Recruiting

Home-Based Exercise

Sponsor:

Dr. Todd A Duhamel

Code:

NCT05834556

Conditions

Frailty

Pre-operative Exercise

Prehabilitation

Cardiac Surgery

Telerehabilitation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prehabilitation

Study Details

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.

1. 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.
2. 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.
3. 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:

1. 7 days prior to the initial assessment
2. 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

Study ID

NCT05834556

Start date

Jul 18, 2023

Status verified date

Oct, 2023

Completion date

Mar, 2024

Anticipated

Primary completion date

Mar, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 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.
2. 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).
3. Patients with an estimated wait time of 3 weeks or longer.
4. Have access to the internet and hardware (smartphone, tablet, computer) to support video telerehabilitation.
5. 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).

Exclusion Criteria:

1. Patients who have unstable or recent unstable cardiac syndrome as defined by:

1. Severe heart failure (NYHA IV) or angina (CCS class IV) symptoms.
2. Critical left main (LM) coronary disease (>50% stenosis).
3. Hospitalization for arrhythmias, congestive heart failure (CHF), or acute coronary syndrome (ACS).
2. 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.
3. Patients who have demonstrated exercise induced ventricular arrhythmias or have experienced a recent hospitalization for arrhythmias.
4. Patients who have cognitive deficits that would preclude prehabilitation.
5. Patients who have physical limitations that would preclude their ability to complete the pre-defined exercises in the intervention.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Prehabilitation group

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.

Interventions

Prehabilitation

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.

Primary outcome measure

  • Adverse events related to exercise [ Time Frame: Reported at the second virtual visit (in week 1) ]
  • Adverse events related to exercise [ Time Frame: Reported at the third virtual visit (in week 2) ]
  • Adverse events related to exercise [ Time Frame: Reported at the fourth virtual visit (end of week 3) ]
  • Timing [ Time Frame: Reported at initial virtual visit (day 1) ]
  • Timing [ Time Frame: Reported at second virtual visit (in week 1) ]
  • Timing [ Time Frame: Reported at third virtual visit (in week 2) ]
  • Timing [ Time Frame: Reported at final virtual visit (end of week 3) ]
  • Exercise technique [ Time Frame: Reported at initial virtual session (day 1) ]
  • Exercise technique [ Time Frame: Reported at second virtual session (in week 1) ]
  • Exercise technique [ Time Frame: Reported at third virtual session (in week 2) ]
  • Exercise technique [ Time Frame: Reported at the final virtual session (end of week 3) ]
  • Exercise adherence [ Time Frame: Reported at second virtual session (in week 1) ]
  • Exercise adherence [ Time Frame: Reported at the third virtual session (in week 2) ]
  • Exercise adherence [ Time Frame: Reported at the final virtual session (end of week 3) ]
  • Education [ Time Frame: Reported at initial virtual session (day 1) ]
  • Education [ Time Frame: Reported at second virtual session (in week 1) ]
  • Education [ Time Frame: Reported at the third virtual session (in week 2) ]
  • Education [ Time Frame: Reported at the final virtual session (end of week 3) ]
  • Change in Euro-qol 5 Question-5 Dimension -5 Level (EQ-5D-5L) [ Time Frame: Completed at baseline and end of week 3 ]

Central Contacts and Locations

Central contacts

Rakesh Arora, MD

12165082112rakeshcarora@gmail.com

Kelly Codispodi

umwaterk@myumanitoba.ca

Locations

St Boniface Hospital

Recruiting

Winnipeg, Manitoba, Canada, R2H 2A6

Contacts

David Kent, MSc

204-237-2985dkent@sbgh.mb.ca

More Information

Sponsor

Dr. Todd A Duhamel

Last update posted

Oct 30, 2023

Last verified

Oct, 2023

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dr. Todd A Duhamel on 2023-10-30.