Feasibility of HIIT in Older Adults with HIV and Hypertension

NCT06888596 | Completed

• 2 other identifiers: IRB-300009214UWSC14238
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this HIV and Aging Pilot Program Proposal is to foster interdisciplinary collaborations in HIV and geroscience by providing emerging researchers with experience and mentorship in translational research. The focus is on collecting data on the efficacy and feasibility of short-term high-intensity interval training among older people with HIV (PWH) and co-occurring hypertension. Non-AIDS defining comorbidities are increasingly prevalent among aging PWH. The use of antiretroviral therapies (ART) has extended life expectancy, presenting unique risks for aging-related multimorbidities. Hypertension, affecting over 50% of HIV-infected adults in the U.S., is a significant chronic disorder among PWH. Regular exercise improves function and prevents decline in adults with comorbidities. Functional outcomes are good predictors of cardiovascular health in older PWH with hypertension. Exercise improves cardiovascular, metabolic, and functional measures in young PWH, but older PWH often do not meet physical activity guidelines due to barriers like motivation, time, and pain. The impact of high-intensity exercise on physical function in older PWH is unknown, despite evidence of benefits from low-moderate intensity exercise. Assessing the feasibility and acceptability of high-intensity exercise in older PWH with hypertension will provide valuable information for future studies. The specific aims of the proposed study are to assess the integrity of the study protocol, including safety, adherence, and retention, to develop standard operating procedures for future trials, while determining participant perceived benefits and barriers. Additionally, the study aims to assess the variance of secondary outcomes and the effects of the intervention on the 6-minute walk test, lower extremity function as assessed by the Short Physical Performance Battery, skeletal muscle strength and endurance as assessed by isokinetic muscle testing, chronic pain evaluated by the Brief Pain Inventory and Pain assessments, markers of vascular health such as arterial stiffness, and circulating indices of inflammation including inflammatory profile, skeletal muscle degradation, and metabolism.

Conditions

HIV; Hypertension; Exercise

Keywords

HIIT

Outcome Measures

Primary Outcomes (1)

• Feasibility and Acceptability

  Feasibility and acceptability was assessed by collecting data on recruitment and retention rates, intervention adherence rates, number of eligible participants required to recruit to sample size, rate of completion of the intervention (i.e., number of participants who complete all aspects of the intervention), and completion rates.

  From enrollment to the end of treatment at 6 weeks

Secondary Outcomes (6)

• Blood Pressure

  From enrollment to the end of treatment at 6 weeks

• Perceived Benefits and Barriers to Exercise

  Baseline and 6 weeks

• Rating of Perceived Exertion

  Week 1-6 of Intervention

• Body Mass Index

  From enrollment to the end of treatment at 6 weeks

• Cardiorespiratory Fitness

  From enrollment to the end of treatment at 6 weeks

Study Arms (1)

High-Intensity Interval Training

EXPERIMENTAL

Participants will follow a HIIT program adapted from previously successful exercise interventions. Participants will attend 2-weekly sessions of HIIT training for 6 weeks for a total of 12 visits. We have previously established commitments in other high-risk clinical populations, and are confident that we can ensure a moderate adherence rate in the current study population. Intensity is based on age-predicted HR max. Each session was performed using cycle ergometer. 4 sets of 4-minute HIIT at 80-90% HR max with 3 sets of 3-minute active recovery intervals at 60-70% HR max. This is followed by a final 5-minute cool-down.

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

Exercise using cycle ergometer

Also known as: HIIT

High-Intensity Interval Training

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>= 50 years of age at study entry
• must be on ART regimen
• Inactive Lifestyle (\<150 minutes per week of moderate activity on CHAMPS Questionnaire)
• CD4 T-cell count greater than 200 cell/mm\^3 (
• Hypertensive (untreated SBP \>=130mmHg or DBP \>=80 mmHg)
• Functional limitations inhibiting the ability to exercise.

You may not qualify if:

• BP \>140/90 despite the use of 4+ antihypertensive medications
• chronic kidney disease
• severe cardiac condition (CHF, stenosis, history of cardiac arrest, defibrillator, angina)
• Ischemic heart disease
• self reported \>= 90 days of daily opioid use
• Beta Blocker Significant cognitive impairment

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35205, United States

Location

MeSH Terms

Conditions

Hypertension; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Raymond Jones, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 21, 2025
• Study Start: June 2, 2022
• Primary Completion: February 21, 2024
• Study Completion: February 21, 2024
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)