An interventional study of Positively Fit and Strong! in Mobility Impairment and Frailty, sponsored by University of Illinois Chicago. Not yet recruiting. Open to female participants aged 50 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by University of Illinois Chicago · Not applicable, Interventional, and Treatment
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.
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.
1,284 studies on the registry are indexed under Frailty; 452 are open to participants now.
This study's planned enrollment of 210 is above the median of 81 across 767 interventional studies indexed under Frailty.
Browse Frailty studies →University of Illinois Chicago is the lead sponsor of 20 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:women must be aged 50 or older, have , 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 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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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Will receive the physical activity and health intervention and provide measurements at specified time periods
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.
Behavioral: 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
Lower Extremity Leg Strength Using Sit-to-Stand
Chair-stand test: number of sit-to-stands in 30 seconds
Time frame: Baseline, 3, 6 and 9 mos
Pain
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) 5-question subscale measures pain; LE stiffness and function also measured
Time frame: Baseline, 3, 6, and 9 months
No study locations are listed for this record.
Start is estimated for Jun 2027; primary completion for May 2030, 35 months later.
Of 513 non-industry interventional studies with no phase under Frailty, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 39. This study's planned 35 months is above that.
Counting every sponsor, half of 517 studies reached it within 22 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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University of Illinois Chicago