Clinical trial NCT05834556: Home-based Exercise for Frail Individuals Prior to Cardiac Surgery
Official title: Home-based Prehabilitation for Frail Cardiac Surgery Patients (HOME FREE) - A Quasi-experimental Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Frailty
Pre-operative Exercise
Prehabilitation
Cardiac Surgery
Telerehabilitation
Keywords: telerehabilitation
prehabilitation
cardiac surgery
frailty
pre-operative exercise
Lead sponsor: St. Boniface Hospital
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: The study will be a single-centre, prospective, quasi-experimental feasibility study to evaluate a home-based prehab intervention on frail adults undergoing cardiac surgery. The investigators will recruit patients from the St. Boniface Hospital, Winnipeg, Manitoba, an academic, tertiary care hospital.

The goal of this research is to determine the feasibility and safety of a preoperative home-based prehab exercise intervention for frail cardiac surgery patients. The primary research questions include:

1. Will patients display interest in participating in a virtually delivered home-based prehabilitation option compared to in person, center-based recruitment rates?

   a. The investigators hypothesize that patients will display a greater interest in virtually delivered home-based prehabilitation evaluated by recruitment rate being ≥30% (defined as the number of eligible patients that consent to participate).
2. Is the intervention practical, will patients adhere to the prescribed exercises 3 x/week?

   a. The investigators hypothesize that ≥65% of patients will adhere to the exercise protocol.
3. Are the provided exercise images, and live, virtual sessions with the Physiotherapist sufficient to ensure patients are independent with performing the prescribed exercises safely?
4. Are the 4 virtual sessions with the physiotherapist able to be completed in the identified time frames (1 hour for initial assessment and 30 minutes for each of the 3 follow up sessions)?
5. Can the exercise program be completed in the absence of major adverse events?
6. What are the physical activity behaviours of frail patients awaiting cardiac surgery and do they improve with an individualized prehabilitation program?

All patients will participate in a home-based prehab program with individual video sessions via University of Manitoba (UM) Microsoft Teams or UM Zoom, whichever the patient prefers. During a period of three weeks, the patient will meet one on one with a physiotherapist at 4 time points (Figure 1): 1) Initial assessment; 2) within 1 week of the initial assessment; 3) in week two and 4) reassessment of outcomes at the end of three weeks.

The initial session will take an hour and consist of a subjective assessment to confirm the patients scheduled surgery, their past medical history, current medications and inquire about any recent angina or worsening symptoms to determine the patient's medical status to participate. A physical assessment using the Short Physical Performance Battery (SPPB) to stratify patients into an individualized exercise program, followed by exercise demonstration and education. The education will be provided in both verbal and written forms and cover the benefits of exercise on cardiovascular health, the role of balance and strength exercises on improving functional capacity and abnormal responses to exercise with a focus on cardiac symptoms, and an action plan in the event of angina or musculoskeletal discomfort. Patients will be instructed to complete the exercises independently 3x/week in addition to the 4 virtual sessions. 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 and the presence of abnormal responses to exercise followed by a reassessment of physical function. No sessions will be recorded.

The SPPB includes a 3 meter walk test. For patients who do not have a measuring tape to mark the distance within their home, a 3 meter length of yarn will be mailed to them prior to the initial assessment to ensure accuracy.

The 3-week prehabilitation program will focus on balance and strengthening exercises based upon the Otago strength and balance training exercise programme and the Weight-bearing Exercise for Better Balance (WEBB) program. For this study the exercises have been organized into four different levels based on degrees of difficulty, with level 1 being the simplest and level 4 the most challenging. Patients will be stratified into a set of predefined exercises based on the balance component score of the SPPB assessment. Level 1 -SPPB balance score of ≤1; Level 2 - SPPB balance score of 2; Level 3 - SPPB balance score of 3; Level 4 - SPPB balance score of 4. Exercises will be prescribed to be completed three times per week, for three weeks. Patients will be provided with a handout via email discussing the benefits of exercise in cardiovascular health, images with a description of the exercises, signs and symptoms of activity intolerance and an action plan in the event of angina. Additionally, the rating of perceived exertion scale will be provided and explained for patients to best monitor their intensity with the goal of achieving a moderate intensity.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adverse events related to exercise
timeFrame: Reported at the second virtual visit (in week 1)
measure: Adverse events related to exercise
timeFrame: Reported at the third virtual visit (in week 2)
measure: Adverse events related to exercise
timeFrame: Reported at the fourth virtual visit (end of week 3)
measure: Timing
timeFrame: Reported at initial virtual visit (day 1)
measure: Timing
timeFrame: Reported at second virtual visit (in week 1)
measure: Timing
timeFrame: Reported at third virtual visit (in week 2)
measure: Timing
timeFrame: Reported at final virtual visit (end of week 3)
measure: Exercise technique
timeFrame: Reported at initial virtual session (day 1)
measure: Exercise technique
timeFrame: Reported at second virtual session (in week 1)
measure: Exercise technique
timeFrame: Reported at third virtual session (in week 2)
measure: Exercise technique
timeFrame: Reported at the final virtual session (end of week 3)
measure: Exercise adherence
timeFrame: Reported at second virtual session (in week 1)
measure: Exercise adherence
timeFrame: Reported at the third virtual session (in week 2)
measure: Exercise adherence
timeFrame: Reported at the final virtual session (end of week 3)
measure: Education
timeFrame: Reported at initial virtual session (day 1)
measure: Education
timeFrame: Reported at second virtual session (in week 1)
measure: Education
timeFrame: Reported at the third virtual session (in week 2)
measure: Education
timeFrame: Reported at the final virtual session (end of week 3)
measure: Change in Euro-qol 5 Question-5 Dimension -5 Level (EQ-5D-5L)
timeFrame: Completed at baseline and end of week 3
Secondary outcomes:
measure: Change in Short Physical Performance Battery baseline to week 3
timeFrame: Completed at baseline and end of week 3
measure: Change in Duke Activity Status Index baseline to week 3
timeFrame: Completed at baseline and end of week 3
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: St Boniface Hospital
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Kelly Codispodi, BMR PT
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manitoba
name: Rakesh Aroroa, MD
role: STUDY_DIRECTOR
affiliation: University of Manitoba
name: Todd Duhamel, PhD
role: STUDY_DIRECTOR
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