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

NCT01860261 | Completed

• 1 other identifier: UCSF IRB 12-09153
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

HIV; AIDS; sedentary; fitness; aging; V02max; d-dimer; IL-6; CRP; ChiWalking; ChiRunning; aerobic exercise; strength training

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• METs

  12 weeks (baseline to exit)

• C-reactive protein

  Six weeks (baseline to week 6) and 12 weeks (baseline to exit)

• NIH PROMIS 29

  6 weeks (baseline to week 6) and 12 weeks (baseline to exit)

• Feasibility of recruitment

  11 weeks (01Jan2013 to 14Mar2013)

• Acceptability of study materials

  Six months (01Jan2013 - 30June2013)

Other Outcomes (3)

• CD4+ T-cell count

  change from week 0 to week 12

• d-dimer

  change from 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

  week 0 to week 12

Study Arms (2)

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.

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.

Interventions

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.

Also known as: ChiWalking, ChiRunning

Aerobic and Strength Training

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Sedentary Behavior

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Behavior

Study Officials

• Frederick M Hecht, M.D.

  UCSF Osher Center for Integrated Medicine, UCSF Positive Health Program

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2013
• First Posted: May 22, 2013
• Study Start: January 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: November 8, 2023

Record last verified: 2023-11

Locations

US (1)