RECRUITING

Effect of High-Intensity Exercise to Attenuate Cognitive Function Limitations and Train Exercise Habits in Older People Living With HIV

Conditions

HIV Infections Cognitive Impairment HIV Cognitive Function Exercise

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. The current study will leverage an existing R01 to address these gaps and provide implications for development of personalized approaches for the treatment and prevention of cognitive impairment and dementia in older people with HIV.

Official Title

Examining the Effect of High-Intensity Exercise to Attenuate Cognitive Function Limitations and Train Exercise Habits in Older People Living With HIV (HEALTH-Cog)

Quick Facts

Study Start:2023-08-01

Study Completion:2028-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06013579

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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: 1. 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 follow-up evaluation by their primary care provider with initiation or adjustment of anti-hypertensive medications, 2. 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, 3. New York Heart Association Class III or IV congestive heart failure, clinically significant aortic stenosis, uncontrolled angina, or uncontrolled arrhythmia, 4. Pulmonary disease requiring the use of supplemental oxygen at rest or with physical exertion, 5. Malignancy requiring chemotherapy or radiation therapy within 24 weeks prior to enrollment, 6. Poorly controlled diabetes, as evidenced by hemoglobin A1c \> 8.5, documented within 6 months of study visit or current use of insulin, 7. 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, 8. Balance impairments that may impact functional testing and ability to safely exercise as reported by the participant or in their medical record, 9. 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 to have severely restricted range of motion even after modifications have been made), 10. Persons who, in the judgment of the study clinician, appear to have unstable health or are incapable of safely participating in the exercise intervention.

Inclusion Criteria

Exclusion 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:
1. 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 follow-up evaluation by their primary care provider with initiation or adjustment of anti-hypertensive medications,
2. 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,
3. New York Heart Association Class III or IV congestive heart failure, clinically significant aortic stenosis, uncontrolled angina, or uncontrolled arrhythmia,
4. Pulmonary disease requiring the use of supplemental oxygen at rest or with physical exertion,
5. Malignancy requiring chemotherapy or radiation therapy within 24 weeks prior to enrollment,
6. Poorly controlled diabetes, as evidenced by hemoglobin A1c \> 8.5, documented within 6 months of study visit or current use of insulin,
7. 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,
8. Balance impairments that may impact functional testing and ability to safely exercise as reported by the participant or in their medical record,
9. 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 to have severely restricted range of motion even after modifications have been made),
10. Persons who, in the judgment of the study clinician, appear to have unstable health or are incapable of safely participating in the exercise intervention.

Contacts and Locations

Study Contact

Pariya Wheeler, PhD

CONTACT

205-996-0330

plfazeli@uab.edu

Study Locations (Sites)

University of Alabama at Birmingham

Birmingham, Alabama, 35294

United States

University of Colorado Denver

Aurora, Colorado, 80045

United States

University of Washington

Seattle, Washington, 98195

United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-01

Study Completion Date2028-03

Study Record Updates

Study Start Date2023-08-01

Study Completion Date2028-03

Terms related to this study

Keywords Provided by Researchers

HIV
Cognitive Function
Exercise

Additional Relevant MeSH Terms

HIV Infections
Cognitive Impairment