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HIVHARCNCT06888596

Feasibility of HIIT in Older Adults with HIV and Hypertension

A study testing Exercise in people with HIV and Hypertension, run by University of Alabama at Birmingham at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
HIV, Hypertension, Exercise
What is being tested?
Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteUnited States
Study dates
2 Jun 2022to 21 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • >= 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Alabama at Birmingham

    Birmingham, Alabama, 35205

Other trials in United States

About this study

Official title: Feasibility of High-intensity Interval Training in Older Adults with HIV and Co-Occurring Hypertension

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.

Read more

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.

Read the detailed description

Life expectancy for people with HIV (PWH) has increased in the antiretroviral therapy (ART) era and shifted the demography of the HIV epidemic toward the aging population. By the year 2030, an estimated 70% of PWH in the United States will be at least 50 years of age, thus implicating age-related comorbidities as a potential challenge for PWH. In particular, hypertension represents a major co-morbidity burden among PWH. Regular physical activity improves function in adult populations with comorbidities and prevents functional declines.

Maintenance of functional status, determined by measures of physical performance, is a good predictor of cardiovascular outcomes among older PWH with co-occurring hypertension. Exercise is the only intervention with evidence to support its use in treating age-related functional declines. Exercise is a strategy employed by PWH and rehabilitation professionals to address the functional decline and improve the health and quality of life of those individuals. Exercise interventions in PWH support the evidence that exercise can improve cardiovascular, metabolic, and functional measures in younger PWH. Though meeting the recommended guidelines for regular physical activity in older adults is feasible, the repercussions of high-intensity interval training in improving physical function are unknown despite evidence displaying functional improvements following low and moderate-intensity interventions.

While many exercise studies have reflected the benefit of six to twelve weeks of exercise, many report that the results are limited to the participants who are motivated with good compliance and completion profiles. In real-world situations, adherence to exercise, particularly high-intensity exercise, may fall below desirable levels and hinder the effectiveness of the programs. This may be due, in part, to perceived benefits and barriers to exercise in older PWH. Despite the growing body of research aimed at determinants of adherence to pharmaceutical treatment, adherence to exercise among PWH remains an under-researched area.

The purpose here is to evaluate the efficacy and efficacy of a high-intensity interval training intervention for improving the physical function of older PWH and co-occurring hypertension. The central hypothesis is that high-intensity exercise will improve functional decrements of older PWH. An evaluation of high-intensity interval training in PWH may be important as this population has impairment in functional outcomes compared with age-matched uninfected controls, with even greater impairments among older PWH. Underlying inflammation, pain, and skeletal muscle degradation related to HIV suggest that older PWH may require higher doses of exercise to restore or achieve levels of physical function. Thus, the objective of this pilot application is to evaluate the efficacy and feasibility of short-term high-intensity interval training among 15-20 older PWH > 50 years with co-occurring hypertension, recruited from CNICS. To achieve this objective, the investigators propose to conduct a pilot study to address the following specific aims, which are crucial to designing future studies:

Specific Aim 1: To assess the integrity of the study protocol, including safety, adherence to the interventions, and retention to study visits, in order to develop standard operating procedures for guidance of a future trial. Additionally the investigators will determine participant perceived benefits and barriers, assessed by the Exercise Benefits and Barriers Scale.

Specific Aim 2: To assess the variance of secondary outcomes and effects of the intervention on outcomes including 1) 6-minute walk test, 2) lower extremity function, assessed by the Short Physical Performance Battery (SPPB), 3) skeletal muscle strength and endurance, assessed by isokinetic muscle testing, 4) chronic pain, evaluated by the Brief Pain Inventory and Pain assessments, 5) markers of vascular health (e.g., arterial stiffness), 6) circulating indices of inflammation (e.g. inflammatory profile [IL-1β, TNF-α, IL-6, CRP, IL-8, IL-10], skeletal muscle degradation [creatine kinase], and metabolism [fasting glucose, HA1C, lactate, and fasting cholesterol].

Being tested
Exercise
Keywords
HIIT
Medical subject headings
Hypertension, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseBehavioural

    Also called HIIT

    Exercise using cycle ergometer

Study groups in NCT06888596
Study groupRoleWhat they receive
High-Intensity Interval TrainingExperimentalParticipants 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.
Receives: Behavioral: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From enrollment to the end of treatment at 6 weeks

Secondary outcomes (6)
  1. Blood Pressure

    Blood pressure was assessed using oscillometry following quiet rest.

    Measured: From enrollment to the end of treatment at 6 weeks

  2. Perceived Benefits and Barriers to Exercise

    The Exercise Barriers and Benefits Scale was developed to assess people's perceptions on exercise and benefits barriers to exercise. The instrument has a four-response, forced-choice Likert-type format with responses ranging from 1 ('Strongly Disagree') to 4 ('Strongly Agree'). Scores on the total instrument can range from 43 to 172, where the higher the score, the more positively the individual perceives exercise. Additionally, the EBBS is separated into a 29-item Benefits Scale and a 14-item Barriers scale.

    Measured: Baseline and 6 weeks

  3. Rating of Perceived Exertion

    measured using the Borg RPE 6-20 Scale

    Measured: Week 1-6 of Intervention

  4. Body Mass Index

    Body mass index was assessed using height and weight at baseline and post-intervention.

    Measured: From enrollment to the end of treatment at 6 weeks

  5. Cardiorespiratory Fitness

    Cardiorespiratory fitness was assessed using the fast-paced 6-minute walk test

    Measured: From enrollment to the end of treatment at 6 weeks

  6. Physical Function

    SPPB was performed as a measure of functional status through the domains of balance, strength, and gait measurements. The balance tests consisted of standing static balance in three positions; lower limb strength through sit-to-stand from a chair; and walking speed at a normal pace (4-meter walk test). Each test is scored from 0 (inability to perform the task) to 4 points (best performance) with total SPPB scores ranging from 0 to 12 points across all tasks.

    Measured: From enrollment to the end of treatment at 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2025
  2. Study start2 Jun 2022
  3. Primary completion21 Feb 2024
  4. Study completion21 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06888596
Sponsor's protocol ID
IRB-300009214
Other IDs
UWSC14238
Acronym
HARC
Status last verified
Mar 2025
First submitted
13 Mar 2025
Last updated
21 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: These data are very preliminary and thus exploratory in nature. This was used to build a larger intervention. However, should researchers request information, we will disseminate IPD as deemed necessary.

Publications

  • Hankes MJ, Taylor TL, Zumbro EL, Enogela EM, Dodds F, Tharpe M, Sint Jago SC, Goodin BR, Willig AL, Buford TW, Jones R. Feasibility of high-intensity interval training in older adults with HIV and co-occurring hypertension. Pilot Feasibility Stud. 2026 Mar 31;12(1):62. doi: 10.1186/s40814-026-01812-y.

    PubMed 41918041

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with HIV and Hypertension, run by University of Alabama at Birmingham at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility and Acceptability (time frame: From enrollment to the end of treatment at 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06888596, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.

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