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The Effect of Ischemic Training on Exercise Endurance

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ClinicalTrials.gov Identifier: NCT00333905
Recruitment Status : Completed
First Posted : June 6, 2006
Last Update Posted : February 5, 2009
Sponsor:
Information provided by:
VA Office of Research and Development

Brief Summary:
The purpose of this study is to determine if reducing blood flow to an exercising muscle during exercise training will enhance the training effect on that muscle in people who have limited exercise because of congestive heart failure

Condition or disease Intervention/treatment Phase
Heart Failure Congestive Heart Failure Cardiovascular Disease Procedure: Ischemic exercise training Not Applicable

Detailed Description:
The objective of this study is to determine whether reduction of blood flow during stair-stepping and cycling ergometer leg exercise will contribute to an improvement in whole body exercise capacity or submaximal exercise endurance in patients with mild congestive heart failure. Two groups of 25 patients with mild to moderate CHF, aged 30-70, will be trained for 12 weeks. The experimental group will train with pressure cuffs inflated on one thigh and lower leg during exercise. The cuff will be applied on alternate legs during training, such that each leg has the same duration of ischemic training. The control group will train for a similar duration and intensity without pressure cuffs on the legs. Pre and post training measures will include VO2peak, exercise duration at 30% VO2peak, 6 minute walk test, Minnesota Living with Heart Failure questionnaire

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: The Effect of Ischemic Training on Exercise Endurance
Study Start Date : March 2006
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Exercise duration before and after 12 weeks of training during a submaximal exercise test and distance walked on a 6-minute walk test.

Secondary Outcome Measures :
  1. Peak cycle ergometer VO2max test before and after training


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Ages Eligible for Study:   30 Years to 71 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mild Congestive Heart Failure
  • Must be able to exercise

Exclusion Criteria:

  • Venous or arterial thrombus
  • Lower extremity arthritis
  • Blood clotting abnormalities
  • Claudication
  • Peripheral vascular disease
  • Evidence of deep vein thrombosis on ultrasound

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00333905


Locations
United States, New Mexico
New Mexico VA Health Care System
Albuquerque, New Mexico, United States, 87108
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Milton V Icenogle, MD Cardiology Division Chief, Medicine Service VAMC Albuquerque (501) Albuquerque, NM

Publications:
ClinicalTrials.gov Identifier: NCT00333905     History of Changes
Other Study ID Numbers: F4096R
First Posted: June 6, 2006    Key Record Dates
Last Update Posted: February 5, 2009
Last Verified: June 2006

Keywords provided by VA Office of Research and Development:
Exercise
Exercise Therapy

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases