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Completed

NCT Number: NCT03223558

Early Initiation of Post Sternotomy CArdiac Rehabilitation

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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Key information

Conditions

Coronary Artery Disease Aortic Valve Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Heart Valve Diseases Mitral Valve Disease Myocardial Ischemia Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UHCW NHS trust

Coventry, West Midlands, Cv2 2DX, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

timing of initiation of cardiac rehabilitation

Behavioral

earlier timing of cardiac rehabilitation

Primary outcomes

  1. Change in Six Minute Walk Test Distance

    Time frame: 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 outcomes

  1. Five Times Sit to Stand (Timed)

    Time frame: 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

  2. Handgrip Strength

    Time frame: 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.

  3. Leg Strength

    Time frame: 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.

  4. Euroqol 5 Dimensions Questionnaire

    Time frame: 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

  5. Short Form (SF) -12 Questionnaire

    Time frame: 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

  6. Combined General Anxiety Disorder (GAD)-7 and Patient Health Questionnaire(PHQ) 9

    Time frame: 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

  7. Client Service Receipt Inventory (CSRI) Questionnaire

    Time frame: 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

Other outcomes

  1. Adverse Events

    Time frame: 12 months from surgery.

    Number, type and severity of adverse events during trial

Sponsors and collaborators

Lead sponsor

University Hospitals Coventry and Warwickshire NHS Trust

Other

Collaborators

  • Coventry University

Registry information

Official study title

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

Acronym: SCAR

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 21, 2017
Registry last updated
May 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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