Clinical trial NCT03580551: Older Veterans EmpoweRed To Use Regular Exercise (OVERTURE) II
Official title: Older Veterans EmpoweRed To Use Regular Exercise (OVERTURE) II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Aging
Keywords: Veterans
Sedentary
Chronic illness
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2018-07-09
Enrollment: 6
Sex: ALL
Minimum age (years): 65
Maximum age (years): 99
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of fitness sessions completed based on participants' activity logs - Adherence to the home-based DVD chair exercise program
timeFrame: At the end of 8 weeks.
measure: Number of participants lost to attrition
timeFrame: At the end of 8 weeks.
measure: Participants' program satisfaction
timeFrame: At the end of 8 weeks.
measure: Participants' rating of the program
timeFrame: Week 10
Secondary outcomes:
measure: To evaluate the Quality of Life (QOL) of participants
timeFrame: Baseline and post-assessment at week 8.
measure: Subjective Well-being (SWB)
timeFrame: Baseline and post-assessment at week 8.
measure: Physical Activity
timeFrame: Baseline and post-assessment at week 8.
measure: Blood pressure
timeFrame: Baseline and post-assessment at week 8
measure: Heart Rate (Pulse)
timeFrame: Baseline and post-assessment at week 8
measure: Body Mass Index (BMI)
timeFrame: Baseline and post-assessment at week 8.
measure: Hand Grip Strength
timeFrame: Baseline and post-assessment at week 8.
measure: Short Physical Performance Battery (SPPB)
timeFrame: Baseline and post-assessment at week 8.
measure: Comorbidity
timeFrame: Baseline
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Karlene K Ball, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.