Effect of High-Intensity Exercise to Attenuate Cognitive Function Limitations and Train Exercise Habits in Older People Living With HIV
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- University of Alabama at Birmingham
- Study ID
- NCT06013579
- Status
- Recruiting
Conditions
- Cognitive Impairment
- HIV Infections
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - 80 Years
- Healthy Volunteers
- Accepted
Interventions
- Phase 1 Gym Exercise HIIT — BEHAVIORALFollowing a 5-minute warm-up at 50% VO2peak, high and moderate-intensity exercise bouts alternate, progressing to five bouts of 4-minute high-intensity exercise (90% VO2peak), alternating with four 3-minute bouts of moderate-intensity exercise (50% VO2peak) by week 8, followed by a 5 minute cool-down. The total exercise time is 42 minutes.
- Phase 1 Gym Exercise CME — BEHAVIORALFollowing a 4 minute warm-up at 50% VO2peak, the participant walks for up to 42 continuous minutes at 60% VO2peak172, followed by a 4 minute cool-down. The total exercise time is 50 minutes.
- Phase 2 Home Exercise Coaching Text Messages — BEHAVIORALThe coaching intervention will consist of daily text messages tailored to the individual participant's self-reported symptom experiences and barriers to exercise on that specific day. One daily message with a survey will be sent, and responses to survey items will determine the subsequent once daily motivational message.Tailored messages address a range of possible barriers to adherence based on past research, and will provide advice and guidance. Text messages will be varied each week so that even if participants continue to report the same barriers they receive different text messages.
- Phase 2 Home Exercise Control Text Messages — BEHAVIORALThe control group will receive general daily texts from the study team (i.e., "Hope you are doing well!"), and reminding them of their next study appointments. These text messages are primarily social/generic in content and serve to maintain involvement and enhance retention of the control group.
Study Details
People aging with HIV are at higher risk for Alzheimer's disease and related dementias, and although physical activity is a promising target to mitigate such risk, this population engages in low levels of physical activity. Few studies have tested cognitive effects of exercise interventions or examined mechanisms of adherence to long-term exercise among diverse samples of midlife and older people with HIV. The current study will leverage an existing R01 to address these gaps and provide implications for development of personalized approaches for the treatment and prevention of cognitive impairment and dementia in older people with HIV.
Key Dates
- Start date
- Aug 1, 2023
- Status verified
- Dec 2025
- Primary completion
- Sep 30, 2027
- Completion
- Mar 31, 2028
Study Design
- Enrollment
- 110 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Active Comparator: Continuous Moderate Exercise (CME)Following a 4 minute warm-up at 50% VO2peak, the participant walks for up to 42 continuous minutes at 60% VO2peak172, followed by a 4 minute cool-down. The total exercise time is 50 minutes.
- Active Comparator: High-Intensity Interval Training (HIIT)Following a 5-minute warm-up at 50% VO2peak, high and moderate-intensity exercise bouts alternate, progressing to five bouts of 4-minute high-intensity exercise (90% VO2peak), alternating with four 3-minute bouts of moderate-intensity exercise (50% VO2peak) by week 8, followed by a 5 minute cool-down. The total exercise time is 42 minutes.
Primary Outcome Measure
Cognition [ Time Frame: Baseline visit ]
Central Contacts
- Pariya Wheeler, PhD205-996-0330
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | |
| University of Colorado Denver | Aurora | Colorado | 80045 | |
| University of Washington | Seattle | Washington | 98195 |
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