SheppHeartCABG - Phase One Rehabilitation After Coronary Artery Bypass Grafting

NCT02290262 | Completed DMC

• 1 other identifier: SheppHeartCABG RCT
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischaemic Heart Disease

Keywords

Heart disease; Phase one rehabilitation

Outcome Measures

Primary Outcomes (1)

• 6-minute walk test

  Primary outcome is physical capacity measured by 6-minute walk test 4 weeks following surgery.

  4 week

Secondary Outcomes (1)

• Composite secondary outcomes

  4 week

Study Arms (2)

Comprehensive phase one rehabilitation

EXPERIMENTAL

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

Usual care

NO INTERVENTION

The control group will receive usual care alone.

Interventions

Comprehensive phase one rehabilitation OTHER

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.

Comprehensive phase one rehabilitation

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Odense University Hospital: collaborator

Study Sites (1)

Hjertecentret, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9

Copenhagen, OE, 2100, Denmark

Location

Related Publications (1)

• Hojskov IE, Moons P, Hansen NV, La Cour S, Olsen PS, Gluud C, Winkel P, Lindschou J, Thygesen LC, Egerod I, Berg SK. SheppHeartCABG trial-comprehensive early rehabilitation after coronary artery bypass grafting: a protocol for a randomised clinical trial. BMJ Open. 2017 Jan 17;7(1):e013038. doi: 10.1136/bmjopen-2016-013038.

  PMID: 28096255 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Heart Diseases

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Selina Berg, PhD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior researcher

Study Record Dates

• First Submitted: November 7, 2014
• First Posted: November 14, 2014
• Study Start: November 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: August 1, 2016
• Last Updated: January 2, 2017

Record last verified: 2016-12

Locations

DK (1)