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

Amager Hospital

Status and phase

Completed

Phase 3

Conditions

Chronic Heart Failure

Treatments

Behavioral: Home-based exercise training

Study type

Interventional

Funder types

Other

Identifiers

NCT00214513

Maintain

Details and patient eligibility

About

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.

Full 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.

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.

Enrollment

160 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.