Chronic Heart Failure, Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure NYHA Class IV
Conditions
Keywords
Severe heart failure, Homebased rehabilitation, Physical exercise, Activities of daily living, Intersectoral Cooperation
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.
Interventions
OTHEREarly homebased rehabilitation after hospital admission
Training begins 3-5 days after discharge from hospital, performed by an occupational therapist and a physiotherapist from Gentofte Hospital in the first two weeks. From week three to six the training will be carried out by an occupational therapist and a physiotherapist from the local municipality (Gentofte municipality and Lyngby Taarbæk municipality). Training will take place at home twice a week for 6 weeks, each session lasting 45 minutes. The intervention is individualized and focuses on functional physical and compensatory training to help the patient to manage everyday life at home. A training program will be provided and the patient will be instructed to do the exercises every day
OTHERUsual care
After discharge from the hospital the patients are offered the usual symptom-oriented and preventive medical care and psychosocial support
Sponsors
University Hospital, Gentofte, Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Readmission due to heart failure | assessed one year after inclusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 | — |
| Anxiety and depression | at baseline, after 6 weeks, after 6 month and after one year | measured by Hospital Anxiety and Depression Scale (HAD) |
Countries
Denmark
Contacts
Primary ContactLaura Staun Valentiner, Master in health scien
Backup ContactCarsten Juhl, Ph.D.stud
Outcome results
None listed