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Official title Effect of High-Intensity Exercise to Attenuate Cognitive Function Limitations and Train Exercise Habits in Older People Living With HIV
ClinicalTrials.gov ID: NCT06013579
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 80. Healthy volunteers may be eligible.
You may be able to join if
- Confirmed HIV
- Sedentary lifestyle, defined as self-reported PA that breaks a sweat \<3 days/week, with no regular resistance exercise for 3 months preceding study;
- Fatigued (≥2.0 on either of the first two screening items on the HIV-Related Fatigue Scale)
- On a current, contemporary ART regimen for \>=12 months;
- HIV-1 RNA \<200 copies/mL in the past 12 months (assessed via medical records)
You likely can't join if
- Weight over 450 pounds
- Use of sex hormone therapy, if on for ≤3 months (stable doses for \>3 months will be permitted)
- Use of other hormone replacement, if on for ≤ 3 months (stable doses \>3 months will be permitted)
- Anemia (Hemoglobin ≤9 g/dL for women or ≤10 g/dL for men) due to contribution to fatigue,
- Diagnosis of mitochondrial disease,
- Active substance abuse or other factors that could prevent compliance or safety with study visits, at the discretion of the site investigator,
See the full eligibility criteria
- Confirmed HIV
- Sedentary lifestyle, defined as self-reported PA that breaks a sweat \<3 days/week, with no regular resistance exercise for 3 months preceding study;
- Fatigued (≥2.0 on either of the first two screening items on the HIV-Related Fatigue Scale)
- On a current, contemporary ART regimen for \>=12 months;
- HIV-1 RNA \<200 copies/mL in the past 12 months (assessed via medical records)
- Willing to engage in a supervised exercise program 3 times/week for 4 months
- Cell phone or email to accept messages
- Weight \<450 lbs
- Medical clearance by study healthcare professional
- Weight over 450 pounds
- Use of sex hormone therapy, if on for ≤3 months (stable doses for \>3 months will be permitted)
- Use of other hormone replacement, if on for ≤ 3 months (stable doses \>3 months will be permitted)
- Anemia (Hemoglobin ≤9 g/dL for women or ≤10 g/dL for men) due to contribution to fatigue,
- Diagnosis of mitochondrial disease,
- Active substance abuse or other factors that could prevent compliance or safety with study visits, at the discretion of the site investigator,
- Reasons for medical exclusion, as determined by Nurse Practioner:
- Uncontrolled hypertension defined as resting systolic blood pressure \>150 mmHg or diastolic blood pressure \>90 mmHg; participants who do not meet these criteria at first screening will be reevaluated, including...
- 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...
- New York Heart Association Class III or IV congestive heart failure, clinically significant aortic stenosis, uncontrolled angina, or uncontrolled arrhythmia,
- Pulmonary disease requiring the use of supplemental oxygen at rest or with physical exertion,
- Malignancy requiring chemotherapy or radiation therapy within 24 weeks prior to enrollment,
- Poorly controlled diabetes, as evidenced by hemoglobin A1c \> 8.5, documented within 6 months of study visit or current use of insulin,
- Surgery/trauma/injury/fracture within 24 weeks prior to enrollment that, in the opinion of the study clinician, may impact a subject's baseline functional testing and ability to exercise,
- Balance impairments that may impact functional testing and ability to safely exercise as reported by the participant or in their medical record,
- Orthopedic problems (e.g., severe osteoarthritis, rheumatoid arthritis) that greatly limit the ability to perform moderate intensity resistance exercise (e.g., unable to be properly positioned in exercise equipment or...
- Persons who, in the judgment of the study clinician, appear to have unstable health or are incapable of safely participating in the exercise intervention.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Aurora, Colorado, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Aurora, Colorado, United States; Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.