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临床试验/NCT04368949
NCT04368949进行中(未招募)不适用

Stepping-Up: Partnering With the Community to Prevent Early Mobility Decline

McMaster University2 个研究点 分布在 1 个国家目标入组 249 人开始时间: 2021年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
249
试验地点
2
主要终点
Change in walking speed from baseline

研究概览

简要总结

Preclinical mobility limitations (PCML) manifest early in the process of declining mobility, and are not typically identified or acted upon by clinicians. These mobility limitations manifest as changes in how daily tasks such as walking are performed (slower speed, lower endurance). Persons in the PCML stage are at increased risk for the onset of disability and chronic disease. Persistent deterioration in mobility is a predictor of mortality and has been reported even in the absence of changes in activities of daily living over a two-year period. Further, older persons with mobility limitations, including reduced gait speed, are at risk for falls. These cumulative transitions of a person's life-long mobility form their mobility trajectory and preventing mobility decline at an early stage along this trajectory is the focus of this research initiative. This study will evaluate a novel intervention, STEPPING-UP, for improving walking ability in persons with PCML.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
55 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Community-dwelling
  • Age ≥55-75 years
  • PCML as assessed using a questionnaire that requires respondents to self-report difficulties with their mobility (walking 2.0km). Respondents will be considered in a stage of PCML if they report no task difficulty but report modification of task performance (i.e. modify frequency, method or time to complete the task)
  • Understanding of spoken and written English
  • Own a laptop computer, have an email address and have internet capabilities of running the video-conferencing platform, Zoom©.
  • Resident of Ontario, Canada

排除标准

  • A score of <11 on the MoCA 5-Minute telephone screen
  • Major illness that would prevent participation

研究组 & 干预措施

Stepping-Up Group

Experimental

Participants will attend one 2-hour virtual session (1-hour exercise and 1-hour SM) per week. Each class of 6-8 participants is supervised by a Physiotherapist (PT) and kinesiologist who will individually tailor the exercises for each participant.

干预措施: Stepping-Up (Other)

TELE Group

Active Comparator

The initial telephone session will be 20-30 minutes, with subsequent weekly calls will be approximately 10 minutes.

干预措施: Telephone-Based Coaching Walking Program (Other)

Chair-Based Yoga Group

Placebo Comparator

Participants will attend two 1-hour virtual sessions per week to ensure this group is matched for attention to STEPPING-UP.

干预措施: Chair-Based Yoga Program (Other)

结局指标

主要结局

Change in walking speed from baseline

时间窗: 12 weeks

The 4-Metre Gait Speed Test (4MGS) is a performance-based measure of walking speed. The 4MGS test will be performed from a standing start at both a self-selected (usual) and fastest walking speed.

Walking speed

时间窗: Baseline

The 4-Metre Gait Speed Test (4MGS) is a performance-based measure of walking speed. The 4MGS test will be performed from a standing start at both a self-selected (usual) and fastest walking speed.

次要结局

  • Change in walking speed from baseline(36 weeks)
  • Change in exercise capacity from baseline(36 weeks)
  • Change in mobility patterns from baseline(36 weeks)
  • Change in balance self-efficacy from baseline(36 weeks)
  • Change in knowledge, skill and confidence for self-management from baseline(36 weeks)
  • Balance(Baseline)
  • Hospitalizations(24 weeks to 36 weeks)
  • Exercise capacity(Baseline)
  • Lower body strength(Baseline)
  • Change in lower body strength from baseline(36 weeks)
  • Dual task cost(Baseline)
  • Balance self-efficacy(Baseline)
  • Self-reported mobility(Baseline)
  • Emergency room visits(24 weeks to 36 weeks)
  • Change in dual task cost from baseline(36 weeks)
  • Self-reported change in mobility(12 weeks)
  • Change in self-reported change in mobility from basseline(36 weeks)
  • Knowledge, skill and confidence for self-management(12 weeks)
  • Change in balance from baseline(36 weeks)
  • Change in health-related quality of life from baseline(36 weeks)
  • Change in self-efficacy for physical activity from baseline(36 weeks)
  • Change in self-reported mobility from baseline(36 weeks)
  • Family doctor visits(24 weeks to 36 weeks)
  • Specialist physician visits visits(24 weeks to 36 weeks)
  • Mobility patterns(Baseline)
  • Health-related quality of life(Baseline)
  • Self-efficacy for physical activity:(Baseline)
  • Medical tests or procedures(24 weeks to 36 weeks)

研究者

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

Julie Richardson

Principal Investigator

McMaster University

研究点 (2)

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