Feasibility of an Exercise Intervention (MESH)

This study is currently recruiting participants. (see Contacts and Locations)

Verified December 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: December 1, 2014

Last verified: December 2014

History of Changes

Purpose

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
HIV	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:

MedlinePlus related topics: Exercise and Physical Fitness HIV/AIDS

U.S. FDA Resources

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.


Estimated Enrollment:	60
Study Start Date:	December 2013
Estimated Study Completion Date:	May 2017
Estimated Primary Completion Date:	January 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	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
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.

Arms

Assigned Interventions

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.

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

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.

Detailed Description:

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.

Eligibility


Ages Eligible for Study:	45 Years to 80 Years
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01984060

Contacts


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

Locations


United States, New York
University of Rochester/ Strong Memorial Hospital	Recruiting
Rochester, New York, United States, 14642
Contact: Zahraa Majeed, MD 585-276-6381 zahraa_majeed@urmc.rochester.edu
Contact: Krupa Shah, MD 585 341-0762 krupa_shah@urmc.rochester.edu

Sponsors and Collaborators

University of Rochester

Investigators


Principal Investigator:	Krupa Shah, M.D., M.P.H.	University of Rochester

More Information

No publications provided


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:	December 1, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Rochester:


Home-based exercise (HOME-EX) Self-determination theory (SDT) Quality of life (QOL)

ClinicalTrials.gov processed this record on February 25, 2015

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