San Francisco General Hospital
San Francisco, California, 94110, United States
NCT Number: NCT01860261
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.
Looking for future studies?
Notify Me50 year and older
All sexes
Interventional
Not applicable
San Francisco, California, 94110, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
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.
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).
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.
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.
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".
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.
Time frame: From study baseline to week 12
Exercise related injuries, from self-report on questionnaires, will be compared between groups.
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).
Time frame: change from week 0 to week 12
Change in CD4+ T cell counts during the intervention will be compared between groups.
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.
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.
University of California, San Francisco
Other
Acronym: SEA
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.
Published trials that share one or more normalized conditions with this study.
NCT05752500
Acquired Immunodeficiency Syndrome, Aging
Minneapolis, Minnesota, United States
View Trial DetailsNCT03734393
Acquired Immunodeficiency Syndrome, Blood-Borne Infections
Birmingham, Alabama, United States
View Trial DetailsNCT06176859
ART, Acquired Immunodeficiency Syndrome
Durban, KwaZulu-Natal, South Africa
View Trial DetailsNCT06139354
Acquired Immunodeficiency Syndrome, Blood-Borne Infections
Washington D.C., District of Columbia, United States
View Trial Details