HivHEALTHNCT04550676
High-Intensity Exercise to Attenuate Limitations and Train Habits in Older Adults With HIV
A study testing HIIT (intervention) and Coaching in people with Hiv and Fatigue, run by University of Colorado, Denver at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hiv, Fatigue, Mobility Limitation
- What is being tested?
- HIIT (intervention) and Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Apr 2021to 24 Nov 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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,
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- 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
Who cannot join
- 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.
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- 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 study PIs:
- 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,
- 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 > 8.0, 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),
- Persons who, in the judgment of the study physician, appear to have unstable health or are incapable of safely participating in the exercise intervention.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Part 2 of the Study (both CO and WA)
Aurora, Colorado, 80045
University of Colorado - Anschutz Medical Campus
Aurora, Colorado, 80045
University of Washington
Seattle, Washington, 98195
About this study
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.
Read the detailed description
This is a multi-site, randomized, single-blind (researchers), active treatment concurrent control trial with individuals aged 50 and older 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.
Physical function will be measured by a 400-meter walk test (400MWT) and the short physical performance battery in its original (SPPB) and modified (mSPPB) forms. Fatigue will be measured by the Lee Fatigue Scale (LFS) - a 7-item visual analog self-report scale that asks participants to rate from 0 to 10 how they feel "right now." Mitochondrial bioenergetics will be assessed through blood draws, muscle biopsies and mitochondrial assays. Adherence to physical activity (PA) will be analyzed through ActiGraphy - measurement of PA duration and intensity on three planes of movement captured through PA monitors.
Finally, perceptions of PA will be determined through the analysis of qualitative interviews.
The hypotheses are that that investigators will see greater changes in mitochondrial bioenergetics with HIIT (AIM 1), and that these changes will be related to improved physical function and fatigue (Aim 2). The investigators expect that HIIT will result in greater exercise satisfaction and likelihood of long-term continuation of exercise (Aim 3). Using a coaching intervention for self-directed exercise that combines motivational interviewing and personalized support during the maintenance phase (Aim 3), the investigators seek to develop the ideal "cocktail" to promote healthspan among older PWH in the current era of ART.
- Conditions
- Hiv, Fatigue, Mobility Limitation
- Being tested
- HIIT (intervention), CME (active control), Coaching, Control text message
- Keywords
- mitochondrial function, physical function, frailty, exercise
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Fatigue, Mobility Limitation, Frailty, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIIT (intervention)Behavioural
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.
CME (active control)Behavioural
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.
CoachingBehavioural
The coaching intervention consists of daily text messages tailored to the individual participant's self-reported symptom experiences and barriers to exercise on that specific day. Tailored messages address a range of possible barriers to adherence based on past research, and will provide advice and guidance. Text messages are varied each week so that even if participants continue to report the same barriers they receive different text messages.
Control text messageBehavioural
The control group receives general weekly texts from the study team (i.e., "Hope you are doing well!"), 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.
| Study group | Role | What they receive |
|---|---|---|
| High intensity interval training (HIIT) | Experimental | Part 1 Receives: Behavioral: HIIT (intervention) |
| Continuous moderate intensity exercise (CME) | Active comparator | Part 1 Receives: Behavioral: CME (active control) |
| Coaching (following HIIT) | Experimental | Part 2 Receives: Behavioral: Coaching |
| Control (following CME) | Active comparator | Part 2 Receives: Behavioral: Control text message |
| Control (following HIIT) | Active comparator | Not described Receives: Behavioral: Control text message |
| Coaching (following CME) | Experimental | Not described Receives: Behavioral: Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physical Function (Part 1)
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.
Measured: 0-16 weeks
Secondary outcomes (1)
Change in Fatigue (Part 1)
The Lee Fatigue Score measures severity of fatigue. Possible scores range from 0 to 10, with higher scores indicating a worse outcome.
Measured: 0-16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start2 Apr 2021
- Primary completion24 Jan 2025
- Study completion24 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Sequential
- Model description
- Participants will first be randomized to continuous moderate intensity (CME) or high-intensity interval training (HIIT) for 16 weeks (primary outcomes measured from 0 to 16 weeks). After 16 weeks, participants will be re-randomized to 12-week coaching intervention or control to investigate the effects of biobehavioral support following CME or HIIT.
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Case Western Reserve University, University of Washington
- Responsible party
- Sponsor
- Investigators
- Kristine Erlandson, MD, Principal investigator, University of Colorado, DenverAllison Webel, PhD, RN, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550676
- Sponsor's protocol ID
- 19-1985
- Acronym
- HEALTH
- Status last verified
- May 2026
- First submitted
- 10 Sep 2020
- Last updated
- 28 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified data set may be shared with investigators upon written request, review and approval by institutional officials, and establishing a data use agreement. Investigators requesting other study documents (protocol, analysis plan, informed consent, code, etc) should contact the study team.
Publications
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.
PubMed 34039876Cook PF, Webel AR, Wilson MP, Davey CH, Oliveira VHF, Khuu V, Matzio S, Kulik GL, MaWhinney S, Jankowski CM, Erlandson KM. Efficacy of Tailored Messages for 28-Week Exercise Sustainability in People with HIV. AIDS Behav. 2026 Sep 30. doi: 10.1007/s10461-026-05317-w. Online ahead of print.
PubMed 42814385Iriarte E, Hawkins KL, Wilson MP, Webel AR, Oliveira VH, Khuu V, Kulik GL, Cook P, Ghosh D, Jankowski C, Erlandson KM. The Impact of Social Vulnerability on Exercise Outcomes: A Longitudinal Study of Physical Function in Older People With HIV. J Int Assoc Provid AIDS Care. 2026 Jan-Dec;25:23259582261448699. doi: 10.1177/23259582261448699. Epub 2026 May 12.
PubMed 42124323Kulik GL, Oliveira VHF, Wilson MP, Khuu V, Jankowski CM, Dillon S, Cook P, MaWhinney S, Ghosh D, Webel AR, Erlandson KM. The effects of high-intensity interval training versus continuous moderate-intensity exercise on body composition among older adults with HIV. J Gerontol A Biol Sci Med Sci. 2026 May 7;81(6):glag113. doi: 10.1093/gerona/glag113.
PubMed 42080214
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Intensity Exercise to Attenuate Limitations and Train Habits in Older Adults With HIV
- ClinicalTrials.gov ID
- NCT04550676
- Acronym / sponsor ID
- HEALTH / 19-1985
- Conditions
- Hiv, Fatigue, Mobility Limitation
- Keywords
- mitochondrial function, physical function, frailty, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Case Western Reserve University, University of Washington
- Study start
- 2 Apr 2021 (actual)
- Primary completion
- 24 Jan 2025 (actual)
- Study completion
- 24 Nov 2025 (actual)
- First posted
- 16 Sep 2020 (actual)
- Results
- Posted 28 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multi-site, randomized, single-blind (researchers), active treatment concurrent control trial with individuals aged 50 and older 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.
Physical function will be measured by a 400-meter walk test (400MWT) and the short physical performance battery in its original (SPPB) and modified (mSPPB) forms. Fatigue will be measured by the Lee Fatigue Scale (LFS) - a 7-item visual analog self-report scale that asks participants to rate from 0 to 10 how they feel "right now." Mitochondrial bioenergetics will be assessed through blood draws, muscle biopsies and mitochondrial assays. Adherence to physical activity (PA) will be analyzed through ActiGraphy - measurement of PA duration and intensity on three planes of movement captured through PA monitors.
Finally, perceptions of PA will be determined through the analysis of qualitative interviews.
The hypotheses are that that investigators will see greater changes in mitochondrial bioenergetics with HIIT (AIM 1), and that these changes will be related to improved physical function and fatigue (Aim 2). The investigators expect that HIIT will result in greater exercise satisfaction and likelihood of long-term continuation of exercise (Aim 3). Using a coaching intervention for self-directed exercise that combines motivational interviewing and personalized support during the maintenance phase (Aim 3), the investigators seek to develop the ideal "cocktail" to promote healthspan among older PWH in the current era of ART.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Participants will first be randomized to continuous moderate intensity (CME) or high-intensity interval training (HIIT) for 16 weeks (primary outcomes measured from 0 to 16 weeks). After 16 weeks, participants will be re-randomized to 12-week coaching intervention or control to investigate the effects of biobehavioral support following CME or HIIT.
| Arm | Type | Receives |
|---|---|---|
| High intensity interval training (HIIT) | Experimental | Behavioral: HIIT (intervention)Part 1 |
| Continuous moderate intensity exercise (CME) | Active comparator | Behavioral: CME (active control)Part 1 |
| Coaching (following HIIT) | Experimental | Behavioral: CoachingPart 2 |
| Control (following CME) | Active comparator | Behavioral: Control text messagePart 2 |
| Control (following HIIT) | Active comparator | Behavioral: Control text message |
| Coaching (following CME) | Experimental | Behavioral: Coaching |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIIT (intervention)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. | Behavioural | High intensity interval training (HIIT) |
| CME (active control)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. | Behavioural | Continuous moderate intensity exercise (CME) |
| CoachingThe coaching intervention consists of daily text messages tailored to the individual participant's self-reported symptom experiences and barriers to exercise on that specific day. Tailored messages address a range of possible barriers to adherence based on past research, and will provide advice and guidance. Text messages are varied each week so that even if participants continue to report the same barriers they receive different text messages. | Behavioural | Coaching (following CME), Coaching (following HIIT) |
| Control text messageThe control group receives general weekly texts from the study team (i.e., "Hope you are doing well!"), 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. | Behavioural | Control (following CME), Control (following HIIT) |
Primary outcome
Change in Physical Function (Part 1)
Time frame: 0-16 weeks
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.
1 secondary outcome
Change in Fatigue (Part 1)
Time frame: 0-16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 34039876Oliveira 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.
- Derived from this study: PubMed 42814385Cook PF, Webel AR, Wilson MP, Davey CH, Oliveira VHF, Khuu V, Matzio S, Kulik GL, MaWhinney S, Jankowski CM, Erlandson KM. Efficacy of Tailored Messages for 28-Week Exercise Sustainability in People with HIV. AIDS Behav. 2026 Sep 30. doi: 10.1007/s10461-026-05317-w. Online ahead of print.
- Derived from this study: PubMed 42124323Iriarte E, Hawkins KL, Wilson MP, Webel AR, Oliveira VH, Khuu V, Kulik GL, Cook P, Ghosh D, Jankowski C, Erlandson KM. The Impact of Social Vulnerability on Exercise Outcomes: A Longitudinal Study of Physical Function in Older People With HIV. J Int Assoc Provid AIDS Care. 2026 Jan-Dec;25:23259582261448699. doi: 10.1177/23259582261448699. Epub 2026 May 12.
- Derived from this study: PubMed 42080214Kulik GL, Oliveira VHF, Wilson MP, Khuu V, Jankowski CM, Dillon S, Cook P, MaWhinney S, Ghosh D, Webel AR, Erlandson KM. The effects of high-intensity interval training versus continuous moderate-intensity exercise on body composition among older adults with HIV. J Gerontol A Biol Sci Med Sci. 2026 May 7;81(6):glag113. doi: 10.1093/gerona/glag113.
- Individual participant dataSharing planned: Yes. A de-identified data set may be shared with investigators upon written request, review and approval by institutional officials, and establishing a data use agreement. Investigators requesting other study documents (protocol, analysis plan, informed consent, code, etc) should contact the study team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristine Erlandson, MD principal investigator
University of Colorado, Denver
Allison Webel, PhD, RN principal investigator
University of Washington
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIIT (intervention) and Coaching in people with Hiv and Fatigue, run by University of Colorado, Denver at 3 sites 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 9 inclusion and 18 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 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Yes. Results are posted in the registry (first posted 28 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Physical Function (Part 1) (time frame: 0-16 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 NCT04550676, which also lists 4 linked publications.
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 28 May 2026.