Pilot Study of the Effects of Exercise on Aging Among Older Persons With HIV (SEA)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Pilot Study of the Effects of Exercise on Aging Among Older Persons With HIV|
- VO2 max [ Time Frame: 12 weeks (baseline to exit) ] [ Designated as safety issue: No ]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.
- METs [ Time Frame: 12 weeks (baseline to exit) ] [ Designated as safety issue: No ]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.
- C-reactive protein [ Time Frame: Six weeks (baseline to week 6) and 12 weeks (baseline to exit) ] [ Designated as safety issue: No ]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).
- NIH PROMIS 29 [ Time Frame: 6 weeks (baseline to week 6) and 12 weeks (baseline to exit) ] [ Designated as safety issue: No ]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.
- Feasibility of recruitment [ Time Frame: 11 weeks (01Jan2013 to 14Mar2013) ] [ Designated as safety issue: No ]The investigators will determine how many persons must be screened and enrolled in order to complete cohort enrollment targets.
- Acceptability of study materials [ Time Frame: Six months (01Jan2013 - 30June2013) ] [ Designated as safety issue: No ]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".
- Average distance walked/run per week [ Time Frame: From baseline to week 12 ] [ Designated as safety issue: No ]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.
- Injuries [ Time Frame: From study baseline to week 12 ] [ Designated as safety issue: Yes ]Exercise related injuries, from self-report on questionnaires, will be compared between groups.
- Self-reported physical activity [ Time Frame: Change from week 0 to week 12 ] [ Designated as safety issue: No ]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).
- CD4+ T-cell count [ Time Frame: change from week 0 to week 12 ] [ Designated as safety issue: Yes ]Change in CD4+ T cell counts during the intervention will be compared between groups.
- d-dimer [ Time Frame: change from week 0 to week 12 ] [ Designated as safety issue: Yes ]If funding permits, change in d-dimer will be compared between groups form week 0 to week 12.
- CD4 cluster of differentiation 4 Other Pre-Specified Outcome Measure IL ileum immature lung independent laboratory inguinal ligament interleukin (IL)-6 [ Time Frame: week 0 to week 12 ] [ Designated as safety issue: No ]If funding permits, change in IL-6 will be compared between groups, from week 0 to week 12.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||August 2019|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Experimental: Aerobic and Strength Training
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.
Behavioral: Aerobic and Strength Training Intervention
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.
No Intervention: Control (delayed onset of 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01860261
|United States, California|
|San Francisco General Hospital|
|San Francisco, California, United States, 94110|
|Principal Investigator:||Frederick M Hecht, M.D.||UCSF Osher Center for Integrated Medicine, UCSF Positive Health Program|