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Behavioural Intervention

High-Intensity + Home Exercise for Cognitive Impairment (HEALTH-COG Trial)

N/A

Recruiting

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

On a current, contemporary ART regimen for >=12 months

Fatigued (≥2.0 on either of the first two screening items on the HIV-Related Fatigue Scale)

Must not have

Anemia (Hemoglobin ≤9 g/dL for women or ≤10 g/dL for men) due to contribution to fatigue

Unstable ischemic heart disease (e.g., angina, ST segment depression) or serious arrhythmias at rest or during the graded exercise test without negative follow-up evaluation will be cause for exclusion; follow-up evaluation must include diagnostic testing (e.g., thallium stress test) with interpretation by a cardiologist

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 month follow-up visit

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to discover if physical activity can reduce Alzheimer's risk for aging people with HIV - few studies have tested this yet.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects from intense physical activity may include muscle soreness, joint pain, increased fatigue initially before improvement in endurance occurs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been on my current HIV treatment for at least 12 months.

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I often feel very tired.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have anemia contributing to my fatigue.

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I do not have unstable heart disease or serious heart rhythm problems.

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I have been diagnosed with a mitochondrial disease.

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My diabetes is not well-managed, with an A1c over 8.5 or I'm using insulin.

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I have severe joint problems that prevent me from doing moderate exercise.

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I need extra oxygen to breathe, even when resting or moving.

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I need chemotherapy or radiation for my cancer within the next 6 months.

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I have severe heart issues, including heart failure or uncontrolled heart rhythm problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 month follow-up visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 month follow-up visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month follow-up visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cognition

Secondary study objectives

Psychological Mechanisms of Adherence

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: High-Intensity Interval Training (HIIT)Active Control3 Interventions

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.

Group II: Continuous Moderate Exercise (CME)Active Control3 Interventions

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.

0 / 10Eligibility criteria met