Older Veterans EmpoweRed To Use Regular Exercise (OVERTURE) II
OVERTURE
1 other identifier
interventional
6
1 country
1
Brief Summary
The purpose of this study is to investigate the practicality of a short-term (8-weeks), home-based digital versatile disc (DVD) chair exercise program among 40 sedentary older Black/African American and White/Caucasian veterans with three or more chronic health conditions, such as type 2 diabetes, hypertension, and osteoarthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable quality-of-life
Started Oct 2018
Longer than P75 for not_applicable quality-of-life
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
June 12, 2018
CompletedFirst Posted
Study publicly available on registry
July 9, 2018
CompletedStudy Start
First participant enrolled
October 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2022
CompletedMay 20, 2022
May 1, 2022
1.8 years
June 12, 2018
May 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Number of fitness sessions completed based on participants' activity logs - Adherence to the home-based DVD chair exercise program
Adherence (number of fitness sessions completed based on participants' activity logs). Participants' activity logs will be used to assess subjective completion of fitness sessions.
At the end of 8 weeks.
Number of participants lost to attrition
The number of participants lost to attrition (dropped out). This will be measured by the number of participants that have completed the entire 8 week program. Before and after each session, participants will be instructed to record the date and time the session was started and completed.
At the end of 8 weeks.
Participants' program satisfaction
Satisfaction ratings will be assessed based on participants' satisfaction logs.
At the end of 8 weeks.
Participants' rating of the program
Intervention group participants' ratings of the intervention based on open-ended questions asked during the focus group session.
Week 10
Secondary Outcomes (9)
To evaluate the Quality of Life (QOL) of participants
Baseline and post-assessment at week 8.
Subjective Well-being (SWB)
Baseline and post-assessment at week 8.
Physical Activity
Baseline and post-assessment at week 8.
Blood pressure
Baseline and post-assessment at week 8
Heart Rate (Pulse)
Baseline and post-assessment at week 8
- +4 more secondary outcomes
Study Arms (2)
Intervention Group
EXPERIMENTALTen participants from each racial group (Black/White) will be assigned to the Intervention, which will receive the home-based DVD Chair Exercise Program. This is the group that will receive the chair exercise intervention upon enrollment.
Waitlist Control Group
ACTIVE COMPARATORTen participants from each racial group (Black/White) will be assigned to the Waitlist Control Group, which will receive the home-based DVD Chair Exercise Program at the end of 8 weeks.
Interventions
Intervention group participants will receive the home-based DVD chair exercise program, which will include a DVD player, "Sit and Be Fit" DVD, schedule of exercise sessions, hand weights, exercise balls, resistance bands, exercise log, and satisfaction survey. Participants will be instructed to complete an assigned "Sit and Be Fit" exercise session once a day (sessions last approximately 30 minutes), five days a week (Monday-Friday) for 8 weeks. During the first 6 weeks, the intervention group will not have contact with the study team, unless to trouble-shoot the DVD or answer questions about exercise sessions. At the end of week 6, the intervention group will be contacted to schedule a post-assessment for the end of week 8, which will include repeating all health measures, except for health status.
At week 8, waitlist control group will receive the home-based DVD chair exercise program, which will include a DVD player, "Sit and Be Fit" DVD, schedule of exercise sessions, hand weights, exercise balls, resistance bands, exercise log, and satisfaction survey. The waitlist control group will complete a post-assessment at the end of week 8, which will include all health status measures, except health status. Waitlist control group will be instructed to complete an assigned "Sit and Be Fit" exercise session once a day (sessions last approximately 30 minutes), five days a week (Monday-Friday) for 8 weeks. Waitlist control group will not have contact with the study team, unless to trouble-shoot the DVD or answer questions about exercise sessions. At the end 14 weeks, waitlist control group will be contacted to schedule a final meeting, and to collect the adherence logs and satisfaction survey. At 16 weeks, the waitlist control group will not receive an additional post-assessment.
Eligibility Criteria
You may qualify if:
- Be a veteran, which will be verified through documentation, such as discharge papers, military identification card, or military photographs
- Identify as Black/African American or White/Caucasian; demonstrate proof of age 65+; self-report of three or more chronic health conditions
- Pass a cognitive screening related to thinking/reasoning/decision making; report less than 30 minutes of daily physical activity
- Systolic blood pressure lower than 180
- Diastolic blood pressure lower than 100
- Resting heart rate 90 or lower
- Three or more chronic health conditions
- Permission from primary care physician (PCP)
- Own a sturdy stand-alone chair without arms
- Own an operable television
- Willing to be randomized to the intervention or the waitlist control group
You may not qualify if:
- Non-veteran
- Non-Black or African American/White or Caucasian
- Younger than 65 years of age
- Systolic blood pressure 180 or higher
- Diastolic blood pressure is 100 or higher
- Resting heart rate higher than 90
- Less than three chronic health conditions
- Failure to pass a cognitive screening
- Report more than 30 minutes of daily physical activity
- No approval from PCP
- No sturdy stand-alone chair without arms
- No operable television
- Unwilling to be assigned to the intervention or the waitlist control group
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Related Publications (1)
McCaskill GM, Clay OJ, Motl RW, Ball KK. Older Veterans EmpoweRed To Use Regular Exercise (OVERTURE) II: Design and methods of a randomized controlled trial among older veterans with chronic health conditions. Contemp Clin Trials Commun. 2019 Jun 28;15:100395. doi: 10.1016/j.conctc.2019.100395. eCollection 2019 Sep. No abstract available.
PMID: 31338477BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karlene K Ball, PhD
University of Alabama at Birmingham
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 12, 2018
First Posted
July 9, 2018
Study Start
October 24, 2018
Primary Completion
July 31, 2020
Study Completion
January 31, 2022
Last Updated
May 20, 2022
Record last verified: 2022-05