- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01288365
The Impact of Exercise Training on Functional Capacity in Heart Failure
March 16, 2012 updated by: Meir Medical Center
Impact of Exercise Training on Functional Capacity in Heart Failure Patients With Preserved Ejection Fraction.
The purpose of this study is to determine whether exercise training will improve functional capacity in patients with heart failure and preserved ejection fraction.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Meirav Miara, MA
- Phone Number: 972-2-6776564
- Email: JRmeiravM@clalit.org.il
Study Locations
-
-
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Jerusalem, Israel, IL-91120
- Recruiting
- Hadassah University Hospital
-
Contact:
- Meirav Miara, MA
- Phone Number: 972-2-6776564
- Email: JRmeiravM@clalit.org.il
-
Principal Investigator:
- Israel Gotsman, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinical heart failure
- Preserved ejection fraction (>50%)
- Stable clinically
- New York Heart Association Class II-III
Exclusion Criteria:
- Unable to exercise
- Other debilitating or unstable disease limiting length of life
- Implanted pacemaker
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Control group
|
|
Experimental: Exercise training
Protocol of 3 month exercise training program.
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Exercise training program for 3 months (two times a week).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline of peak oxygen uptake on graded exercise.
Time Frame: After 3 month exercise training
|
Changes in physical fitness after 3 month exercise training.
This will be measured by a cardiopulmonary exercise test with recording of maximal oxygen uptake during incremental exercise.
|
After 3 month exercise training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline of six minute walk
Time Frame: After 3 month exercise training
|
Change in the distance covered during a 6 minute walk after 3 month exercise training.
|
After 3 month exercise training
|
Change from baseline of NYHA class
Time Frame: After 3 month exercise training
|
Change in subjective assessment of function capacity based on the New York Heart Association Class classification after 3 month exercise training.
|
After 3 month exercise training
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Israel Gotsman, MD, Hadassah University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Anticipated)
December 1, 2012
Study Completion (Anticipated)
June 1, 2013
Study Registration Dates
First Submitted
January 26, 2011
First Submitted That Met QC Criteria
February 1, 2011
First Posted (Estimate)
February 2, 2011
Study Record Updates
Last Update Posted (Estimate)
March 19, 2012
Last Update Submitted That Met QC Criteria
March 16, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MeirMc K015/2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Heart Failure With Preserved Ejection Fraction
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University Hospital, AkershusNovartisActive, not recruitingHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection FractionNorway
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University of SienaEuropean Association of Cardiovascular ImagingActive, not recruitingHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction | Heart Failure With Mid Range Ejection FractionSpain, Greece, Turkey, Portugal, Australia, Belgium, Italy, Mexico, Netherlands, North Macedonia, Romania, Tunisia
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Istituti Clinici Scientifici Maugeri SpARecruitingHeart Failure With Preserved Ejection Fraction | Heart Failure With Midrange Ejection FractionItaly
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Milton S. Hershey Medical CenterWithdrawnHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection FractionUnited States
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Board of Trustees of Illinois State UniversityUniversity of Colorado, Denver; Abbott; University of North Carolina, Greensboro and other collaboratorsRecruitingHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection FractionUnited States
-
Milton S. Hershey Medical CenterCompletedHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection FractionUnited States
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Zhijun SunEnrolling by invitationHeart Failure | Heart Failure With Preserved Ejection Fraction | Heart Failure With Mid Range Ejection FractionChina
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Corvia MedicalWithdrawnHeart Failure With Preserved Ejection Fraction | Heart Failure With Mid Range Ejection Fraction
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Occlutech International ABActive, not recruitingHeart Failure With Preserved Ejection Fraction (HFpEF) | Heart Failure With Reduced Ejection Fraction (HFrEF)United States
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Yale UniversityRecruitingHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction | Heart Failure NYHA Class IVUnited States
Clinical Trials on Exercise training
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University of British ColumbiaMichael Smith Foundation for Health ResearchCompleted
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University of Sao PauloFundação de Amparo à Pesquisa do Estado de São PauloCompleted
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Universidade Norte do ParanáCompleted
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University of Colorado, DenverVA Eastern Colorado Health Care SystemCompletedHealthy | Overweight | Type 2 Diabetes Mellitus | Cardiovascular Risk FactorUnited States
-
National Taiwan University HospitalCompletedAtrial FibrillationTaiwan
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Universita di VeronaRecruiting
-
University of LeipzigCompletedImpact of Intensive Exercise Training on Coronary Collateral Circulation in Patients With Stable CADStable Coronary Artery DiseaseGermany
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Helse Stavanger HFStavanger Health ResearchCompletedVentricular TachycardiaNorway
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Toronto Rehabilitation InstituteCompletedAcute Myeloid LeukemiaCanada
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Hacettepe UniversityCompleted