High-Intensity Exercise to Attenuate Limitations and Train Habits in Older Adults With HIV

NCT04550676 | Active Not Recruiting DMC

• 1 other identifier: 19-1985
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 2

Brief Summary

This is a multi-site, randomized, single-blind (researchers), active treatment concurrent control trial with individuals aged 50-80 living with HIV who experience fatigue and live a sedentary lifestyle. The overall goals of this proposal are to determine whether high-intensity interval training (HIIT) can overcome physical function impairments and increased fatigue (Aim 1) and impairments in mitochondrial bioenergetics of older people with HIV (PWH) to a greater extent than continuous moderate-intensity exercise (CME) (Aim 2). The investigators further seek to determine whether a biobehavioral coaching intervention following either HIIT or CME can promote long-term adherence to physical activity (Aim 3), a crucial component of the sustainability of the intervention. This study will enroll 100 participants in Aurora, Colorado and Seattle, Washington. Data collection will occur at each visit, with baseline data collected at the initial visit. A 3-month follow-up will be conducted over the phone from the date of the final visit. The initial enrollment goal of 100 was increased to 120 in 2023 to facilitate a larger number of participants with key secondary outcomes.

Conditions

Hiv; Fatigue; Mobility Limitation

Keywords

mitochondrial function; physical function; frailty; exercise

Outcome Measures

Primary Outcomes (1)

• Change in physical function

  400-m walk time is a continuous measure of the total time required to complete a 400-m walking course. Lower values indicate a faster walking speed.

  0-16 weeks

Secondary Outcomes (1)

• Change in fatigue

  0-16 weeks

Study Arms (2)

High intensity interval training

EXPERIMENTAL

Behavioral: HIIT (intervention)

Continuous moderate intensity exercise

ACTIVE COMPARATOR

Behavioral: CME (active control)

Interventions

HIIT (intervention) BEHAVIORAL

Following a 5-minute warm-up, high and moderate-intensity exercise bouts will alternate: a five bouts of 4-minute high-intensity exercise (90% VO2peak) will alternate with four 3-minute bouts of moderate-intensity exercise (50% VO2peak) by week 8. This is followed by a 5-minute cool-down. The total exercise time will be 42 minutes. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 3 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.

High intensity interval training

CME (active control) BEHAVIORAL

Following a 4-minute warm-up, the participant will walk/jog for up to 42 continuous minutes at 60% VO2peak. This is followed by a 4-minute cool-down. The total exercise time is 50 minutes. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 3 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.

Continuous moderate intensity exercise

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: Any genders can be included
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥ 50years,
• Sedentary lifestyle, defined by self-reported physical activity 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),
• HIV infection, on prescribed HIV antiretroviral therapy for ≥ 12 months, with no current use (within 1 year) of older drugs with established mitochondrial toxicity (i.e., D4T, DDI, ZDV),
• HIV-1 RNA level \< 200 copies/mL, for a minimum of 12 months prior to enrollment, with an allowed blip to 500 copies/mL presuming repeat assessments are below 200 copies,
• Willing to participate in either assigned arm of a 16-week supervised exercise intervention 3 times weekly,
• Thyroid Stimulating Hormone (TSH) within normal lab limits-Cell phone with ability to receive text messaging in order to participate in the biobehavioral maintenance intervention or ability to access to email daily
• Ability and willingness of participant to provide informed consent and consent for access to medical record
• COVID-19 vaccination and appropriate boosters received

You may not qualify if:

• Weight over 450 pounds (due to limitations of the DXA machine)
• 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 For participants undergoing the muscle biopsy only, use of anticoagulant therapy other than low dose aspirin that cannot be held for at least 7 days for the muscle biopsy. Aspirin and non-steroidal use will be permitted but will be held for 7 days prior to the muscle biopsy, and can be resumed following the biopsy.
• Due to the expected fatigue associated with COVID-19 and potential infection risk, anyone with a diagnosis of COVID will not be eligible for enrollment until at least 30 days after symptom resolution and return to baseline level of function.
• 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 re-evaluated, 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 \> 8.0, documented within 6 months of study visit,
• Surgery/trauma/injury/fracture within 24 weeks prior to enrollment that, in the opinion of the study physician, 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),

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Case Western Reserve University: collaborator
• University of Washington: collaborator

Study Sites (2)

University of Colorado - Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (1)

• Oliveira VHF, Erlandson KM, Cook PF, Jankowski C, MaWhinney S, Dirajlal-Fargo S, Knaub L, Hsiao CP, Horvat Davey C, Webel AR. The High-Intensity Exercise Study to Attenuate Limitations and Train Habits in Older Adults With HIV (HEALTH): A Research Protocol. J Assoc Nurses AIDS Care. 2022 Mar-Apr 01;33(2):178-188. doi: 10.1097/JNC.0000000000000276.

  PMID: 34039876 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Fatigue; Mobility Limitation; Frailty; Motor Activity

Interventions

Methods

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Kristine Erlandson, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Allison Webel, PhD, RN

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Outcomes assessors will be blinded for endpoints, as feasible.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will first be randomized to continuous moderate intensity or high-intensity interval training for 16 weeks. After 16 weeks, participants will be re-randomized to 12-week coaching intervention or control.

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: September 16, 2020
• Study Start: April 2, 2021
• Primary Completion: January 24, 2025
• Study Completion: November 24, 2025
• Last Updated: May 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The investigators will make the following available upon request after the primary manuscript is published: the trial description information, protocol, SAP, ICF. Data will be posted to ClinicalTrials.gov after publication of the primary manuscript. Until that time, a message will also appear stating that the trial data will be available after publication of the primary manuscript.
• Access Criteria: Investigators interested in acquiring study data should contact the study team. Sharing of de-identified data will be considered upon review/approval of the request by the Institutional Review Board, with a data use agreement.

Locations

US (2)