Clinical trial NCT06633614: PREhabilitation of Frail Elderly PAtients Undergoing majoR surgEry at HOME (PREPARE-HOME) Using Smart Wearables
Official title: PREhabilitation of Frail Elderly PAtients Undergoing majoR surgEry at HOME (PREPARE-HOME) Using Smart Wearables: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Frailty Syndrome
Keywords: Prehabilitation
Home-based
Perioperative Science
Wearable Technology
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2024-10-09
Enrollment: 190
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This randomized controlled trial (RCT) will compare a prehabilitation program using wearable technology (swSEP) with standard preoperative care (uSEP) in elderly patients undergoing major abdominal surgery. Participants will be randomly assigned to either the intervention or control group, with stratification based on baseline physical function, surgical risk, and physiotherapist involvement. The intervention group will follow a personalized exercise program, remotely supervised via telemedicine, and monitored through a Fitbit Aspire 3 device. The control group will receive standard care without wearable technology. The trial will assess improvements in physical function, postoperative outcomes, and recovery at 4 weeks, aiming to determine the superiority of the prehabilitation program over standard care.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to evaluate whether a prehabilitation program using wearable technology can improve physical function and postoperative outcomes in elderly patients (65 years or older) undergoing major elective non-cardiac surgery. The main questions it aims to answer are:

Does the prehabilitation program improve physical function, as measured by the 6-minute walk test (6MWT), from baseline to pre-surgery? Does the prehabilitation program reduce postoperative complications and enhance recovery? Researchers will compare participants who receive the prehabilitation program with wearable technology (intervention group) to those receiving standard preoperative care (control group) to see if the intervention results in greater improvements in physical function and postoperative outcomes.

Participants will:

Follow a personalized exercise program monitored remotely via telemedicine. Wear a Fitbit Aspire 3 device to track vital signs such as heart rate and physical activity.

Undergo assessments of physical function and quality of life before surgery.

Detailed description: This clinical trial aims to investigate the effectiveness of a prehabilitation program using wearable technology to improve physical function and postoperative outcomes in elderly patients undergoing major elective non-cardiac surgery. The intervention group will receive a comprehensive preoperative rehabilitation program (swSEP) that includes personalized exercise regimens monitored via telemedicine and a wearable device (Fitbit Aspire 3) to track key physiological metrics such as heart rate, physical activity, and sleep patterns. The exercise program will consist of three components: strength training, aerobic exercises, and flexibility exercises. These sessions will be conducted three times per week, with adjustments made by the physiotherapist based on the participant's progress and vital sign responses.

Participants will be monitored closely through telemedicine check-ins twice per week to ensure adherence to the exercise program, address any challenges, and make modifications to the regimen as needed. In addition, all participants will undergo baseline functional assessments, including the 6-minute walk test (6MWT), 30-second sit-to-stand test (30sSTS), handgrip strength (HGS), and maximal inspiratory pressure (MIP), as well as nutritional and quality of life assessments using the MUST score and EQ-5D-5L questionnaire. These assessments will be repeated 1-3 days before surgery to evaluate any improvements in physical function.

The control group (uSEP) will receive standard preoperative care, which includes physiotherapy education and a home-based exercise booklet, but will not be provided with a wearable device or telemedicine supervision. Both groups will be monitored for postoperative outcomes, including the incidence of complications classified by the Clavien-Dindo system, hospital length of stay, ICU admissions, and hospital readmissions. Health-related quality of life (HRQoL) will also be measured at multiple time points.

Exploratory analyses will include postoperative recovery and resumption of physical activity at 12 weeks post-surgery, as well as heart rate variability (HRV) data from the wearable devices to assess physiological responsiveness to the prehabilitation program and its potential predictive value for postoperative outcomes. A qualitative interview study will be conducted concurrently to explore the barriers and facilitators of home-based prehabilitation from the perspectives of both patients and healthcare providers.

Eligibility criteria: Inclusion Criteria:

* Frail elderly patients aged 65 years or older.
* Scheduled to undergo major elective, non-cardiac surgery.
* Anticipated surgery duration of over two hours or expected blood loss greater than 500 mL.
* Frailty status with Edmonton Frail Scale (EFS) score of 6 or higher.
* Capacity to provide informed consent independently.
* Available at least two weeks before surgery to participate in the prehabilitation program.
* Ability to follow exercise instructions independently.
* Ownership of a smartphone with Bluetooth and cellular connectivity.

Exclusion Criteria:

* Severe comorbidities that interfere with participation in the exercise program (e.g., unstable angina, severe aortic stenosis, or uncontrolled arrhythmias).
* Cognitive impairments that prevent understanding or adherence to the intervention.

Primary outcomes:
measure: Change in Physical Function (6-Minute Walk Test) from baseline to before surgery.
timeFrame: baseline to 1-3 days pre-surgery.
Secondary outcomes:
measure: Functional assessments
timeFrame: Baseline to 1-3 days before the surgery
measure: Postoperative complications
timeFrame: Preoperative to up to 4 weeks after surgery.
measure: Health Services outcomes
timeFrame: Preoperative to up to 8 weeks after surgery.
Other outcomes:
Locations:
Study officials:
References: