SheppHeartCABG - Phase One Rehabilitation After Coronary Artery Bypass Grafting (SheppHeart)
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|ClinicalTrials.gov Identifier: NCT02290262|
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : January 2, 2017
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||326 participants|
|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|
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.
- 6-minute walk test [ Time Frame: 4 week ]Primary outcome is physical capacity measured by 6-minute walk test 4 weeks following surgery.
- 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.
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
|Hjertecentret, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9|
|Copenhagen, OE, Denmark, 2100|
|Principal Investigator:||Selina Berg, PhD||Rigshospitalet, Denmark|