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

Chronic Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00214513
• Other study ID #: Maintain
• Status: Completed
• Phase: Phase 3
• First received: September 16, 2005
• Last updated: May 16, 2007
• Start date: June 2004
• Est. completion date: July 2006

Study information

• Verified date: May 2007
• Source: Amager Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ministry of Science, Technology and Innovation
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Heart Failure

Intervention

Behavioral:
• Home-based exercise training

Locations

Country	Name	City	State
Denmark	Amager Hospital	Copenhagen

Sponsors (5)

Lead Sponsor	Collaborator
Amager Hospital	Bispebjerg Hospital, Danish Heart Foundation, Ministry of the Interior and Health, Denmark, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary endpoint: Exercise capacity based on standardised cycle ergometer test after 14 months.
Secondary	Secondary endpoints:
Secondary	Maximum oxygen uptake at 14 months
Secondary	Maximum exercise capacity measured by the Shuttle Walk test at 14 months
Secondary	Exercise capacity measured by 6-minute walking test (6MWT)at 14 months
Secondary	Muscular strength (sit-to-stand) at 14 months
Secondary	QOL (SF36 and Minnesota) at 14 months
Secondary	Serological tests including brain natriuretic peptide at 14 months
Secondary	In a subgroup including 2x20 patients training-induced changes in muscle biopsies will be evaluated at 14 months.
Secondary	After 1,3 and 5 years hospital-admissions and death through record linkage.