Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2025-12-31 @ 4:36 PM
Study NCT ID:
NCT01860261
Status:
COMPLETED
Last Update Posted:
2023-11-08
First Post:
2013-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study of the Effects of Exercise on Aging Among Older Persons With HIV
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
Pilot Study of the Effects of Exercise on Aging Among Older Persons With HIV
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SEA
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: