HIV-1-infectionFLEXNCT03399136
Fitness and Longevity in Exercise
A study testing Exercise training in people with HIV-1-infection and Aging, run by University of Maryland, Baltimore.
Trial summary
The study objective was to determine the safety and efficacy of aerobic exercise in older HIV-infected men in a randomized trial comparing different levels of exercise intensity. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- HIV-1-infection, Aging
- What is being tested?
- Exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- 19 Jul 2007to 23 Apr 2012
- 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
- HIV+
- stable combination antiretroviral therapy (cART)
Who cannot join
- AIDS defining conditions in the prior six months
- Conditions that increase the risk of exercise training per the American College of Sports Medicine (ACSM)
About this study
The study objective was to determine the safety and efficacy of aerobic exercise in older HIV-infected men in a randomized trial comparing different levels of exercise intensity.
Read the detailed description
The study was a randomized trial of moderate-intensity versus high-intensity aerobic exercise (AEX) training in older HIV-infected adults. Funding was provided by K23 AG024896 (PI, Oursler) and the UMB Claude D. Pepper Older Americans Independence Center P60 AG12583 (PI, Goldberg).
The central hypothesis was that high-intensity AEX training is well-tolerated and significantly increases aerobic capacity in older HIV-infected adults.
The study met its objectives:
- Scientific AIMS met:
- High-intensity AEX training significantly increases aerobic capacity
- Both moderate-intensity and high-intensity AEX training improve ambulatory function and endurance.
- Activity of skeletal muscle oxidative enzymes is reduced, and associated with aerobic capacity.
- Feasibility Objectives met:
- AEX training is safe and well-tolerated in older HIV-infected adults.
- Skeletal muscle punch biopsy is safe and well-tolerated in older HIV-infected adults.
- Preliminary data was collected on plasma biomarkers of inflammation.
- Conditions
- HIV-1-infection, Aging
- Being tested
- Exercise training
- Keywords
- Exercise training, Intervention, Aerobic capacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingBehavioural
Participants attended center-based exercise sessions three times per week at the research exercise training facility located at the Baltimore VA Medical Center. All exercise training was performed under the supervision of research exercise physiologists. Heart rate (HR) was measured continuously during each session using a Polar HR watch and chest strap allowing for assessment and maintenance of treatment fidelity. Exercise logs included details on exercise type, duration, time in target heart rate zone, blood pressure and perceived intensity during each training session.
| Study group | Role | What they receive |
|---|---|---|
| Moderate-intensity aerobic exercise | Experimental | In the moderate-intensity aerobic exercise group, participants performed a self-paced 1-mile walk (3-5 METs) on an indoor track in the same exercise center as the high-intensity exercise group. Initial sessions lasted 20-30 minutes and were increased weekly to 45 minutes in parallel to the duration of the high-intensity exercise group. Receives: Behavioral: Exercise training |
| High-intensity aerobic exercise | Experimental | In the high-intensity aerobic exercise group, exercise training was performed on a motorized treadmill with occasional substitution with the elliptical machine as needed for joint pain. Target heart rate was based on the baseline treadmill test and was calculated as percentage of the heart rate reserve (HRR=maximal HR-resting HR). Initially, participants trained for 20-30 minutes at 50-60% of HRR. Duration and intensity was increased by 10% weekly so that within 5-7 weeks the aerobic exercise sessions lasted 30-45 minutes at 70-85% of HRR and at the end of the 16 weeks lasted 40-45 minutes at 75-90% of HRR. Receives: Behavioral: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Cardiorespiratory Fitness at 16 weeks
Cardiorespiratory Fitness measured by VO2peak
Measured: 16-weeks
Secondary outcomes (3)
Change from baseline Six-minute walk distance at 16 weeks
Distance walked at normal pace in 6 minutes
Measured: 16-weeks
Change from baseline body composition at 16 weeks
body composition measured as total and regional lean tissue and fat mass (DXA)
Measured: 16-weeks
Change from baseline exercise endurance at 16 weeks
exercise endurance measured as time on treadmill during modified Bruce protocol
Measured: 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 Jan 2018
- Study start19 Jul 2007
- Primary completion29 Oct 2010
- Study completion23 Apr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KrisAnn Oursler, University of Maryland, Baltimore
- Investigators
- Krisann Oursler, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399136
- Sponsor's protocol ID
- HP-00042601
- Acronym
- FLEX
- Status last verified
- Dec 2022
- First submitted
- 4 Jan 2018
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data, which include PHI, are available from the University of Maryland School of Medicine Institutional Review Board for researchers who meet the criteria for access to confidential data.
Publications
Ortmeyer HK, Ryan AS, Hafer-Macko C, Oursler KK. Skeletal muscle cellular metabolism in older HIV-infected men. Physiol Rep. 2016 May;4(9):e12794. doi: 10.14814/phy2.12794.
PubMed 27166139
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fitness and Longevity in Exercise
- ClinicalTrials.gov ID
- NCT03399136
- Acronym / sponsor ID
- FLEX / HP-00042601
- Conditions
- HIV-1-infection, Aging
- Keywords
- Exercise training, Intervention, Aerobic capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 19 Jul 2007 (actual)
- Primary completion
- 29 Oct 2010 (actual)
- Study completion
- 23 Apr 2012 (actual)
- First posted
- 16 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study objective was to determine the safety and efficacy of aerobic exercise in older HIV-infected men in a randomized trial comparing different levels of exercise intensity.
Detailed description
The study was a randomized trial of moderate-intensity versus high-intensity aerobic exercise (AEX) training in older HIV-infected adults. Funding was provided by K23 AG024896 (PI, Oursler) and the UMB Claude D. Pepper Older Americans Independence Center P60 AG12583 (PI, Goldberg).
The central hypothesis was that high-intensity AEX training is well-tolerated and significantly increases aerobic capacity in older HIV-infected adults.
The study met its objectives:
- Scientific AIMS met:
- High-intensity AEX training significantly increases aerobic capacity
- Both moderate-intensity and high-intensity AEX training improve ambulatory function and endurance.
- Activity of skeletal muscle oxidative enzymes is reduced, and associated with aerobic capacity.
- Feasibility Objectives met:
- AEX training is safe and well-tolerated in older HIV-infected adults.
- Skeletal muscle punch biopsy is safe and well-tolerated in older HIV-infected adults.
- Preliminary data was collected on plasma biomarkers of inflammation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate-intensity aerobic exercise | Experimental | Behavioral: Exercise trainingIn the moderate-intensity aerobic exercise group, participants performed a self-paced 1-mile walk (3-5 METs) on an indoor track in the same exercise center as the high-intensity exercise group. Initial sessions lasted 20-30 minutes and were increased weekly to 45 minutes in parallel to the duration of the high-intensity exercise group. |
| High-intensity aerobic exercise | Experimental | Behavioral: Exercise trainingIn the high-intensity aerobic exercise group, exercise training was performed on a motorized treadmill with occasional substitution with the elliptical machine as needed for joint pain. Target heart rate was based on the baseline treadmill test and was calculated as percentage of the heart rate reserve (HRR=maximal HR-resting HR). Initially, participants trained for 20-30 minutes at 50-60% of HRR. Duration and intensity was increased by 10% weekly so that within 5-7 weeks the aerobic exercise sessions lasted 30-45 minutes at 70-85% of HRR and at the end of the 16 weeks lasted 40-45 minutes at 75-90% of HRR. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- HIV+
- stable combination antiretroviral therapy (cART)
Key exclusion criteria (2 listed)
- AIDS defining conditions in the prior six months
- Conditions that increase the risk of exercise training per the American College of Sports Medicine (ACSM)
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 |
|---|---|---|
| Exercise trainingParticipants attended center-based exercise sessions three times per week at the research exercise training facility located at the Baltimore VA Medical Center. All exercise training was performed under the supervision of research exercise physiologists. Heart rate (HR) was measured continuously during each session using a Polar HR watch and chest strap allowing for assessment and maintenance of treatment fidelity. Exercise logs included details on exercise type, duration, time in target heart rate zone, blood pressure and perceived intensity during each training session. | Behavioural | High-intensity aerobic exercise, Moderate-intensity aerobic exercise |
Primary outcome
Change from baseline Cardiorespiratory Fitness at 16 weeks
Time frame: 16-weeks
Cardiorespiratory Fitness measured by VO2peak
3 secondary outcomes
Change from baseline Six-minute walk distance at 16 weeks
Time frame: 16-weeks
Change from baseline body composition at 16 weeks
Time frame: 16-weeks
Change from baseline exercise endurance at 16 weeks
Time frame: 16-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- Results publication: PubMed 27166139Ortmeyer HK, Ryan AS, Hafer-Macko C, Oursler KK. Skeletal muscle cellular metabolism in older HIV-infected men. Physiol Rep. 2016 May;4(9):e12794. doi: 10.14814/phy2.12794.
- Individual participant dataSharing planned: No. Data, which include PHI, are available from the University of Maryland School of Medicine Institutional Review Board for researchers who meet the criteria for access to confidential data.
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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.
Krisann Oursler, MD principal investigator
University of Maryland, Baltimore
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with HIV-1-infection and Aging, run by University of Maryland, Baltimore.
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 2 inclusion and 2 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 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from baseline Cardiorespiratory Fitness at 16 weeks (time frame: 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 NCT03399136, 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 6 Dec 2022; AzTrials last refreshed its copy on 29 Oct 2026.