Quality of LifeOVERTURENCT03580551
Older Veterans EmpoweRed To Use Regular Exercise (OVERTURE) II
A study testing Intervention Group in people with Quality of Life and Aging, run by University of Alabama at Birmingham at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 65 to 99 years
- Conditions the study is for
- Quality of Life, Aging
- What is being tested?
- Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2018to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 99 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
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.
- Conditions
- Quality of Life, Aging
- Being tested
- Intervention Group, Waitlist Control Group
- Keywords
- Veterans, Sedentary, Chronic illness
- Medical subject headings
- Sedentary Behavior, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupBehavioural
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 GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Behavioral: Intervention Group |
| Waitlist Control Group | Active comparator | 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. Receives: Behavioral: Waitlist Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At the end of 8 weeks.
Participants' program satisfaction
Satisfaction ratings will be assessed based on participants' satisfaction logs.
Measured: 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.
Measured: Week 10
Secondary outcomes (9)
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.
Measured: Baseline and post-assessment at week 8.
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.
Measured: Baseline and post-assessment at week 8.
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.
Measured: Baseline and post-assessment at week 8.
Blood pressure
Blood pressure (systolic and diastolic) will be assessed using a standard blood pressure cuff.
Measured: Baseline and post-assessment at week 8
Heart Rate (Pulse)
Pulse rate will be assessed using a standard blood pressure cuff.
Measured: Baseline and post-assessment at week 8
Body Mass Index (BMI)
BMI will be assessed using a standard weight scale and a folding yardstick.
Measured: Baseline and post-assessment at week 8.
Hand Grip Strength
Hand grip strength will be assessed using a Baseline Hydraulic Hand Dynamometer.
Measured: Baseline and post-assessment at week 8.
Short Physical Performance Battery (SPPB)
The SPPB will assess lower body function with a balance test, gait (walk) test, and chair stands.
Measured: Baseline and post-assessment at week 8.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2018
- Study start24 Oct 2018
- Primary completion31 Jul 2020
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karlene K Ball, University of Alabama at Birmingham
- Investigators
- Karlene K Ball, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03580551
- Sponsor's protocol ID
- IRB-300001897
- Acronym
- OVERTURE
- Status last verified
- May 2022
- First submitted
- 12 Jun 2018
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Older Veterans EmpoweRed To Use Regular Exercise (OVERTURE) II
- ClinicalTrials.gov ID
- NCT03580551
- Acronym / sponsor ID
- OVERTURE / IRB-300001897
- Conditions
- Quality of Life, Aging
- Keywords
- Veterans, Sedentary, Chronic illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 24 Oct 2018 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 9 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Intervention GroupTen 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 comparator | Behavioral: Waitlist Control GroupTen 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. |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention GroupIntervention 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. | Behavioural | Intervention Group |
| Waitlist Control GroupAt 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. | Behavioural | Waitlist Control Group |
Primary outcome
Number of fitness sessions completed based on participants' activity logs - Adherence to the home-based DVD chair exercise program
Time frame: At the end of 8 weeks.
Adherence (number of fitness sessions completed based on participants' activity logs). Participants' activity logs will be used to assess subjective completion of fitness sessions.
Number of participants lost to attrition
Time frame: At the end of 8 weeks.
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.
Participants' program satisfaction
Time frame: At the end of 8 weeks.
Satisfaction ratings will be assessed based on participants' satisfaction logs.
Participants' rating of the program
Time frame: Week 10
Intervention group participants' ratings of the intervention based on open-ended questions asked during the focus group session.
9 secondary outcomes
To evaluate the Quality of Life (QOL) of participants
Time frame: Baseline and post-assessment at week 8.
Subjective Well-being (SWB)
Time frame: Baseline and post-assessment at week 8.
Physical Activity
Time frame: Baseline and post-assessment at week 8.
Blood pressure
Time frame: Baseline and post-assessment at week 8
Heart Rate (Pulse)
Time frame: Baseline and post-assessment at week 8
Body Mass Index (BMI)
Time frame: Baseline and post-assessment at week 8.
Hand Grip Strength
Time frame: Baseline and post-assessment at week 8.
Short Physical Performance Battery (SPPB)
Time frame: Baseline and post-assessment at week 8.
Comorbidity
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- Background: PubMed 31338477McCaskill 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karlene K Ball, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Quality of Life and Aging, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of fitness sessions completed based on participants' activity logs - Adherence to the home-based DVD chair exercise program (time frame: At the end of 8 weeks.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03580551, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2022.