Feasibility of an Exercise Intervention

Not Applicable

Completed

• Conditions: HIV
• Interventions: Other: HOME-EX

• Registration Number: NCT01984060
• Lead Sponsor: University of Rochester

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-10-24
• Study First Submitted QC: 2013-11-07
• Study First Posted: 2013-11-14
• Study Start: 2013-12
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HOME-EX	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.

Primary Outcome Measures

Name	Time	Method
Change in Feasibility	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

Name	Time	Method
Change in Autonomy	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.
Change in Efficacy	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.

Trial Locations

Locations (1)

University of Rochester/ Strong Memorial Hospital; 🇺🇸 Rochester, New York, United States