Older Veterans EmpoweRed To Use Regular Exercise (OVERTURE) II

Quality of Life Clinical Trial

— OVERTURE  

Official title:

Older Veterans EmpoweRed To Use Regular Exercise (OVERTURE) II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03580551
• Other study ID #: IRB-300001897
• Status: Completed
• Phase: N/A
• Start date: October 24, 2018
• Est. completion date: January 31, 2022

Study information

• Verified date: May 2022
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study will determine the feasibility of a home-based DVD chair exercise program, "Sit and Be Fit." Participants will be asked to complete a chair-exercise program Monday through Friday. Each chair exercise session lasts approximately 30 minutes. Participants will receive a new DVD player, the exercise DVD, and the necessary exercise equipment to complete each session. The equipment includes a set of 1 pound hand weights, a 10" exercise ball, a small handball, a resistance band, an exercise log, and a satisfaction survey. Upon initial enrollment, both groups will receive a baseline health assessment that will include health-related quality of life, subjective well-being, body mass index (BMI), comorbidity, blood pressure, lower body extremity fitness, physical activity, and hand grip strength. Excluding health status, all other measures will be completed at post-assessment (the end of week 8 for Group A and Group B). The intervention group (Group A) will receive the equipment after completing eligibility screening, an informed consent, and health assessments. The waitlist control group (Group B) will receive the equipment at week 9 after the post-assessment. Group B will complete the program through week 16. The waitlist control group(Group B) will not receive an additional post assessment at the end of week 16.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: January 31, 2022
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 99 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Aging
• Quality of Life

Intervention

Behavioral:
• Intervention Group
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.
• Waitlist Control Group
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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	Participants' program satisfaction	Satisfaction ratings will be assessed based on participants' satisfaction logs.	At the end of 8 weeks.
Primary	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	To evaluate the Quality of Life (QOL) of participants	The 36-Item Short Form Survey (SF-36) will be used to assess QOL outcomes. A 0 score indicates the lowest level of QOL measured by the scale and a 100 indicates the highest level of QOL measured by the scale.	Baseline and post-assessment at week 8.
Secondary	Subjective Well-being (SWB)	How an individual rates general feelings of happiness (well-being). SWB will be measured using a modified SWB scale. The scale consists of 4 items that assess overall happiness. Respondents were asked two questions about their happiness as well as two questions comparing their happiness to the happiness of others on a scale from 1 to 7, with 7 reflecting a high degree of perceived happiness. Composite scores on the scale range from 4 to 28.	Baseline and post-assessment at week 8.
Secondary	Physical Activity	The Physical Activity Scale for the Elderly (PASE) will be used to assess level of physical activity. Score ranges from 0 to 360. A high score indicates a high level of physical activity.	Baseline and post-assessment at week 8.
Secondary	Blood pressure	Blood pressure (systolic and diastolic) will be assessed using a standard blood pressure cuff.	Baseline and post-assessment at week 8
Secondary	Heart Rate (Pulse)	Pulse rate will be assessed using a standard blood pressure cuff.	Baseline and post-assessment at week 8
Secondary	Body Mass Index (BMI)	BMI will be assessed using a standard weight scale and a folding yardstick.	Baseline and post-assessment at week 8.
Secondary	Hand Grip Strength	Hand grip strength will be assessed using a Baseline Hydraulic Hand Dynamometer.	Baseline and post-assessment at week 8.
Secondary	Short Physical Performance Battery (SPPB)	The SPPB will assess lower body function with a balance test, gait (walk) test, and chair stands.	Baseline and post-assessment at week 8.
Secondary	Comorbidity	Comorbidity will be assessed using the Charlson Comorbidity Index. Comorbidity is the presence of additional chronic health conditions that can impact life expectancy. Individual chronic conditions will be assigned a score based on severity and averaged. Based on the chronic condition, assigned scores can be 1, 2, 3, or 6.	Baseline

External Links

•   Link to Pub Med