Adapting an Evidence-Based Physical Activity Intervention to Prevent Frailty and Functional Decline in Older Women Living With HIV
This study will examine the effectiveness and implementation of a physical activity and health education intervention by comparing outcomes of participants in the intervention group to those in a control group.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Older women living with HIV (OWWH) experience early onset and accelerated progression of geriatric syndromes, including musculoskeletal pain, functional decline, and frailty, than the general population, placing them at heightened risk for falls, disability, loss of independence, and reduced quality of life. These aging-related conditions are compounded by multimorbidity, long-term HIV treatment effects, HIV-related stigma, and social and structural factors that limit access to and sustained engagement in evidence-based health promotion programs. Interventions that preserve physiologic reserve, maintain strength and mobility, and slow frailty progression are critical to supporting healthy aging in this growing and understudied population. Physical activity programs that combine strength training, balance, and behavior change strategies effectively improve function and reduce frailty risk among older adults; however, such programs have not been rigorously adapted or tested for OWWH whose physical and psychosocial contexts of aging differ from those of the general population. The goal of this study is to adapt and test the Fit & Strong! (F&S) evidence-based physical activity and education intervention to address HIV-specific physical, psychosocial, and contextual needs of women, aged 50 years and older, living with HIV. The tailored intervention will integrate group-based physical activity and behavior change strategies, fostering social support and empowerment while addressing modifiable individual-, interpersonal-, and community-level implementation determinants identified by OWWH as influencing program participation and maintenance. Using a community-engaged approach, this study will: 1) collaborate with a Community Advisory Board of OWWH to tailor the F&S program using the ADAPT-ITT model and pilot test the new intervention; 2) conduct a fully powered randomized waitlist-controlled trial with 210 participants to evaluate the intervention's impact on participant health outcomes; and 3) assess implementation outcomes, including acceptability, feasibility, fidelity, and sustainability, at the participant, instructor, and organizational levels. By targeting modifiable mechanisms of functional decline through an evidence-based group intervention, this project addresses a critical public health gap and has the potential to preserve functional independence and improve aging trajectories among women aging with HIV.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:women must be aged 50 or older, have HIV, currently taking ART, and speak and read adequate English to fill out the surveys and understand class instructions.
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Exclusion Criteria:We will exclude all individuals with moderate or high risk for contraindications of possible injury or death when undertaking strenuous or maximal exercise using a modified Physical Activity Readiness Questionnaire (PAR-Q)73; this is a simple, 7-item self-reported screening tool for determining safety and possible risk (i.e. heart, bone, joint conditions) for starting a PA program that will be administered during enrollment screening. If a participant verbally responds 'YES' to items 1-4, we will ask for physician's approval prior to participation. Other key exclusion criteria include: (1) current participation in any organized physical activity program; (2) significant cognitive impairment or severe psychiatric illness that would preclude safe consent or adherence. Recruiters will be trained to recognize signs of mental stress and will immediately contact a project physician (French, Collison) as needed. We also have relationships with mental health providers at CORE and if one of our clinicians thinks it is necessary the recruiter will accompany the person to the ER; (3) pregnant; and (4) substance use will only be an exclusion if it is felt to impact the safety of participants
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Will receive the physical activity and health intervention and provide measurements at specified time periods |
A 12 week (2 x week) class with 60 minutes of combined aerobic and strength training and 30 minutes of health education |
|
Other: Control
The control participants will take all measurements and then, after those have been completed, will receive the intervention later. A waitlist control. |
A 12 week (2 x week) class with 60 minutes of combined aerobic and strength training and 30 minutes of health education |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lower Extremity Leg Strength Using Sit-to-Stand
Time Frame: Baseline, 3, 6 and 9 mos
|
Chair-stand test: number of sit-to-stands in 30 seconds |
Baseline, 3, 6 and 9 mos
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain
Time Frame: Baseline, 3, 6, and 9 months
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) 5-question subscale measures pain; LE stiffness and function also measured |
Baseline, 3, 6, and 9 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026-0691
- RF1AG105013 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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