CClinicalTrials.gg
Status unknownNCT01288365Updated Mar 19, 2012

The Impact of Exercise Training on Functional Capacity in Heart Failure

An interventional study of Exercise training in Heart Failure With Preserved Ejection Fraction, sponsored by Meir Medical Center. Status unknown at 1 site in Israel. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-03-19.

Sponsored by Meir Medical Center · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Heart Failure With Preserved Ejection Fraction

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Keywords

  • heart failure
  • preserved ejection fraction
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.

This study's planned enrollment of 80 is above the median of 72 across 3,733 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Meir Medical Center is the lead sponsor of 389 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Unable to exercise
  • Other debilitating or unstable disease limiting length of life
  • Implanted pacemaker
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Exercise training

    Protocol of 3 month exercise training program.

    Behavioral: Exercise training

  • No intervention
    Control

    Control group

Interventions

  • BehavioralExercise training

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

06

What researchers measure

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.

    Time frame: After 3 month exercise training

Secondary outcomes

  1. Change from baseline of six minute walk

    Change in the distance covered during a 6 minute walk after 3 month exercise training.

    Time frame: After 3 month exercise training

  2. 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.

    Time frame: After 3 month exercise training

07

Study locations

1 of 1 sites recruiting
  • Hadassah University Hospital
    Jerusalem, IL-91120, Israel
    • Meirav Miara, MA · Contact · JRmeiravM@clalit.org.il · 972-2-6776564
    • Israel Gotsman, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01288365
Lead sponsor
Meir Medical Center
Collaborators
Clalit Health Services, Hadassah Medical Organization
Responsible party
Sponsor
First posted
Feb 2, 2011
Start date
Mar 2011
Primary completion
Dec 2012 (estimated)
Completion
Jun 2013 (estimated)
Last update
Mar 19, 2012

Study contacts

Meirav Miara, MA
Contact
JRmeiravM@clalit.org.il
972-2-6776564
Israel Gotsman, MD
principal investigator · Hadassah University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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