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

NCT01669395 | Unknown

• 1 other identifier: H-2-2012-021
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Readmission due to heart failure

  assessed one year after inclusion

Secondary Outcomes (7)

• 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

Study Arms (2)

Early homebased rehabilitation

EXPERIMENTAL

After discharge from the hospital patients are offered a homebased rehabilitation program lasting 6 weeks.

Other: Early homebased rehabilitation after hospital admission

control group: Ususal care

EXPERIMENTAL

After discharge from the hospital the patients are offered the usual symptom-oriented and preventive medical care and psychosocial support

Other: Usual care

Interventions

Early homebased rehabilitation after hospital admission OTHER

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

Also known as: severe heart failure, homebased rehabilitation, physical exercise, activities of daily living

Early homebased rehabilitation

Usual care OTHER

After discharge from the hospital the patients are offered the usual symptom-oriented and preventive medical care and psychosocial support

control group: Ususal care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead

Study Sites (1)

Department of Occupational Therapy and Physiotherapy, Copenhagen University Hospital Gentofte,

Copenhagen, Gentofte, 2900, Denmark

Location

MeSH Terms

Conditions

Heart Failure; Motor Activity

Interventions

Exercise; Activities of Daily Living

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Laura Staun Valentiner, Master in health scien

CONTACT

+ 45 39 77 39 51; laura.risted.staun.valentiner@regionh.dk

Carsten Juhl, Ph.D.stud

CONTACT

+ 45 39 77 39 51; carsten.juhl@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research and Development Physiotherapist

Study Record Dates

• First Submitted: August 14, 2012
• First Posted: August 21, 2012
• Study Start: September 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: July 1, 2016
• Last Updated: August 21, 2012

Record last verified: 2012-08

Locations

DK (1)