Cardiovascular DiseasesRest-CRNCT03200756
Cardiac Rehabilitation and Sedentary Behavior
A study testing Sedentary Group and Exercise Group in people with Cardiovascular Diseases, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This trial randomizes patients who plan to attend cardiac rehabilitation to either a behavioral intervention to specifically reduce sedentary behavior or to usual care which exclusively focuses on increasing exercise. Read more about this study
- Who is it for?
- Ages 50 to 99 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Sedentary Group and Exercise Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2017to 20 Jun 2017
- 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 50 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients enrolled in Cardiac Rehabilitation
- Age 50 years old or greater
- Short Physical Performance Battery (SPPB) score equal or less than 10
Who cannot join
- Hypoxia
- Orthopedic Disease that limits mobility
- Neurologic Disease that limits mobility
- Metastatic Cancer
- Life expectancy of <6 months
- Depression
Show all 10Show fewer
- Montreal Cognitive Assessment less than 24
- Left Ventricular Assist Device (LVAD)
- Cardiac Transplant
- Patient Health Questionnaire-9 (PHQ-9) of 15 or greater
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital Cardiovascular Rehabilitation
Aurora, Colorado, 80045
About this study
Official title: The Effect of Cardiac Rehabilitation on Sedentary Behavior
This trial randomizes patients who plan to attend cardiac rehabilitation to either a behavioral intervention to specifically reduce sedentary behavior or to usual care which exclusively focuses on increasing exercise.
Read the detailed description
Cardiac rehabilitation after a cardiac event or procedure is of key importance to physical and psychological recovery. Cardiac rehabilitation comprises a standardized stepwise approach to exercise in a supervised setting and is proven to reduce morbidity and mortality after a cardiac event. However, cardiac rehabilitation does not necessarily change behavior in the long-term and many do not attend cardiac rehabilitation due to lack of motivation, difficulty accessing programs, and cost. These individuals loose an important opportunity to improve their health, sense of well-being and outcomes. The investigators propose to test the effect of a patient-centered approach to reduce sedentary behavior for aging adults added to usual cardiac rehabilitation. In this study, the investigators will identify patients at their introductory visit to cardiac rehabilitation and randomize to either a program to decrease in-home sedentary behavior vs. a standard program to increase in-home exercise. Both groups will receive additional support and encouragement to attend cardiac rehabilitation. Using motivational interviewing techniques in both groups the investigators will assist the patients in recognizing their potential and goal-setting. Patients will be monitored using the ActivPAL monitor, a new technology that quantifies sedentary time and steps/day. Patients will be monitored four times as they proceed through cardiac rehabilitation for a total of 13 weeks and receive 3 educational and goal setting sessions. Those in the intervention group will have sedentary behavior change emphasized with feedback from the ActivPAL monitor. The control group will focus on standard exercise recommendations and feedback from his/her exercise diary. Outcomes include change in sedentary time and steps/day. Anticipated results include a significant change in the intervention group vs. the control: a decrease in in-home sedentary time, an increase in steps/day. The results of this study will provide the basis for designing a larger randomized controlled trial to investigate the effects of an intervention to reduce sedentary behavior as an adjunct to cardiac rehabilitation especially for older adults. Additional investigation will be warranted for those who do not attend cardiac rehabilitation but are able to follow a post-cardiac event program to reduce in-home sedentary behavior.
- Conditions
- Cardiovascular Diseases
- Being tested
- Sedentary Group, Exercise Group
- Keywords
- sedentary behavior
- Medical subject headings
- Cardiovascular Diseases, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedentary GroupBehavioural
The sedentary group undergoes a behavioral intervention to reduce sedentary behavior which includes a patient centered approach with monitoring and goal setting.
Exercise GroupBehavioural
The Active Comparative group undergoes a standard clinical approach to increase exercise which is patient centered with monitoring and goal setting.
| Study group | Role | What they receive |
|---|---|---|
| Sedentary Group | Experimental | The experimental group undergoes a behavioral intervention to reduce sedentary behavior which includes a patient centered approach with monitoring and goal setting. Receives: Behavioral: Sedentary Group |
| Exercise Group | Active comparator | The Active Comparative group undergoes a standard clinical approach to increase exercise which is patient centered with monitoring and goal setting. Receives: Behavioral: Exercise Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in steps per day from before to after cardiac rehabilitation
The number of steps per day will be recorded using the Activpal monitor. Investigators will compare the number of steps per day prior to the subject beginning rehabiliation to the number of steps per day after cardiac rehabilitation is complete
Measured: 1 full week of Activpal data collected at week1, week 7, week 13, week 17 of the study
Change in sedentary time from before to after cardiac rehabilitation
The number of sedentary hours per day will be recorded using the Activpal monitor.Investigators will compare the number of sedentary hours per day recorded prior to the subject beginning cardiac rehabilitation to the number of sedentary hours per day recorded after cardiac rehabilitation is complete
Measured: 1 full week of Activpal data collected at week1, week 7, week 13, week 17 of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start20 Jun 2017
- Primary completion20 Jun 2017
- Study completion20 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Boxer Rebecca, MD,MS, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03200756
- Sponsor's protocol ID
- 15-1914
- Acronym
- Rest-CR
- Status last verified
- Jun 2021
- First submitted
- 21 Jun 2017
- Last updated
- 7 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cardiac Rehabilitation on Sedentary Behavior
- ClinicalTrials.gov ID
- NCT03200756
- Acronym / sponsor ID
- Rest-CR / 15-1914
- Conditions
- Cardiovascular Diseases
- Keywords
- sedentary behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 20 Jun 2017 (actual)
- Study completion
- 20 Jun 2017 (actual)
- First posted
- 27 Jun 2017 (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.
This trial randomizes patients who plan to attend cardiac rehabilitation to either a behavioral intervention to specifically reduce sedentary behavior or to usual care which exclusively focuses on increasing exercise.
Detailed description
Cardiac rehabilitation after a cardiac event or procedure is of key importance to physical and psychological recovery. Cardiac rehabilitation comprises a standardized stepwise approach to exercise in a supervised setting and is proven to reduce morbidity and mortality after a cardiac event. However, cardiac rehabilitation does not necessarily change behavior in the long-term and many do not attend cardiac rehabilitation due to lack of motivation, difficulty accessing programs, and cost. These individuals loose an important opportunity to improve their health, sense of well-being and outcomes. The investigators propose to test the effect of a patient-centered approach to reduce sedentary behavior for aging adults added to usual cardiac rehabilitation. In this study, the investigators will identify patients at their introductory visit to cardiac rehabilitation and randomize to either a program to decrease in-home sedentary behavior vs. a standard program to increase in-home exercise. Both groups will receive additional support and encouragement to attend cardiac rehabilitation. Using motivational interviewing techniques in both groups the investigators will assist the patients in recognizing their potential and goal-setting. Patients will be monitored using the ActivPAL monitor, a new technology that quantifies sedentary time and steps/day. Patients will be monitored four times as they proceed through cardiac rehabilitation for a total of 13 weeks and receive 3 educational and goal setting sessions. Those in the intervention group will have sedentary behavior change emphasized with feedback from the ActivPAL monitor. The control group will focus on standard exercise recommendations and feedback from his/her exercise diary. Outcomes include change in sedentary time and steps/day. Anticipated results include a significant change in the intervention group vs. the control: a decrease in in-home sedentary time, an increase in steps/day. The results of this study will provide the basis for designing a larger randomized controlled trial to investigate the effects of an intervention to reduce sedentary behavior as an adjunct to cardiac rehabilitation especially for older adults. Additional investigation will be warranted for those who do not attend cardiac rehabilitation but are able to follow a post-cardiac event program to reduce in-home sedentary behavior.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sedentary Group | Experimental | Behavioral: Sedentary GroupThe experimental group undergoes a behavioral intervention to reduce sedentary behavior which includes a patient centered approach with monitoring and goal setting. |
| Exercise Group | Active comparator | Behavioral: Exercise GroupThe Active Comparative group undergoes a standard clinical approach to increase exercise which is patient centered with monitoring and goal setting. |
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients enrolled in Cardiac Rehabilitation
- Age 50 years old or greater
- Short Physical Performance Battery (SPPB) score equal or less than 10
Key exclusion criteria (10 listed)
- Hypoxia
- Orthopedic Disease that limits mobility
- Neurologic Disease that limits mobility
- Metastatic Cancer
- Life expectancy of <6 months
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 |
|---|---|---|
| Sedentary GroupThe sedentary group undergoes a behavioral intervention to reduce sedentary behavior which includes a patient centered approach with monitoring and goal setting. | Behavioural | Sedentary Group |
| Exercise GroupThe Active Comparative group undergoes a standard clinical approach to increase exercise which is patient centered with monitoring and goal setting. | Behavioural | Exercise Group |
Primary outcome
Change in steps per day from before to after cardiac rehabilitation
Time frame: 1 full week of Activpal data collected at week1, week 7, week 13, week 17 of the study
The number of steps per day will be recorded using the Activpal monitor. Investigators will compare the number of steps per day prior to the subject beginning rehabiliation to the number of steps per day after cardiac rehabilitation is complete
Change in sedentary time from before to after cardiac rehabilitation
Time frame: 1 full week of Activpal data collected at week1, week 7, week 13, week 17 of the study
The number of sedentary hours per day will be recorded using the Activpal monitor.Investigators will compare the number of sedentary hours per day recorded prior to the subject beginning cardiac rehabilitation to the number of sedentary hours per day recorded after cardiac rehabilitation is complete
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 7 Jun 2021.
- Individual participant dataSharing planned: No
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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.
Boxer Rebecca, MD,MS principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sedentary Group and Exercise Group in people with Cardiovascular Diseases, run by University of Colorado, Denver 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 3 inclusion and 10 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 7 Jun 2021. 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?
Change in steps per day from before to after cardiac rehabilitation (time frame: 1 full week of Activpal data collected at week1, week 7, week 13, week 17 of the study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jun 2021.