Heart FailureNCT00333905
The Effect of Ischemic Training on Exercise Endurance
A study testing Ischemic exercise training in people with Heart Failure and Congestive Heart Failure, run by US Department of Veterans Affairs at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 30 to 71 years
- Conditions the study is for
- Heart Failure, Congestive Heart Failure, Cardiovascular Disease
- What is being tested?
- Ischemic exercise training
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Feb 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 71 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild Congestive Heart Failure
- Must be able to exercise
Who cannot join
- Venous or arterial thrombus
- Lower extremity arthritis
- Blood clotting abnormalities
- Claudication
- Peripheral vascular disease
- Evidence of deep vein thrombosis on ultrasound
Trial locations and contacts
1 site in 1 country.
United States1 site
New Mexico VA Health Care System
Albuquerque, New Mexico, 87108
About this study
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
Read the 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
- Being tested
- Ischemic exercise training
- Keywords
- Exercise, Exercise Therapy
- Medical subject headings
- Heart Failure, Cardiovascular Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ischemic exercise trainingProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (1)
Peak cycle ergometer VO2max test before and after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2006 (estimated)
- Study startMar 2006
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Milton V Icenogle, MD, Principal investigator, Cardiology Division Chief, Medicine Service VAMC Albuquerque (501) Albuquerque, NM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00333905
- Sponsor's protocol ID
- F4096R
- Status last verified
- Jun 2006
- First submitted
- 2 Jun 2006
- Last updated
- 5 Feb 2009
- Results posted
- No
Publications
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.
PubMed 16320146
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ischemic Training on Exercise Endurance
- ClinicalTrials.gov ID
- NCT00333905
- Acronym / sponsor ID
- F4096R
- Keywords
- Exercise, Exercise Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Mar 2006
- Study completion
- Feb 2008 (actual)
- First posted
- 6 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 30 to 71 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mild Congestive Heart Failure
- Must be able to exercise
Key exclusion criteria (6 listed)
- Venous or arterial thrombus
- Lower extremity arthritis
- Blood clotting abnormalities
- Claudication
- Peripheral vascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ischemic exercise training | Procedure or surgery | – |
Primary outcome
Exercise duration before and after 12 weeks of training during a submaximal exercise test and distance walked on a 6-minute walk test.
1 secondary outcome
Peak cycle ergometer VO2max test before and after training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2009.
- Background: PubMed 16320146Loeppky 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milton V Icenogle, MD principal investigator
Cardiology Division Chief, Medicine Service VAMC Albuquerque (501) Albuquerque, NM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ischemic exercise training in people with Heart Failure and Congestive Heart Failure, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise duration before and after 12 weeks of training during a submaximal exercise test and distance walked on a 6-minute walk test.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00333905, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2009.