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Behavioral Intervention
High-Intensity Exercise for Cognitive Impairment with HIV
N/A
Recruiting
Led By Raymond Jones, Ph.D.
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, up to 16 weeks, 3-months post-intervention
Awards & highlights
No Placebo-Only Group
Summary
This trial will study if exercise can help people 50+ living with HIV who have suboptimal cognition. 60 participants in Alabama will be monitored over 3 months to measure the effects of exercise.
Who is the study for?
This trial is for adults over 50 living with HIV who have cognitive challenges and a sedentary lifestyle. They must be on HIV treatment without old drugs known to harm mitochondria, speak English, and not engage in moderate exercise more than 150 minutes per week. Exclusions include severe heart disease, uncontrolled diabetes or hypertension, kidney or mitochondrial diseases, active substance abuse, orthopedic limitations to exercise, other trials' participation, or needing oxygen for lung issues.
What is being tested?
The study compares two types of exercises: high-intensity interval training (HIIT) versus continuous moderate exercise to see which better improves blood vessel health and brain function in older adults with HIV after 12 weeks. It also explores participants' barriers to exercising and their views on the interventions.
What are the potential side effects?
While specific side effects are not listed for these exercises, general risks may include muscle soreness, fatigue during or after workouts, joint pain due to physical activity intensity increase especially if previously sedentary.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, up to 16 weeks, 3-months post-intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, up to 16 weeks, 3-months post-intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in cognitive function
Change in vascular function
Secondary study objectives
Barriers to Engagement in Exercise
Perceptions of the Study and Exercise Interventions
Other study objectives
Participant Safety, Adherence to the Intervention, Retention
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: High-Intensity Interval TrainingExperimental Treatment1 Intervention
Group II: Continuous Moderate ExerciseActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
High-Intensity Interval Training
2019
Completed Phase 2
~790
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,645 Previous Clinical Trials
2,342,792 Total Patients Enrolled
Raymond Jones, Ph.D.Principal InvestigatorUniversity of Alabama at Birmingham
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been on HIV treatment for over a year without using drugs known to harm mitochondria.I have chronic kidney disease.I have been diagnosed with a mitochondrial disease.My diabetes is not well-managed.I have had a heart attack confirmed by my medical history and an ECG.I have bone or joint issues that prevent me from exercising.I need extra oxygen to breathe properly.I am 50 years old or older.I do not have severe heart problems like heart failure, aortic stenosis, or uncontrolled chest pain.
Research Study Groups:
This trial has the following groups:- Group 1: High-Intensity Interval Training
- Group 2: Continuous Moderate Exercise
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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