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

Conditions

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 Locations

  • Israel
      • Jerusalem, Israel, IL-91120
        • Recruiting
        • Hadassah University Hospital
        • Contact:
        • 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.
Behavioral: Exercise training
Exercise training program for 3 months (two times a week).

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

Meir Medical Center

Collaborators

Hadassah Medical Organization
Clalit Health Services

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.

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