The Impact of Exercise Training on Functional Capacity in Heart Failure

Heart Failure With Preserved Ejection Fraction Clinical Trial

Official title:

Impact of Exercise Training on Functional Capacity in Heart Failure Patients With Preserved Ejection Fraction.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01288365
• Other study ID #: MeirMc K015/2011
• Status: Recruiting
• Phase: N/A
• First received: January 26, 2011
• Last updated: March 16, 2012
• Start date: March 2011
• Est. completion date: June 2013

Study information

• Verified date: March 2012
• Source: Meir Medical Center
• Contact: Meirav Miara, MA
• Phone: 972-2-6776564
• Email: JRmeiravM[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Preserved Ejection Fraction

Intervention

Behavioral:
• Exercise training
Exercise training program for 3 months (two times a week).

Locations

Country	Name	City	State
Israel	Hadassah University Hospital	Jerusalem

Sponsors (3)

Lead Sponsor	Collaborator
Meir Medical Center	Clalit Health Services, Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	After 3 month exercise training	No
Secondary	Change from baseline of six minute walk	Change in the distance covered during a 6 minute walk after 3 month exercise training.	After 3 month exercise training	No
Secondary	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.	After 3 month exercise training	No