Home-based Prehabilitation for Frail Cardiac Surgery Patients (HOME FREE) - A Quasi-experimental Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Exercise adherence
研究概览
简要总结
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.
详细描述
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:
- 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?
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Exercise adherence
时间窗: Reported at the final virtual session (end of week 3)
The frequency of home exercises completed and documented in diary
Education
时间窗: Reported at the final virtual session (end of week 3)
Frequency of education topics completed
Adverse events related to exercise
时间窗: Reported at the fourth virtual visit (end of week 3)
Presence of adverse events related to the exercise intervention
Timing
时间窗: Reported at final virtual visit (end of week 3)
Length of virtual session
Exercise technique
时间窗: Reported at the final virtual session (end of week 3)
Number of exercises requiring technique correction
Change in Euro-qol 5 Question-5 Dimension -5 Level (EQ-5D-5L)
时间窗: Completed at baseline and end of week 3
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.
次要结局
- 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)
研究者
Dr. Todd A Duhamel
Professor, Faculty of Kinesiology and Recreation Management
St. Boniface Hospital