Home-based Exercise for Frail Individuals Prior to Cardiac Surgery

NCT05834556 | Unknown

• 1 other identifier: HOME FREE
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this quasi-experimental feasibility study is to determine if a home based exercise program, that is supported virtually by a physiotherapist, is feasible for frail adults that are waiting for cardiac surgery. The main questions it aims to answer are:

• Will patients be interested in participating in a virtual home-based exercise program before surgery?
• Is the prescribed program practical? Will participants complete the exercises as prescribed, 3x/week?
• Are the exercise images, videos, and live, virtual sessions with the physiotherapists good enough to allow the participant to be independent with good exercise technique?
• Are the 4 virtual sessions able to be done in the specified time frames (1hr initial assessment, 30 minute follow ups)?
• Can the exercise program be done with out any major adverse events?
• What are the physical activity behaviours of frail participants awaiting cardiac surgery? Do they improve with an exercise program? Participants will be required to:
• meet with a physiotherapist virtually (Zoom or Microsoft Teams) 4 times over a 3 week period.
• the first session will be 1 hour to complete an interview about current health and upcoming surgery, a physical assessment, followed by individual exercise demonstration and education.
• the second and third session will be follow up sessions to review exercise technique and progress, the presence of abnormal responses, provide encouragement and to address any barriers to activity completion.
• the fourth, final session will be at the end of week 3 and will take 30 minutes to review exercise progress, presence of abnormal responses with activity and complete a reassessment of physical function.
• Complete an individualized exercise program 3x/week independently as instructed by the physiotherapist following the initial assessment.
• Complete a home exercise diary to track exercises done and intensity of exercise, in addition to documenting any abnormal responses For participants who reside in Winnipeg:
• Accelerometers will be delivered to the patients home to wear for:
• 7 days prior to the initial assessment
• 14 days, from day 8 - 21 of the initial assessment.
• Accelerometer diaries will be provided for participants to complete during the days when the accelerometers are worn.

Conditions

Frailty; Pre-operative Exercise; Prehabilitation; Cardiac Surgery; Telerehabilitation

Keywords

telerehabilitation; prehabilitation; cardiac surgery; frailty; pre-operative exercise

Outcome Measures

Primary Outcomes (19)

• Adverse events related to exercise

  Presence of adverse events related to the exercise intervention

  Reported at the second virtual visit (in week 1)

• Adverse events related to exercise

  Presence of adverse events related to the exercise intervention

  Reported at the third virtual visit (in week 2)

• Adverse events related to exercise

  Presence of adverse events related to the exercise intervention

  Reported at the fourth virtual visit (end of week 3)

• Timing

  Length of virtual session

  Reported at initial virtual visit (day 1)

• Timing

  Length of virtual session

  Reported at second virtual visit (in week 1)

• Timing

  Length of virtual session

  Reported at third virtual visit (in week 2)

• Timing

  Length of virtual session

  Reported at final virtual visit (end of week 3)

• Exercise technique

  Number of exercises requiring technique correction

  Reported at initial virtual session (day 1)

• Exercise technique

  Number of exercises requiring technique correction

  Reported at second virtual session (in week 1)

• Exercise technique

  Number of exercises requiring technique correction

  Reported at third virtual session (in week 2)

• Exercise technique

  Number of exercises requiring technique correction

  Reported at the final virtual session (end of week 3)

• Exercise adherence

  The frequency of home exercises completed and documented in diary

  Reported at second virtual session (in week 1)

• Exercise adherence

  The frequency of home exercises completed and documented in diary

  Reported at the third virtual session (in week 2)

• Exercise adherence

  The frequency of home exercises completed and documented in diary

  Reported at the final virtual session (end of week 3)

• Education

  Frequency of education topics completed

  Reported at initial virtual session (day 1)

• Education

  Frequency of education topics completed

  Reported at second virtual session (in week 1)

• Education

  Frequency of education topics completed

  Reported at the third virtual session (in week 2)

• Education

  Frequency of education topics completed

  Reported at the final virtual session (end of week 3)

• Change in Euro-qol 5 Question-5 Dimension -5 Level (EQ-5D-5L)

  The EQ-5D-5L is a quality of life measure that comprises of a short descriptive system questionnaire and a visual analogue scale (EQ-VAS). There are 5 dimensions of health measured to describe current health; 1- Mobility, 2- Self-care, 3 - usual activities, 4 - Pain/discomfort, and 5 - anxiety/depression. Each dimension has 5 descriptive options for each ranging from having no problems/pain (score 1) to being unable to complete activities or being extremely limited by pain or anxiety (score 5). A lower score in each dimension indicates better health. The EQ-VAS is a measure of health "today" on a scale of 0 - 100 with 100 being the best health you can imagine and 0 being the worst health you can imagine. A higher score on the EQ-VAS indicates better health.

  Completed at baseline and end of week 3

Secondary Outcomes (2)

• Change in Short Physical Performance Battery baseline to week 3

  Completed at baseline and end of week 3

• Change in Duke Activity Status Index baseline to week 3

  Completed at baseline and end of week 3

Study Arms (1)

Prehabilitation group

EXPERIMENTAL

Participants will engage in 4 virtual sessions with a physiotherapist, over a 3 week period. They will be prescribed an individual exercise program (based on assessment). Participants will complete the program 3x/week independently and diarize the exercise on provided documents. For participants living within Winnipeg, they will also diarize their accelerometer use/sleeping times during wear.

Behavioral: Prehabilitation

Interventions

Prehabilitation BEHAVIORAL

Everyone will participate in a home-based prehab program with individual video sessions with a physiotherapist at 4 time points over a period of 3 weeks. The initial session will take an hour and consist of a subjective and physical assessment followed by an individualized exercise program demonstration and education. Patients will be instructed to complete the exercises independently 3x/week. The second and third sessions will be 30 minutes in duration and will check in on activity progress, the presence of abnormal responses to exercise, review exercise technique, address barriers and facilitators to activity completion as well as provide support and encouragement for the current level of activity. The final session will take 30 minutes and will review exercise progress, presence of abnormal responses to exercise followed by a reassessment of physical function.

Prehabilitation group

Eligibility Criteria

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

You may qualify if:

• Adults (≥ 18 years of age) undergoing elective isolated coronary artery bypass graft (CABG), aortic valve repair or replacement for moderate aortic stenosis or severe regurgitation, mitral valve repair or replacement for moderate stenosis or severe regurgitation or combined CABG/valve procedures.
• Patients with a Clinical Frailty Score (CFS) between 3 (managing well) and 6 (living with moderate frailty) as determined by the Cardiac Surgeons or the Nurse Practitioner and/or a score of less than/= 60 on the Short Form 36 Physical Function (SF-36 PF).
• Patients with an estimated wait time of 3 weeks or longer.
• Have access to the internet and hardware (smartphone, tablet, computer) to support video telerehabilitation.
• Have a support person (family member, friend, or caregiver) who is available for all exercise sessions (virtual and independent home exercises). This person should be able to provide technical assistance if needed (help navigate a device to join the telerehabilitation session, set up the device to best view the patient while exercising), is physically capable to stand beside the patient and provide physical assistance if the patient were to lose their balance and is able to respond to any unexpected emergency while the patient is exercising (i.e. provide assistance and/or call 911 if needed).

You may not qualify if:

• Patients who have unstable or recent unstable cardiac syndrome as defined by:
• Severe heart failure (NYHA IV) or angina (CCS class IV) symptoms.
• Critical left main (LM) coronary disease (\>50% stenosis).
• Hospitalization for arrhythmias, congestive heart failure (CHF), or acute coronary syndrome (ACS).
• Patients who have severe left ventricular obstructive disease as defined by:
• a. Severe aortic or mitral stenosis (aortic or mitral valve area \<1.0 cm2 or mean gradient \> 40 mmHg or \> 10 mmHg respectively); or dynamic left ventricular outflow obstruction.
• Patients who have demonstrated exercise induced ventricular arrhythmias or have experienced a recent hospitalization for arrhythmias.
• Patients who have cognitive deficits that would preclude prehabilitation.
• Patients who have physical limitations that would preclude their ability to complete the pre-defined exercises in the intervention.

Sponsors & Collaborators

• Dr. Todd A Duhamel: lead

Study Sites (1)

St Boniface Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

RECRUITING

Related Publications (17)

• Steinmetz C, Bjarnason-Wehrens B, Baumgarten H, Walther T, Mengden T, Walther C. Prehabilitation in patients awaiting elective coronary artery bypass graft surgery - effects on functional capacity and quality of life: a randomized controlled trial. Clin Rehabil. 2020 Oct;34(10):1256-1267. doi: 10.1177/0269215520933950. Epub 2020 Jun 16.

  PMID: 32546065 BACKGROUND

• Boreskie KF, Hay JL, Kehler DS, Johnston NM, Rose AV, Oldfield CJ, Kumar K, Toleva O, Arora RC, Duhamel TA. Prehabilitation: The Right Medicine for Older Frail Adults Anticipating Transcatheter Aortic Valve Replacement, Coronary Artery Bypass Graft, and Other Cardiovascular Care. Clin Geriatr Med. 2019 Nov;35(4):571-585. doi: 10.1016/j.cger.2019.07.006. Epub 2019 Jul 3.

  PMID: 31543187 BACKGROUND

• Yau DKW, Underwood MJ, Joynt GM, Lee A. Effect of preparative rehabilitation on recovery after cardiac surgery: A systematic review. Ann Phys Rehabil Med. 2021 Mar;64(2):101391. doi: 10.1016/j.rehab.2020.03.014. Epub 2020 Oct 14.

  PMID: 32446762 BACKGROUND

• Lytwyn J, Stammers AN, Kehler DS, Jung P, Alexander B, Hiebert BM, Dubiel C, Kimber D, Hamm N, Clarke M, Fraser C, Pedreira B, Duhamel TA, Tangri N, Arora RC. The impact of frailty on functional survival in patients 1 year after cardiac surgery. J Thorac Cardiovasc Surg. 2017 Dec;154(6):1990-1999. doi: 10.1016/j.jtcvs.2017.06.040. Epub 2017 Jun 24.

  PMID: 28734627 BACKGROUND

• Graham A, Brown CH 4th. Frailty, Aging, and Cardiovascular Surgery. Anesth Analg. 2017 Apr;124(4):1053-1060. doi: 10.1213/ANE.0000000000001560.

  PMID: 27622718 BACKGROUND

• Waite I, Deshpande R, Baghai M, Massey T, Wendler O, Greenwood S. Home-based preoperative rehabilitation (prehab) to improve physical function and reduce hospital length of stay for frail patients undergoing coronary artery bypass graft and valve surgery. J Cardiothorac Surg. 2017 Oct 26;12(1):91. doi: 10.1186/s13019-017-0655-8.

  PMID: 29073924 BACKGROUND

• Arora RC, Brown CH 4th, Sanjanwala RM, McKelvie R. "NEW" Prehabilitation: A 3-Way Approach to Improve Postoperative Survival and Health-Related Quality of Life in Cardiac Surgery Patients. Can J Cardiol. 2018 Jul;34(7):839-849. doi: 10.1016/j.cjca.2018.03.020.

  PMID: 29960613 BACKGROUND

• Engelman DT, Ben Ali W, Williams JB, Perrault LP, Reddy VS, Arora RC, Roselli EE, Khoynezhad A, Gerdisch M, Levy JH, Lobdell K, Fletcher N, Kirsch M, Nelson G, Engelman RM, Gregory AJ, Boyle EM. Guidelines for Perioperative Care in Cardiac Surgery: Enhanced Recovery After Surgery Society Recommendations. JAMA Surg. 2019 Aug 1;154(8):755-766. doi: 10.1001/jamasurg.2019.1153.

  PMID: 31054241 BACKGROUND

• Lear SA. The Delivery of Cardiac Rehabilitation Using Communications Technologies: The "Virtual" Cardiac Rehabilitation Program. Can J Cardiol. 2018 Oct;34(10 Suppl 2):S278-S283. doi: 10.1016/j.cjca.2018.07.009. Epub 2018 Jul 18.

  PMID: 30274638 BACKGROUND

• Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85.

  PMID: 8126356 BACKGROUND

• Arthur HM, Daniels C, McKelvie R, Hirsh J, Rush B. Effect of a preoperative intervention on preoperative and postoperative outcomes in low-risk patients awaiting elective coronary artery bypass graft surgery. A randomized, controlled trial. Ann Intern Med. 2000 Aug 15;133(4):253-62. doi: 10.7326/0003-4819-133-4-200008150-00007.

  PMID: 10929164 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

• Grant R, Birch N. Otago strength and balance training exercise programme. An information guide for patients. 2021;1-27.

  BACKGROUND

• Hlatky MA, Boineau RE, Higginbotham MB, Lee KL, Mark DB, Califf RM, Cobb FR, Pryor DB. A brief self-administered questionnaire to determine functional capacity (the Duke Activity Status Index). Am J Cardiol. 1989 Sep 15;64(10):651-4. doi: 10.1016/0002-9149(89)90496-7.

  PMID: 2782256 BACKGROUND

• Bowen DJ, Kreuter M, Spring B, Cofta-Woerpel L, Linnan L, Weiner D, Bakken S, Kaplan CP, Squiers L, Fabrizio C, Fernandez M. How we design feasibility studies. Am J Prev Med. 2009 May;36(5):452-7. doi: 10.1016/j.amepre.2009.02.002.

  PMID: 19362699 BACKGROUND

• Granger CL, Irving L, Antippa P, Edbrooke L, Parry SM, Krishnasamy M, Denehy L. CAPACITY: A physical activity self-management program for patients undergoing surgery for lung cancer, a phase I feasibility study. Lung Cancer. 2018 Oct;124:102-109. doi: 10.1016/j.lungcan.2018.07.034. Epub 2018 Jul 23.

  PMID: 30268446 BACKGROUND

• Stammers AN, Kehler DS, Afilalo J, Avery LJ, Bagshaw SM, Grocott HP, Legare JF, Logsetty S, Metge C, Nguyen T, Rockwood K, Sareen J, Sawatzky JA, Tangri N, Giacomantonio N, Hassan A, Duhamel TA, Arora RC. Protocol for the PREHAB study-Pre-operative Rehabilitation for reduction of Hospitalization After coronary Bypass and valvular surgery: a randomised controlled trial. BMJ Open. 2015 Mar 9;5(3):e007250. doi: 10.1136/bmjopen-2014-007250.

  PMID: 25753362 BACKGROUND

MeSH Terms

Conditions

Frailty

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Kelly Codispodi, BMR PT

  University of Manitoba

  PRINCIPAL INVESTIGATOR

• Rakesh Aroroa, MD

  University of Manitoba

  STUDY DIRECTOR

• Todd Duhamel, PhD

  University of Manitoba

  STUDY DIRECTOR

Central Study Contacts

Rakesh Arora, MD

CONTACT

12165082112; rakeshcarora@gmail.com

Kelly Codispodi

CONTACT

umwaterk@myumanitoba.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Faculty of Kinesiology and Recreation Management

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 28, 2023
• Study Start: July 18, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be available following publication
• Access Criteria: It will be stored on the University of Manitoba's dataverse server

Locations

CA (1)