Diastolic Heart FailureNCT01047631
Role of Exercise in Diastolic Heart Failure
A study testing Functional circuit training and lifestyle counseling and Health education and independent walking in people with Diastolic Heart Failure and Heart Failure With Preserved Ejection Fraction, run by University of Michigan at 1 site in United States.
Trial summary
Diastolic heart failure is now being recognized as a key form of heart failure in older people. The focus of this research is to study ways to improve and maintain physical activity and functioning. This knowledge may improve the health and well-being in people with diastolic heart failure. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Diastolic Heart Failure, Heart Failure With Preserved Ejection Fraction
- What is being tested?
- Functional circuit training and lifestyle counseling and Health education and independent walking
- 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
- Dec 2008to Mar 2012
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 60 and over
- Evidence of diastolic dysfunction on echocardiogram
- Normal Left Ventricular Function (LVEF≥50%)
- Heart Failure-NYHA Class II/III
- Able and willing to participate in exercise program
- Able to come to Ann Arbor Michigan for testing
Who cannot join
- Regularly exercising(30 minute per day, 3 times per week)
- Orthopedic or musculoskeletal condition that limits weight bearing
- Uncontrolled atrial fibrillation
- History of heart valve replacement
- Unstable or serious medical condition (ie. on dialysis, oxygen; severe anemia, uncontrolled blood pressure or coronary artery disease)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Mobility Research Center
Ann Arbor, Michigan, 48105
About this study
Official title: Relationship of Cardiovascular and Muscular Capacity to Daily Functioning in Frail Older Adults
Diastolic heart failure is now being recognized as a key form of heart failure in older people. The focus of this research is to study ways to improve and maintain physical activity and functioning. This knowledge may improve the health and well-being in people with diastolic heart failure.
Read the detailed description
The purpose of this project is to better understand how endurance and fatigue relate to performing daily activities and how we might better improve endurance and reduce fatigue through an exercise program.
- Being tested
- Functional circuit training and lifestyle counseling, Health education and independent walking
- Medical subject headings
- Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional circuit training and lifestyle counselingBehavioural
Tests are performed at the beginning, and repeated after 12 and 24 weeks:
- Measure general fitness levels such as walking, strength and balance.
- Walk on a treadmill to measure your maximum fitness while wearing a mask to analyze your oxygen use.
- Blood and urine tests and a heart ultrasound.
- Questionnaires \& activity measures.
Group assignment for 12 weeks:
-Exercise classes \& activity guidance: Twice-weekly class that focuses on exercises that are similar to daily activities, such as walking and carrying objects. Obtain customized information and education to help you exercise and follow a low salt diet.
Follow-up:
-Monthly phone calls during the 12 week follow up period.
Health education and independent walkingBehavioural
Tests are performed at the beginning, and repeated after 12 and 24 weeks.
- Measure general fitness levels such as walking, strength and balance.
- Walk on a treadmill to measure your maximum fitness while wearing a mask to analyze your oxygen use.
- Blood and urine tests and a heart ultrasound.
- Questionnaires \& activity measures.
Group assignment for 12 weeks:
-Health education and walking: Weekly health education classes covering general topics related to heart failure, like medications, diet and exercise. Receive a pedometer for an at-home walking program.
Follow-up:
-No follow up support
| Study group | Role | What they receive |
|---|---|---|
| Functional circuit training and lifestyle counseling | Experimental | Not described Receives: Behavioral: Functional circuit training and lifestyle counseling |
| Health education and independent walking | Active comparator | Not described Receives: Behavioral: Health education and independent walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute walk
Measured: Baseline, 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startDec 2008
- Primary completionDec 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diastolic Heart FailureStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047631
- Sponsor's protocol ID
- 1997-585
- Status last verified
- Jan 2010
- First submitted
- 12 Jan 2010
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Cardiovascular and Muscular Capacity to Daily Functioning in Frail Older Adults
- ClinicalTrials.gov ID
- NCT01047631
- Acronym / sponsor ID
- 1997-585
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 13 Jan 2010 (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.
Diastolic heart failure is now being recognized as a key form of heart failure in older people. The focus of this research is to study ways to improve and maintain physical activity and functioning. This knowledge may improve the health and well-being in people with diastolic heart failure.
Detailed description
The purpose of this project is to better understand how endurance and fatigue relate to performing daily activities and how we might better improve endurance and reduce fatigue through an exercise program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional circuit training and lifestyle counseling | Experimental | Behavioral: Functional circuit training and lifestyle counseling |
| Health education and independent walking | Active comparator | Behavioral: Health education and independent walking |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 60 and over
- Evidence of diastolic dysfunction on echocardiogram
- Normal Left Ventricular Function (LVEF≥50%)
- Heart Failure-NYHA Class II/III
- Able and willing to participate in exercise program
Key exclusion criteria (5 listed)
- Regularly exercising(30 minute per day, 3 times per week)
- Orthopedic or musculoskeletal condition that limits weight bearing
- Uncontrolled atrial fibrillation
- History of heart valve replacement
- Unstable or serious medical condition (ie. on dialysis, oxygen; severe anemia, uncontrolled blood pressure or coronary artery disease)
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 |
|---|---|---|
| Functional circuit training and lifestyle counselingTests are performed at the beginning, and repeated after 12 and 24 weeks: * Measure general fitness levels such as walking, strength and balance. * Walk on a treadmill to measure your maximum fitness while wearing a mask to analyze your oxygen use. * Blood and urine tests and a heart ultrasound. * Questionnaires \& activity measures. Group assignment for 12 weeks: -Exercise classes \& activity guidance: Twice-weekly class that focuses on exercises that are similar to daily activities, such as walking and carrying objects. Obtain customized information and education to help you exercise and follow a low salt diet. Follow-up: -Monthly phone calls during the 12 week follow up period. | Behavioural | Functional circuit training and lifestyle counseling |
| Health education and independent walkingTests are performed at the beginning, and repeated after 12 and 24 weeks. * Measure general fitness levels such as walking, strength and balance. * Walk on a treadmill to measure your maximum fitness while wearing a mask to analyze your oxygen use. * Blood and urine tests and a heart ultrasound. * Questionnaires \& activity measures. Group assignment for 12 weeks: -Health education and walking: Weekly health education classes covering general topics related to heart failure, like medications, diet and exercise. Receive a pedometer for an at-home walking program. Follow-up: -No follow up support | Behavioural | Health education and independent walking |
Primary outcome
6 minute walk
Time frame: Baseline, 12 weeks, 24 weeks
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 28 May 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional circuit training and lifestyle counseling and Health education and independent walking in people with Diastolic Heart Failure and Heart Failure With Preserved Ejection Fraction, run by University of Michigan 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 6 inclusion and 5 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 28 May 2015. 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?
6 minute walk (time frame: Baseline, 12 weeks, 24 weeks). 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 28 May 2015.