NCT01288365

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 2, 2011

Completed
27 days until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

March 19, 2012

Status Verified

March 1, 2012

Enrollment Period

1.8 years

First QC Date

January 26, 2011

Last Update Submit

March 16, 2012

Conditions

Heart Failure With Preserved Ejection Fraction

Keywords

heart failurepreserved ejection fraction

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Change from baseline of six minute walk

    After 3 month exercise training

  • Change from baseline of NYHA class

    After 3 month exercise training

Study Arms (2)

Exercise training

EXPERIMENTAL

Protocol of 3 month exercise training program.

Behavioral: Exercise training

Control

NO INTERVENTION

Control group

Interventions

Exercise trainingBEHAVIORAL

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

Exercise training

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical heart failure
  • Preserved ejection fraction (\>50%)
  • Stable clinically
  • New York Heart Association Class II-III

You may not qualify if:

  • Unable to exercise
  • Other debilitating or unstable disease limiting length of life
  • Implanted pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah University Hospital

Jerusalem, IL-91120, Israel

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Exercise

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Israel Gotsman, MD

    Hadassah University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Meirav Miara, MA

CONTACT

972-2-6776564JRmeiravM@clalit.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2011

First Posted

February 2, 2011

Study Start

March 1, 2011

Primary Completion

December 1, 2012

Study Completion

June 1, 2013

Last Updated

March 19, 2012

Record last verified: 2012-03

Locations

IL(1)