Heart FailurePhase 2NCT00176384
Impact of Exercise Training on Exercise Capacity in Patients With Severe Chronic Heart Failure
A Phase 2 study testing Aerobic endurance exercise training (ergometer) in people with Heart Failure, run by University of Leipzig at 1 site in Germany.
Trial summary
Patients with heart failure are limited in their exercise capacity due to skeletal muscle alteration and an impairment of peripheral perfusion. Regular physical exercise training has been shown to partially correct these peripheral maladaptations in patients with stable heart failure, which was associated with an… Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Heart Failure
- What is being tested?
- Aerobic endurance exercise training (ergometer)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2003to Dec 2006
- Phase
- Phase 2
- 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 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic heart failure (NYHA class III b)
- peak oxygen uptake <20 mL/min/kg body weight
- left ventricular ejection fraction <25 %
- left ventricular end-diastolic diameter >60 mm
Who cannot join
- exercise-induced myocardial ischemia
- cardiac decompensation within the last 8 weeks
- ventricular arrhythmias (>Lown 4b) in patients not protected by an ICD
- insulin-dependent diabetes mellitus
- uncontrolled arterial hypertension
- orthopedic conditions excluding training participation
- body mass index >30 kg/m2
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Leipzig, Heart Center, Department of Internal Medicine / Cardiology
Leipzig, Saxony, 04289
About this study
Official title: Impact of Three Months of Aerobic Exercise Training on Exercise Capacity and Peripheral Maladaptations in Patients With Severe Chronic Heart Failure (NYHA III b)
Patients with heart failure are limited in their exercise capacity due to skeletal muscle alteration and an impairment of peripheral perfusion. Regular physical exercise training has been shown to partially correct these peripheral maladaptations in patients with stable heart failure, which was associated with an improvement in exercise capacity. However, it is unknown so far, whether regular physical activity also exerts beneficial effects in patients with severe chronic heart failure.
Aim of the trial is therefore to assess the effects of aerobic exercise training on exercise capacity, muscle maladaptations and peripheral perfusion in patients with severe chronic heart failure according to NYHA class III b.
Read the detailed description
A total of 36 patients with severe chronic heart failure are prospectively randomized to either 3 months of aerobic ergometer training or a sedentary control group.
Before and after the intervention period maximal exercise capacity is assessed by ergospirometry, endothelial function is determined by high-resolution A-mode ultrasound, and muscle mass is determined by CT. Skeletal muscle biopsies are obtained at begin and after 3 months and are analyzed for markers of muscle catabolism/anabolism.
- Conditions
- Heart Failure
- Being tested
- Aerobic endurance exercise training (ergometer)
- Keywords
- chronic heart failure, exercise training
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic endurance exercise training (ergometer)Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen uptake
Secondary outcomes (3)
Endothelial function
Skeletal muscle mass
Markers of muscle anabolism / catabolism
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMar 2003
- Study completionDec 2006
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 2
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Stiftung für Herzforschung
- Investigators
- Rainer P Hambrecht, MD, Principal investigator, University of Leipzig, Heart Center, Department of Internal Medicine / Cardiology, Leipzig, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00176384
- Sponsor's protocol ID
- F21/02
- Status last verified
- Jul 2007
- First submitted
- 10 Sep 2005
- Last updated
- 1 Aug 2007
- Results posted
- No
Publications
Erbs S, Hollriegel R, Linke A, Beck EB, Adams V, Gielen S, Mobius-Winkler S, Sandri M, Krankel N, Hambrecht R, Schuler G. Exercise training in patients with advanced chronic heart failure (NYHA IIIb) promotes restoration of peripheral vasomotor function, induction of endogenous regeneration, and improvement of left ventricular function. Circ Heart Fail. 2010 Jul;3(4):486-94. doi: 10.1161/CIRCHEARTFAILURE.109.868992. Epub 2010 Apr 29.
PubMed 20430934
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Three Months of Aerobic Exercise Training on Exercise Capacity and Peripheral Maladaptations in Patients With Severe Chronic Heart Failure (NYHA III b)
- ClinicalTrials.gov ID
- NCT00176384
- Acronym / sponsor ID
- F21/02
- Conditions
- Heart Failure
- Keywords
- chronic heart failure, exercise training
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Collaborators
- Deutsche Stiftung für Herzforschung
- Study start
- Mar 2003
- Study completion
- Dec 2006 (actual)
- First posted
- 15 Sep 2005 (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.
Patients with heart failure are limited in their exercise capacity due to skeletal muscle alteration and an impairment of peripheral perfusion. Regular physical exercise training has been shown to partially correct these peripheral maladaptations in patients with stable heart failure, which was associated with an improvement in exercise capacity. However, it is unknown so far, whether regular physical activity also exerts beneficial effects in patients with severe chronic heart failure.
Aim of the trial is therefore to assess the effects of aerobic exercise training on exercise capacity, muscle maladaptations and peripheral perfusion in patients with severe chronic heart failure according to NYHA class III b.
Detailed description
A total of 36 patients with severe chronic heart failure are prospectively randomized to either 3 months of aerobic ergometer training or a sedentary control group.
Before and after the intervention period maximal exercise capacity is assessed by ergospirometry, endothelial function is determined by high-resolution A-mode ultrasound, and muscle mass is determined by CT. Skeletal muscle biopsies are obtained at begin and after 3 months and are analyzed for markers of muscle catabolism/anabolism.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- chronic heart failure (NYHA class III b)
- peak oxygen uptake <20 mL/min/kg body weight
- left ventricular ejection fraction <25 %
- left ventricular end-diastolic diameter >60 mm
Key exclusion criteria (7 listed)
- exercise-induced myocardial ischemia
- cardiac decompensation within the last 8 weeks
- ventricular arrhythmias (>Lown 4b) in patients not protected by an ICD
- insulin-dependent diabetes mellitus
- uncontrolled arterial hypertension
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 |
|---|---|---|
| Aerobic endurance exercise training (ergometer) | Behavioural | – |
Primary outcome
Peak oxygen uptake
3 secondary outcomes
Endothelial function
Skeletal muscle mass
Markers of muscle anabolism / catabolism
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 1 Aug 2007.
- Derived from this study: PubMed 20430934Erbs S, Hollriegel R, Linke A, Beck EB, Adams V, Gielen S, Mobius-Winkler S, Sandri M, Krankel N, Hambrecht R, Schuler G. Exercise training in patients with advanced chronic heart failure (NYHA IIIb) promotes restoration of peripheral vasomotor function, induction of endogenous regeneration, and improvement of left ventricular function. Circ Heart Fail. 2010 Jul;3(4):486-94. doi: 10.1161/CIRCHEARTFAILURE.109.868992. Epub 2010 Apr 29.
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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.
Rainer P Hambrecht, MD principal investigator
University of Leipzig, Heart Center, Department of Internal Medicine / Cardiology, Leipzig, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aerobic endurance exercise training (ergometer) in people with Heart Failure, run by University of Leipzig at 1 site in Germany.
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 4 inclusion and 7 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 1 Aug 2007. 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 Germany. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Peak oxygen uptake. 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 NCT00176384, 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 1 Aug 2007.