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

NCT ID: NCT00214513

Last Updated: 2007-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2006-07-31

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.

Conditions

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Chronic Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Home-based exercise training

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. NYHA II-IV
2. Ejection Fraction ≤45% assessed by echocardiography within the last 6 months
3. Optimal medical treatment according to guidelines
4. Informed consent -

Exclusion Criteria

1. Hæmodynamically significant obstructive heart valve disease
2. Hæmodynamically significant valve insufficiency
3. Recent Myocardial infarction (8 weeks)
4. Significant arrythmia at exercise testing (NSVT, VT, VF or SVT with ventricular action \>150)
5. Significant ischaemia or angina at low strain(£ 50 W)
6. Disabilities that render physical training impossible
7. Dementia
8. Serious other illness with expected shortened survival
9. Participation in other scientific protocols that do not allow participation
10. Lack of informed consent
11. 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bispebjerg Hospital

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role collaborator

Danish Heart Foundation

OTHER

Sponsor Role collaborator

Ministry of the Interior and Health, Denmark

OTHER_GOV

Sponsor Role collaborator

Amager Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Eva Prescott, MD

Role: PRINCIPAL_INVESTIGATOR

Dept of Cardiology, Rigshospitalet, Copenhagen, Denmark

Locations

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Amager Hospital

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 19491687 (View on PubMed)

Other Identifiers

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Maintain

Identifier Type: -

Identifier Source: org_study_id