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Clinical Trials/NCT02939729
NCT02939729
Completed
N/A

The Effect of a Physiotherapy Prehabilitation Programme on Postoperative Outcomes in Patients Undergoing Cardiac or Thoracic Surgery

Golden Jubilee National Hospital1 site in 1 country40 target enrollmentSeptember 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Golden Jubilee National Hospital
Enrollment
40
Locations
1
Primary Endpoint
Difference between groups functional activity from baseline to point of admission for surgery as measured by the 6MWT.
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The purpose of this study is to determine the effects of a physiotherapy prehabilitation programme (walking and deep breathing exercises) in cardiac or thoracic patients by measuring changes in lung volumes, functional capacity physiotherapy length of stay postoperatively.

Detailed Description

Preoperative rehabilitation or "Prehabilitation" can be defined as "the process of enhancing the functional capacity of the individual to enable him or her to withstand a stressful event". Prehabilitation is a relatively new concept with emerging evidence demonstrating a reduction in length of hospital stay and disability, improved functional capacity and quality of life as well as fewer peri-operative complications compared to usual care. Patients who are awaiting Cardiothoracic surgery are often fearful of being physically active, however extended periods of physical inactivity lead to a loss of muscle mass, physical deconditioning and pulmonary complications which can in turn lead to decreased quality of life, higher levels of morbidity, increased hospital length of stay and even fatality. Based on literature supporting the positive effects of physical activity, physiotherapy prehabilitation aims to enhance functional exercise capacity in patients undergoing Cardiothoracic surgery and hence minimising the risk of postoperative morbidity and enhancing postsurgical recovery. Although there is evidence for prehabilitation in cardiothoracic specialties these are mainly within heart failure patients therefore not comparable to patients undergoing CABG or lobectomy surgeries. The aim of this study is to determine whether a home based preoperative prehabilitation programme improves patients' functional capacity, as measured by a 6 minute walk test (6MWT) prior to surgery and improve post surgical recovery and recovery of functional capacity earlier. This study will compare functional capacity levels from baseline (at time of being accepted for surgery) and on the day of admission for surgery. Secondary aims are to determine functional capacity prior to discharge from hospital and at 6-8 week follow up appointment. Increasing maximal tidal volumes preoperatively would in turn decrease the chance of atelectasis postoperatively thereby decreasing pulmonary complications. Time to achieve discharge criteria from physiotherapy and total post-operative hospital length of stay will be assessed. Patient health related satisfaction will be assessed using the EQ-5D. The endpoint of this study will be when the patient returns for their routine 6-8 week follow up appointment and completes final 6MWT, tidal volume (TV) measurement and EQ-5D.

Registry
clinicaltrials.gov
Start Date
September 2016
End Date
August 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Cardiac surgery -
  • Patients undergoing primary CABG surgery
  • Age \>18 years old
  • Able to mobilise independently with/without a walking aid
  • Thoracic surgery -
  • Patients undergoing lobectomy surgery
  • Age \>18 years old
  • Able to mobilise independently with/without a walking aid

Exclusion Criteria

  • Cardiac surgery -
  • Unstable angina (Grade IIIb as described in Braunwald Classification of Unstable Angina/ angina at rest within the last 48 hours)
  • History of cerebrovascular accident (CVA)
  • History of traumatic brain injury (TBI)
  • Patients who require interpreter
  • Falls risk as classified by the GJNH falls risk document
  • Patients included within cardiac surgery ERAS programme
  • Any patient who lacks capacity to consent
  • Patients who are admitted for urgent or emergency cardiac surgery e.g. aortic stenosis
  • Thoracic surgery -

Outcomes

Primary Outcomes

Difference between groups functional activity from baseline to point of admission for surgery as measured by the 6MWT.

Time Frame: From date of randomisation to date of admission for surgery (up to 8 weeks)

The 6MWT is a validated test that requires no exercise equipment or "advanced" training for the assessor. Walking is an activity carried out on a daily basis by most people. The 6MWT measures the distance that a person can walk on a flat surface over a period of 6 minutes. The majority of activities of daily living are carried out at "sub-maximal" levels similar to the level of exertion of the 6MWT as the patient sets their own intensity (American Thoracic Society 2002). A review of functional walking tests suggested that "the 6MWT is easy to administer, better tolerated, and more reflective of activities of daily living than the other walk tests" (Solway et al 2001). Other prehabilitation studies have used the 6MWT as an outcome measure of functional activity therefore is widely accepted as a reliable measure of functional activity (Sawatzky et al 2014; Carli et al 2010; Gillis et al 2014).

Secondary Outcomes

  • EQ-5D score.(At baseline and follow up clinic appointment (up to 8 weeks).)
  • Functional capacity as measured by 6MWT on day of discharge and at return clinic appointment (up to 8 weeks)(Date of discharge from physiotherapy and at return clinic appointment (up to 8 weeks))
  • Tidal Volume (TV) measures with incentive spirometer.(At baseline, preoperative, postoperative days 1, 2 and 3 and at return clinic appointment (up to 8 weeks))
  • Day of discharge from Physiotherapy.(Once all physiotherapy criteria have been met (approximately 3 to 5 days).)
  • Total postoperative hospital length of stay.(Once all hospital discharge criteria have been met (approximately 5-7 days).)

Study Sites (1)

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