. The efficacy outcome was assessed in all participants assigned to treatment, and the safety outcome was assessed in all participants who received at least one dose of study treatment. This study is registered with ClinicalTrials.gov, NCT04304508, and is now complete. Between June 15, 2020, and July 22, 2021, 1880 patients were screened and 1808 participants were randomly assigned to asundexian 10 mg (n=455), 20 mg (n=450), or 50 mg (n=447), or placebo (n=456). Mean age was 67 years (SD 10) and 615 (34%) participants were women, 1193 (66%) were men, 1505 (83%) were White, and 268 (15%) were Asian. The mean time from index stroke to randomisation was 36 h (SD 10) and median baseline National Institutes of Health Stroke Scale score was 2·0 (IQR 1·0-4·0). 783 (43%) participants received dual antiplatelet treatment for a mean duration of 70·1 days (SD 113·4) after randomisation. At 26 weeks, the primary efficacy outcome was observed in 87 (19%) of 456 participants in the placebo group versus 86 (19%) of 455 in the asundexian 10 mg group (crude incidence ratio 0·99 [90% CI 0·79-1·24]), 99 (22%) of 450 in the asundexian 20 mg group (1·15 [0·93-1·43]), and 90 (20%) of 447 in the asundexian 50 mg group (1·06 [0·85-1·32]; t statistic -0·68; p=0·80). The primary safety outcome was observed in 11 (2%) of 452 participants in the placebo group versus 19 (4%) of 445 in the asundexian 10 mg group, 14 (3%) of 446 in the asundexian 20 mg group, and 19 (4%) of 443 in the asundexian 50 mg group (all asundexian doses pooled vs placebo hazard ratio 1·57 [90% CI 0·91-2·71]). In this phase 2b trial, FXIa inhibition with asundexian did not reduce the composite of covert brain infarction or ischaemic stroke and did not increase the composite of major or clinically relevant non-major bleeding compared with placebo in patients with acute, non-cardioembolic ischaemic stroke. Bayer AG.

The additional value of e-Health for patients with a temporomandibular disorder: a mixed methods study on the perspectives of orofacial physical therapists and patients

Purpose To assess the experience and perceived added value of an e-Health application during the physical therapy treatment of patients with temporomandibular disorders (TMD). Materials and methods A mixed-methods study including semi-structured interviews was performed with orofacial physical therapists (OPTs) and with TMD patients regarding their experience using an e-Health application, Physitrack. The modified telemedicine satisfaction and usefulness questionnaire and pain intensity score before and after treatment were collected from the patients. Results Ten OPTs, of which nine actively used Physitrack, described that the e-Health application can help to provide personalised care to patients with TMD, due to the satisfying content, user-friendliness, accessibility, efficiency, and ability to motivate patients. Ten patients, of which nine ended up using Physitrack, felt that shared decision-making was very important. These patients were positive towards the application as it was clear, convenient, and efficient, it helped with reassurance and adherence to the exercises and overall increased self-efficacy. This was mostly built on their experience with exercise videos, as this feature was most used. None of the OPTs or patients used all features of Physitrack. The overall satisfaction of Physitrack based on the telemedicine satisfaction and usefulness questionnaire (TSUQ) was 20.5 ± 4.0 and all patients (100%) showed a clinically relevant reduction of TMD pain (more than 2 points and minimally 30% difference). Conclusion OPTs and patients with TMD shared the idea that exercise videos are of added value on top of usual physical therapy care for TMD complaints, which could be delivered through e-Health. Implications for Rehabilitation Physical therapists and patients with temporomandibular disorders do not use all features of the e-Health application Physitrack in a clinical setting. Exercise videos were the most often used feature and seen as most valuable by physical therapists and patients. Based on a small number of participants, e-Health applications such as Physitrack may be perceived as a valuable addition to the usual care, though this would need verification by a study designed to evaluate the therapeutic effect (e.g., a randomised clinical trial).

Proprioceptive Neuromuscular Facilitation compared to usual resistance exercise therapy in individuals with knee osteoarthritis: a randomized clinical trial protocol

Background/Aims: Knee osteoarthritis (KOA) is characterized by functional impairment in performing of daily life activities. Proprioceptive Neuromuscular Facilitation (PNF) is a treatment concept that recommends performing exercises within a context of functionality. To develop a protocol to evaluate the efficacy of (PNF) compared to conventional physiotherapy (CPT group) on pain reduction and improvement in physical functioning and quality of life in individuals with KOA. Methods: A protocol for a randomized controlled trial was proposed to evaluate the effectiveness of the PNF protocol in pain reduction, improvement physical functioning, quality of life and evaluation of adverse effects, according Consolidated Standards of Reporting Trials. Participants will be randomly assigned (1:1) to PNF or CPT group and twelve weekly sessions will be carried out for three months. To assess primary outcome measures are knee pain severity (Numeric Rating Scale) and physical functioning (The Western Ontario and McMaster Universities questionnaire). The outcomes will be performed at baseline, 12th session (6 weeks), 24th session (12 weeks) and three-month follow-up. Intention-to-treat will be performed. Results: A PNF protocol was developed for KOA, consisting of seven illustrated exercises. Biomechanical objectives, observations, positions of individuals and therapists, load progression, PNF principles, procedures and techniques have been described. Conclusion: The detailed elaboration of a physical therapy treatment protocol based on the PNF-concept allows a treatment approach based on the principles of learning and motor control, favoring the mitigating and improving physical functioning and quality of life of the individuals with KOA.

The Effect of Maintenance Treatment with Erdosteine on Exacerbation Treatment and Health Status in Patients with COPD: A Post-Hoc Analysis of the RESTORE Dataset.

PurposeTo explore the effect of erdosteine on COPD exacerbations, health-related quality of life (HRQoL), and subjectively assessed COPD severity.Patients and methodsThis post-hoc analysis of the RESTORE study included participants with COPD and spirometrically moderate (GOLD 2; post-bronchodilator forced expiratory volume in 1 second [FEV1] 50‒79% predicted; n = 254), or severe airflow limitation (GOLD 3; post-bronchodilator FEV1 30‒49% predicted; n = 191) who received erdosteine 300 mg twice daily or placebo added to usual maintenance therapy for 12 months. Antibiotic and oral corticosteroid use was determined together with patient-reported HRQoL (St George’s Respiratory Questionnaire, SGRQ). Patient and physician subjective COPD severity scores (scale 0‒4) were rated at baseline, 6 and 12 months. Data were analyzed using descriptive statistics for exacerbation severity, COPD severity, and treatment group. Comparisons between treatment groups used Student’s t-tests or ANCOVA as appropriate.ResultsAmong GOLD 2 patients, 43 of 126 erdosteine-treated patients exacerbated (7 moderate-to-severe exacerbations), compared to 62 of 128 placebo-treated patients (14 moderate-to-severe exacerbations). Among those with moderate-to-severe exacerbations, erdosteine-treated patients had a shorter mean duration of corticosteroid treatment (11.4 days vs 13.3 days for placebo, P = 0.043), and fewer patients required antibiotic treatment with/without oral corticosteroids (71.4% vs 85.8% for placebo, P < 0.001). Erdosteine-treated GOLD 2 patients who exacerbated showed significant improvements from baseline in SGRQ total scores and subjective disease severity scores (patient- and physician-rated), compared with placebo-treated patients regardless of exacerbation severity. Among GOLD 3 patients, there were no significant differences between treatment groups on any of these measures.ConclusionAdding erdosteine to the usual maintenance therapy of COPD patients with moderate airflow limitation reduced the number of exacerbations, the duration of treatment with corticosteroids and the episodes requiring treatment with antibiotics. Additionally, treatment with erdosteine improved HRQoL and patient-reported disease severity.

Stratified exercise therapy does not improve outcomes compared with usual exercise therapy in people with knee osteoarthritis (OCTOPuS study): a cluster randomised trial.

In people with knee osteoarthritis, how much more effective is stratified exercise therapy that distinguishes three subgroups (high muscle strength subgroup, low muscle strength subgroup, obesity subgroup) in reducing knee pain and improving physical function than usual exercise therapy? Pragmatic cluster randomised controlled trial in a primary care setting. A total of 335people with knee osteoarthritis: 153 in an experimental arm and 182 in a control arm. Physiotherapy practices were randomised into an experimental arm providing stratified exercise therapy (supplemented by a dietary intervention from a dietician for the obesity subgroup) or a control arm providing usual, non-stratified exercise therapy. Primary outcomes were knee pain severity (numerical rating scale for pain, 0 to 10) and physical function (Knee Injury and Osteoarthritis Outcome Score subscale activities of daily living, 0 to 100). Measurements were performed at baseline, 3 months (primary endpoint) and 6 and 12 months (follow-up). Intention-to-treat, multilevel, regression analysis was performed. Negligible differences were found between the experimental and control groups in knee pain (mean adjusted difference 0.2, 95% CI -0.4 to 0.7) and physical function (-0.8, 95% CI -4.3 to 2.6) at 3 months. Similar effects between groups were also found for each subgroup separately, as well as at other time points and for nearly all secondary outcome measures. This pragmatic trial demonstrated no added value regarding clinical outcomes of the model of stratified exercise therapy compared with usual exercise therapy. This could be attributed to the experimental arm therapists facing difficulty in effectively applying the model (especially in the obesity subgroup) and to elements of stratified exercise therapy possibly being applied in the control arm. Netherlands National Trial Register NL7463.

Empagliflozin for Heart Failure With Preserved Left Ventricular Ejection Fraction With and Without Diabetes.

Background:Empagliflozin improves outcomes in patients with heart failure with a preserved ejection fraction, but whether the effects are consistent in patients with and without diabetes remains to be elucidated.Methods:Patients with class II through IV heart failure and a left ventricular ejection fraction >40% were randomized to receive empagliflozin 10 mg or placebo in addition to usual therapy. We undertook a prespecified analysis comparing the effects of empagliflozin versus placebo in patients with and without diabetes.Results:Of the 5988 patients enrolled, 2938 (49%) had diabetes. The risk of the primary outcome (first hospitalization for heart failure or cardiovascular death), total hospitalizations for heart failure, and estimated glomerular filtration rate decline was higher in patients with diabetes. Empagliflozin reduced the rate of the primary outcome irrespective of diabetes status (hazard ratio, 0.79 [95% CI, 0.67, 0.94] for patients with diabetes versus hazard ratio, 0.78 [95% CI, 0.64, 0.95] in patients without diabetes; Pinteraction=0.92). The effect of empagliflozin to reduce total hospitalizations for heart failure was also consistent in patients with and without diabetes. The effect of empagliflozin to attenuate estimated glomerular filtration rate decline during double-blind treatment was also present in patients with and without diabetes, although more pronounced in patients with diabetes (1.77 in diabetes versus 0.98 mL/min/1.73m2 in patients without diabetes; Pinteraction=0.01). Across these 3 end points, the effect of empagliflozin did not differ in patients with prediabetes or normoglycemia (33% and 18% of the patient population, respectively). When investigated as a continuous variable, baseline hemoglobin A1c did not modify the effects on the primary outcome (Pinteraction=0.26). There was no increased risk of hypoglycemic events in either subgroup as compared with placebo.Conclusions:In patients with heart failure and a preserved ejection fraction enrolled in the EMPEROR-Preserved (Empagliflozin Outcome Trial in Patients With Chronic Heart Failure With Preserved Ejection Fraction), empagliflozin significantly reduced the risk of heart failure outcomes irrespective of diabetes status at baseline.Registration:URL: https://www.clinicaltrials.gov; Unique identifier: NCT03057951.

Unpacking the black box of voice therapy: A clinical application and revision of the Motor Learning Classification Framework (MLCF)

Purpose: Voice therapy is a complex behavioural intervention. Understanding its components is integral for continued advancement of voice therapy research, translation of evidence into the clinical setting and improved client care. The Motor Learning Classification Framework (MLCF) offers an excellent opportunity for increasing such knowledge, specifically in relation to identifying variables that affect motor learning (ML), an important mechanism hypothesised to bring about voice change during voice therapy. The MLCF has shown promising results in identifying speech-language pathologists’ (SLPs) use of ML variables during experimentally controlled voice therapy contexts. The purpose of this study was to test the feasibility of applying the framework in the clinical context of everyday voice therapy practice. Method: Data consisted of two video-recorded voice therapy sessions representing usual voice therapy care. Classification of ML variables used by SLPs during the recorded sessions was attempted based on the MLCF. Result: Several problematic features of the framework were identified. Based on deliberations between the authors of the current paper, the MLCF was revised using an iterative process. This resulted in the construction of an updated version of the framework (MLCF-V2). The MLCF-V2 organises ML strategies into two broad categories: directly observable behaviours and learning processes. The framework incorporates greater consideration of theory and empirical evidence supporting motivational, attentional focus and subjective error estimation influences on ML. Several examples of each ML variable are included as well as an attempt to provide clearer classification instruction. Conclusion: It is anticipated that the MLCF-V2 will provide a more useful and reliable classification for use in future investigations of SLPs’ use of ML variables during usual voice therapy practice.

Patients’ and clinicians’ experiences with stratified exercise therapy in knee osteoarthritis: a qualitative study

BackgroundWe have developed a model of stratified exercise therapy that distinguishes three knee osteoarthritis (OA) subgroups (‘high muscle strength subgroup’, ‘low muscle strength subgroup’, ‘obesity subgroup’), which are provided subgroup-specific exercise therapy (supplemented by a dietary intervention for the ‘obesity subgroup’). In a large clinical trial, this intervention was found to be no more effective than usual exercise therapy. The present qualitative study aimed to explore experiences from users of this intervention, in order to identify possible improvements.MethodsQualitative research design embedded within a cluster randomized controlled trial in a primary care setting. A random sample from the experimental arm (i.e., 15 patients, 11 physiotherapists and 5 dieticians) was interviewed on their experiences with receiving or applying the intervention. Qualitative data from these semi-structured interviews were thematically analysed.ResultsWe identified four themes: one theme regarding the positive experiences with the intervention and three themes regarding perceived barriers. Although users from all 3 perspectives (patients, physiotherapists and dieticians) generally perceived the intervention as having added value, we also identified several barriers, especially for the ‘obesity subgroup’. In this ‘obesity subgroup’, physiotherapists perceived obesity as difficult to address, dieticians reported that more consultations are needed to reach sustainable weight loss and both physiotherapists and dieticians reported a lack of interprofessional collaboration. In the ‘high muscle strength subgroup’, the low number of supervised sessions was perceived as a barrier by some patients and physiotherapists, but as a facilitator by others. A final theme addressed barriers to knee OA treatment in general, with lack of motivation as the most prominent of these.ConclusionOur qualitative study revealed a number of barriers to effective application of the stratified exercise therapy, especially for the ‘obesity subgroup’. Based on these barriers, the intervention and its implementation could possibly be improved. Moreover, these barriers are likely to account at least partly for the lack of superiority over usual exercise therapy.Trial registrationThe Netherlands National Trial Register (NTR): NL7463 (date of registration: 8 January 2019).

Prescription-grade crystalline glucosamine sulfate as an add-on therapy to conventional treatments in erosive osteoarthritis of the hand: results from a 6-month observational retrospective study

ObjectiveTo evaluate the efficacy of prescription-grade Crystalline Glucosamine Sulfate (pCGS) as an add-on treatment to conventional therapy, compared to usual therapy alone, in patients with erosive osteoarthritis of the hand (EHOA).MethodsThis 6-month retrospective case–control study included patients with concomitant knee osteoarthritis and symptomatic EHOA. Participants were stratified into two groups based on whether or not pCGS (1500 mg/day) was added to the conventional therapy (education and training in ergonomic principles, exercise and use on-demand of symptomatic drugs) for hand osteoarthritis. Patients were evaluated at baseline, after 3 and 6 months. Primary outcomes were the change from baseline to month 6 in Visual Analogue Scale (VAS) hand pain and in Functional Index for Hand Osteoarthritis (FIHOA) score. A set of secondary parameters was also evaluated.Results123 patients were included as follows: 67 treated with pCGS in addition to conventional therapy (pCGS Group) and 56 with conventional therapy alone (Control Group). After 6 months a significant difference in VAS and in FIHOA score (p < 0.01 and p < 0.001, respectively) was observed in favor of pCGS Group. Similar results were found for morning stiffness duration (p < 0.05), health assessment questionnaire (p < 0.01) and physical and mental component score of 36-item short form (p < 0.05 and p < 0.001, respectively). A significant reduction of symptomatic drug consumption at 3 and 6 months was reported in the pCGS Group (p < 0.001). No serious adverse event was recorded in both groups.ConclusionsDespite all the limitations inherent to an observational study, our results suggest the potential effectiveness of pCGS, when used in combination with conventional therapy in EHOA. Further randomized placebo-controlled trials are needed to confirm these positive findings.Trial RegistrationClinicalTrials.gov, http://www.clinicaltrials.gov, date of registration: February 2, 2022, NCT05237596. The present trial was retrospectively registered.

Effects of Dynamic Sitting Exercise with Delayed Visual Feedback in the Early Post-Stroke Phase: A Pilot Double-Blinded Randomized Controlled Trial.

Sitting ability in the early post-stroke phase affects functional balance ability and other prognoses. We investigated whether dynamic sitting exercise with delayed visual feedback in the mediolateral and anteroposterior directions affected postural control in the early post-stroke phase. In this pilot randomized controlled trial, 27 hemiparetic stroke patients were randomized to experimental (n = 13) and control (n = 14) groups. Dynamic sitting exercise (30 times/day, 5 days/week) in the mediolateral and anteroposterior directions, with 500-ms-delayed (experimental group) or real-time (control group) visual feedback on a computer, was added to usual physical therapy. We evaluated the postural assessment scale for stroke (PASS), static and dynamic sitting balance tasks, the five-times sit-to-stand test, trunk impairment scale, functional ambulation category, and functional independence measure–motor items. In intention-to-treat analysis, the experimental group demonstrated a significant intervention effect on the PASS score (p < 0.05). The mean percentage of body weight on the moving side in the lateral sitting task and the number of successes in the five-times sit-to-stand test were significantly higher in the experimental group than those in the control group (p < 0.05). Thus, the proposed exercise improves postural control, dynamic sitting balance, and sit-to-stand ability in early post-stroke patients.

Rescue packs for COPD: problem or panacea?

Exacerbations of COPD require additional acute treatment. Beverley Bostock discusses the rationale for offering rescue packs as part of patient self-management For many people who have been diagnosed with COPD, there is a risk of experiencing an exacerbation of their symptoms which will require additional acute treatment to supplement their usual therapy. Exacerbations of COPD are associated with reduced quality of life, loss of lung function and a higher risk of dying. People living with COPD may be advised to keep a ‘rescue pack’ of oral corticosteroids and antibiotics to start if they develop symptoms of an exacerbation. Patient education should include advice on how to recognise exacerbations and when and how to treat them, with information about the effects and side-effects of any medication.

Physical Therapist Training Challenges for an Embedded Pragmatic Trial: Fibromyalgia TENS in Physical Therapy Study

Transcutaneous electrical nerve stimulation (TENS), a non-pharmacological treatment, is safe and effective for movement-evoked pain in individuals with Fibromyalgia (FM). The purpose of our NIH-funded pragmatic clinical trial, Fibromyalgia TENS in PT Study (FM-TIPS), assesses feasibility and effectiveness of adding TENS to usual physical therapy (PT) treatment in individuals with FM. We partnered with 33 sites in 6 healthcare systems, training 150+ Midwest clinicians. Outpatient PT clinic sites are cluster randomized to a TENS or a No-TENS intervention, stratified by system and clinic size. We will recruit ∼600 patients with a primary or secondary diagnosis of FM. We developed comprehensive communication and training procedures to ensure study fidelity and adapted over the course of the study to enhance learning. We will provide an overview and the impact of the pandemic on these procedures. Representatives for each healthcare system, each clinic and the study team were identified for communication and training. Training included initial study introduction, human subjects protection, and study procedures. We used a hybrid approach with written, video, onsite, and virtual instruction. All materials and procedures, for clinician and patient-facing materials, website, videos, equipment use (iPad for screening, TENS units), and clinician procedures for PT visits 1-3, were piloted and reviewed by clinicians from each healthcare system. Additional communication and feedback include weekly enrollment reports, monthly newsletters, relationship building with clinicians, enrollment incentives, and continuing education webinars. The pandemic required creative and evolving solutions to maintain study involvement and recruitment. Barriers for enrollment are screening PT Visit 1, comfort level of clinicians for PT Visits 2 and 3, delays/alterations in training and planning, clinician demands, clinicians/patient illness, and staff shortages in the clinics. Current enrollment, study training and implementation has been affected by COVID-19 and we developed creative methods for training and implementation for FM-TIPS. Grant support from Research supported in this USASP Abstract was supported by National Institutes of Health Heal Initiative Grant UG3/UH3 AR076387-01 and UL1TR002537.

Efficacy of Dual Task Training versus Conventional Therapy on Hand Function and Visual Perception Ability in Children with Cerebral Palsy

This pilot study aimed to assess the effect of dual-task training, compared to conventional therapy on the hand functional ability and visual perception in children with cerebral palsy. It was a pretest-posttest control group design, conducted for 4 weeks with ten children ranged between 5-13 years old. Participants were randomly allocated either to the experimental group (dual-task training) or the control group (conventional treatment). The experimental group received the usual physical therapy session and dual-task training sessions 3 sessions/week for 4 weeks. The control group received only the conventional physical therapy 3 sessions/week for 4 weeks. Fine and gross motor hand function were assessed by the Jebsen-Taylor hand function test and the Motor-free Visual Perception Test 3rd edition was used to assess visual perceptual ability before intervention and at 4 weeks after intervention. Only the experimental group showed an improvement in hand function (p<0.05) and no significant differences were observed between the groups (p>0.05). Statistically significant changes were noticed in three of the five subscales of the visual perception in the experimental group (p<0.05) with the experimental group superior to the control group. These findings suggest that dual-task training conducted with a precise goal to achieve (problem-solving) and including cognitive tasks is beneficial in means of improving hand function and visual perceptional ability of children with hemiplegic cerebral palsy with a short-term effect. However, further studies on children with cerebral palsy with a similar approach are warranted.

Occupational therapy for cognitive impairment in stroke patients.

Occupational therapy for cognitive impairment in stroke patients.