Early Initiation of Post Sternotomy CArdiac Rehabilitation

Not Applicable

Completed

• Conditions: Mitral Valve Disease; Coronary Artery Disease; Aortic Valve Disease
• Interventions: Behavioral: timing of initiation of cardiac rehabilitation

• Registration Number: NCT03223558
• Lead Sponsor: University Hospitals Coventry and Warwickshire NHS Trust

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-07-05
• Study Start: 2017-07-10
• Study First Submitted QC: 2017-07-19
• Study First Posted: 2017-07-21
• Primary Completion: 2020-08-05
• Study Completion: 2020-08-05
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-04
• Last Update Posted: 2021-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
usual care group	timing of initiation of cardiac rehabilitation	start 8 weeks of cardiac rehabilitation 6 weeks post surgery
early rehab group	timing of initiation of cardiac rehabilitation	start of 8 weeks cardiac rehabilitation 2 weeks following surgery

Primary Outcome Measures

Name	Time	Method
Change in Six Minute Walk Test Distance	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.	Distance walked unassisted in 6 minutes

Secondary Outcome Measures

Name	Time	Method
Euroqol 5 Dimensions 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.	Quality of life/cost benefit analysis questionnaire
Client Service Receipt Inventory (CSRI) Questionnaire	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	health service use questionnaire for economic analysis
Combined General Anxiety Disorder (GAD)-7 and Patient Health Questionnaire(PHQ) 9	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.	General Anxiety and Depression Questionnaire
Five Times Sit to Stand (Timed)	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.	Time taken to stand up and sit down five times
Handgrip Strength	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.	Participant squeezes dynamometer as forcefully as possible. 3 times in each hand.
Leg Strength	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.	Isometric quadriceps extension. Measured using a dynamometer.
Short Form (SF) -12 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.	12 Question Quality of Life Questionnaire

Trial Locations

Locations (1)

UHCW NHS trust; 🇬🇧 Coventry, West Midlands, United Kingdom