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Completed

NCT Number: NCT01860261

Pilot Study of the Effects of Exercise on Aging Among Older Persons With HIV

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Aerobic and Strength Training Intervention

Behavioral

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.

Other names: ChiWalking, ChiRunning

Primary outcomes

  1. 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.

Secondary outcomes

  1. METs

    Time frame: 12 weeks (baseline to exit)

    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.

  2. C-reactive protein

    Time frame: Six weeks (baseline to week 6) and 12 weeks (baseline to exit)

    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).

  3. NIH PROMIS 29

    Time frame: 6 weeks (baseline to week 6) and 12 weeks (baseline to exit)

    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.

  4. Feasibility of recruitment

    Time frame: 11 weeks (01Jan2013 to 14Mar2013)

    The investigators will determine how many persons must be screened and enrolled in order to complete cohort enrollment targets.

  5. Acceptability of study materials

    Time frame: Six months (01Jan2013 - 30June2013)

    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".

  6. Average distance walked/run per week

    Time frame: From baseline to week 12

    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.

  7. Injuries

    Time frame: From study baseline to week 12

    Exercise related injuries, from self-report on questionnaires, will be compared between groups.

  8. Self-reported physical activity

    Time frame: Change from week 0 to week 12

    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).

Other outcomes

  1. CD4+ T-cell count

    Time frame: change from week 0 to week 12

    Change in CD4+ T cell counts during the intervention will be compared between groups.

  2. d-dimer

    Time frame: change from week 0 to week 12

    If funding permits, change in d-dimer will be compared between groups form week 0 to week 12.

  3. 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

    If funding permits, change in IL-6 will be compared between groups, from week 0 to week 12.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Acronym: SEA

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 22, 2013
Registry last updated
Nov 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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