Feasibility of an Exercise Intervention (MESH)
|ClinicalTrials.gov Identifier: NCT01984060|
Recruitment Status : Completed
First Posted : November 14, 2013
Last Update Posted : May 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|HIV||Other: HOME-EX||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Health Services Research|
|Official Title:||Feasibility of an Exercise Intervention In HIV+ Older Adults|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
Motivational Counseling: Six patient-centered motivational counseling sessions based on the self-determination theory (SDT) of behavior change will be conducted with the patients in the HOME-EX group over 12 weeks.
Exercise Intervention: an individually tailored home-based exercise program performed 5-7 days a week that consists of walking prescription, and individualized strength training exercise designed to provide moderately intense progressive resistance exercise. Subjects will be given a set of 3 color-coded therapeutic resistance bands representing varying levels of resistance and they will start with a number of sets which is customized for each individual and they will be encouraged to progressively increase from their individual baseline sets.
Motivational Counseling: The first session will be an hour face-to-face interview to establish a rapport with subjects, assess motives and competence. The rest will be 30 min. phone calls to assess week's performance and agree on an action plan for next 2 weeks.
Exercise Intervention: Using the average number of steps for each subject from their baseline assessment, the targeted number of steps the subject needs to walk every day will be calculated. The individualized strength training exercise will target the upper and lower body. If possible, they will be encouraged to progressively increase from their individual baseline sets and repetitions to a maximum of 4 sets of 15 repetitions for each exercise
No Intervention: Control
Subjects are instructed to maintain their usual activities during the study period. This group did not receive any PA counseling or recommendations.
- Change in Feasibility [ Time Frame: At day zero of the study and after 12 weeks of intervension. ]To develop and establish the feasibility of home-exercise(HOME-EX)in HIV positive subjects as evaluated by measuring exercise adherence and acceptability, exercise intensity and adverse events. We hypothesize that HOME-EX is a feasible and safe intervention for HOA.
- Change in Efficacy [ Time Frame: At day zero of the study and after 12 weeks of intervension. ]To determine the potential efficacy of HOME-EX in HIV positive adults in improving physical function as evaluated by the physical performance test (PPT). We hypothesize that physical function will improve in the HOME-EX group compared to the CONTROL group.
- Change in Autonomy [ Time Frame: At day zero of the study and after 12 weeks of intervension. ]To determine the potential efficacy of HOME-EX in HIV positive on exercise-related psychological mediators as evaluated by the SDT-based questionnaires. We hypothesize that the HOME-EX group will report greater perceived autonomy support, more autonomous self-regulation, higher intrinsic motivation and perceived competence compared to the CONTROL group.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01984060
|United States, New York|
|University of Rochester/ Strong Memorial Hospital|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Krupa Shah, M.D., M.P.H.||University of Rochester|