Training- and Cost-effectiveness of an Internet-based Lifestyle-integrated Functional Exercise Program (iLiFE)

Официальное название

Training- and Cost-effectiveness of an Internet-based Lifestyle-integrated Functional Exercise Program (iLiFE) on Reducing Falls, and Promoting Exercise Adherence in Community Older Fallers: a Randomized Controlled Trial

Обзор

Falls are the second leading cause of unintentional injury and death around the globe. About one in every three older adults falls each year worldwide. With the aging population, the cost of treating fall-related injuries is increasing exponentially. There is a pressing need for a cost-effective fall prevention program. Ample evidence has shown the substantial standalone effectiveness of well-designed physical exercises in preventing falls. However, continuous exercise adherence is required for a long-lasting fall prevention effect. Unfortunately, adherence to an exercise program was generally only 21%. Building up the habit of doing regular exercise is thus crucial in preventing falls. Lifestyle integrated Functional Exercise program (LiFE) has been shown to be able to reduce the fall rate by 31% and maintain 64% of the participants exercising at 12 months follow-up. This proposed randomized controlled trial aims at comparing the effectiveness of an internet-based LiFE in reducing subsequent falls and promoting exercise adherence in community-dwelling older adults.

Подробное описание

All subjects will then be randomly assigned to receive either an internet-based therapist-led LiFE program with a home environment safety assessment (iLiFE) or attention control intervention. Randomization into block groups of four in a 1:1 ratio (the iLiFE group or the attention control group) will be generated in a password-protected excel file by independent research personnel not involved in data collection or intervention after the baseline assessment. The randomization will be concealed by the independent personnel. Research assistants who are blinded to the group allocation will conduct all the subsequent monthly surveillance and assessments at baseline and follow-up sessions. All data will also be entered and checked by the blinded research assistants. All procedures concur with the Declaration of Helsinki (2013).

Вмешательства

• Поведенческое internet-based Lifestyle-integrated Functional Exercise (iLiFE)
  receiving internet-based LiFE training and home safety assessment
• Поведенческое upper limb exercise training
  upper limb exercise training

Первичные конечные точки

• fall incidence as assessed by monthly telephone or internet follow-up [Срок оценки: 12 months]

Вторичные конечные точки (12)

• physiological fall risk as assessed by the Physiological Profile Assessment (PPA) [Срок оценки: 4 months]
• balance as assessed by the 4-stage stance [Срок оценки: 4 months]
• balance as assessed by functional reach tests [Срок оценки: 4 months]
• mobility as assessed by the Short Physical Performance Battery Test [Срок оценки: 4 months]
• mobility as assessed by the Timed Up and Go Test [Срок оценки: 4 months]
• mobility as assessed by the Ten Metre Walk Test [Срок оценки: 4 months]
• muscle mass as assessed by the Bioimpedance Analysis (BIA) [Срок оценки: 4 months]
• postural hypotension as assessed by the blood pressure in sitting and standing [Срок оценки: 4 months]
• physical activity level as assessed by thigh-worn accelerometer (ActivPAL4 physical activity monitor, PAL Technologies Ltd., Glasgow, UK) [Срок оценки: 4 months]
• Cognitive flexibility as assessed by Trail Making Test [Срок оценки: 4 months]
• balance confidence as assessed by the Short version of the Chinese version of the Activities-specific Balance Confidence Scale [Срок оценки: 12 months]
• exercise adherence as assessed by Section B of the Exercise Adherence Rating Scale [Срок оценки: 12 months]

Критерии участия

Критерии включения

• aged ≥ 65 years,
• community-dwelling,
• have a fall history in the previous 12 months,
• have a moderate or above risk of falls as assessed by the Physiological Profile Assessment (total z-score ≥ 1)
• can ambulate on level surfaces without physical contact of another person as assessed by Functional Ambulation Category (score ≥ 3)
• cognitively intact as assessed by the Hong Kong version of the Montreal Cognitive Assessment-5-minute protocol (score ≥ 16th percentile of the age and education-adjusted cut-off score)
• able to communicate effectively.

Критерии исключения

• uncorrected vision or hearing impairment,
• unstable medical condition that may preclude the planned exercises, and
• have been receiving or planning to receive any fall prevention program within the study period.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• The Chinese University of Hong Kong Jockey Club Centre for Osteoporosis Care and Control — Гонконг

Идентификаторы

NCT: NCT05694494 · 2020.622-T

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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