Feasibility of an Exercise Intervention (MESH)

This study has been completed.
Information provided by (Responsible Party):
Krupa Shah, University of Rochester
ClinicalTrials.gov Identifier:
First received: October 24, 2013
Last updated: May 10, 2016
Last verified: May 2016
The overall purpose of this research is to evaluate the effect of a home-based exercise program on physical function and to improve the health and quality of life for the HIV-infected older adult community.

Condition Intervention
Other: HOME-EX

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
Official Title: Feasibility of an Exercise Intervention In HIV+ Older Adults

Resource links provided by NLM:

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Change in Feasibility [ Time Frame: At day zero of the study and after 12 weeks of intervension. ] [ Designated as safety issue: No ]
    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.

Secondary Outcome Measures:
  • Change in Efficacy [ Time Frame: At day zero of the study and after 12 weeks of intervension. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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.

Enrollment: 74
Study Start Date: December 2013
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions

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.

Other: HOME-EX

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.

Detailed Description:
Subjects are being asked to participate in this study if they are infected with the human immunodeficiency virus (HIV), and they are 45 years of age or older.

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • HIV positive, both genders, all races, English speaking individuals, age 45 years or older, on HAART before enrollment. .

Exclusion Criteria:

  • Subject will be excluded if he/she has history or currently has severe cardiopulmonary illness, severe orthopedic or neuromuscular impairments, significant cognitive or sensory impairments, history of active malignancy, untreated depression, manic or psychotic disorder, and normal PPT score.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01984060

United States, New York
University of Rochester/ Strong Memorial Hospital
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Principal Investigator: Krupa Shah, M.D., M.P.H. University of Rochester
  More Information

Responsible Party: Krupa Shah, M.D. Assistant professor, University of Rochester
ClinicalTrials.gov Identifier: NCT01984060     History of Changes
Other Study ID Numbers: 1K23AG043319-01A1 
Study First Received: October 24, 2013
Last Updated: May 10, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Physical Activity
Physical Function
Autonomous Motivation

ClinicalTrials.gov processed this record on May 26, 2016