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CompletedNCT03580551OVERTUREUpdated May 20, 2022

Older Veterans EmpoweRed To Use Regular Exercise (OVERTURE) II

An interventional study of Intervention Group and Waitlist Control Group in Quality of Life and Aging, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 65 Years to 99 Years. Per ClinicalTrials.gov, last updated 2022-05-20.

Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Randomized
Ages
65 Years to 99 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Quality of Life
  • Aging

Keywords

  • Veterans
  • Sedentary
  • Chronic illness
03

In context

Sedentary Behavior

368 studies on the registry are indexed under Sedentary Behavior; 165 are open to participants now.

This study's enrollment of 6 is below the median of 70 across 315 interventional studies indexed under Sedentary Behavior.

Browse Sedentary Behavior studies →

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,416 studies on the registry; 278 are open to participants now.

Of its 160 completed or terminated interventional studies of FDA-regulated products, 128 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    Intervention Group

    Ten 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.

    Behavioral: Intervention Group

  • Active comparator
    Waitlist Control Group

    Ten 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.

    Behavioral: Waitlist Control Group

Interventions

  • BehavioralIntervention 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.

  • BehavioralWaitlist 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At the end of 8 weeks.

  2. 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.

    Time frame: At the end of 8 weeks.

  3. Participants' program satisfaction

    Satisfaction ratings will be assessed based on participants' satisfaction logs.

    Time frame: At the end of 8 weeks.

  4. Participants' rating of the program

    Intervention group participants' ratings of the intervention based on open-ended questions asked during the focus group session.

    Time frame: Week 10

Secondary outcomes

  1. 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.

    Time frame: Baseline and post-assessment at week 8.

  2. 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.

    Time frame: Baseline and post-assessment at week 8.

  3. 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.

    Time frame: Baseline and post-assessment at week 8.

  4. Blood pressure

    Blood pressure (systolic and diastolic) will be assessed using a standard blood pressure cuff.

    Time frame: Baseline and post-assessment at week 8

  5. Heart Rate (Pulse)

    Pulse rate will be assessed using a standard blood pressure cuff.

    Time frame: Baseline and post-assessment at week 8

  6. Body Mass Index (BMI)

    BMI will be assessed using a standard weight scale and a folding yardstick.

    Time frame: Baseline and post-assessment at week 8.

  7. Hand Grip Strength

    Hand grip strength will be assessed using a Baseline Hydraulic Hand Dynamometer.

    Time frame: Baseline and post-assessment at week 8.

  8. Short Physical Performance Battery (SPPB)

    The SPPB will assess lower body function with a balance test, gait (walk) test, and chair stands.

    Time frame: Baseline and post-assessment at week 8.

  9. 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.

    Time frame: Baseline

07

Study locations

1 site
  • University of Alabama at Birmingham
    Birmingham, Alabama 35294, United States
08

References and documents

Publications

  • 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. PubMed 31338477 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03580551
Responsible party
Karlene K Ball (Principal Investigator, University of Alabama at Birmingham) — Principal investigator
First posted
Jul 9, 2018
Start date
Oct 24, 2018
Primary completion
Jul 31, 2020
Completion
Jan 31, 2022
Last update
May 20, 2022

Study contacts

Karlene K Ball, PhD
principal investigator · University of Alabama at Birmingham

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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