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

NCT06013579 | Recruiting DMC

• 1 other identifier: 1R01AG077997-01A1
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

HIV Infections; Cognitive Impairment

Keywords

HIV; Cognitive Function; Exercise

Outcome Measures

Primary Outcomes (4)

• Cognition

  Cognitive assessment battery test speed of processing, learning, memory, executive functioning, verbal fluency, working memory, motor, subjective cognitive complaints, and everyday functioning.

  Baseline visit

• Cognition

  Cognitive assessment battery test speed of processing, learning, memory, executive functioning, verbal fluency, working memory, motor, subjective cognitive complaints, and everyday functioning.

  4 month follow-up visit

• Cognition

  Cognitive assessment battery test speed of processing, learning, memory, executive functioning, verbal fluency, working memory, motor, subjective cognitive complaints, and everyday functioning.

  7 month follow-up visit

• Cognition

  Cognitive assessment battery tests speed of processing, learning, memory, executive functioning, verbal fluency, working memory, motor, subjective cognitive complaints, and everyday functioning.

  12 month follow-up visit

Secondary Outcomes (1)

• Psychological Mechanisms of Adherence

  12 month follow-up visit

Study Arms (2)

Continuous Moderate Exercise (CME)

ACTIVE COMPARATOR

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.

Behavioral: Phase 1 Gym Exercise CME; Behavioral: Phase 2 Home Exercise Coaching Text Messages; Behavioral: Phase 2 Home Exercise Control Text Messages

High-Intensity Interval Training (HIIT)

ACTIVE COMPARATOR

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.

Behavioral: Phase 1 Gym Exercise HIIT; Behavioral: Phase 2 Home Exercise Coaching Text Messages; Behavioral: Phase 2 Home Exercise Control Text Messages

Interventions

Phase 1 Gym Exercise HIIT BEHAVIORAL

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.

High-Intensity Interval Training (HIIT)

Phase 1 Gym Exercise CME BEHAVIORAL

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.

Continuous Moderate Exercise (CME)

Phase 2 Home Exercise Coaching Text Messages BEHAVIORAL

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.

Continuous Moderate Exercise (CME); High-Intensity Interval Training (HIIT)

Phase 2 Home Exercise Control Text Messages BEHAVIORAL

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.

Continuous Moderate Exercise (CME); High-Intensity Interval Training (HIIT)

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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)
• 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

You may not qualify 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,
• 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,
• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• University of Colorado, Denver: collaborator
• University of Washington: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (3)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

NOT YET RECRUITING

University of Colorado Denver

Aurora, Colorado, 80045, United States

RECRUITING

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

MeSH Terms

Conditions

HIV Infections; Cognitive Dysfunction; Motor Activity

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior

Central Study Contacts

Pariya Wheeler, PhD

CONTACT

205-996-0330; plfazeli@uab.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: August 28, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

US (3)