A Randomized Trial of Effect of Low-Cost Maintenance Training on Exercise Capacity, Quality of Life and Morbidity
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| ClinicalTrials.gov Identifier: NCT00214513 |
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Recruitment Status :
Completed
First Posted : September 22, 2005
Last Update Posted : May 17, 2007
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Heart Failure | Behavioral: Home-based exercise training | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 160 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Maintain. A Randomized Trial of Effect of Low-Cost Maintenance Training on Exercise Capacity, Quality of Life and Morbidity |
| Study Start Date : | June 2004 |
| Actual Study Completion Date : | July 2006 |
- Primary endpoint: Exercise capacity based on standardised cycle ergometer test after 14 months.
- 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.
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- NYHA II-IV
- Ejection Fraction ≤45% assessed by echocardiography within the last 6 months
- Optimal medical treatment according to guidelines
- Informed consent -
Exclusion Criteria:
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00214513
| Denmark | |
| Amager Hospital | |
| Copenhagen, Denmark, 2300 S | |
| Principal Investigator: | Eva Prescott, MD | Dept of Cardiology, Rigshospitalet, Copenhagen, Denmark |
| ClinicalTrials.gov Identifier: | NCT00214513 |
| Other Study ID Numbers: |
Maintain |
| First Posted: | September 22, 2005 Key Record Dates |
| Last Update Posted: | May 17, 2007 |
| Last Verified: | May 2007 |