The Effect of Ischemic Training on Exercise Endurance

Heart Failure Clinical Trial

Official title:

The Effect of Ischemic Training on Exercise Endurance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00333905
• Other study ID #: F4096R
• Status: Completed
• Phase: N/A
• First received: June 2, 2006
• Last updated: February 3, 2009
• Start date: March 2006
• Est. completion date: February 2008

Study information

• Verified date: June 2006
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 71 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Congestive Heart Failure
• Heart Failure

Intervention

Procedure:
• Ischemic exercise training

Locations

Country	Name	City	State
United States	New Mexico VA Health Care System	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Loeppky JA, Gurney B, Kobayashi Y, Icenogle MV. Effects of ischemic training on leg exercise endurance. J Rehabil Res Dev. 2005 Jul-Aug;42(4):511-22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise duration before and after 12 weeks of training during a submaximal exercise test and distance walked on a 6-minute walk test.
Secondary	Peak cycle ergometer VO2max test before and after training