The Impact of Exercise Training on Functional Capacity in Heart Failure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Meir Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Clalit Health Services
Hadassah Medical Organization
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01288365
First received: January 26, 2011
Last updated: March 16, 2012
Last verified: March 2012
  Purpose

The purpose of this study is to determine whether exercise training will improve functional capacity in patients with heart failure and preserved ejection fraction.


Condition Intervention
Heart Failure With Preserved Ejection Fraction
Behavioral: Exercise training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of Exercise Training on Functional Capacity in Heart Failure Patients With Preserved Ejection Fraction.

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Change from baseline of peak oxygen uptake on graded exercise. [ Time Frame: After 3 month exercise training ] [ Designated as safety issue: No ]
    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 [ Time Frame: After 3 month exercise training ] [ Designated as safety issue: No ]
    Change in the distance covered during a 6 minute walk after 3 month exercise training.

  • Change from baseline of NYHA class [ Time Frame: After 3 month exercise training ] [ Designated as safety issue: No ]
    Change in subjective assessment of function capacity based on the New York Heart Association Class classification after 3 month exercise training.


Estimated Enrollment: 80
Study Start Date: March 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise training
Protocol of 3 month exercise training program.
Behavioral: Exercise training
Exercise training program for 3 months (two times a week).
No Intervention: Control
Control group

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01288365

Contacts
Contact: Meirav Miara, MA 972-2-6776564 JRmeiravM@clalit.org.il

Locations
Israel
Hadassah University Hospital Recruiting
Jerusalem, Israel, IL-91120
Contact: Meirav Miara, MA    972-2-6776564    JRmeiravM@clalit.org.il   
Principal Investigator: Israel Gotsman, MD         
Sponsors and Collaborators
Meir Medical Center
Clalit Health Services
Hadassah Medical Organization
Investigators
Principal Investigator: Israel Gotsman, MD Hadassah University Hospital
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01288365     History of Changes
Other Study ID Numbers: MeirMc K015/2011
Study First Received: January 26, 2011
Last Updated: March 16, 2012
Health Authority: Israel: Ethics Commission

Keywords provided by Meir Medical Center:
heart failure
preserved ejection fraction

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014