- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07922499
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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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Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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 |
|
Otro: 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 |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Lower Extremity Leg Strength Using Sit-to-Stand
Periodo de tiempo: Baseline, 3, 6 and 9 mos
|
Chair-stand test: number of sit-to-stands in 30 seconds |
Baseline, 3, 6 and 9 mos
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pain
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026-0691
- RF1AG105013 (Subvención/contrato del NIH de EE. UU.)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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