Chronic Heart FailurePhase 3NCT00214513
A Randomized Trial of Effect of Low-Cost Maintenance Training on Exercise Capacity, Quality of Life and Morbidity
A Phase 3 study testing Home-based exercise training in people with Chronic Heart Failure, run by Amager Hospital at 1 site in Denmark.
Trial summary
The aim of the study is to determine whether a low-cost home-based training programme can maintain the achieved effect of physical training on exercise capacity and QOL in patients with Chronic Heart Failure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Home-based exercise training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 160 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2004to Jul 2006
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- NYHA II-IV
- Ejection Fraction ≤45% assessed by echocardiography within the last 6 months
- Optimal medical treatment according to guidelines
- Informed consent -
Who cannot join
- Hæmodynamically significant obstructive heart valve disease
- Hæmodynamically significant valve insufficiency
- Recent Myocardial infarction (8 weeks)
- Significant arrythmia at exercise testing (NSVT, VT, VF or SVT with ventricular action >150)
- Significant ischaemia or angina at low strain(£ 50 W)
- Disabilities that render physical training impossible
Show all 11Show fewer
- Dementia
- Serious other illness with expected shortened survival
- Participation in other scientific protocols that do not allow participation
- Lack of informed consent
- If the patient cannot train in a team supervised by only one physiotherapist, e.g. due to poor balance, the patient can be excluded within the first two weeks of inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maintain. A Randomized Trial of Effect of Low-Cost Maintenance Training on Exercise Capacity, Quality of Life and Morbidity
The aim of the study is to determine whether a low-cost home-based training programme can maintain the achieved effect of physical training on exercise capacity and QOL in patients with Chronic Heart Failure.
Read the detailed description
Guidelines recommend physical training in the treatment of patients with CHF. Several studies have demonstrated that even short-term training programmes can increase maximal oxygen intake, improve muscular strength, reduce neurohumoral activity and result in other effects, which are of potential benefit. Following 2-3 months training at 70 - 80% of maximal capacity, improved exercise capacity and oxygen uptake due to increased cardiac output and also better oxygen uptake in the peripheral muscles have been demonstrated. Moreover, studies have indicated an improvement of the quality of life (QOL). However, the effects of exercise training are rapidly lost without maintenance. Thus the crucial question is to identify a method to sustain the physical activity outside an expensive, enthusiastic and highly motivating protocol.
The aim of the study is to determine whether a low-cost home-based training programme can maintain the achieved effect of physical training on exercise capacity and QOL in patients with Chronic Heart Failure.
Comparison:
Patients fulfilling specified criteria for Chronic Heart Failure are randomised to either eight weeks with supervised group-based training (1.5 hrs.) twice a week followed by home-based training according to a specified protocol with supervised group-based training every 2 weeks (1,5 hrs), or to eight weeks with supervised training followed by usual care. During the whole period patients in both groups can contact the Heart Failure Clinic when needed.
- Conditions
- Chronic Heart Failure
- Being tested
- Home-based exercise training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based exercise trainingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint: Exercise capacity based on standardised cycle ergometer test after 14 months.
Secondary outcomes (9)
Secondary endpoints:
Maximum oxygen uptake at 14 months
Maximum exercise capacity measured by the Shuttle Walk test at 14 months
Exercise capacity measured by 6-minute walking test (6MWT)at 14 months
Muscular strength (sit-to-stand) at 14 months
QOL (SF36 and Minnesota) at 14 months
Serological tests including brain natriuretic peptide at 14 months
In a subgroup including 2x20 patients training-induced changes in muscle biopsies will be evaluated at 14 months.
After 1,3 and 5 years hospital-admissions and death through record linkage.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJun 2004
- Study completionJul 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 Chronic 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amager Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bispebjerg Hospital, University of Copenhagen, Danish Heart Foundation, Ministry of the Interior and Health, Denmark
- Investigators
- Eva Prescott, MD, Principal investigator, Dept of Cardiology, Rigshospitalet, Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00214513
- Sponsor's protocol ID
- Maintain
- Status last verified
- May 2007
- First submitted
- 16 Sep 2005
- Last updated
- 17 May 2007
- Results posted
- No
Publications
Prescott E, Hjardem-Hansen R, Dela F, Orkild B, Teisner AS, Nielsen H. Effects of a 14-month low-cost maintenance training program in patients with chronic systolic heart failure: a randomized study. Eur J Cardiovasc Prev Rehabil. 2009 Aug;16(4):430-7. doi: 10.1097/HJR.0b013e32831e94f8.
PubMed 19491687
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintain. A Randomized Trial of Effect of Low-Cost Maintenance Training on Exercise Capacity, Quality of Life and Morbidity
- ClinicalTrials.gov ID
- NCT00214513
- Acronym / sponsor ID
- Maintain
- Conditions
- Chronic Heart Failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Amager HospitalUniversity, hospital or other
- Collaborators
- Bispebjerg Hospital, University of Copenhagen, Danish Heart Foundation, Ministry of the Interior and Health, Denmark
- Study start
- Jun 2004
- Study completion
- Jul 2006 (actual)
- First posted
- 22 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.
The aim of the study is to determine whether a low-cost home-based training programme can maintain the achieved effect of physical training on exercise capacity and QOL in patients with Chronic Heart Failure.
Detailed description
Guidelines recommend physical training in the treatment of patients with CHF. Several studies have demonstrated that even short-term training programmes can increase maximal oxygen intake, improve muscular strength, reduce neurohumoral activity and result in other effects, which are of potential benefit. Following 2-3 months training at 70 - 80% of maximal capacity, improved exercise capacity and oxygen uptake due to increased cardiac output and also better oxygen uptake in the peripheral muscles have been demonstrated. Moreover, studies have indicated an improvement of the quality of life (QOL). However, the effects of exercise training are rapidly lost without maintenance. Thus the crucial question is to identify a method to sustain the physical activity outside an expensive, enthusiastic and highly motivating protocol.
The aim of the study is to determine whether a low-cost home-based training programme can maintain the achieved effect of physical training on exercise capacity and QOL in patients with Chronic Heart Failure.
Comparison:
Patients fulfilling specified criteria for Chronic Heart Failure are randomised to either eight weeks with supervised group-based training (1.5 hrs.) twice a week followed by home-based training according to a specified protocol with supervised group-based training every 2 weeks (1,5 hrs), or to eight weeks with supervised training followed by usual care. During the whole period patients in both groups can contact the Heart Failure Clinic when needed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- NYHA II-IV
- Ejection Fraction ≤45% assessed by echocardiography within the last 6 months
- Optimal medical treatment according to guidelines
- Informed consent -
Key exclusion criteria (11 listed)
- Hæmodynamically significant obstructive heart valve disease
- Hæmodynamically significant valve insufficiency
- Recent Myocardial infarction (8 weeks)
- Significant arrythmia at exercise testing (NSVT, VT, VF or SVT with ventricular action >150)
- Significant ischaemia or angina at low strain(£ 50 W)
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 |
|---|---|---|
| Home-based exercise training | Behavioural | – |
Primary outcome
Primary endpoint: Exercise capacity based on standardised cycle ergometer test after 14 months.
9 secondary outcomes
Secondary endpoints:
Maximum oxygen uptake at 14 months
Maximum exercise capacity measured by the Shuttle Walk test at 14 months
Exercise capacity measured by 6-minute walking test (6MWT)at 14 months
Muscular strength (sit-to-stand) at 14 months
QOL (SF36 and Minnesota) at 14 months
Serological tests including brain natriuretic peptide at 14 months
In a subgroup including 2x20 patients training-induced changes in muscle biopsies will be evaluated at 14 months.
After 1,3 and 5 years hospital-admissions and death through record linkage.
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 17 May 2007.
- Derived from this study: PubMed 19491687Prescott E, Hjardem-Hansen R, Dela F, Orkild B, Teisner AS, Nielsen H. Effects of a 14-month low-cost maintenance training program in patients with chronic systolic heart failure: a randomized study. Eur J Cardiovasc Prev Rehabil. 2009 Aug;16(4):430-7. doi: 10.1097/HJR.0b013e32831e94f8.
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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.
Eva Prescott, MD principal investigator
Dept of Cardiology, Rigshospitalet, Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Home-based exercise training in people with Chronic Heart Failure, run by Amager Hospital at 1 site in Denmark.
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 11 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 17 May 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 Denmark. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Primary endpoint: Exercise capacity based on standardised cycle ergometer test after 14 months.. 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 NCT00214513, 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 17 May 2007.