Physiotherapy Prehabilitation in Patients Undergoing Cardiac or Thoracic Surgery

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Lung Cancer; Lung Tumor
• Interventions: Other: Walking Programme; Device: Incentive Spirometer; Other: Deep Breathing Exercises

• Registration Number: NCT02939729
• Lead Sponsor: Golden Jubilee National Hospital

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.

Study Timeline

• Study First Submitted: 2016-08-25
• Study Start: 2016-09
• Study First Submitted QC: 2016-10-18
• Study First Posted: 2016-10-20
• Primary Completion: 2019-08
• Study Completion: 2019-08
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-25
• Last Update Posted: 2019-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 -

• 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
• Any patient who lacks capacity to consent
• Patients who are admitted for urgent or emergency surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prehabilitation	Deep Breathing Exercises	This group will receive standard preoperative information and education and be provided with a physiotherapy prehabilitation programme. This programme will be carried out from time of consenting to participate in the study until day of admission to surgery for cardiac or thoracic surgery. The prehabilitation programme consists of: walking programme, deep breathing exercises and tidal volume measurement using the incentive spirometer.
Prehabilitation	Incentive Spirometer	This group will receive standard preoperative information and education and be provided with a physiotherapy prehabilitation programme. This programme will be carried out from time of consenting to participate in the study until day of admission to surgery for cardiac or thoracic surgery. The prehabilitation programme consists of: walking programme, deep breathing exercises and tidal volume measurement using the incentive spirometer.
Prehabilitation	Walking Programme	This group will receive standard preoperative information and education and be provided with a physiotherapy prehabilitation programme. This programme will be carried out from time of consenting to participate in the study until day of admission to surgery for cardiac or thoracic surgery. The prehabilitation programme consists of: walking programme, deep breathing exercises and tidal volume measurement using the incentive spirometer.

Primary Outcome Measures

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

Name	Time	Method
EQ-5D score.	At baseline and follow up clinic appointment (up to 8 weeks).	A standardized and validated measure of health status which can be used in a wide range of health conditions. It is a simple method which patients can complete at the beginning and end of treatment. It encompasses five dimensions of health: mobility, ability to self care, ability to complete activities of daily living, pain and discomfort, and anxiety and depression (Chartered Society of Physiotherapists, 2016).
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)	Measure of level of physical activity measured in metres
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)	Lung volume measure in mls
Day of discharge from Physiotherapy.	Once all physiotherapy criteria have been met (approximately 3 to 5 days).	Physiotherapy discharge criteria: mobilising safely and independently with or without walking aid approximately 100 metres; independently managing chest and safely completed stairs assessment (approximately post op day 3 to 5).
Total postoperative hospital length of stay.	Once all hospital discharge criteria have been met (approximately 5-7 days).	Total post operative hospital length is days in hospital after surgery.

Trial Locations

Locations (1)

Golden Jubilee National Hospital; 🇬🇧 Glasgow, United Kingdom