The Effect of Ischemic Training on Exercise Endurance

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00333905
First received: June 2, 2006
Last updated: February 3, 2009
Last verified: June 2006
  Purpose

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 Intervention
Heart Failure
Congestive Heart Failure
Cardiovascular Disease
Procedure: Ischemic exercise training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: The Effect of Ischemic Training on Exercise Endurance

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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:
  • Peak cycle ergometer VO2max test before and after training

Estimated Enrollment: 50
Study Start Date: March 2006
Study Completion Date: February 2008
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

  Eligibility

Ages Eligible for Study:   30 Years to 71 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00333905

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

Publications:
ClinicalTrials.gov Identifier: NCT00333905     History of Changes
Other Study ID Numbers: F4096R
Study First Received: June 2, 2006
Last Updated: February 3, 2009
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Exercise
Exercise Therapy

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on September 18, 2014