ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01669395
Recruitment Status : Unknown
Verified August 2012 by Laura Staun Valentiner, University Hospital, Gentofte, Copenhagen.
Recruitment status was:  Not yet recruiting
First Posted : August 21, 2012
Last Update Posted : August 21, 2012
Sponsor:
Information provided by (Responsible Party):
Laura Staun Valentiner, 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.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Heart Failure NYHA Class II Heart Failure NYHA Class III Heart Failure NYHA Class IV Other: Early homebased rehabilitation after hospital admission Other: Usual care Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Early Homebased Rehabilitation for Patients With Severe Heart Failure - An Intersectoral Randomized Controlled Trial
Study Start Date : September 2012
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Early homebased rehabilitation
After discharge from the hospital patients are offered a homebased rehabilitation program lasting 6 weeks.
Other: Early 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
Other Names:
  • severe heart failure
  • homebased rehabilitation
  • physical exercise
  • activities of daily living
Experimental: control group: Ususal care
After discharge from the hospital the patients are offered the usual symptom-oriented and preventive medical care and psychosocial support
Other: 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 :
  1. Readmission due to heart failure [ Time Frame: assessed one year after inclusion ]

Secondary Outcome Measures :
  1. Physical capacity [ Time Frame: 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

  2. Activity of Daily Living [ Time Frame: 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

  3. Number of total hospital admissions [ Time Frame: at baseline, after 6 weeks, after 6 month and after one year ]
  4. Exercise Compliance [ Time Frame: at baseline, after 6 weeks, after 6 month and after one year ]
    registration of exercise

  5. Anxiety and depression [ Time Frame: at baseline, after 6 weeks, after 6 month and after one year ]
    measured by Hospital Anxiety and Depression Scale (HAD)

  6. Quality of life [ Time Frame: at baseline, after 6 weeks, after 6 month and after one year ]
    measured by The Minnesota Living with Heart Failure Questionnaire

  7. Number of patients who starts outpatient cardiac rehabilitation after intervention (municipality or hospital) [ Time Frame: at 6 weeks, after 6 month and after one year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01669395


Contacts
Contact: Laura Staun Valentiner, Master in health scien + 45 39 77 39 51 laura.risted.staun.valentiner@regionh.dk
Contact: Carsten Juhl, Ph.D.stud + 45 39 77 39 51 carsten.juhl@regionh.dk

Locations
Denmark
Department of Occupational Therapy and Physiotherapy, Copenhagen University Hospital Gentofte, Not yet recruiting
Copenhagen, Gentofte, Denmark, 2900
Contact: Laura Staun Valentiner, masters in health sciences    + 45 39 77 39 51    laura.risted.staun.valentiner@regionh.dk   
Contact: Carsten Juhl, Ph.D stud.    + 45 39 77 39 51    carsten.juhl@regionh.dk   
Principal Investigator: Laura Staun Valentiner, Masters in Health Science         
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen

Responsible Party: Laura Staun Valentiner, Research and Development Physiotherapist, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT01669395     History of Changes
Other Study ID Numbers: H-2-2012-021
First Posted: August 21, 2012    Key Record Dates
Last Update Posted: August 21, 2012
Last Verified: August 2012

Keywords provided by Laura Staun Valentiner, University Hospital, Gentofte, Copenhagen:
Severe heart failure
Homebased rehabilitation
Physical exercise
Activities of daily living
Intersectoral Cooperation

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases