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Feasibility of an Exercise Intervention (MESH)

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ClinicalTrials.gov Identifier: NCT01984060
Recruitment Status : Completed
First Posted : November 14, 2013
Last Update Posted : May 12, 2016
Sponsor:
Information provided by (Responsible Party):
Krupa Shah, University of Rochester

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
HIV Other: HOME-EX Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
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

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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, 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01984060


Locations
United States, New York
University of Rochester/ Strong Memorial Hospital
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Krupa Shah, M.D., M.P.H. University of Rochester
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Krupa Shah, M.D. Assistant professor, University of Rochester
ClinicalTrials.gov Identifier: NCT01984060     History of Changes
Other Study ID Numbers: 1K23AG043319-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 14, 2013    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016

Keywords provided by Krupa Shah, University of Rochester:
Aging
Physical Activity
Physical Function
HIV
 Frailty
Autonomous Motivation
Depression