Clinical trial NCT02939729: Physiotherapy Prehabilitation in Patients Undergoing Cardiac or Thoracic Surgery
Official title: The Effect of a Physiotherapy Prehabilitation Programme on Postoperative Outcomes in Patients Undergoing Cardiac or Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lung Cancer
Lung Tumor
Keywords: prehabilitation
physiotherapy
cardiac
thoracic
preoperative
Lead sponsor: Golden Jubilee National Hospital
Sponsor class: OTHER_GOV
First posted: 2016-10-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 -

* 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

Primary outcomes:
measure: Difference between groups functional activity from baseline to point of admission for surgery as measured by the 6MWT.
timeFrame: From date of randomisation to date of admission for surgery (up to 8 weeks)
Secondary outcomes:
measure: Functional capacity as measured by 6MWT on day of discharge and at return clinic appointment (up to 8 weeks)
timeFrame: Date of discharge from physiotherapy and at return clinic appointment (up to 8 weeks)
measure: Tidal Volume (TV) measures with incentive spirometer.
timeFrame: At baseline, preoperative, postoperative days 1, 2 and 3 and at return clinic appointment (up to 8 weeks)
measure: Day of discharge from Physiotherapy.
timeFrame: Once all physiotherapy criteria have been met (approximately 3 to 5 days).
measure: Total postoperative hospital length of stay.
timeFrame: Once all hospital discharge criteria have been met (approximately 5-7 days).
measure: EQ-5D score.
timeFrame: At baseline and follow up clinic appointment (up to 8 weeks).
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Golden Jubilee National Hospital
Study officials:
affiliation: National Waiting Times Centre Board
name: Fiona Nolan, Grad Dip
role: STUDY_CHAIR
affiliation: National Waiting Times Centre Board
name: Katie L Lyon, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.