Heart FailureRest-HFNCT02911493
Reducing Sedentary Time in Patients With Heart Failure
A study testing Reducing Sedentary Behavior and Physical Activity Group in people with Heart Failure, run by University of Colorado, Denver at 1 site in United States.
Trial summary
To determine the change in sedentary time and number of steps/day for older patients with heart failure at risk for mobility disability who receive a program to decrease sedentary behavior versus a standard program to increase exercise. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Reducing Sedentary Behavior and Physical Activity Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Apr 2019
- 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 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- NYHA II-IV,
- Age ≥ 65,
- SPPB score of > 4 and ≤ 10 of 12,
- and deemed (by 1° cardiologist) to be at maximal tolerated dose of heart failure medication (ACE-inhibitor (ACE-I)/angiotensin receptor blocker and beta blocker (BB) for patients with HF with reduced ejection fraction (HFrEF), and
- blood pressure controlled for HF with preserved ejection fraction (HFpEF) according to the American Heart Failure Association HF guidelines.
Who cannot join
- Patients requiring medication titration such as ACE-I or BB, (will return to their cardiologist and be eligible after 3 months of stable medication.)
- Oxygen dependent lung disease,
- Orthopedic or neurologic disease that severely limits mobility,
- Active cancer diagnosis except non-melanoma skin cancer,
- Geriatric Depression Scale (GDS) score of ≥ 9 ,
- Limited life-expectancy of <6 months,
- Known dementia or disease that effects ability to learn/follow directions, or
- Failed MiniCog test.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado University
Aurora, Colorado, 80045
About this study
To determine the change in sedentary time and number of steps/day for older patients with heart failure at risk for mobility disability who receive a program to decrease sedentary behavior versus a standard program to increase exercise.
- Conditions
- Heart Failure
- Being tested
- Reducing Sedentary Behavior, Physical Activity Group
- Keywords
- sedentary time, number of steps/day, mobility, disability
- Medical subject headings
- Heart Failure, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reducing Sedentary BehaviorBehavioural
The experimental group will wear an activPAL and have counseling sessions that use the Health Belief Model and Motivational Interviewing strategies to reduce sedentary time.
Physical Activity GroupBehavioural
The Active Comparative group will wear an activPAL and have counseling sessions that use the Health Belief Model and Motivational Interviewing strategies to increase exercise time.
| Study group | Role | What they receive |
|---|---|---|
| Sedentary Group-Experimental | Experimental | The experimental group will wear an activPAL and have counseling sessions that use the Health Belief Model and Motivational Interviewing strategies to reduce sedentary time. Receives: Behavioral: Reducing Sedentary Behavior |
| Physical Activity Group | Active comparator | The Active Comparative group will wear an activPAL and have counseling sessions that use the Health Belief Model and Motivational Interviewing strategies to increase exercise time. Receives: Behavioral: Physical Activity Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects that are more active than Control.
Measured: Monthly for 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionApr 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca Boxer, MD, MSc, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02911493
- Sponsor's protocol ID
- 16-1330
- Acronym
- Rest-HF
- Status last verified
- Aug 2019
- First submitted
- 20 Sep 2016
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Sedentary Time in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT02911493
- Acronym / sponsor ID
- Rest-HF / 16-1330
- Conditions
- Heart Failure
- Keywords
- sedentary time, number of steps/day, mobility, disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 22 Sep 2016 (estimated)
- 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.
To determine the change in sedentary time and number of steps/day for older patients with heart failure at risk for mobility disability who receive a program to decrease sedentary behavior versus a standard program to increase exercise.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sedentary Group-Experimental | Experimental | Behavioral: Reducing Sedentary BehaviorThe experimental group will wear an activPAL and have counseling sessions that use the Health Belief Model and Motivational Interviewing strategies to reduce sedentary time. |
| Physical Activity Group | Active comparator | Behavioral: Physical Activity GroupThe Active Comparative group will wear an activPAL and have counseling sessions that use the Health Belief Model and Motivational Interviewing strategies to increase exercise time. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- NYHA II-IV,
- Age ≥ 65,
- SPPB score of > 4 and ≤ 10 of 12,
Key exclusion criteria (8 listed)
- Patients requiring medication titration such as ACE-I or BB, (will return to their cardiologist and be eligible after 3 months of stable medication.)
- Oxygen dependent lung disease,
- Orthopedic or neurologic disease that severely limits mobility,
- Active cancer diagnosis except non-melanoma skin cancer,
- Geriatric Depression Scale (GDS) score of ≥ 9 ,
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 |
|---|---|---|
| Reducing Sedentary BehaviorThe experimental group will wear an activPAL and have counseling sessions that use the Health Belief Model and Motivational Interviewing strategies to reduce sedentary time. | Behavioural | Sedentary Group-Experimental |
| Physical Activity GroupThe Active Comparative group will wear an activPAL and have counseling sessions that use the Health Belief Model and Motivational Interviewing strategies to increase exercise time. | Behavioural | Physical Activity Group |
Primary outcome
Number of Subjects that are more active than Control.
Time frame: Monthly for 3 months
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 21 Aug 2019.
- Individual participant dataSharing planned: No
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HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
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Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
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Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
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Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
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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.
Rebecca Boxer, MD, MSc 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 Reducing Sedentary Behavior and Physical Activity Group in people with Heart Failure, 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 5 inclusion and 8 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 21 Aug 2019. 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 Subjects that are more active than Control. (time frame: Monthly for 3 months). 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 21 Aug 2019.