RecruitingNot ApplicableNCT06013579

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

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

Sponsor

University of Alabama at Birmingham

Enrollment

110 participants

Start Date

Aug 1, 2023

Study Type

INTERVENTIONAL

Conditions

Cognitive Impairment HIV Infections

Summary

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.

Eligibility

Min Age: 50 YearsMax Age: 80 Years

Inclusion Criteria9

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

Exclusion Criteria17

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 follow-up evaluation by their primary care provider with initiation or adjustment of anti-hypertensive medications,
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,
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 to have severely restricted range of motion even after modifications have been made),
Persons who, in the judgment of the study clinician, appear to have unstable health or are incapable of safely participating in the exercise intervention.

Interventions

BEHAVIORALPhase 1 Gym Exercise HIIT

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.

BEHAVIORALPhase 1 Gym Exercise CME

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.

BEHAVIORALPhase 2 Home Exercise Coaching Text Messages

The coaching intervention will consist of daily text messages tailored to the individual participant's self-reported symptom experiences and barriers to exercise on that specific day. One daily message with a survey will be sent, and responses to survey items will determine the subsequent once daily motivational message.Tailored messages address a range of possible barriers to adherence based on past research, and will provide advice and guidance. Text messages will be varied each week so that even if participants continue to report the same barriers they receive different text messages.

BEHAVIORALPhase 2 Home Exercise Control Text Messages

The control group will receive general daily texts from the study team (i.e., "Hope you are doing well!"), and reminding them of their next study appointments. These text messages are primarily social/generic in content and serve to maintain involvement and enhance retention of the control group.