- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02939729
Physiotherapy Prehabilitation in Patients Undergoing Cardiac or Thoracic Surgery
The Effect of a Physiotherapy Prehabilitation Programme on Postoperative Outcomes in Patients Undergoing Cardiac or Thoracic Surgery
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Glasgow, United Kingdom, G81 4DY
- Golden Jubilee National Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
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.
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 Names:
|
No Intervention: Standard Care
This group will receive standard preoperative information and education only.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
From date of randomisation to date of admission for surgery (up to 8 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Measure of level of physical activity measured in metres
|
Date of discharge from physiotherapy and at return clinic appointment (up to 8 weeks)
|
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)
|
Lung volume measure in mls
|
At baseline, preoperative, postoperative days 1, 2 and 3 and at return clinic appointment (up to 8 weeks)
|
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).
|
Once all physiotherapy criteria have been met (approximately 3 to 5 days).
|
Total postoperative hospital length of stay.
Time Frame: Once all hospital discharge criteria have been met (approximately 5-7 days).
|
Total post operative hospital length is days in hospital after surgery.
|
Once all hospital discharge criteria have been met (approximately 5-7 days).
|
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).
|
At baseline and follow up clinic appointment (up to 8 weeks).
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Fiona Nolan, Grad Dip, National Waiting Times Centre Board
- Principal Investigator: Katie L Lyon, MSc, National Waiting Times Centre Board
Publications and helpful links
General Publications
- ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available. Erratum In: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.
- Solway S, Brooks D, Lacasse Y, Thomas S. A qualitative systematic overview of the measurement properties of functional walk tests used in the cardiorespiratory domain. Chest. 2001 Jan;119(1):256-70. doi: 10.1378/chest.119.1.256.
- Carli F, Charlebois P, Stein B, Feldman L, Zavorsky G, Kim DJ, Scott S, Mayo NE. Randomized clinical trial of prehabilitation in colorectal surgery. Br J Surg. 2010 Aug;97(8):1187-97. doi: 10.1002/bjs.7102.
- Carli F, Zavorsky GS. Optimizing functional exercise capacity in the elderly surgical population. Curr Opin Clin Nutr Metab Care. 2005 Jan;8(1):23-32. doi: 10.1097/00075197-200501000-00005.
- Valkenet K, van de Port IG, Dronkers JJ, de Vries WR, Lindeman E, Backx FJ. The effects of preoperative exercise therapy on postoperative outcome: a systematic review. Clin Rehabil. 2011 Feb;25(2):99-111. doi: 10.1177/0269215510380830. Epub 2010 Nov 8.
- Topp R, Ditmyer M, King K, Doherty K, Hornyak J 3rd. The effect of bed rest and potential of prehabilitation on patients in the intensive care unit. AACN Clin Issues. 2002 May;13(2):263-76. doi: 10.1097/00044067-200205000-00011.
- Ditmyer MM, Topp R, Pifer M. Prehabilitation in preparation for orthopaedic surgery. Orthop Nurs. 2002 Sep-Oct;21(5):43-51; quiz 52-4. doi: 10.1097/00006416-200209000-00008.
- Gillis C, Li C, Lee L, Awasthi R, Augustin B, Gamsa A, Liberman AS, Stein B, Charlebois P, Feldman LS, Carli F. Prehabilitation versus rehabilitation: a randomized control trial in patients undergoing colorectal resection for cancer. Anesthesiology. 2014 Nov;121(5):937-47. doi: 10.1097/ALN.0000000000000393.
- Santa Mina D, Clarke H, Ritvo P, Leung YW, Matthew AG, Katz J, Trachtenberg J, Alibhai SM. Effect of total-body prehabilitation on postoperative outcomes: a systematic review and meta-analysis. Physiotherapy. 2014 Sep;100(3):196-207. doi: 10.1016/j.physio.2013.08.008. Epub 2013 Nov 13.
- Mooney M, Fitzsimons D, Richardson G. "No more couch-potato!" Patients' experiences of a pre-operative programme of cardiac rehabilitation for those awaiting coronary artery bypass surgery. Eur J Cardiovasc Nurs. 2007 Mar;6(1):77-83. doi: 10.1016/j.ejcnurse.2006.05.002. Epub 2006 Jul 10.
- McKelvie RS, Teo KK, Roberts R, McCartney N, Humen D, Montague T, Hendrican K, Yusuf S. Effects of exercise training in patients with heart failure: the Exercise Rehabilitation Trial (EXERT). Am Heart J. 2002 Jul;144(1):23-30. doi: 10.1067/mhj.2002.123310.
- Sawatzky JA, Kehler DS, Ready AE, Lerner N, Boreskie S, Lamont D, Luchik D, Arora RC, Duhamel TA. Prehabilitation program for elective coronary artery bypass graft surgery patients: a pilot randomized controlled study. Clin Rehabil. 2014 Jul;28(7):648-57. doi: 10.1177/0269215513516475. Epub 2014 Jan 23.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16/CARD/18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coronary Artery Disease
-
Elixir Medical CorporationIstituto Clinico HumanitasActive, not recruitingCoronary Artery Disease | Chronic Total Occlusion of Coronary Artery | Multi Vessel Coronary Artery Disease | Bifurcation of Coronary Artery | Long Lesions Coronary Artery DiseaseItaly
-
Fundación EPICActive, not recruitingCoronary Artery Disease | Left Main Coronary Artery Disease | Left Main Coronary Artery Stenosis | Restenosis, CoronarySpain
-
Peking Union Medical College HospitalNot yet recruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
Peking Union Medical College HospitalRecruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
IGLESIAS Juan FernandoUniversity of BernNot yet recruiting
-
National Institutes of Health Clinical Center (CC)National Heart, Lung, and Blood Institute (NHLBI)CompletedCoronary Arteriosclerosis | Coronary Artery Disease (CAD) | Obstructive Coronary Artery DiseaseUnited States
-
Barts & The London NHS TrustImperial College London; Brunel UniversityNot yet recruitingCORONARY ARTERY DISEASE
-
Fundación EPICRecruitingCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Left Main Coronary Artery Disease | Coronary Artery StenosisSpain
-
Abbott Medical DevicesCompletedCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Chronic Total Occlusion of Coronary Artery | Coronary Restenosis | Coronary Artery Stenosis | Coronary Artery RestenosisBelgium
-
China National Center for Cardiovascular DiseasesRecruitingLeft Main Coronary Artery DiseaseChina
Clinical Trials on Walking Programme
-
University Hospital of LimerickUniversity of LimerickCompleted
-
Manchester Metropolitan UniversityBrecon Beacons National Park AuthorityCompleted
-
Oxford University Hospitals NHS TrustCompletedKnee Osteoarthritis | Hip Osteoarthritis | Knee Arthroplasty | Hip ArthroplastyUnited Kingdom
-
Revmatismesykehuset ASSouth-Eastern Norway Regional Health AuthorityCompletedMusculoskeletal Diseases or ConditionsNorway
-
Beijing Chao Yang HospitalPeking University First Hospital; Guang'anmen Hospital of China Academy of... and other collaboratorsUnknownInflammation | COPDChina
-
University of HelsinkiFinnish Medical FoundationCompleted
-
Region SkaneLund UniversityCompleted
-
University of CagliariSuspendedHemorrhagic StrokeItaly
-
Medical University of LodzCompletedChronic Obstructive Pulmonary Disease (COPD)Poland
-
Universidad San JorgeHospital Royo Villanova; Hospital Real Nuestra Señora de GraciaCompletedFatigue | Coronavirus | Musculoskeletal ComplicationSpain