Clinical trial NCT01860261: Pilot Study of the Effects of Exercise on Aging Among Older Persons With HIV
Official title: Pilot Study of the Effects of Exercise on Aging Among Older Persons With HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
AIDS
sedentary
fitness
aging
V02max
d-dimer
IL-6
CRP
ChiWalking
ChiRunning
aerobic exercise
strength training
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2013-05-22
Enrollment: 34
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 . 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.

Eligibility criteria: 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.

Primary outcomes:
measure: VO2 max
timeFrame: 12 weeks (baseline to exit)
Secondary outcomes:
measure: METs
timeFrame: 12 weeks (baseline to exit)
measure: C-reactive protein
timeFrame: Six weeks (baseline to week 6) and 12 weeks (baseline to exit)
measure: NIH PROMIS 29
timeFrame: 6 weeks (baseline to week 6) and 12 weeks (baseline to exit)
measure: Feasibility of recruitment
timeFrame: 11 weeks (01Jan2013 to 14Mar2013)
measure: Acceptability of study materials
timeFrame: Six months (01Jan2013 - 30June2013)
measure: Average distance walked/run per week
timeFrame: From baseline to week 12
measure: Injuries
timeFrame: From study baseline to week 12
measure: Self-reported physical activity
timeFrame: Change from week 0 to week 12
Other outcomes:
measure: CD4+ T-cell count
timeFrame: change from week 0 to week 12
measure: d-dimer
timeFrame: change from week 0 to week 12
measure: CD4 cluster of differentiation 4 Other Pre-Specified Outcome Measure IL ileum immature lung independent laboratory inguinal ligament interleukin (IL)-6
timeFrame: week 0 to week 12
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
Study officials:
affiliation: UCSF Osher Center for Integrated Medicine, UCSF Positive Health Program
name: Frederick M Hecht, M.D.
role: PRINCIPAL_INVESTIGATOR
References: