The Effect of Ischemic Training on Exercise Endurance | NCT00333905

Studies
The Effect of Ischemic Training on Exercise Endurance

NCT00333905

Sponsor

US Department of Veterans Affairs

Status

Completed

Last Update Posted

Feb 5, 2009Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Heart Failure
Congestive Heart Failure
Cardiovascular Disease

Interventions

Ischemic exercise training

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2006

Primary Completion Date

Not provided

Completion Date

Feb 2008Actual

First Submitted Date

Jun 2, 2006

First Submission Date that Met QC Criteria

Jun 2, 2006

First Posted Date

Jun 6, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2009

Last Update Posted Date

Feb 5, 2009Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Name	Type	Description	Arm Group Labels	Other Names
Ischemic exercise training	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Exercise duration before and after 12 weeks of training during a submaximal exercise test and distance walked on a 6-minute walk test.

Secondary Outcomes

Measure	Description	Time Frame
Peak cycle ergometer VO2max test before and after training

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

71 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Milton V Icenogle, MD	Cardiology Division Chief, Medicine Service VAMC Albuquerque (501) Albuquerque, NM	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New Mexico VA Health Care System		Albuquerque	New Mexico	87108	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16320146	Background	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.

ID	Term
D006333	Heart Failure
D002318	Cardiovascular Diseases
D009043	Motor Activity

ID	Term
D006331	Heart Diseases
D001519	Behavior