PREhabilitation of Frail Elderly PAtients Undergoing majoR surgEry at HOME (PREPARE-HOME) Using Smart Wearables

Официальное название

PREhabilitation of Frail Elderly PAtients Undergoing majoR surgEry at HOME (PREPARE-HOME) Using Smart Wearables: A Prospective Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Supervised prehabilitation programme
  Participants will receive standard preoperative physiotherapy education along with a Fitbit Aspire 3 wearable device to track vital signs such as heart rate, physical activity, and sleep patterns. They will follow a personalized exercise program, supervised remotely by a physiotherapist via telemedicine twice a week. The program will include 20-minute sessions at least three times per week, focusing on strength training, aerobic exercises (at 40% of maximal heart rate), and flexibility exercises

Первичные конечные точки

• Change in Physical Function (6-Minute Walk Test) from baseline to before surgery. [Срок оценки: baseline to 1-3 days pre-surgery.]

Вторичные конечные точки (3)

• Functional assessments [Срок оценки: Baseline to 1-3 days before the surgery]
• Postoperative complications [Срок оценки: Preoperative to up to 4 weeks after surgery.]
• Health Services outcomes [Срок оценки: Preoperative to up to 8 weeks after surgery.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Leong YH, Tay VYJ, Yang X, Tan CJ, Au-Yong PS, Sim JLX, Ng RRG, Ong MEH, Tan BPY, Abdullah HR, Ke Y. Prehabilitation of frail elderly PAtients undergoing majoR surgEry at HOME (PREPARE-HOME): a superiority parallel-group randomised controlled trial protocol evaluating smart wearable enhanced prehabilitation versus usual care. BMJ Open. 2025 Oct 23;15(10):e094986. doi: 10.1136/bmjopen-2024-094986. PMID 41130682

Идентификаторы

NCT: NCT06633614 · 202410-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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