Back to resultsThe Impact of Exercise Training on Functional Capacity in Heart Failure
Primary Purpose
Heart Failure With Preserved Ejection Fraction
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Exercise training
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure With Preserved Ejection Fraction focused on measuring heart failure, preserved ejection fraction
Eligibility Criteria
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
Sites / Locations
- Hadassah University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercise training
Control
Arm Description
Protocol of 3 month exercise training program.
Control group
Outcomes
Primary Outcome Measures
Change from baseline of peak oxygen uptake on graded exercise.
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.
Secondary Outcome Measures
Change from baseline of six minute walk
Change in the distance covered during a 6 minute walk after 3 month exercise training.
Change from baseline of NYHA class
Change in subjective assessment of function capacity based on the New York Heart Association Class classification after 3 month exercise training.
Full Information
NCT ID
NCT01288365
First Posted
January 26, 2011
Last Updated
March 16, 2012
Sponsor
Meir Medical Center
Collaborators
Clalit Health Services, Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT01288365
Brief Title
The Impact of Exercise Training on Functional Capacity in Heart Failure
Official Title
Impact of Exercise Training on Functional Capacity in Heart Failure Patients With Preserved Ejection Fraction.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
June 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center
Collaborators
Clalit Health Services, Hadassah Medical Organization
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether exercise training will improve functional capacity in patients with heart failure and preserved ejection fraction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Preserved Ejection Fraction
Keywords
heart failure, preserved ejection fraction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise training
Arm Type
Experimental
Arm Description
Protocol of 3 month exercise training program.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group
Intervention Type
Behavioral
Intervention Name(s)
Exercise training
Intervention Description
Exercise training program for 3 months (two times a week).
Primary Outcome Measure Information:
Title
Change from baseline of peak oxygen uptake on graded exercise.
Description
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.
Time Frame
After 3 month exercise training
Secondary Outcome Measure Information:
Title
Change from baseline of six minute walk
Description
Change in the distance covered during a 6 minute walk after 3 month exercise training.
Time Frame
After 3 month exercise training
Title
Change from baseline of NYHA class
Description
Change in subjective assessment of function capacity based on the New York Heart Association Class classification after 3 month exercise training.
Time Frame
After 3 month exercise training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meirav Miara, MA
Phone
972-2-6776564
Email
JRmeiravM@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Israel Gotsman, MD
Organizational Affiliation
Hadassah University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah University Hospital
City
Jerusalem
ZIP/Postal Code
IL-91120
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meirav Miara, MA
Phone
972-2-6776564
Email
JRmeiravM@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Israel Gotsman, MD
12. IPD Sharing Statement
Learn more about this trial
The Impact of Exercise Training on Functional Capacity in Heart Failure
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