Testing the Dose-response of Coordination Training for Older Adults.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Ankle coordination variability
研究概览
简要总结
There is an urgent need for interventions to reduce mobility limitations that affect over 15 million older adults and contribute to falls, disability, hospitalization and death. This training will give Dr. James the skills to become an independent researcher developing interventions to decrease mobility limitations, disability and falls in older adults. His multidisciplinary mentorship team, led by Kathleen Bell, MD, has extensive experience with externally sponsored research, expertise in the targeted training domains, mentoring new investigators, and is highly committed to Dr. James' development as a researcher.
Dr. James has identified novel impairments in rhythmic interlimb and gait coordination as strongly linked to mobility among community-dwelling older adults. Currently, no treatment for limb coordination exists. In an effort to advance the development of treatments for mobility limitations, the objective of the proposed research is to examine the dose-response of an innovative intervention to improve coordination in community-dwelling older adults with mobility limitations. The intervention uses a metronome to retrain coordination impairments that develop with age, and consists of practice improving the coordination of the right and left: a) ankles; b) shoulders; and c) ankles and shoulders, while lying supine, and d) the arms and legs during walking; by synchronizing movements with a metronome.
This project is significant in that the approach may offer a cost-effective, clinically applicable, and efficacious means of reducing mobility limitations in older adults. We will initially refine the intervention, and subsequently conduct a randomized trial of 2-, 4- and 8-week intervention treatments vs. physical activity control with (N=120) community-dwelling older adults aged >70 years with mobility limitations. These treatment durations correspond to what rehabilitative care providers would consider a short vs. medium vs. long duration (dose) of treatment. We will examine the magnitude and duration of change in interlimb ankle coordination and gait coordination for each group. We will estimate the coordination effect sizes for a minimal clinically important difference in mobility performance, and explore changes in upper limb coordination and performance-based and self-reported mobility.
详细描述
Concise Summary of Project:
The objective of the proposed research is to examine the dose-response of an intervention to improve interlimb and gait coordination in community-dwelling older adults with mobility limitations. The investigators will compare the effects of 3 doses of the intervention and a physical activity control. The intervention will consist of exercises for performing movement coordination patterns: 1) plantar flexing and dorsiflexing the right and left ankles; 2) flexing and extending the right and left shoulders; and 3) synchronizing the steps during walking with auditory metronome tones. Treatment will mirror outpatient rehabilitative care in that it will involve 1 weekly visit to the clinical laboratory and 4 days of home exercises each week, focusing on limb movement coordination. A physical activity control group will perform a similar treatment program of range of motion exercises that do not target coordination.
The treatment arms will consist of three doses of an intervention to improve coordination and a physical activity control arm. The three doses will consist of different durations of daily training in coordination exercises. Primary outcome variables are the standard deviation of relative phase of the ankles during rhythmic ankle coordination, and the Phase Coordination Index (a measure of gait coordination) during normal pace walking. Secondary outcomes will be the standard deviation of relative phase during rhythmic shoulder coordination, and Short Physical Performance Battery score. Key study endpoints will be at the end of the 8 week intervention, and 2-week follow up assessments up to 8-weeks post-intervention.
The maximum number of subjects to be consented, including projected screen failures and early withdrawals is 250. The study will last five years. Conditions that would result in subjects exiting the study prior to expected completion are death, moving away from the area, injury, the development of exclusionary comorbidities, safety reasons, and withdrawal of consent.
Study Procedures:
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The Principal Investigator and Research Coordinators conducting participant assessments will be masked as to participant group assignment.
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 70 years or older
- •Walk 20 feet without personal assistance
- •Sufficient vision to read written materials
- •Sufficient hearing to synchronize movements with auditory metronome tones.
排除标准
- •Severe language, visual, or hearing deficits
- •Inability to perform the intervention exercises
- •Self-report of:
- •A diagnosis or prescription of medications consistent with any psychiatric disorder Parkinson's disease Alzheimer's disease Stroke Severe head injury in the last two years A history of cardiovascular disease Having a terminal disease Major surgery or myocardial infarction in the past 6 months Planned major surgery Major medical problems interfering with safe and successful balance and walking Inability to read, speak and understand English Plan to leave the area within the next 1 year. Chronic pain that interferes with walking or standing
- •The Short Physical Performance Battery score will be administered during the two baseline testing sessions. A score outside the range of 4-9 on either day will result in exclusion.
- •5.07/10-g monofilament testing will be conducted on the two baseline testing sessions to screen for clinically relevant neuropathy. A negative outcome on this test on either day will result in exclusion.
- •Mini-Mental State Examination score <18
结局指标
主要结局
Ankle coordination variability
时间窗: Every 2 weeks from baseline until 8 weeks post-intervention.
Change in the standard deviation of the relative phase between the ankles during rhythmic antiphase coordination synchronizing with a metronome.
Gait coordination
时间窗: Every 2 weeks from baseline until 8 weeks post-interention.
Change in the Phase Coordination Index of the right-left stepping pattern during normal pace walking.
次要结局
- Short Physical Performance Battery(Every 2 weeks from baseline until 8 weeks post-intervention.)
- Shoulder coordination variability(Every 2 weeks from baseline until 8 weeks post-intervention.)
研究者
Kathleen Bell
Professor
University of Texas Southwestern Medical Center