Feasibility of an Exercise Intervention (MESH)

May 10, 2016 updated by: Krupa Shah, University of Rochester

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester/ Strong Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At day zero of the study and after 12 weeks of intervension.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At day zero of the study and after 12 weeks of intervension.
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.
At day zero of the study and after 12 weeks of intervension.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

October 24, 2013

First Submitted That Met QC Criteria

November 7, 2013

First Posted (Estimate)

November 14, 2013

Study Record Updates

Last Update Posted (Estimate)

May 12, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1K23AG043319-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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