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SheppHeartCABG - Phase One Rehabilitation After Coronary Artery Bypass Grafting (SheppHeart)

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: NCT02290262
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : January 2, 2017
Sponsor:
Collaborator:
Odense University Hospital
Information provided by (Responsible Party):
Selina Kikkenborg Berg, Rigshospitalet, Denmark

Brief Summary:

Background: Patients undergoing coronary artery bypass graft surgery often experience a range of problems and symptoms related to the procedure and the underlying heart disease.These problems include anxiety and depressive symptoms, immobility issues, complications such as wound seeping, neck and shoulder pains, interrupted and insufficient sleep. No studies have tested a combined intervention on phase 1 rehabilitation in coronary artery bypass graft surgery patients. However, randomised trials with either a physical or a mental part have been conducted with positive result, but evidence is lacking for a combined intervention. Before a large randomised trial was set up a pilot trial was conducted to evaluate the feasibility of patient recruitment and intervention: to test the safety and tolerability of the intervention by patients and to provide outcome data for sample size calculations. The SheppHeartCABG pilot showed trial feasibility, safety and sufficient inclusion rate and high compliance with most elements. Outcome data from the pilot trial has been used to sample size and power calculation in this randomised clinical trial.

Objective: The objective of this trial is to investigate the benefits and harms of a phase 1 comprehensive cardiac rehabilitation programme consisting of an exercise-training and a psycho-educative component, including plus treatment as usual in patients who undergo coronary artery bypass grafting.


Condition or disease Intervention/treatment Phase
Ischaemic Heart Disease Other: Comprehensive phase one rehabilitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 326 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: SheppheartCABG. A Randomised Clinical Trial of a Comprehensive Physical and Psycho-educative Rehabilitation Programme Plus Usual Care Versus Usual Care in Phase 1 Rehabilitation After Coronary Artery Bypass Grafting
Study Start Date : November 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Comprehensive phase one rehabilitation
Patients allocated to the experimental group receive a rehabilitation programme consisting of physical exercise and psycho-education plus usual care.
Other: Comprehensive phase one rehabilitation

Patients allocated to the experimental group receive a rehabilitation programme consisting of physical exercise and psycho-education.

The physical exercises consist of; breathing exercises with and without using incentive spirometry with expiratory positive pressure airway, walking and cycling exercises and neck/shoulder exercises during hospitalisation and an exercise programme running from discharge until 4 weeks following surgery. The psycho-educative rehabilitation programme consists of four psycho-educative consultations with a specially trained nurse.


No Intervention: Usual care
The control group will receive usual care alone.



Primary Outcome Measures :
  1. 6-minute walk test [ Time Frame: 4 week ]
    Primary outcome is physical capacity measured by 6-minute walk test 4 weeks following surgery.


Secondary Outcome Measures :
  1. Composite secondary outcomes [ Time Frame: 4 week ]
    . Secondary outcomes consists of perceived mental and physical(SF 12), health-related quality of life (HeartQoL), anxiety and depression (HADS), sleep (PSQI), pain (ÖMPSQ) and leg endurance and strength (sit and stand test) measured 4 weeks after surgery.



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients 18 years or older with ischaemic heart disease,
  • Who have to undergo elective coronary artery bypass grafting,
  • Who speak and understand Danish and
  • Who provide a written informed consent will be included.

Exclusion Criteria:

Patients will be excluded from the trial:

  • Patients at intermediate or high risk to their cardiovascular status according to guidelines,
  • Patients with neurological or orthopaedic deficits which prevent training and
  • Patients who do not wish to participate.

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): NCT02290262


Locations
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Denmark
Hjertecentret, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9
Copenhagen, OE, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Odense University Hospital
Investigators
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Principal Investigator: Selina Berg, PhD Rigshospitalet, Denmark
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Selina Kikkenborg Berg, Senior researcher, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02290262    
Other Study ID Numbers: SheppHeartCABG RCT
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: January 2, 2017
Last Verified: December 2016
Keywords provided by Selina Kikkenborg Berg, Rigshospitalet, Denmark:
Heart disease
Phase one rehabilitation
Additional relevant MeSH terms:
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Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases