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

HIV Clinical Trial

— SEA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01860261
• Other study ID #: UCSF IRB 12-09153
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: August 2013

Study information

• Verified date: November 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 . 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV

Intervention

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.

Locations

Country	Name	City	State
United States	San Francisco General Hospital	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	CD4+ T-cell count	Change in CD4+ T cell counts during the intervention will be compared between groups.	change from week 0 to week 12
Other	d-dimer	If funding permits, change in d-dimer will be compared between groups form week 0 to week 12.	change from week 0 to week 12
Other	CD4 cluster of differentiation 4 Other Pre-Specified Outcome Measure IL ileum immature lung independent laboratory inguinal ligament interleukin (IL)-6	If funding permits, change in IL-6 will be compared between groups, from week 0 to week 12.	week 0 to week 12
Primary	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.	12 weeks (baseline to exit)
Secondary	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.	12 weeks (baseline to exit)
Secondary	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).	Six weeks (baseline to week 6) and 12 weeks (baseline to exit)
Secondary	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.	6 weeks (baseline to week 6) and 12 weeks (baseline to exit)
Secondary	Feasibility of recruitment	The investigators will determine how many persons must be screened and enrolled in order to complete cohort enrollment targets.	11 weeks (01Jan2013 to 14Mar2013)
Secondary	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".	Six months (01Jan2013 - 30June2013)
Secondary	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.	From baseline to week 12
Secondary	Injuries	Exercise related injuries, from self-report on questionnaires, will be compared between groups.	From study baseline to week 12
Secondary	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).	Change from week 0 to week 12