Mobility ImpairmentNCT07922499
Adapting an Evidence-Based Physical Activity Intervention to Prevent Frailty and Functional Decline in Older Women Living With HIV
A study testing Positively Fit and Strong! in people with Mobility Impairment and Frailty, run by University of Illinois Chicago.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 100 years, women only
- Conditions the study is for
- Mobility Impairment, Frailty
- What is being tested?
- Positively Fit and Strong!
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- Jun 2027to May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
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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About this study
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.
Read the 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.
- Conditions
- Mobility Impairment, Frailty
- Being tested
- Positively Fit and Strong!
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positively Fit and Strong!Behavioural
A 12 week (2 x week) class with 60 minutes of combined aerobic and strength training and 30 minutes of health education
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Will receive the physical activity and health intervention and provide measurements at specified time periods Receives: Behavioral: Positively Fit and Strong! |
| Control | Other | The control participants will take all measurements and then, after those have been completed, will receive the intervention later. A waitlist control. Receives: Behavioral: Positively Fit and Strong! |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower Extremity Leg Strength Using Sit-to-Stand
Chair-stand test: number of sit-to-stands in 30 seconds
Measured: Baseline, 3, 6 and 9 mos
Secondary outcomes (1)
Pain
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) 5-question subscale measures pain; LE stiffness and function also measured
Measured: Baseline, 3, 6, and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study startJun 2027 (estimated)
- Primary completionMay 2030 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mobility ImpairmentStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07922499
- Sponsor's protocol ID
- 2026-0691
- Other IDs
- RF1AG105013
- Status last verified
- Jun 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting an Evidence-Based Physical Activity Intervention to Prevent Frailty and Functional Decline in Older Women Living With HIV
- ClinicalTrials.gov ID
- NCT07922499
- Acronym / sponsor ID
- 2026-0691
- Conditions
- Mobility Impairment, Frailty
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Jun 2027 (estimated)
- Primary completion
- May 2030 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Positively Fit and Strong!Will receive the physical activity and health intervention and provide measurements at specified time periods |
| Control | Other | Behavioral: Positively Fit and Strong!The control participants will take all measurements and then, after those have been completed, will receive the intervention later. A waitlist control. |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positively Fit and Strong!A 12 week (2 x week) class with 60 minutes of combined aerobic and strength training and 30 minutes of health education | Behavioural | Control, Intervention |
Primary outcome
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
1 secondary outcome
Pain
Time frame: Baseline, 3, 6, and 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Positively Fit and Strong! in people with Mobility Impairment and Frailty, run by University of Illinois Chicago.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower Extremity Leg Strength Using Sit-to-Stand (time frame: Baseline, 3, 6 and 9 mos). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.