A Phase 3 interventional study of Home-based exercise training in Chronic Heart Failure, sponsored by Amager Hospital. Completed at 1 site in Denmark. Per ClinicalTrials.gov, last updated 2007-05-17.
Sponsored by Amager Hospital · Phase 3, Interventional, and Prevention
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.
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.
Amager Hospital is the lead sponsor of 21 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
This study is completed, as verified in May 2007. You cannot join it, but the record below documents what was studied.
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Amager Hospital