Feasibility of an Exercise Intervention
MESH
1 other identifier
interventional
74
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hiv
Started Dec 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2013
CompletedFirst Posted
Study publicly available on registry
November 14, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedMay 12, 2016
May 1, 2016
1.7 years
October 24, 2013
May 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Feasibility
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 Outcomes (2)
Change in Efficacy
At day zero of the study and after 12 weeks of intervension.
Change in Autonomy
At day zero of the study and after 12 weeks of intervension.
Study Arms (2)
HOME-EX
OTHERMotivational 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.
Control
NO INTERVENTIONSubjects are instructed to maintain their usual activities during the study period. This group did not receive any PA counseling or recommendations.
Interventions
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
Eligibility Criteria
You may qualify if:
- HIV positive, both genders, all races, English speaking individuals, age 45 years or older, on HAART before enrollment. .
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Rochester/ Strong Memorial Hospital
Rochester, New York, 14642, United States
Related Publications (1)
Shah KN, Majeed Z, Yoruk YB, Yang H, Hilton TN, McMahon JM, Hall WJ, Walck D, Luque AE, Ryan RM. Enhancing physical function in HIV-infected older adults: A randomized controlled clinical trial. Health Psychol. 2016 Jun;35(6):563-73. doi: 10.1037/hea0000311. Epub 2016 Feb 11.
PMID: 26867045DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Krupa Shah, M.D., M.P.H.
University of Rochester
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D. Assistant professor
Study Record Dates
First Submitted
October 24, 2013
First Posted
November 14, 2013
Study Start
December 1, 2013
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
May 12, 2016
Record last verified: 2016-05