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临床试验/NCT07433153
NCT07433153招募中不适用

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

Binghamton University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2026年2月16日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
36
试验地点
1
主要终点
Gait Velocity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • Lower limb amputation
  • Visual impairment uncorrectable with lenses
  • Uncontrolled hypertension, diabetes, neurological or musculoskeletal impairment
  • Persistent symptoms of dizziness or lightheadedness
  • Spine or lower-extremity surgery in the past 12 months
  • Self-reported pain of >7 on a scale of 0-10

研究组 & 干预措施

Smartphone In-home Delivery

Experimental

In-home 8-week OTAGO program

干预措施: Smartphone-Based Intervention (Behavioral)

Group In-Person Delivery

Active Comparator

In-Person 8-week Group OTAGO Program

干预措施: Group-Based Intervention (Behavioral)

结局指标

主要结局

Gait Velocity

时间窗: Baseline (Day 0) and 1 week post-training (9 weeks later)

Self-selected walking speed (m/s) over level surface

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vipul Lugade

Associate Professor

Binghamton University

研究点 (1)

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