Physiotherapy Prehabilitation in Patients Undergoing Cardiac or Thoracic Surgery

NCT02939729 | Completed

• 1 other identifier: 16/CARD/18
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Lung Cancer; Lung Tumor

Keywords

prehabilitation; physiotherapy; cardiac; thoracic; preoperative

Outcome Measures

Primary Outcomes (1)

• Difference between groups functional activity from baseline to point of admission for surgery as measured by the 6MWT.

  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 Outcomes (5)

• 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)

• 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)

• Day of discharge from Physiotherapy.

  Once all physiotherapy criteria have been met (approximately 3 to 5 days).

• Total postoperative hospital length of stay.

  Once all hospital discharge criteria have been met (approximately 5-7 days).

• EQ-5D score.

  At baseline and follow up clinic appointment (up to 8 weeks).

Study Arms (2)

Prehabilitation

EXPERIMENTAL

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; Device: Incentive Spirometer; Other: Deep Breathing Exercises

Standard Care

NO INTERVENTION

This group will receive standard preoperative information and education only.

Interventions

Walking Programme OTHER

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.

Prehabilitation

Incentive Spirometer DEVICE

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.

Prehabilitation

Deep Breathing Exercises OTHER

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.

Also known as: Breathing Exercises

Prehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Golden Jubilee National Hospital: lead

Study Sites (1)

Golden Jubilee National Hospital

Glasgow, G81 4DY, United Kingdom

Location

Related Publications (12)

• 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.

  PMID: 12432699 BACKGROUND

• 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.

  PMID: 12011598 BACKGROUND

• 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.

  PMID: 24439570 BACKGROUND

• 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.

  PMID: 20602503 BACKGROUND

• 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.

  PMID: 16831570 BACKGROUND

• 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.

  PMID: 21059667 BACKGROUND

• 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.

  PMID: 15585997 BACKGROUND

• 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.

  PMID: 12094184 BACKGROUND

• 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.

  PMID: 12091180 BACKGROUND

• 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.

  PMID: 11157613 BACKGROUND

• 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.

  PMID: 24459173 BACKGROUND

• 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.

  PMID: 25076007 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Lung Neoplasms

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Fiona Nolan, Grad Dip

  National Waiting Times Centre Board

  STUDY CHAIR

• Katie L Lyon, MSc

  National Waiting Times Centre Board

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: October 20, 2016
• Study Start: September 1, 2016
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: October 29, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)