Clinical trial NCT01669395: Severe Heart Failure and Homebased Rehabilitation - An Intersectoral Randomized Controlled Trial
Official title: Early Homebased Rehabilitation for Patients With Severe Heart Failure - An Intersectoral Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Heart Failure
Heart Failure NYHA Class II
Heart Failure NYHA Class III
Heart Failure NYHA Class IV
Keywords: Severe heart failure
Homebased rehabilitation
Physical exercise
Activities of daily living
Intersectoral Cooperation
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2012-08-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Readmission due to heart failure
timeFrame: assessed one year after inclusion
Secondary outcomes:
measure: Physical capacity
timeFrame: Assessed at baseline, after 6 weeks, after 6 month and after one year
measure: Activity of Daily Living
timeFrame: Assessed at baseline, after 6 weeks, after 6 month and after one year
measure: Number of total hospital admissions
timeFrame: at baseline, after 6 weeks, after 6 month and after one year
measure: Exercise Compliance
timeFrame: at baseline, after 6 weeks, after 6 month and after one year
measure: Anxiety and depression
timeFrame: at baseline, after 6 weeks, after 6 month and after one year
measure: Quality of life
timeFrame: at baseline, after 6 weeks, after 6 month and after one year
measure: Number of patients who starts outpatient cardiac rehabilitation after intervention (municipality or hospital)
timeFrame: at 6 weeks, after 6 month and after one year
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Occupational Therapy and Physiotherapy, Copenhagen University Hospital Gentofte,
state: Gentofte
Study officials:
References: