The Effect of Ischemic Training on Exercise Endurance
Primary Purpose
Heart Failure, Congestive Heart Failure, Cardiovascular Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ischemic exercise training
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Exercise, Exercise Therapy
Eligibility 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
Sites / Locations
- New Mexico VA Health Care System
Outcomes
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
Full Information
NCT ID
NCT00333905
First Posted
June 2, 2006
Last Updated
February 3, 2009
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00333905
Brief Title
The Effect of Ischemic Training on Exercise Endurance
Official Title
The Effect of Ischemic Training on Exercise Endurance
Study Type
Interventional
2. Study Status
Record Verification Date
June 2006
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
5. Study Description
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive Heart Failure, Cardiovascular Disease
Keywords
Exercise, Exercise Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Ischemic exercise training
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Peak cycle ergometer VO2max test before and after training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
71 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Milton V Icenogle, MD
Organizational Affiliation
Cardiology Division Chief, Medicine Service VAMC Albuquerque (501) Albuquerque, NM
Official's Role
Principal Investigator
Facility Information:
Facility Name
New Mexico VA Health Care System
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16320146
Citation
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. doi: 10.1682/jrrd.2004.06.0069.
Results Reference
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The Effect of Ischemic Training on Exercise Endurance
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