Severe Heart Failure and Homebased Rehabilitation - An Intersectoral Randomized Controlled Trial

Not Applicable

• Conditions: Heart Failure NYHA Class II; Heart Failure NYHA Class III; Heart Failure NYHA Class IV; Chronic Heart Failure
• Interventions: Other: Early homebased rehabilitation after hospital admission; Other: Usual care

• Registration Number: NCT01669395
• Lead Sponsor: University Hospital, Gentofte, Copenhagen

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.

Study Timeline

• Status Verified: 2012-08
• Study First Submitted: 2012-08-14
• Study First Submitted QC: 2012-08-16
• Last Update Submitted: 2012-08-16
• Study First Posted: 2012-08-21
• Last Update Posted: 2012-08-21
• Study Start: 2012-09
• Primary Completion: 2015-09
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early homebased rehabilitation	Early homebased rehabilitation after hospital admission	After discharge from the hospital patients are offered a homebased rehabilitation program lasting 6 weeks.
control group: Ususal care	Usual care	After discharge from the hospital the patients are offered the usual symptom-oriented and preventive medical care and psychosocial support

Primary Outcome Measures

Name	Time	Method
Readmission due to heart failure	assessed one year after inclusion

Secondary Outcome Measures

Name	Time	Method
Physical capacity	Assessed at baseline, after 6 weeks, after 6 month and after one year	measured by the Morton Mobility Index, Timed Up \& Go and Modified Sit to Stand Test
Activity of Daily Living	Assessed at baseline, after 6 weeks, after 6 month and after one year	Recorded at an ADL interview to assess the performance of everyday activities
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	registration of exercise
Anxiety and depression	at baseline, after 6 weeks, after 6 month and after one year	measured by Hospital Anxiety and Depression Scale (HAD)
Quality of life	at baseline, after 6 weeks, after 6 month and after one year	measured by The Minnesota Living with Heart Failure Questionnaire
Number of patients who starts outpatient cardiac rehabilitation after intervention (municipality or hospital)	at 6 weeks, after 6 month and after one year

Trial Locations

Locations (1)

Department of Occupational Therapy and Physiotherapy, Copenhagen University Hospital Gentofte,; 🇩🇰 Copenhagen, Gentofte, Denmark