Physiotherapy Prehabilitation in Patients Undergoing Cardiac or Thoracic Surgery
NCT ID: NCT02939729
Last Updated: 2019-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2016-09-30
2019-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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
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.
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.
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.
Standard Care
This group will receive standard preoperative information and education only.
No interventions assigned to this group
Interventions
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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.
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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Golden Jubilee National Hospital
OTHER_GOV
Responsible Party
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Principal Investigators
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Fiona Nolan, Grad Dip
Role: STUDY_CHAIR
National Waiting Times Centre Board
Katie L Lyon, MSc
Role: PRINCIPAL_INVESTIGATOR
National Waiting Times Centre Board
Locations
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Golden Jubilee National Hospital
Glasgow, , United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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16/CARD/18
Identifier Type: -
Identifier Source: org_study_id
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