Early Initiation of Post Sternotomy CArdiac Rehabilitation

Coronary Artery Disease Clinical Trial

— SCAR  

Official title:

Early Initiation of Cardiac Rehabilitation Exercise Training After Sternotomy: A Randomised Controlled Trial and Economic Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03223558
• Other study ID #: SE191516
• Status: Completed
• Phase: N/A
• Start date: July 10, 2017
• Est. completion date: August 5, 2020

Study information

• Verified date: May 2021
• Source: University Hospitals Coventry and Warwickshire NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of this trial is to investigate the effects of starting exercise rehabilitation earlier than current practice after coronary artery bypass graft(CABG) or Aortic/Mitral valve replacement (VR) surgery.

Description:

The trial will compare health improvements after cardiac rehabilitation, (CR) between participants randomly allocated to one of two groups: an early CR group starting exercise after 2 weeks, and a usual care group starting at 6 weeks. It will also collect information on the financial cost of earlier CR to both the health service and the patients.

All primary and secondary outcome measures will be taken at baseline (1 week) and repeated at the start and end of 8 weeks exercise rehabilitation program (2 and 10 weeks from baseline for the early group, 6 and 14 weeks in the usual care group respectively) and at 12 months follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: August 5, 2020
• Est. primary completion date: August 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Coronary artery bypass graft, and mitral/aortic valve replacement patients recovering from sternotomy procedure eligible for cardiac rehabilitation

• Able to provide written informed consent

• Male or female 18 years of age or greater

Exclusion Criteria:

• Patients with any of the following:

• Serious cardiac arrhythmias

• Current neurological disorders or previous Cerebral Vascular Accident with residual neurological deficit significant enough to limit exercise

• Enrolled on another clinical trial that involved exercise

• Unable to enroll for duration of study

• Patients who are unable to provide written consent.

• Patients under the age of 18 or over the age of 90.

Related Conditions & MeSH terms

• Aortic Valve Disease
• Coronary Artery Disease
• Mitral Valve Disease

Intervention

Behavioral:
• timing of initiation of cardiac rehabilitation
earlier timing of cardiac rehabilitation

Locations

Country	Name	City	State
United Kingdom	UHCW NHS trust	Coventry	West Midlands

Sponsors (2)

Lead Sponsor	Collaborator
University Hospitals Coventry and Warwickshire NHS Trust	Coventry University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events	Number, type and severity of adverse events during trial	12 months from surgery.
Primary	Change in Six Minute Walk Test Distance	Distance walked unassisted in 6 minutes	Early Group- Change between baseline, 2 weeks post-surgery, 10 weeks post-surgery, and 12-month follow-up. Usual care group- Change between baseline, 6 weeks post-surgery and 14 weeks post-surgery and 12 months follow-up.
Secondary	Five Times Sit to Stand (Timed)	Time taken to stand up and sit down five times	Early Group- Change between baseline, 2 weeks post-surgery, 10 weeks post-surgery, and 12-month follow-up. Usual care group- Change between baseline, 6 weeks post-surgery and 14 weeks post-surgery and 12 months follow-up.
Secondary	Handgrip Strength	Participant squeezes dynamometer as forcefully as possible. 3 times in each hand.	Early Group- Change between baseline, 2 weeks post-surgery, 10 weeks post-surgery, and 12-month follow-up. Usual care group- Change between baseline, 6 weeks post-surgery and 14 weeks post-surgery and 12 months follow-up.
Secondary	Leg Strength	Isometric quadriceps extension. Measured using a dynamometer.	Early Group- Change between baseline, 2 weeks post-surgery, 10 weeks post-surgery, and 12-month follow-up. Usual care group- Change between baseline, 6 weeks post-surgery and 14 weeks post-surgery and 12 months follow-up.
Secondary	Euroqol 5 Dimensions Questionnaire	Quality of life/cost benefit analysis questionnaire	Early Group- Change between baseline, 2 weeks post-surgery, 10 weeks post-surgery, and 12-month follow-up. Usual care group- Change between baseline, 6 weeks post-surgery and 14 weeks post-surgery and 12 months follow-up.
Secondary	Short Form (SF) -12 Questionnaire	12 Question Quality of Life Questionnaire	Early Group- Change between baseline, 2 weeks post-surgery, 10 weeks post-surgery, and 12-month follow-up. Usual care group- Change between baseline, 6 weeks post-surgery and 14 weeks post-surgery and 12 months follow-up.
Secondary	Combined General Anxiety Disorder (GAD)-7 and Patient Health Questionnaire(PHQ) 9	General Anxiety and Depression Questionnaire	Early Group- Change between baseline, 2 weeks post-surgery, 10 weeks post-surgery, and 12-month follow-up. Usual care group- Change between baseline, 6 weeks post-surgery and 14 weeks post-surgery and 12 months follow-up.
Secondary	Client Service Receipt Inventory (CSRI) Questionnaire	health service use questionnaire for economic analysis	Early Group- Change between baseline, 10 weeks post-surgery, and 12-month follow-up. Usual care group- Change between baseline, 14 weeks post-surgery and 12 months follow-up