Feasibility of an Exercise Intervention (MESH)

This study is currently recruiting participants.
Verified March 2014 by University of Rochester
Sponsor:
Information provided by (Responsible Party):
Krupa Shah, University of Rochester
ClinicalTrials.gov Identifier:
NCT01984060
First received: October 24, 2013
Last updated: March 21, 2014
Last verified: March 2014

October 24, 2013
March 21, 2014
December 2013
January 2017   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01984060 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Feasibility of an Exercise Intervention
Feasibility of an Exercise Intervention In HIV+ Older Adults

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.

Subjects are being asked to participate in this study if they are infected with the human immunodeficiency virus (HIV), and they are 40 years of age or older.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
HIV
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 goal is to get all subjects to a minimum of 10,000 steps per day. 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

  • HOME-EX

    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 tracked by a pedometer, 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.

    Intervention: Other: HOME-EX
  • No Intervention: Control
    Subjects are instructed to maintain their usual activities. They will be given a pedometer and instructed to document their daily diary (DD). Every alternate week, we will conduct phone calls to answer questions and verify use of the pedometer and DD documentation.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
May 2017
January 2017   (final data collection date for primary outcome measure)

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.
Both
45 Years to 80 Years
No
Contact: Krupa Shah, M.D., M.P.H. (585) 341-0762 krupa_shah@urmc.rochester.edu
Contact: Zahraa Majeed, M.D., MS. (585) 276-6381 zahraa_majeed@urmc.rochester.edu
United States
 
NCT01984060
1K23AG043319-01A1
No
Krupa Shah, University of Rochester
University of Rochester
Not Provided
Principal Investigator: Krupa Shah, M.D., M.P.H. University of Rochester
University of Rochester
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP