A Randomized Trial of Effect of Low-Cost Maintenance Training on Exercise Capacity, Quality of Life and Morbidity

Study Overview
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Brief Summary
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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
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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.

Official Title
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Maintain. A Randomized Trial of Effect of Low-Cost Maintenance Training on Exercise Capacity, Quality of Life and Morbidity

Conditions
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Chronic Heart Failure

Intervention / Treatment
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* Behavioral: Home-based exercise training


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Home-based exercise training|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary endpoint: Exercise capacity based on standardised cycle ergometer test after 14 months. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  |