At a glance
ClinicalIndex Comparison Record- ✓Age 50 years or older
- ✓Sedentary: <3 days/week of sweating activity and no regular resistance exercise for 3 months prior
- ✓Significant fatigue (score ≥2.0 on first two items of HIV-Related Fatigue Scale)
- ✓HIV infection on antiretroviral therapy ≥12 months, avoiding D4T, DDI, ZDV within 1 year
- ✕Weight >450 pounds (DXA machine limitation)
- ✕Sex hormone therapy or other hormone replacement if used ≤3 months (stable >3 months allowed)
- ✕Anemia: Hemoglobin ≤9 g/dL (women) or ≤10 g/dL (men)
- ✕Diagnosis of mitochondrial disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
High-Intensity Exercise to Attenuate Limitations and Train Habits in Older Adults With HIV
In Brief
A clinical study evaluating HIIT (intervention), CME (active control), and 2 other interventions for Hiv and 2 related conditions. Completed, enrolled 118 participants across 3 sites.
Detailed Summary
This is a multi-site, randomized, single-blind (researchers), active treatment concurrent control trial with individuals aged 50-80 living with HIV who experience fatigue and live a sedentary lifestyle. The overall goals of this proposal are to determine whether high-intensity interval training (HIIT) can overcome physical function impairments and increased fatigue (Aim 1) and impairments in mitochondrial bioenergetics of older people with HIV (PWH) to a greater extent than continuous moderate-intensity exercise (CME) (Aim 2). The investigators further seek to determine whether a biobehavioral coaching intervention following either HIIT or CME can promote long-term adherence to physical activity (Aim 3), a crucial component of the sustainability of the intervention. This study will enroll 100 participants in Aurora, Colorado and Seattle, Washington. Data collection will occur at each visit, with baseline data collected at the initial visit. A 3-month follow-up will be conducted over the phone from the date of the final visit. The initial enrollment goal of 100 was increased to 120 in 2023 to facilitate a larger number of participants with key secondary outcomes.
Study Details
Timeline
Interventions
Following a 5-minute warm-up, high and moderate-intensity exercise bouts will alternate: a five bouts of 4-minute high-intensity exercise (90% VO2peak) will alternate with four 3-minute bouts of moderate-intensity exercise (50% VO2peak) by week 8. This is followed by a 5-minute cool-down. The total exercise time will be 42 minutes. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 3 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
Following a 4-minute warm-up, the participant will walk/jog for up to 42 continuous minutes at 60% VO2peak. This is followed by a 4-minute cool-down. The total exercise time is 50 minutes. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 3 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
The coaching intervention consists of daily text messages tailored to the individual participant's self-reported symptom experiences and barriers to exercise on that specific day. Tailored messages address a range of possible barriers to adherence based on past research, and will provide advice and guidance. Text messages are varied each week so that even if participants continue to report the same barriers they receive different text messages.
The control group receives general weekly texts from the study team (i.e., "Hope you are doing well!"), 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.