HIVSEANCT01860261
Pilot Study of the Effects of Exercise on Aging Among Older Persons With HIV
A study testing Aerobic and Strength Training Intervention in people with HIV, run by University of California, San Francisco at 1 site in United States.
Trial summary
This pilot study will test the feasibility and acceptability of a 12 week combined aerobic and strength training intervention among persons with HIV who are age 50 or older and do not exercise frequently, and its preliminary effects on aging-related outcomes . Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Aerobic and Strength Training Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Aug 2013
- 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-positive
- Age >=50 years on date of enrollment visit
- Less than 60min/week of vigorous exercise on average in the 90d prior to enrollment
- Able to complete study documents and activities in English (in this pilot we are only prepared to use English language questionnaires and instructional materials)
- Interested in and willing to do an exercise program
- Receiving continuous antiretroviral therapy (ART) for at least six months with an undetectable viral load at most recent clinic visit, or if not on ART then must have been off continuously for six months with no plan to start ART and have CD4 count > 400 cells/µl (to avoid enrolling patients at risk of developing opportunistic infections or other HIV-associated illnesses).
Who cannot join
- Medical conditions likely to limit the ability to participate in the planned exercise, including renal failure (creatinine > 2 mg/dl, congestive heart failure, significant lung disease, or severe osteoarthritis, Any health condition(s) that the study physician determines would preclude safe participation in the intervention or may require special modification of the exercise protocol (e.g. angina or myocardial infarction in the past 6 months)
- Substantial deconditioning or current impairment of physical function; this will be tested for by assessing whether patients can climb up and back down one flight of stairs (approximately 3 meters of elevation gain) without stopping 8.
- Unable or unwilling to actively participate in the intervention for the duration of the pilot study
- Unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco General Hospital
San Francisco, California, 94110
About this study
This pilot study will test the feasibility and acceptability of a 12 week combined aerobic and strength training intervention among persons with HIV who are age 50 or older and do not exercise frequently, and its preliminary effects on aging-related outcomes . The study uses an randomized, controlled trial design and is intended to lead to a larger clinical trial with long-term follow-up. The intervention incorporates small group instruction from a trainer, a small wearable accelerometer to provide accurate data on physical activity, and real-time feedback to participants about exercise levels. The primary outcome measure will be changes in fitness, measured as change in maximal oxygen consumption (VO2 max). The control group will receive a comparable exercise intervention after they complete 12 weeks of observation.
Read the detailed description
Approximately 40 individuals with HIV infection of at least 6 months duration who currently exercise infrequently will be randomized in a 2:1 ratio to either Intervention Arm (immediate exercise intervention program for 12 weeks duration), or the Control Arm (observation only for 12 weeks duration followed by treatment onset after observation is completed).
Persons assigned to the Intervention Arm will meet initially once per week with a personal trainer, and once per week in small groups with a personal trainer, for a total of two weekly sessions of assisted strength training. In addition, participants will be encouraged to engage in three sessions of aerobic exercise per week of gradually increasing intensity of about 40 minutes duration each, for the 12 week intervention period. Instruction in walking and running form and body awareness that may reduce the risk of injuries (ChiWalking and ChiRunning technique) will be provided to the Intervention Arm by a certified coach during three sessions over the course of the 12 week intervention period as part of the aerobic exercise plan.
Paid gym memberships will be provided for the 12 week treatment period for both groups (memberships for participants assigned to the Control Arm will not begin until the end of the 12 week observation period).
Data will be collected for strength training activity using the passive FitLinxx system at the study gym, and for aerobic steps and pace using accelerometers (Pebble by FitLinxx). Participants in both groups will be asked to wear accelerometers for the duration of the study period.
Participants will be evaluated at baseline, week 6 and week 12 for changes in lab values and questionnaire items. Change in fitness will be assessed using V02 max at baseline and week 12.
- Conditions
- HIV
- Being tested
- Aerobic and Strength Training Intervention
- Keywords
- HIV, AIDS, sedentary, fitness, aging, V02max, d-dimer, IL-6, CRP, ChiWalking, ChiRunning, aerobic exercise, strength training
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic and Strength Training InterventionBehavioural
Also called ChiWalking, ChiRunning
The exercise intervention has three components: (1) aerobic exercise with a metabolic equivalent of task (MET) energy expenditure of at least 900 MET-minutes per week; (2) strength training consisting of 2 sets of 4 upper body exercises (bench press, seated row, shoulder press, and pull down), 3 sets of 3 leg exercises (leg press, extension, and flexion) and 2 sets each of abdominal crunches and back extensions. Weights for each exercise will be gradually increased as participants can complete 12 repetitions for each set on 2 consecutive sessions, with participants performing strength training twice per week total. Three workshops on using ChiWalking or ChiRunning technique for achievement of aerobic activity goals will be provided to participants in the experimental arm.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic and Strength Training | Experimental | Participants in the Aerobic and Strength Training intervention group will receive a standardized aerobic and strength training exercise program for 12 weeks, including paid gym membership, personal training, and 3 workshops in ChiWalkRun technique. Receives: Behavioral: Aerobic and Strength Training Intervention |
| Control (delayed onset of intervention) | No intervention | After 12 weeks of active observation, this group will receive a modified version of the exercise intervention consisting of a free gym membership for 12 weeks, with limited personal training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2 max
Fitness will be assessed by maximal oxygen consumption (V02max) during a stationary bike test, to be completed at baseline and repeated 12 weeks later at the exit visit.
Measured: 12 weeks (baseline to exit)
Secondary outcomes (8)
METs
The measure will assess change in physical activity as summarized by METs (metabolic equivalent tasks), as measured by an accelerometer. Accelerometer data will be available for both the intervention and control groups.
Measured: 12 weeks (baseline to exit)
C-reactive protein
The investigators will assess change in high-sensitivity C-Reactive Protein using blood samples drawn and processed at baseline, week 6 (interim) and week 12 (exit).
Measured: Six weeks (baseline to week 6) and 12 weeks (baseline to exit)
NIH PROMIS 29
NIH PROMIS-29 Adult Profile measures will be collected by computerized self-assessment or paper questionnaire. These will include current depression and anxiety, physical functioning and mobility, fatigue, sleep, pain, and ability to participate in social roles and activities (this is a standardized instrument in NIH PROMIS called "The PROMIS-29 Adult Profile"). These data will be collected at baseline, week 6 (interim) and week 12 (exit) for both intervention and control groups.
Measured: 6 weeks (baseline to week 6) and 12 weeks (baseline to exit)
Feasibility of recruitment
The investigators will determine how many persons must be screened and enrolled in order to complete cohort enrollment targets.
Measured: 11 weeks (01Jan2013 to 14Mar2013)
Acceptability of study materials
The investigators will assess the appropriateness and quality of study procedures from the point of view of the study participants. To do this, they will collect questionnaire data. Key procedures (such as V02max, use of the accelerometer) will be rated as "highly acceptable", "acceptable/could be improved" or "needs improvement".
Measured: Six months (01Jan2013 - 30June2013)
Average distance walked/run per week
The average change in distance traveled by walking or running per week, as measured by an accelerometer, from the beginning of the study until week 12 will be compared between treatment groups.
Measured: From baseline to week 12
Injuries
Exercise related injuries, from self-report on questionnaires, will be compared between groups.
Measured: From study baseline to week 12
Self-reported physical activity
Change in self-reported physical activity levels, as average minutes of physical activity of different intensity levels, will be compared between groups using the International Physical Activity Questionnaire (IPAQ).
Measured: Change from week 0 to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study startJan 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederick M Hecht, M.D., Principal investigator, UCSF Osher Center for Integrated Medicine, UCSF Positive Health Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01860261
- Sponsor's protocol ID
- UCSF IRB 12-09153
- Acronym
- SEA
- Status last verified
- Nov 2023
- First submitted
- 29 Apr 2013
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Effects of Exercise on Aging Among Older Persons With HIV
- ClinicalTrials.gov ID
- NCT01860261
- Acronym / sponsor ID
- SEA / UCSF IRB 12-09153
- Conditions
- HIV
- Keywords
- HIV, AIDS, sedentary, fitness, aging, V02max, d-dimer, IL-6
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 22 May 2013 (estimated)
- 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.
This pilot study will test the feasibility and acceptability of a 12 week combined aerobic and strength training intervention among persons with HIV who are age 50 or older and do not exercise frequently, and its preliminary effects on aging-related outcomes . The study uses an randomized, controlled trial design and is intended to lead to a larger clinical trial with long-term follow-up. The intervention incorporates small group instruction from a trainer, a small wearable accelerometer to provide accurate data on physical activity, and real-time feedback to participants about exercise levels. The primary outcome measure will be changes in fitness, measured as change in maximal oxygen consumption (VO2 max). The control group will receive a comparable exercise intervention after they complete 12 weeks of observation.
Detailed description
Approximately 40 individuals with HIV infection of at least 6 months duration who currently exercise infrequently will be randomized in a 2:1 ratio to either Intervention Arm (immediate exercise intervention program for 12 weeks duration), or the Control Arm (observation only for 12 weeks duration followed by treatment onset after observation is completed).
Persons assigned to the Intervention Arm will meet initially once per week with a personal trainer, and once per week in small groups with a personal trainer, for a total of two weekly sessions of assisted strength training. In addition, participants will be encouraged to engage in three sessions of aerobic exercise per week of gradually increasing intensity of about 40 minutes duration each, for the 12 week intervention period. Instruction in walking and running form and body awareness that may reduce the risk of injuries (ChiWalking and ChiRunning technique) will be provided to the Intervention Arm by a certified coach during three sessions over the course of the 12 week intervention period as part of the aerobic exercise plan.
Paid gym memberships will be provided for the 12 week treatment period for both groups (memberships for participants assigned to the Control Arm will not begin until the end of the 12 week observation period).
Data will be collected for strength training activity using the passive FitLinxx system at the study gym, and for aerobic steps and pace using accelerometers (Pebble by FitLinxx). Participants in both groups will be asked to wear accelerometers for the duration of the study period.
Participants will be evaluated at baseline, week 6 and week 12 for changes in lab values and questionnaire items. Change in fitness will be assessed using V02 max at baseline and week 12.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic and Strength Training | Experimental | Behavioral: Aerobic and Strength Training InterventionParticipants in the Aerobic and Strength Training intervention group will receive a standardized aerobic and strength training exercise program for 12 weeks, including paid gym membership, personal training, and 3 workshops in ChiWalkRun technique. |
| Control (delayed onset of intervention) | No intervention | –After 12 weeks of active observation, this group will receive a modified version of the exercise intervention consisting of a free gym membership for 12 weeks, with limited personal training. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- HIV-positive
- Age >=50 years on date of enrollment visit
- Less than 60min/week of vigorous exercise on average in the 90d prior to enrollment
- Able to complete study documents and activities in English (in this pilot we are only prepared to use English language questionnaires and instructional materials)
- Interested in and willing to do an exercise program
Key exclusion criteria (4 listed)
- Medical conditions likely to limit the ability to participate in the planned exercise, including renal failure (creatinine > 2 mg/dl, congestive heart failure, significant lung disease, or severe osteoarthritis, Any health condition(s) that the study physician determines would preclude safe participation in the intervention or may require special modification of the exercise protocol (e.g. angina or myocardial infarction in the past 6 months)
- Substantial deconditioning or current impairment of physical function; this will be tested for by assessing whether patients can climb up and back down one flight of stairs (approximately 3 meters of elevation gain) without stopping 8.
- Unable or unwilling to actively participate in the intervention for the duration of the pilot study
- Unable to provide informed consent.
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 |
|---|---|---|
| Aerobic and Strength Training InterventionAlso: ChiWalking, ChiRunningThe exercise intervention has three components: (1) aerobic exercise with a metabolic equivalent of task (MET) energy expenditure of at least 900 MET-minutes per week; (2) strength training consisting of 2 sets of 4 upper body exercises (bench press, seated row, shoulder press, and pull down), 3 sets of 3 leg exercises (leg press, extension, and flexion) and 2 sets each of abdominal crunches and back extensions. Weights for each exercise will be gradually increased as participants can complete 12 repetitions for each set on 2 consecutive sessions, with participants performing strength training twice per week total. Three workshops on using ChiWalking or ChiRunning technique for achievement of aerobic activity goals will be provided to participants in the experimental arm. | Behavioural | Aerobic and Strength Training |
Primary outcome
VO2 max
Time frame: 12 weeks (baseline to exit)
Fitness will be assessed by maximal oxygen consumption (V02max) during a stationary bike test, to be completed at baseline and repeated 12 weeks later at the exit visit.
8 secondary outcomes
METs
Time frame: 12 weeks (baseline to exit)
C-reactive protein
Time frame: Six weeks (baseline to week 6) and 12 weeks (baseline to exit)
NIH PROMIS 29
Time frame: 6 weeks (baseline to week 6) and 12 weeks (baseline to exit)
Feasibility of recruitment
Time frame: 11 weeks (01Jan2013 to 14Mar2013)
Acceptability of study materials
Time frame: Six months (01Jan2013 - 30June2013)
Average distance walked/run per week
Time frame: From baseline to week 12
Injuries
Time frame: From study baseline to week 12
Self-reported physical activity
Time frame: Change from week 0 to week 12
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 8 Nov 2023.
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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.
Frederick M Hecht, M.D. principal investigator
UCSF Osher Center for Integrated Medicine, UCSF Positive Health Program
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic and Strength Training Intervention in people with HIV, run by University of California, San Francisco 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 4 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 8 Nov 2023. 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?
VO2 max (time frame: 12 weeks (baseline to exit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2023.