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Physiotherapy Prehabilitation in Patients Undergoing Cardiac or Thoracic Surgery

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ClinicalTrials.gov Identifier: NCT02939729
Recruitment Status : Unknown
Verified October 2016 by Golden Jubilee National Hospital.
Recruitment status was:  Recruiting
First Posted : October 20, 2016
Last Update Posted : October 20, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Lung Cancer Lung Tumor Other: Walking Programme Device: Incentive Spirometer Other: Deep Breathing Exercises Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: The Effect of a Physiotherapy Prehabilitation Programme on Postoperative Outcomes in Patients Undergoing Cardiac or Thoracic Surgery
Study Start Date : September 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Prehabilitation
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.
Other: Walking Programme
Walking programme measured by daily step count on pedometer provided to participant. Participants will be advised to increase daily step count from their baseline measure - realistic incremental rise according to individual ability and symptoms. Daily step count will be recorded in a participant study diary.

Device: Incentive Spirometer
An incentive spirometer is a device used to measure lung tidal volumes. Participants will be asked to use the incentive spirometer to measure their tidal volume daily. Participants will record daily tidal volume measurement in the participant diary. A physiotherapist will teach participants how to use the incentive spirometer and provide an instruction sheet.

Other: Deep Breathing Exercises
Participants will be taught deep breathing exercises - these are the same deep breathing exercises shown to all patients after cardiac surgery as part of chest physiotherapy treatment. Participants will be asked to carry out deep breathing exercises at home during the prehabilitation phase. An instruction sheet for the deep breathing exercises will be provided to participants.
Other Name: Breathing Exercises

No Intervention: Standard Care
This group will receive standard preoperative information and education only.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Functional capacity as measured by 6MWT on day of discharge and at return clinic appointment (up to 8 weeks) [ Time Frame: Date of discharge from physiotherapy and at return clinic appointment (up to 8 weeks) ]
  2. Tidal Volume (TV) measures with incentive spirometer. [ Time Frame: At baseline, preoperative, postoperative days 1, 2 and 3 and at return clinic appointment (up to 8 weeks) ]
  3. Day of discharge from Physiotherapy. [ Time Frame: 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).

  4. Total postoperative hospital length of stay. [ Time Frame: Once all hospital discharge criteria have been met (approximately 5-7 days). ]
  5. EQ-5D score. [ Time Frame: 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 -

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939729


Contacts
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Contact: Fiona Nolan, Grad Dip 0141 951 5121 fiona.nolan@gjnh.scot.nhs.uk
Contact: Katie L Lyon, MSc 0141 951 5121 katie.lyon@gjnh.scot.nhs.uk

Locations
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United Kingdom
Golden Jubilee National Hospital Recruiting
Glasgow, United Kingdom, G81 4DY
Contact: Fiona Nolan, Graduate Dip    0141 951 5121    fiona.nolan@gjnh.scot.nhs.uk   
Contact: Katie Lyon, MSc    0141 951 5121    katie.lyon@gjnh.scot.nhs.uk   
Sub-Investigator: Natalie E Logan, BSc (Hons)         
Sub-Investigator: Kirsty L Graham, MSc         
Sponsors and Collaborators
Golden Jubilee National Hospital
Investigators
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Study Chair: Fiona Nolan, Grad Dip National Waiting Times Centre Board
Principal Investigator: Katie L Lyon, MSc National Waiting Times Centre Board

Publications:

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Responsible Party: Golden Jubilee National Hospital
ClinicalTrials.gov Identifier: NCT02939729     History of Changes
Other Study ID Numbers: 16/CARD/18
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: October 20, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Golden Jubilee National Hospital:
prehabilitation
physiotherapy
cardiac
thoracic
preoperative

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases