Considerations for assessing physical function and physical activity in clinical trials during the COVID-19 pandemic

Background and objective: Managing the decrease in physical function in the elderly is a major task in aging societies globally. Here, we aimed to compare the physical function and metabolic syndrome (MetS) risk factors according to levels of physical activity (PA). Material and methods: We measured PA in 77 elderly Korean men (74.21 ± 6.26 years old) with an accelerometer and recorded body composition, physical function, and MetS-related risk factors. Participants were divided into three groups based on daily moderate-vigorous physical activity (MVPA): low (under 60 min), middle (60-120 min), and high (over 120 min). The groups were compared using a one-way analysis of variance and the Scheffe post hoc test. Odds ratios (OR) were calculated by logistic regression analysis. Results: Signiﬁcant differences were found between the groups for sedentary behavior time (P < 0.001), light PA (P < 0.05), moderate PA (P < 0.001), vigorous PA (P < 0.05), and total energy expenditure (P < 0.001). The high PA group showed a signiﬁcantly lower percentage of body fat and fat mass and higher muscle mass than did the low and middle PA groups (P < 0.05). The 6-min walk test was signiﬁcantly better in the high PA group than in the low and middle PA groups (P < 0.05). Grip strength and the Berg balance scale were also signiﬁcantly better in the high PA group (P < 0.05). Bone mineral density (BMD) and high-density lipoprotein cholesterol (HDL-C) were signiﬁcantly higher in the high PA group than in the low PA group (P < 0.05). Systolic blood pressure (SBP) was signiﬁcantly higher in the middle PA group than in the low PA group (P < 0.05). Participants with more than three MetS criteria showed an OR of 0.09 (95% conﬁdence interval 0.01-0.82) in the high PA group as compared with the low PA group (P < 0.05). Conclusions: Moderate-vigorous physical activity of more than 120 min daily showed better physical function and lower OR of MetS than did lower MVPA levels in elderly Korean men.

Download Full-text

Does Hemodialysis Affect Upper Extremity Functional Capacity, Physical Activity and Physical Function of Patients?

Case Medical Research ◽

10.31525/ct1-nct04099953 ◽

2019 ◽

Author(s):

Keyword(s):

Physical Activity ◽

Physical Function ◽

Upper Extremity ◽

Functional Capacity

Download Full-text

Women’s Health Initiative Strong and Healthy Pragmatic Physical Activity Intervention Trial for Cardiovascular Disease Prevention: Design and Baseline Characteristics

The Journals of Gerontology Series A ◽

10.1093/gerona/glaa325 ◽

2021 ◽

Author(s):

Marcia L Stefanick ◽

Abby C King ◽

Sally Mackey ◽

Lesley F Tinker ◽

Mark A Hlatky ◽

...

Keyword(s):

Physical Activity ◽

Cardiovascular Disease ◽

Physical Function ◽

Women’S Health ◽

Women's Health ◽

Physical Activity Intervention ◽

Women's Health Initiative ◽

Women’S Health Initiative ◽

Health Initiative ◽

Race Ethnicity

Abstract Background National guidelines promote physical activity to prevent cardiovascular disease (CVD), yet no randomized controlled trial has tested whether physical activity reduces CVD. Methods The Women’s Health Initiative (WHI) Strong and Healthy (WHISH) pragmatic trial used a randomized consent design to assign women for whom cardiovascular outcomes were available through WHI data collection (N = 18 985) or linkage to the Centers for Medicare and Medicaid Services (N30 346), to a physical activity intervention or “usual activity” comparison, stratified by ages 68–99 years (in tertiles), U.S. geographic region, and outcomes data source. Women assigned to the intervention could “opt out” after receiving initial physical activity materials. Intervention materials applied evidence-based behavioral science principles to promote current national recommendations for older Americans. The intervention was adapted to participant input regarding preferences, resources, barriers, and motivational drivers and was targeted for 3 categories of women at lower, middle, or higher levels of self-reported physical functioning and physical activity. Physical activity was assessed in both arms through annual questionnaires. The primary outcome is major cardiovascular events, specifically myocardial infarction, stroke, or CVD death; primary safety outcomes are hip fracture and non-CVD death. The trial is monitored annually by an independent Data Safety and Monitoring Board. Final analyses will be based on intention to treat in all randomized participants, regardless of intervention engagement. Results The 49 331 randomized participants had a mean baseline age of 79.7 years; 84.3% were White, 9.2% Black, 3.3% Hispanic, 1.9% Asian/Pacific Islander, 0.3% Native American, and 1% were of unknown race/ethnicity. The mean baseline RAND-36 physical function score was 71.6 (± 25.2 SD). There were no differences between Intervention (N = 24 657) and Control (N = 24 674) at baseline for age, race/ethnicity, current smoking (2.5%), use of blood pressure or lipid-lowering medications, body mass index, physical function, physical activity, or prior CVD (10.1%). Conclusion The WHISH trial is rigorously testing whether a physical activity intervention reduces major CV events in a large, diverse cohort of older women. Clinical Trials Registration Number: NCT02425345

Download Full-text

Novel Analytic Approaches to Investigate Minute-Level Actigraphy and Associations With Physical Function

Innovation in Aging ◽

10.1093/geroni/igaa057.630 ◽

2020 ◽

Vol 4 (Supplement_1) ◽

pp. 194-195

Author(s):

Kaiyuan Hua ◽

Sheng Luo ◽

Katherine Hall ◽

Miriam Morey ◽

Harvey Cohen

Keyword(s):

Physical Activity ◽

Data Analysis ◽

Physical Function ◽

Functional Data Analysis ◽

Functional Data ◽

Gait Speed ◽

Community Dwelling ◽

Accelerometer Data ◽

Single Leg Stance ◽

Minute Walk

Abstract Background. Functional decline in conjunction with low levels of physical activity has implications for health risks in older adults. Previous studies have examined the associations between accelerometry-derived activity and physical function, but most of these studies reduced these data into average means of total daily physical activity (e.g., daily step counts). A new method of analysis “functional data analysis” provides more in-depth capability using minute-level accelerometer data. Methods. A secondary analysis of community-dwelling adults ages 30 to 90+ residing in southwest region of North Carolina from the Physical Performance across the Lifespan (PALS) study. PALS assessments were completed in-person at baseline and one-week of accelerometry. Final analysis includes 669 observations at baseline with minute-level accelerometer data from 7:00 to 23:00, after removing non-wear time. A novel scalar-on-function regression analysis was used to explore the associations between baseline physical activity features (minute-by-minute vector magnitude generated from accelerometer) and baseline physical function (gait speed, single leg stance, chair stands, and 6-minute walk test) with control for baseline age, sex, race and body mass index. Results. The functional regressions were significant for specific times of day indicating increased physical activity associated with increased physical function around 8:00, 9:30 and 15:30-17:00 for rapid gait speed; 9:00-10:30 and 15:00-16:30 for normal gait speed; 9:00-10:30 for single leg stance; 9:30-11:30 and 15:00-18:00 for chair stands; 9:00-11:30 and 15:00-18:30 for 6-minute walk. Conclusion. This method of functional data analysis provides news insights into the relationship between minute-by-minute daily activity and health.

Download Full-text

A Physical Activity Intervention Feasibility Study for Kidney Inpatients: A Basic Research Protocol

Canadian Journal of Kidney Health and Disease ◽

10.1177/2054358120987052 ◽

2021 ◽

Vol 8 ◽

pp. 205435812098705

Author(s):

Kathryn Wytsma-Fisher ◽

Stefan Mustata ◽

Theresa Cowan ◽

Manuel Ester ◽

S. Nicole Culos-Reed

Keyword(s):

Quality Of Life ◽

Physical Activity ◽

Physical Function ◽

Kidney Failure ◽

Standard Care ◽

Physical Activity Intervention ◽

Clinical Care ◽

Activity Promotion ◽

Cardiovascular Morbidity And Mortality

Background: Low physical activity levels and poor physical functioning are strongly associated with poor clinical outcomes and mortality in adult kidney failure patients, regardless of treatment modality. Compared with the general population, individuals with chronic kidney disease are physically inactive, have reduced physical abilities and difficulties performing routine daily tasks, lower health-related quality of life, and higher cardiovascular morbidity and mortality. In addition, frail kidney failure patients have higher hospitalization and mortality rates as compared with other kidney failure patients. Evidence suggests that assessment and recommendations for physical activity should be part of standard care for kidney failure patients. Structured exercise can improve physical function and quality of life in frail older adults and may be used specifically for management of frailty in kidney failure. However, research is needed to determine best practices for implementation of physical function measurements and physical activity promotion in standard kidney failure care. Objective: The proposed Move More study will assess the feasibility of a physical activity intervention offered to the kidney failure inpatients in Calgary, Alberta. Specifically, this study is designed to examine the effects of an early physical activity/mobility intervention led by a kinesiologist, and supported by the clinical care team including physiotherapists (PT) and nurse clinicians. Methods: The Move More study is a single-arm pilot intervention examining feasibility and optimal improvement in real-world conditions. Kidney failure inpatients at the Foothills Medical Centre will be recruited to participate. Patients will receive an individualized in-hospital physical activity/mobility intervention. Frailty and physical function will be assessed at baseline and postintervention prior to hospital discharge. The goal is to recruit 24 to 36 patients. Conclusions: Evidence needed to support the inclusion of mobility and physical activity as part of standard care will be gathered, with knowledge gained used to help direct future physical activity programming for kidney failure inpatients.

Download Full-text

Long-Term Dietary and Physical Activity Interventions in the School Setting and Their Effects on BMI in Children Aged 6–12 Years: Meta-Analysis of Randomized Controlled Clinical Trials

Healthcare ◽

10.3390/healthcare9040396 ◽

2021 ◽

Vol 9 (4) ◽

pp. 396

Author(s):

Purificación Cerrato-Carretero ◽

Raúl Roncero-Martín ◽

Juan D. Pedrera-Zamorano ◽

Fidel López-Espuela ◽

Luis M. Puerto-Parejo ◽

...

Keyword(s):

Physical Activity ◽

Clinical Trials ◽

Dietary Habits ◽

Meta Analysis ◽

Controlled Clinical Trials ◽

Randomized Controlled Clinical Trials ◽

Randomized Controlled ◽

School Based ◽

School Based Interventions

Preventive actions and potential obesity interventions for children are mainly researched throughout the school period, either as part of the school curricula or after regular school hours, via interventions mostly lasting less than 12 months. We aimed to perform a meta-analysis on randomized controlled clinical trials to evaluate the evidence of the efficacy of long-term school-based interventions in the management of childhood obesity in terms of BMI from a dietary and physical activity-based approach. Eleven randomized controlled clinical trials were examined using the random effects model, and the results showed that there were no significant effects associated with physical activity + nutrition intervention in school children aged 6–12 years, with a pooled standardized mean difference (SMD) (95% CI) of −0.00 (−0.05, 0.04). No effects were observed after subgroup analysis based on the intervention length. The findings from our study indicate that long-term school-based interventions on physical activity and dietary habits received by children aged 6–12 years seem to have no effect on BMI. However, the promotion of such interventions should not be discouraged, as they promote additional positive health outcomes for other domains of children’s health.

Download Full-text

Feelings of well being in elderly people: Relationship to physical activity and physical function

Archives of Gerontology and Geriatrics ◽

10.1016/j.archger.2008.02.010 ◽

2009 ◽

Vol 48 (3) ◽

pp. 306-312 ◽

Cited By ~ 64

Author(s):

Nuria Garatachea ◽

Olga Molinero ◽

Raquel Martínez-García ◽

Rodrigo Jiménez-Jiménez ◽

Javier González-Gallego ◽

...

Keyword(s):

Physical Activity ◽

Physical Function ◽

Elderly People ◽

Well Being

Download Full-text

Development of an evidence-informed recommendation guide to facilitate physical activity counseling between oncology care providers and patients in Canada

Translational Behavioral Medicine ◽

10.1093/tbm/ibaa127 ◽

2021 ◽

Author(s):

Angela J Fong ◽

Catherine M Sabiston ◽

Michelle B Nadler ◽

Jonathan Sussman ◽

Hugh Langley ◽

...

Keyword(s):

Physical Activity ◽

Cancer Survivors ◽

Physical Function ◽

Sports Medicine ◽

Development Process ◽

Assessment Criteria ◽

Care Providers ◽

Agree Ii ◽

Physical Activity Counseling ◽

Oncology Care

Abstract Decision support aids help reduce decision conflict and are reported as acceptable by patients. Currently, an aid from the American College of Sports Medicine exists to help oncology care providers advise, assess, and refer patients to physical activity (PA). However, some limitations include the lack of specific resources and programs for referral, detailed PA, and physical function assessments and not being designed following an international gold standard (Appraisal of Guidelines for Research and Evaluation [AGREE] II). This study aimed to develop a recommendation guide to facilitate PA counseling by assessing the risk for PA-related adverse events and offering a referral to an appropriate recommendation. Recommendation guide development followed AGREE II, and an AGREE methodologist was consulted. Specifically, a stakeholder group of oncology care providers and cancer survivors were engaged to develop the assessment criteria for comorbidities, PA levels, and physical function. Assessment criteria were developed from published PA interventions, consultations with content experts, and targeted web-based searches for cancer-specific PA programs. Feedback on the recommendation guide was solicited from stakeholders and external reviewers with relevant knowledge and clinical experience. Independent AGREE methodologists appraised the development process. The recommendation guide is a five-page document, including a preamble, assessment criteria for absolute contraindications to PA, comorbidities, and PA/functional capacity with a list of appropriate resources. Independent AGREE methodologists rated the development process as strong and recommended the guide for use. The recommendation guide has the potential to facilitate PA counseling between oncology care providers and cancer survivors, thus, potentially impacting PA behavior.

Download Full-text

Health-Related Quality of Life in Former National Collegiate Athletic Association Division I Collegiate Athletes Compared With Noncollegiate Athletes: A 5-Year Follow-Up

Journal of Athletic Training ◽

10.4085/1062-6050-0107.20 ◽

2021 ◽

Author(s):

Janet E. Simon ◽

Mallory Lorence ◽

Carrie L. Docherty

Keyword(s):

Physical Activity ◽

Physical Function ◽

National Collegiate Athletic Association ◽

Division I ◽

Related Quality ◽

Health Related ◽

Division I Athletes

Context The effect of athletic participation on lifelong health among elite athletes has received increasing attention, as sport-related injuries can have a substantial influence on long-term health. Objective To determine the current health-related quality of life (HRQoL) of former National Collegiate Athletic Association Division I athletes compared with noncollegiate athletes 5 years after an initial assessment. Design Cohort study. Setting Online survey. Patients or Other Participants From the former Division I athletes, 193 responses were received (response rate = 83.2%; 128 men, 65 women; age = 58.47 ± 6.17 years), and from the noncollegiate athletes, 169 surveys were returned (response rate = 75.1%; 80 men, 89 women; age = 58.44 ± 7.28 years). Main Outcome Measure(s) The independent variables were time (baseline, 5 years later) and group (former Division I athlete, noncollegiate athlete). Participants completed 7 Patient-Reported Outcomes Measurement Information System scales: sleep disturbance, anxiety, depression, fatigue, pain interference, physical function, and satisfaction with participation in social roles. Results Sleep disturbance, depression, fatigue, pain, and physical function were significant for a time × group interaction (P < .05), with the largest differences seen in pain and physical function between groups at time point 2 (22.19 and 13.99 points, respectively). Former Division I athletes had worse scores for depression, fatigue, pain, and physical function at follow-up (P < .05), with the largest differences seen on the depression, fatigue, and physical function scales (8.33, 6.23, and 6.61 points, respectively). Conclusions Because of the competitive nature of sport, the long-term risks of diminished HRQoL need to become a priority for health care providers and athletes during their athletic careers. Additionally, physical activity transition programs need to be explored to help senior student-athletes transition from highly structured and competitive collegiate athletics to lifestyle physical activity, as it appears that individuals in the noncollegiate athlete cohort engaged in more physical activity, weighed less, and had increased HRQoL.

Download Full-text

Physical Activity, Physical Function, and Quadriceps Muscle Thickness in Male Patients with Sub-Acute Stroke during Hospitalization: A Pilot Study

European Neurology ◽

10.1159/000494991 ◽

2018 ◽

Vol 80 (3-4) ◽

pp. 157-162 ◽

Cited By ~ 1

Author(s):

Masafumi Nozoe ◽

Hiroki Kubo ◽

Asami Furuichi ◽

Masashi Kanai ◽

Miho Yamamoto ◽

...

Keyword(s):

Physical Activity ◽

Acute Stroke ◽

Physical Function ◽

Muscle Thickness ◽

Haemorrhagic Stroke ◽

Quadriceps Muscle ◽

Stroke Recurrence ◽

Daily Number ◽

Paretic Side ◽

Male Patients

Increasing physical activity (PA) is an important rehabilitation target for patients with sub-acute stroke during hospitalization in order to recover physical function and prevent stroke recurrence. However, the characteristics of low PA in stroke patients during hospitalization who were targets for increased intervention have not been reported. The purpose of this study was to investigate the relationship between the daily number of steps and physical function and quadriceps muscle thickness (QMT) in patients with sub-acute stroke during hospitalization for convalescence rehabilitation. Twenty-nine patients with ischemic or haemorrhagic stroke (mean age, 69 ± 11 years) hospitalized for inpatient convalescent rehabilitation were included. PA was measured using a three-dimensional accelerometer that calculates the daily number of steps taken. Physical function was measured by a short physical performance battery (SPPB; 0–12 points) and the leg motor selectivity score (6 motor stages defined by Brunnstrom), and the QMT of both legs was measured using ultrasonography. PA was significantly correlated with the SPPB score (r = 0.63, p = 0.0002), QMT on the paretic side (r = 0.41, p = 0.02), and QMT on non-paretic side (r = 0.56, p = 0.002). There were no significant effects of the leg motor selectivity score on daily PA (F = 1.37, p = 0.27). In the multiple regression analysis, only the SPPB score showed significant linear regression (β = 0.44, p = 0.02). PA in male patients with sub-acute stroke during hospitalization was related to physical function and QMT and not with the severity of paresis.

Download Full-text