Change In Self-reported Physical Function Research Articles

Study design and methods for the pilot study of muscadine grape extract supplement to improve fatigue among older adult cancer survivors (FOCUS) trial

IntroductionFatigue is a prevalent symptom among both cancer survivors and older adults. Negative consequences of fatigue include increased sedentary behavior, decreased physical activity and function, and lower quality of life. Few pharmacologic interventions improve fatigue. Our preclinical and clinical data show promising effects of a muscadine grape extract supplement (MGES) on oxidative stress, mitochondrial bioenergetics, the microbiome, and the symptom of fatigue. This pilot study seeks to translate these observations to cancer survivorship by testing the preliminary effect of MGE supplementation on older adult cancer survivors with self-reported fatigue. Materials and MethodsWe designed a double-blinded placebo-controlled pilot study to evaluate preliminary efficacy of MGE supplementation versus placebo on fatigue among older adult cancer survivors (aged ≥65 years) who report baseline fatigue. Sixty-four participants will be enrolled and randomized 1:1 to twice daily MGES (four tablets twice daily) versus placebo for 12 weeks. The primary outcome is change in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue score from baseline to 12 weeks. Secondary outcomes are change in self-reported physical function, physical fitness (6-min walk test), self-reported physical activity, global quality of life (QOL), and the Fried frailty index. Correlative biomarker assays will assess changes in 8-hydroxy-2 deoxyguanosine, peripheral blood mitochondrial function, inflammatory markers, and the gut microbiome. DiscussionThis pilot study builds on preclinical and clinical observations to estimate effects of MGE supplementation on fatigue, physical function, QOL, and biologic correlates in older adult cancer survivors.Trial registration #: CT.govNCT04495751; IND 152908.

Swiss Experience in Therapy With Dual Bronchodilation in Chronic Obstructive Pulmonary Disease in Relation to Self-Reported Physical Functionality.

BackgroundMedical therapy in chronic obstructive pulmonary disease (COPD) usually includes inhaled dual bronchodilation leading not only to an improvement in symptoms but also to an increase in physical performance. However, it remains unknown whether responder rates to dual bronchodilation differ between the Swiss subgroup in comparison to participants of other European countries.MethodsThe non-interventional OTIVACTO trial investigated changes in self-reported physical functioning in COPD patients treated with tiotropium/olodaterol 5/5 µg fixed dose combination for 6 weeks. The cut-off between responder and non-responder was defined as a minimum increase of 10 points using the 10-question physical functioning questionnaire (PF-10) score. We searched for patterns of the responder patient group and compared the results of the whole dataset with the subgroup of Swiss participants.ResultsCompared to the total cohort (n = 7,608), the Swiss participants (n = 94) were predominantly > 65 years of age and had significantly more comorbidities. There were no significant differences according to COPD stage, smoking status, exacerbation rate in the last 12 months and modified Medical Research Council questionnaire (mMRC) score between the total cohort and the Swiss collective. There were no significant differences between the Swiss subgroup and the total cohort with regard to response to the medication in the PF-10 score. In the intragroup comparison, patients with high mMRC score showed significantly higher values in the PF-10 in both groups. The number of exacerbations had no influence on the PF-10 score in the Swiss subgroup but in the total cohort.ConclusionIn terms of age and number of comorbidities, significant differences were found between the overall patient population and the Swiss participants, having no influence on the success of the medication. The patients suffering from increased dyspnea benefited most from tiotropium/olodaterol treatment (Clinical Trials Registry NCT02720757).

Improvement In Self-Reported Physical Functioning With Tiotropium/Olodaterol In Central And Eastern European COPD Patients.

BackgroundReduced physical activity is associated with increased morbidity and mortality in patients with COPD. Studies suggest that treatment with the long-acting muscarinic antagonist tiotropium and the long-acting β2-agonist olodaterol increases exercise capacity. This study assessed the effects of a fixed-dose combination (FDC) of tiotropium/olodaterol (delivered via Respimat®) on physical functioning in patients with stable COPD in a “real-world setting”.MethodsAn international, open-label, single-arm, non-interventional study conducted in nine countries measuring changes in self-reported physical functioning in COPD patients treated with tiotropium/olodaterol 5/5 μg FDC for approximately 6 weeks. The primary endpoint was therapeutic success, defined as a minimum 10-point increase in the 10-question Physical Functioning Questionnaire (PF-10) score. Secondary endpoints included absolute change in PF-10 from Visit 1 to Visit 2, patient general condition (measured by Physician’s Global Evaluation score) and patient satisfaction with the treatment and device (assessed by Patient Satisfaction Questionnaire at the end of the study period).ResultsTherapeutic success was observed in 67.8% of 7218 patients (95% CI 66.7, 68.8) in the final analysis set after approximately 6 weeks of treatment with tiotropium/olodaterol. Mean change in PF-10 score between Visit 1 and Visit 2 was 16.6 points (95% CI 16.2, 17.0). Therapeutic success was 64.3% (95% CI 63.0–65.6%) in patients with infrequent (≤1) and 76.1% (95% CI 74.3–77.9%) in patients with frequent (≥2) exacerbations (p<0.0001). Patient general condition improved as indicated by an improvement in Physician’s Global Evaluation scores between visits. Most patients were very satisfied or satisfied with tiotropium/olodaterol treatment in general (81%), reported inhalation satisfaction (85%), and satisfactory handling of the device (84%). 1.3% of patients reported an investigator-defined drug-related adverse event.ConclusionTreatment with tiotropium/olodaterol led to an improvement in self-reported physical functioning in patients with COPD.

The Effects of Lower Extremity Strengthening Delivered in the Workplace on Physical Function and Work-Related Outcomes Among Desk-Based Workers: A Randomized Controlled Trial.

The aim of this study was to assess the effectiveness of a workplace leg-strengthening program on self-reported function, physical capacity, and work-related outcomes among desk-based workers. Forty-three desk-based workers were randomized to a 12-week exercise program or no exercise control. The primary outcome was change in self-reported physical function on the Lower Extremity Functional Scale (LEFS) from baseline to follow-up. Secondary outcomes were physical capacity (mobility, strength), self-reported outcomes (pain, depressive symptoms), and work-related outcomes (resilience, work ability). The exercise group showed greater improvements in LEFS and mobility. No significant between-group differences existed in knee strength or remaining self-reported and work-related outcomes. Workplace implemented leg-strengthening exercises are effective at improving self-reported and physical health outcomes of desk-based workers. Moving forward, occupational exercise interventions may be essential to enhance worker longevity among the aging, sedentary workforce.

A randomized trial of a motivational interviewing intervention to increase lifestyle physical activity and improve self-reported function in adults with arthritis.

Arthritis is a leading cause of chronic pain and functional limitations. Exercise is beneficial for improving strength and function and decreasing pain. We evaluated the effect of a motivational interviewing-based lifestyle physical activity intervention on self-reported physical function in adults with knee osteoarthritis (KOA) or rheumatoid arthritis (RA). Participants were randomized to intervention or control. Control participants received a brief physician recommendation to increase physical activity to meet national guidelines. Intervention participants received the same brief baseline physician recommendation in addition to motivational interviewing sessions at baseline, 3, 6, and 12 months. These sessions focused on facilitating individualized lifestyle physical activity goal setting. The primary outcome was change in self-reported physical function. Secondary outcomes were self-reported pain and accelerometer-measured physical activity. Self-reported KOA outcomes were evaluated by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for KOA (WOMAC scores range from 0 to 68 for function and 0 to 20 for pain) and the Health Assessment Questionnaire (HAQ) for RA. Outcomes were measured at baseline, 3, 6, 12, and 24 months. Multiple regression accounting for repeated measures was used to evaluate the overall intervention effect on outcomes controlling for baseline values. Participants included 155 adults with KOA (76 intervention and 79 control) and 185 adults with RA (93 intervention and 92 control). Among KOA participants, WOMAC physical function improvement was greater in the intervention group compared to the control group [difference = 2.21 (95% CI: 0.01, 4.41)]. WOMAC pain improvement was greater in the intervention group compared to the control group [difference = 0.70 (95% CI: -0.004, 1.41)]. There were no significant changes in physical activity. Among RA participants, no significant intervention effects were found. Participants with KOA receiving the lifestyle intervention experienced modest improvement in self-reported function and a trend toward improved pain compared to controls. There was no intervention effect for RA participants. Further refinement of this intervention is needed for more robust improvement in function, pain, and physical activity.

Protocol for a single-centre, parallel-arm, randomised controlled superiority trial evaluating the effects of transcatheter arterial embolisation of abnormal knee neovasculature on pain, function and quality of life in people with knee osteoarthritis

IntroductionSymptomatic knee osteoarthritis (OA) is common. Advanced knee OA is successfully treated with joint replacement surgery, but effectively managing mild to moderate knee OA can be difficult. Angiogenesis increases with...

Decline in physical functioning in first 2 years after breast cancer diagnosis predicts 10-year survival in older women

Breast cancer patients often experience a decline in physical functioning following cancer diagnosis. Although most patients recover after treatment, some patients do not. These changes may be magnified in older women with comorbid conditions and could impact survival outcomes. We used longitudinal data from a prospective cohort study of women 65+ years of age, recruited shortly after diagnosis of early stage breast cancer, to examine changes in self-reported physical functioning measured with the Physical Function Index (PF-10) of the Medical Outcomes Study Short Form-36. Outcomes were constructed for small (0.2 SD), medium (0.5 SD), and large (0.8 SD) declines in the PF-10 measurement over two intervals: (1) 3 to 15 months following cancer diagnosis, encompassing treatment and early recovery, and (2) 3 to 27 months following cancer diagnosis, in order to detect sustained recovery versus persistent decline. Cox-proportional hazards regression was used to examine association between survival and decline in PF-10 scores. A large (>0.8 SD) decline in PF-10 scores from 3 to 27 months predicted shorter 10-year survival (hazard ratio = 1.34, 95 % confidence interval 1.1-1.6). Persistent decline at 27 months was associated with less education, higher baseline PF-10, increased comorbidity, and higher body mass index. Older women with breast cancer who experience a large and persistent decline in PF-10 are at increased mortality risk. Future research should examine the value of clinical assessment of physical function as a marker for mortality and test interventions to prevent decline in physical function to improve post-treatment survival outcomes. Many breast cancer survivors experience a decline in physical functioning in the year following their cancer diagnosis. While the majority of patients recover in the year after treatment is completed, individuals who experience a persistent decline in physical functioning without recovery are at risk of functional decline and early mortality. Our results highlight the importance of assessing functional status to identify those at risk for functional decline, and suggest a potential role for early intervention in these individuals.

Decline in physical functioning in first 2 years after breast cancer diagnosis to predict survival in older women.

e11003 Background: Breast cancer patients often experience a decline in physical functioning following cancer diagnosis. Although most patients recover after treatment, some patients do not. These changes may be magnified in older women with comorbid conditions and could impact survival outcomes. Methods: We used longitudinal data from a prospective cohort study of women 65+ years of age, recruited shortly after diagnosis of early stage breast cancer, to examine changes in self-reported physical functioning measured with the Physical Function Index (PF-10) of the Medical Outcomes Study Short Form-36 (SF-36). Outcomes were constructed for small (0.2 SD), medium (0.5 SD), and large (0.8 SD) decline in the PF-10 measurement over two intervals 1) 3 to 15 months following cancer diagnosis, encompassing treatment and early recovery, and 2) 3 to 27 months following cancer diagnosis, in order to detect sustained recovery versus persistent decline. Cox-proportional hazards regression was used to examine association between survival and decline in PF-10 scores. Results: A large (&gt; 0.8 SD) decline in PF-10 scores from 3 to 27 months predicted shorter 10 year survival (HR=1.37, 95% CI 1.07-1.74). Persistent decline at 27 months was associated with less education, higher baseline PF-10, increased comorbidity, and lack of exercise at baseline. Conclusions: Older women with breast cancer who experience a large and persistent decline in PF-10 are at increased mortality risk. Future research should examine the value of clinical assessment of physical function as a marker for mortality and test interventions to prevent decline in physical function to improve post-treatment survival outcomes.

Impact of Cardiac Rehabilitation on the Ability of Elderly Cardiac Patients to Perform Common Household Tasks

The consequences of coronary artery disease may significantly limit functional independence of elderly patients. While cardiac rehabilitation (CR) exercise programs have been shown to improve health outcomes such as exercise capacity, little is known about the impact such programs have on daily functional abilities. The purpose of this study was to determine the impact of CR on ability of elderly patients to perform common household tasks. Twenty-two postmyocardial infarction patients (10 women and 12 men; age 75 ± 6.3 years) were studied. Patients were tested pre-CR and post-CR. Physical function (PF) was assessed using the Continuous Scale Physical Function Performance 10 test battery, which includes 10 everyday tasks that progress from easy (personal tasks) to moderate (household tasks) to difficult (mobility tasks). Self-reported PF was measured using the Medical Outcomes Survey Short Form 36-Item questionnaire. Post-CR, the global Continuous Scale Physical Function Performance 10 score increased significantly (57 + 12 vs 50 ± 16; P = .002). Prior to CR, 7 patients scored at or above the threshold for independent living, as defined by a global score of 57 or more units; however, post-CR, 12 patients scored above the threshold. There was no change in self-reported PF, post-CR. A 20-session exercise-based CR program significantly enhanced elderly patient ability to live independently by improving ability to perform common household tasks.

Performance measures were necessary to obtain a complete picture of osteoarthritic patients

Objectives Self-report questionnaires and performance measures represent two methods for assessing physical function. A recurring theme is that self-report measures are superior to performance measures. This study investigated the association between three performance test outcomes of four activities (pain, exertion, and time or distance; for self-paced walk, stair test, timed up-and-go, 6-minute walk) with self-reports of physical function (WOMAC Physical Function subscale and LEFS) and the association between the change scores of the performance tests and those of the self-report measures. Study Design and Setting Performance and self-report measures were administered three times (presurgery and at ∼1 week and ∼8 weeks post arthroplasty) to 85 patients who underwent total hip or knee arthroplasty. Components of the performance tests were pooled within each domain across the four measures. Multiple regression analyses were applied. Independent variables were performance tests components; dependent variables were self-report measures. Standardized regression coefficients described the cross-sectional and longitudinal associations. Results Pain was the principal determinant of WOMAC Physical Function subscale scores. Pain, exertion, and time or distance were strongly associated with the LEFS at the first, second, and third assessments, respectively. Change in pain was most strongly associated with change in self-reported physical function. Conclusion Our findings caution against the isolated use of self-report assessments of physical function.

Changes in lean body mass and total body weight are weakly associated with physical functioning in patients with HIV infection.

For clinicians managing weight loss in patients with HIV, it would be useful to understand how changes in lean body mass (LBM) effect physical functioning, and whether LBM is more strongly related to physical functioning than total body weight (TBW). To determine the relationship of changes in LBM and changes in total body weight (TBW) to changes in self-reported physical functioning in men and women with HIV infection. Study design was longitudinal analysis of 1474 patient-intervals (each interval was approximately 6 months long) in 486 persons. Patients were participants in Nutrition for Healthy Living, a cohort study of HIV positive persons in Massachusetts and Rhode Island. The main outcome measure was change in self-reported physical functioning. Of the 1,474 intervals, 1,165 were contributed by men and 309 by women. The mean CD4 count for the 1,474 intervals was 383 cells/ micro L. In men, 5 kg changes in LBM and TBW were associated with 2.2 (95% confidence interval, 0.9, 3.4, P= 0.001) and 2.6 (95% confidence interval, 1.3, 3.9, P= 0.0002) point changes in physical functioning (on a 100-point scale), respectively, after adjusting for covariates. The relationships of changes in LBM and TBW to changes in physical functioning were linear. In women, there were no significant relationships between changes in LBM or TBW to changes in physical functioning. In this longitudinal analysis of relatively healthy persons with HIV infection, changes in LBM and TBW were significantly related to changes in physical functioning in men, but the magnitude of the relationship was small. In women, changes in LBM and TBW were not related to changes in physical functioning. Our data suggest that it is not necessary to measure body composition (lean and fat compartments) to understand the impact of changes in weight on physical functioning - it is sufficient to follow total body weight.

Performance-based and self-reported physical functioning in low-functioning older persons: congruence of change and the impact of depressive symptoms.

This prospective cohort study examines the impact of depressive symptoms on changes in self-reported physical functioning in 574 low-functioning older persons. The data were collected in two waves in 1993 and 1995. Initial levels of depressive symptoms were not predictive for subsequent change in self-reported physical functioning. Changes in self-reported physical functioning were only moderately associated with changes in performance-based physical functioning. The strongest congruence of measured change between self-reported and performance-based physical functioning was found in older persons with increased depressive symptoms. The results suggest that preventing an increase in depressive symptoms may help prevent further deterioration in physical functioning in poorly functioning older persons.

Analysis of Change in Self-reported Physical Function among Older Persons in Four Population Studies

Change in self-reported physical function was examined using baseline and 5 years of follow-up data between 1982 and 1991 from the four Established Populations for Epidemiologic Studies of the Elderly studies. In East Boston, Massachusetts (n = 3,809), Iowa and Washington Counties, Iowa (n = 3,673), New Haven, Connecticut (n = 2,812), and North Carolina (n = 4,163), noninstitutionalized persons aged 65 years and older were asked a series of questions to assess their physical function: a modified Katz Activities of Daily Living (ADL) scale, three items from the Rosow-Breslau Functional Health Scale, and questions on physical performance, adapted from Nagi, as well as information on demographic, social, and health characteristics. Longitudinal statistical analyses (random effects and Markov transition models) were used to evaluate improvement, stability, and deterioration in functional ability at both an individual and a population level over multiple years of data. The average decline in physical function associated with age was found to be greater than previous cross-sectional studies have suggested, and the rate of decline increased with increasing age. Considerable individual variation was evident. Although many people experienced declines, a smaller but substantial portion experienced recovery. Women reported a greater rate of decline in physical function and were less likely to recover from disability.