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Clinical Trials/NCT01669395
NCT01669395
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N/A

Early Homebased Rehabilitation for Patients With Severe Heart Failure - An Intersectoral Randomized Controlled Trial

University Hospital, Gentofte, Copenhagen1 site in 1 country80 target enrollmentSeptember 2012

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Heart Failure
Sponsor
University Hospital, Gentofte, Copenhagen
Enrollment
80
Locations
1
Primary Endpoint
Readmission due to heart failure
Last Updated
13 years ago

Overview

Brief Summary

The purpose of this study is to investigate the effect of an early, coordinated rehabilitation intervention for patients with severe heart failure in NYHA class III and IV with a ejection fraction of <40% of normal cardiac function measured on frequency of readmissions, physical ability and participation in activities of daily living and quality of life.

Detailed Description

Approximately 400,000 Danes live today with heart disease. Disease severity is crucial for patients quality of life. Patients with severe heart disease often struggle with everyday life, characterized by reduced physical capacity, tendency to depression and anxiety to perform everyday activities that may provoke symptoms. A large proportion of patients who are offered cardiac rehabilitation deselect that offer. Of the patients who do participate, more than 50% stop the rehabilitation ahead of time. A large group of patients with severe heart failure and classified in NYHA Class III and IV, deselect the offer because of lack of energy to participate in cardiac rehabilitation or is when specified by a medical assessment discharged from the hospital without the offer of training or any other form of rehabilitation. The offer of rehabilitation for patients with severe heart failure is lacking as it is today. This study assesses the effectiveness of an early home based rehabilitation program that complements the general psycho-social support, symptom-oriented and preventive medical treatment that these patients always have the option to get.

Registry
clinicaltrials.gov
Start Date
September 2012
End Date
July 2016
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Gentofte, Copenhagen
Responsible Party
Principal Investigator
Principal Investigator

Laura Staun Valentiner

Research and Development Physiotherapist

University Hospital, Gentofte, Copenhagen

Eligibility Criteria

Inclusion Criteria

  • Patients admitted to the Gentofte Hospital due to heart failure.
  • Patients with a functional equivalent to NYHA grade III or IV
  • Patients with ejection fraction \<40%
  • Patients who score between10-15 in the total score for question 3 dealing with physical functioning in SF-36 questionnaire on health status
  • Patients who lives in Gentofte Municipality or Lyngby Tårbæk Municipality.
  • Patients who can speak and understand Danish

Exclusion Criteria

  • Patients with cognitive and psychological problems that prevents cooperation (aphasia, dementia, severe depression).
  • Patients with terminal illness with expected death within a year.

Outcomes

Primary Outcomes

Readmission due to heart failure

Time Frame: assessed one year after inclusion

Secondary Outcomes

  • Physical capacity(Assessed at baseline, after 6 weeks, after 6 month and after one year)
  • Activity of Daily Living(Assessed at baseline, after 6 weeks, after 6 month and after one year)
  • Number of total hospital admissions(at baseline, after 6 weeks, after 6 month and after one year)
  • Exercise Compliance(at baseline, after 6 weeks, after 6 month and after one year)
  • Anxiety and depression(at baseline, after 6 weeks, after 6 month and after one year)
  • Quality of life(at baseline, after 6 weeks, after 6 month and after one year)
  • Number of patients who starts outpatient cardiac rehabilitation after intervention (municipality or hospital)(at 6 weeks, after 6 month and after one year)

Study Sites (1)

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