Идёт набор NCT07433153

Comparison of Smartphone and Community-Based Delivery of the Otago Exercise Program for Fall Risk in Older Adults

Без фазы С лечением Frail Elderly Fall

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Smartphone-Based Intervention, Group-Based Intervention.
Кому может быть актуально: Состояния в реестре: Frail Elderly, Fall. Базовые параметры: от 55 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Effectiveness of Smartphone-Based Versus Community-Based Otago Exercise Programs for Fall Risk Reduction in Community-Dwelling Older Adults: A Randomized Controlled Trial

Обзор

The long-term goal of this project is to effectively bridge the research-clinic-community gap and to foster partnerships that support the implementation, utilization, and advocacy of evidence-based fall prevention programs in the older adult community. The Otago Exercise Program (OEP) is an evidence-based fall prevention program that has been shown to reduce falls and fall-related injuries among older adults. Traditionally, OEP is delivered in the home by a physical therapist and focuses on muscle strengthening and balance training. Despite its proven effectiveness, adherence and compliance rates have been low. The personnel and resource demands of program delivery, along with challenges in monitoring participant adherence, represent significant barriers to broader implementation. Alternative delivery systems using remote and community-based platforms may help address these limitations. Specific Aim 1: To compare the effectiveness of two delivery modes of the Otago Exercise Program: a remotely delivered, home-based smartphone program and an in-person, community-based program. Specific Aim 2: To examine the feasibility, acceptability, and usability of the Otago Exercise Program delivered through both smartphone-based and in-person formats.

Подробное описание

Thirty eligible participants will provide written informed consent prior to enrollment. In accordance with the World Guidelines for Falls Prevention, participants will be stratified into low-, intermediate-, and high-risk groups. Following the first visit assessment, older adults classified as intermediate or high risk will be randomly assigned to one of two intervention groups: (1) a remotely delivered, smartphone- based Otago Exercise Program, or (2) an in-person, community-based Otago Exercise Program.

Participants in both groups will receive individualized 60-minute training sessions, two times per week for eight weeks. Across the sixteen training sessions, participants will receive a progressive balance, mobility, and strengthening program following the structure of the Otago Exercise Program.

Prior to and immediately following the exercise program, participants are asked to complete several surveys and evaluations, including: demographics, STEADI-12, SF-36, Geriatric Depression Scale (GDS), Falls Efficacy Scale-International (FES-I), Four-Square Stepping Test, Timed Up and Go Test (TUG), Ten-meter Walk Test, Four-Stage Balance Test, 30-second chair stand, and the Physiological Profile Assessment (PPA). All outcome measures will be collected at baseline and at the end of the intervention, with testers blinded to participant group allocation, and trainers blinded to baseline outcomes. In addition, gait speed will be assessed weekly using smartphone-based measurements.

Вмешательства

Поведенческое Smartphone-Based Intervention
Participants in the smartphone-based group will receive Otago Exercise Program instructions delivered through Improve, an investigator-developed application. This application, installed on each participant's iOS or Android smartphone, will allow participants to track their exercises and review workout instructions. Participants in the smartphone-based group will be contacted weekly by phone to ensure safety and adherence and to assist with troubleshooting any technology-related issues. All parti
Поведенческое Group-Based Intervention
Participants in the in-person, community-based group will complete the individualized Otago Exercise Program in a group setting at the Johnson City Senior Center, under the guidance of Doctor of Physical Therapy students (4) and supervision of licensed Physical Therapists.

Первичные конечные точки

Gait Velocity [Срок оценки: Baseline (Day 0) and 1 week post-training (9 weeks later)]

Вторичные конечные точки (10)

Injurious Falls [Срок оценки: Up to 1-year post intervention]
PPA-Short Form: Postural Sway [Срок оценки: Baseline (Day 0) and 1 week post-training (9 weeks later)]
PPA-Short Form: Finger Reaction Time [Срок оценки: Baseline (Day 0) and 1 week post-training (9 weeks later)]
PPA-Short Form: Knee Extensor Strength [Срок оценки: Baseline (Day 0) and 1 week post-training (9 weeks later)]
PPA-Short Form: Visual Contrast Sensitivity [Срок оценки: Baseline (Day 0) and 1 week post-training (9 weeks later)]
PPA-Short Form: Proprioception [Срок оценки: Baseline (Day 0) and 1 week post-training (9 weeks later)]
30-second Chair Stand [Срок оценки: Baseline (Day 0) and 1 week post-training (9 weeks later)]
TUG [Срок оценки: Baseline (Day 0) and 1 week post-training (9 weeks later)]
Four-Stage Balance [Срок оценки: Baseline (Day 0) and 1 week post-training (9 weeks later)]
Smartphone-based assessments [Срок оценки: Weekly during 8-week training program]

Критерии участия

Критерии включения

Community-dwelling older adults 55 years of age or older
Communicate in English
Able to ambulate at least 10 meters with or without an assistive device.
Cognitively intact based on scoring 18/22 or greater on the Montreal Cognitive Assessment (MoCA)-Blind during a phone screening process
Have access to an Android or iOS smartphone
Intermediate or high risk of falling, based on World Guidelines for Falls Prevention (Montero-Odasso et al, 2022)