Trials / Unknown
UnknownNCT05435521
Impact of a Personalized Multicomponent Exercise Program in Real Conditions Among Older Adults With HIV
MOVIhNG Study: Impact of a Personalized Multicomponent Exercise Program in Real Conditions on Physical Function, Frailty, and Quality of Life Among Older Adults With HIV
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Hospital Universitario Ramon y Cajal · Academic / Other
- Sex
- All
- Age
- 50 Years – 120 Years
- Healthy volunteers
- Accepted
Summary
Longitudinal prospective multicenter study with intervention and control groups and a two-year follow up. Participants will include 40 sedentary adults 50 years old or older with HIV infection and 20 sedentary adults 50 years old or older without HIV infection. Our main objective is to analyze the effects of a personalized multicomponent exercise program (strength, resistance, balance, and flexibility) (PMEP) on physical function, frailty, and quality of life among older adults with HIV. As secondary objectives, we are going to analyze the effects of a PMEP on body composition, muscle function biomarkers, immunological biomarkers, microbiome, and adherence to PMEP in real conditions under intense, moderate nonexistent monitoring.
Detailed description
PMEPs will be designed according to the specific characteristics of each participant and their grade of usual physical activity. Physical activity will be registered on physical activity bracelets to get objective information in order to evaluate adherence to the PMEP. A global evaluation of the patients will be made at baseline and months 3, 6, and 12. At each evaluation, samples of blood, stool, urine, and saliva will be taken, and a phone meeting will be scheduled at month 24.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Personalized multicomponent exercise program (strength, resistance, balance, and flexibility) (PMEP) | Physical activity expert will design for each participant a personalized exercise program according to baseline situation and previous physical activity. Both will be measured prior to initiation of activity program. Each participant is free to perform physical activity program at his house, outdoor or in a gym as long as it fulfills the prespecified requirements. Exercise programs will be acquired a more personalized shape during the course of the study. In order to motivate participants, personal motivational messages will be sent each week through mail contact or using "WhatsApp" Social Media. Physical activity will be registered in an activity wristband delivered to each participant at baseline evaluation. |
| OTHER | Body composition | Analyze the effects of PMEP on body composition in each evaluation using an impedance threshold device |
| OTHER | Musculoskeletal and visceral Ultrasound | Quadriceps muscle ultrasound (US) of the rectus femoris measured in each evaluation in order to analyze the effects of PMEP Visceral fat will be analyzed in each visit |
Timeline
- Start date
- 2021-01-01
- Primary completion
- 2023-10-01
- Completion
- 2023-12-31
- First posted
- 2022-06-28
- Last updated
- 2022-06-28
Locations
2 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT05435521. Inclusion in this directory is not an endorsement.