110 Participants Needed

High-Intensity + Home Exercise for Cognitive Impairment

(HEALTH-COG Trial)

Recruiting at 2 trial locations
PW
Overseen ByPariya Wheeler, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
Must be taking: ART regimen
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how different exercise routines can reduce the risk of Alzheimer's and related dementias in people living with HIV. Participants will engage in either high-intensity interval training (short bursts of hard exercise mixed with easier exercise) or continuous moderate exercise. The goal is to understand how these exercises can improve cognitive health and find ways to encourage long-term exercise habits. The trial seeks individuals with HIV who don't exercise often, feel fatigued, and are willing to commit to a supervised exercise program. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research on exercise and cognitive health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be on a stable ART regimen for at least 12 months, and any hormone therapy must be stable for more than 3 months.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that high-intensity interval training (HIIT) is safe and beneficial for the brain. Studies have found that HIIT can enhance thinking and memory skills in older adults and is safe for individuals with various health conditions. Importantly, these studies did not report any serious side effects.

Continuous moderate exercise (CME) is also manageable. Research suggests that CME can slightly enhance brain function over time. Participants in studies typically perform these exercises without major issues, making it a safe option.

Both HIIT and CME are supported by research indicating they are safe and can improve brain health. Participants can feel confident about the safety of these exercise options.12345

Why are researchers excited about this trial?

Researchers are excited about the High-Intensity + Home Exercise approach for cognitive impairment because it introduces a novel use of exercise intensity to potentially improve cognitive function. Unlike standard treatments for cognitive impairment, which typically involve medications or cognitive therapies, this method uses physical exercise as a therapeutic tool. The High-Intensity Interval Training (HIIT) arm offers a unique blend of high and moderate-intensity exercise, which could enhance brain health through increased blood flow and neuroplasticity. Meanwhile, the Continuous Moderate Exercise (CME) provides a consistent, sustainable physical activity option that might help maintain cognitive abilities. This trial also explores the role of home-based exercise, supported by coaching text messages, making it accessible and potentially more engaging for participants.

What evidence suggests that this trial's treatments could be effective for cognitive impairment in people with HIV?

Research has shown that high-intensity interval training (HIIT), which participants in this trial may receive, can boost brain function. Studies indicate that HIIT improves memory and thinking skills, especially when performed for 4 to 16 weeks at high effort levels. This type of exercise appears more beneficial for brain health than less intense workouts.

Continuous moderate exercise (CME) is another treatment option in this trial. It helps maintain mental sharpness and may reduce the risk of memory issues. Regular aerobic activities, such as walking, have enhanced brain health and improved memory in older adults. Both HIIT and CME hold promise for individuals with cognitive concerns.23456

Are You a Good Fit for This Trial?

This trial is for older individuals living with HIV who have low viral loads, are on stable antiretroviral therapy, experience fatigue, and lead a sedentary lifestyle. They must be willing to exercise regularly and able to receive text messages. Exclusions include severe health conditions like heart failure, uncontrolled hypertension or diabetes, recent major surgery or injury, and certain medication uses.

Inclusion Criteria

You do not engage in physical activity that makes you sweat at least 3 days a week, and you haven't done regular strength training in the past 3 months.
Willing to engage in a supervised exercise program 3 times/week for 4 months
Weight <450 lbs
See 6 more

Exclusion Criteria

Active substance abuse or other factors that could prevent compliance or safety with study visits, at the discretion of the site investigator
I have been on stable doses of sex hormone therapy for more than 3 months.
I have been on a stable dose of hormone replacement for more than 3 months.
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 4 months of supervised high-intensity interval training (HIIT) or continuous moderate exercise (CME)

16 weeks
Regular in-person exercise sessions

Text-messaging intervention

Participants receive a 3-month text-messaging intervention to improve physical activity adherence

12 weeks

Follow-up

Participants are monitored for cognitive functioning and psychological mechanisms of adherence

12 months
12 month follow-up visit

What Are the Treatments Tested in This Trial?

Interventions

  • Phase 1 Gym Exercise CME
  • Phase 1 Gym Exercise HIIT
  • Phase 2 Home Exercise Coaching Text Messages
  • Phase 2 Home Exercise Control Text Messages
Trial Overview The study tests the effects of high-intensity gym exercises followed by home exercise coaching via text messages on cognitive function in older people with HIV. It aims to see if these interventions can improve brain health and establish long-term exercise habits.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: High-Intensity Interval Training (HIIT)Active Control3 Interventions
Group II: Continuous Moderate Exercise (CME)Active Control3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

University of Colorado, Denver

Collaborator

Trials
1,842
Recruited
3,028,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

University of Washington

Collaborator

Trials
1,858
Recruited
2,023,000+

Published Research Related to This Trial

A systematic review of 16 studies involving 1180 participants with Alzheimer's disease or Mild Cognitive Impairment found that separate exercise combined cognitive training (ECT) was the most effective for improving overall cognitive function, with a high probability of being the best approach.
For enhancing memory function specifically, interactive ECT showed the greatest effectiveness, while the best method for improving executive function remains unclear, as both dual-task and separate modalities had similar effectiveness.
The relative effectiveness of different combination modes for exercise and cognitive training on cognitive function in people with mild cognitive impairment or Alzheimer's disease: a network meta-analysis.Zhao, X., Huang, X., Cai, Y., et al.[2023]
A systematic review of 29 randomized controlled trials involving 2458 patients with cognitive impairment found that multicomponent exercise is the most effective type of exercise for improving global cognition, with a significant effect size (SMD = 0.84).
Short-duration (≤45 min), vigorous intensity, and high-frequency (5-7 times/week) exercises also showed strong efficacy in enhancing cognitive function, indicating that these specific exercise characteristics are beneficial for older adults with cognitive impairment.
Which Specific Exercise Models Are Most Effective on Global Cognition in Patients with Cognitive Impairment? A Network Meta-Analysis.Yang, J., Dong, Y., Yan, S., et al.[2023]
Circuit class therapy can provide sufficient exercise dosage to induce a cardiorespiratory fitness effect in 62% of adults with severe traumatic brain injury, based on caloric expenditure criteria.
Providing feedback from heart rate monitors did not significantly influence exercise intensity or the time spent in the target heart rate zone during the therapy sessions.
Circuit class therapy can provide a fitness training stimulus for adults with severe traumatic brain injury: a randomised trial within an observational study.Hassett, LM., Moseley, AM., Whiteside, B., et al.[2012]

Citations

Examining High-Intensity Exercise on Cognitive and Vascular ...... continuous moderate exercise (CME) on cognitive outcomes and underlying correlates. ... Phase 1: 1:1 randomization to 4-months HIIT or CME ...
High-Intensity + Home Exercise for Cognitive ImpairmentParticipants showed significant improvements in functional capacity and systolic blood pressure, indicating that this approach can effectively enhance health ...
The Role of Physical Exercise in Cognitive PreservationCognitively intact adults who completed 12-weeks of 1 hour thrice weekly supervised aerobic exercise improved in immediate and delayed text-level memory when ...
Physical Exercise as a Preventive or Disease-Modifying ...A rapidly growing literature strongly suggests that exercise, specifically aerobic exercise, may attenuate cognitive impairment and reduce dementia risk.
Effects of exercise interventions for specific cognitive...Effects of exercise interventions for specific cognitive domains in old adults with mild cognitive impairment. A protocol of subgroup meta-analysis of ...
Effect of Physical Activity on Cognitive Function in Older ...In this study of adults with subjective memory impairment, a 6-month program of physical activity provided a modest improvement in cognition over an 18-month ...
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