Trial of Rehabilitation in Phase 1 After Coronary Artery Bypass Grafting

NCT01941355 | Completed DMC

• 1 other identifier: SheppHeartCABG
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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. Over the last 2 decades, cardiac rehabilitation has become recognized as a significant component in the continuum of care for persons with cardiovascular disease. Furthermore, cardiac rehabilitation has undergone a significant evolution moving from a focused exercise intervention to a comprehensive disease management program. In Guidelines for Coronary Artery Bypass Graft Surgery cardiac rehabilitation is described to include early ambulation during hospitalisation, and outpatient prescriptive exercise training beginning 6-8 weeks following surgery. Our hypothesis is that physical exercise with moderate intensity and a psycho-educative component as a part of cardiac rehabilitation can begin in early postoperatively during hospitalising. Results from studies on phase 1 rehabilitation in coronary artery bypass graft surgery patients are promising. However, no randomised trials have been conducted, and evidence is therefore lacking. The objective of this pilot trial is to investigate the effect of a phase 1 comprehensive cardiac rehabilitation programme consisting of a psycho-educative component, an exercise-training component including pulmonary training, cycling, neck and shoulder exercises, these in combination plus treatment as usual and treatment as usual in patients who undergo coronary artery bypass grafting. SheppHeartCABG is an investigator-initiated 2 x 2 factorial randomised clinical pilot trial with blinded outcome assessment. Recruitment from one site with 1:1:1:1 central randomisation to phase 1 rehabilitation; 1) exercise-training plus usual care, 2) psycho-educative plus usual care 3) exercise-training and psycho-educative plus usual, 4) usual care alone.

Conditions

Ischaemic Heart Disease

Outcome Measures

Primary Outcomes (2)

• Change in peak oxygen uptake (VO2) between groups

  At hospital discharge and 4 weeks following surgery

• Change in self-reported health measured by SF-36 between groups

  At hospital discharge and 4 weeks following surgery

Study Arms (4)

Exercise training, psycho-educative

EXPERIMENTAL

Behavioral: Exercise training component; Behavioral: Psycho-educative component

Psycho-educative component

EXPERIMENTAL

Behavioral: Psycho-educative component

Exercise training component

EXPERIMENTAL

Behavioral: Exercise training component

Usual care

NO INTERVENTION

Interventions

Exercise training component BEHAVIORAL

The physical exercises consist of; deep breathing exercises and breathing exercises using incentive spirometry with expiratory positive pressure airway, cycling exercises during hospitalisation and an individualised exercise programme running from discharge to 4 weeks following surgery.

Exercise training component; Exercise training, psycho-educative

Psycho-educative component BEHAVIORAL

The psycho-educative rehabilitation programme consists of four psycho-educative consultations with a specially trained nurse. The last consultation will take place 4 weeks following surgery.

Exercise training, psycho-educative; Psycho-educative component

Eligibility Criteria

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

You may qualify if:

• years or older.
• Persons with ischaemic heart disease referred to elective coronary artery bypass graft surgery.
• Speaks and understands Danish.
• Provide written informed consent.

You may not qualify if:

• Patients at intermediate or high risk according to their cardiovascular status
• Patients with illness limiting the ability to exercise.
• Patients without permanent residence.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Selina K Berg, PhD, Post doc

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, PhD, Post doc

Study Record Dates

• First Submitted: September 6, 2013
• First Posted: September 13, 2013
• Study Start: September 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: April 1, 2014
• Last Updated: November 5, 2015

Record last verified: 2015-11

Locations

DK (1)