Early Initiation of Post Sternotomy CArdiac Rehabilitation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-10

Study Completion Date

2020-08-05

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coronary Artery Disease Aortic Valve Disease Mitral Valve Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A single blinded parallel group randomised controlled trial will be used to determine non-inferiority of early (2 weeks post operation) vs usual care (6 weeks post operation ) CR for a period of 8 weeks.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

researchers will be blinded during baseline assessment prior to group allocation.

Participants and the clinical CR team will know the group allocation and therefore cannot be blinded. University hospitals for Coventry and Warwickshire NHS trust research and design department will generate the randomisation sequence remotely using permuted block randomisation.

Study Groups

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early rehab group

start of 8 weeks cardiac rehabilitation 2 weeks following surgery

Group Type EXPERIMENTAL

timing of initiation of cardiac rehabilitation

Intervention Type BEHAVIORAL

earlier timing of cardiac rehabilitation

usual care group

start 8 weeks of cardiac rehabilitation 6 weeks post surgery

Group Type ACTIVE_COMPARATOR

timing of initiation of cardiac rehabilitation

Intervention Type BEHAVIORAL

earlier timing of cardiac rehabilitation

Interventions

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timing of initiation of cardiac rehabilitation

earlier timing of cardiac rehabilitation

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No