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临床试验/NCT02663778
NCT02663778已完成不适用

Task Specific Timing and Coordination Exercise to Improve Mobility in Older Adults

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 353 人开始时间: 2016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
已完成
入组人数
353
试验地点
1
主要终点
Gait speed

研究概览

简要总结

This randomized clinical trial targets 248 community-dwelling older adults with impaired mobility (i.e. walking slowly; gait speed < 1.20 m/s). The trial compares a 12 week "standard-plus" program of strength, endurance, flexibility plus task specific timing and coordination training to a standard 12 week strength, endurance and flexibility program. The primary outcome is gait speed at 12 weeks. Secondary and tertiary outcomes represent components of the intervention and measures of activity and participation. Delayed and sustained effects of the intervention are examined at 24 and 36 weeks.

详细描述

Walking difficulty is common and costly in older adults. While traditional exercise has been shown to promote physical and mental health and may prevent walking difficulty, such exercise has focused on strength and endurance, and has overlooked a critical component of walking ability; the timing and coordination of movement. Aging and disease alter timing and coordination as reflected by slowed neuromotor performance, increased gait variability and reduced smoothness of movement. Task specific timing and coordination exercise that includes practice of smooth coordinated aspects of gait over multiple walking conditions has the potential to improve walking ability greater than a standard program. Our preliminary data suggest that interventions on timing and coordination of gait impact mobility greater than the standard strength and endurance program. The next key step and the objective of this proposal is to combine the two interventions to determine if potential gains in mobility, activity and participation obtained from a standard plus timing and coordination program, are larger than the gains obtained from the standard program alone. Therefore, the primary aim of the proposed project is to evaluate the impact of adding timing and coordination training to standard strength and endurance training on mobility. Secondary aims include examining 1) additional outcomes representing the components of the intervention and measures of activity and participation, 2) the delayed and sustained effects of the intervention, and 3) the effects of the intervention within various other subgroups of interest. This randomized clinical trial in 248 community-dwelling older adults who walk slowly (i.e. < 1.20 m/s) will compare a standard 12 week strength, endurance and flexibility program to a 12 week "standard-plus" program of strength, endurance, flexibility plus task specific timing and coordination training. The primary outcome is gait speed at 12 weeks. We will also examine secondary and tertiary outcomes representing components of the intervention and measures of activity and participation and the delayed and sustained effects at 24 and 36 weeks. The findings from this efficacy trial will provide evidence for the added value of task specific timing and coordination training for promoting walking ability in older adults and will form the basis for future effectiveness trials. Future work includes translation to nonprofessional exercise leaders with the long-term goal to incorporate neurological training into standard exercise programs for health promotion for older adults.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • 65 years of age and older
  • Ambulatory without an assistive device or the assistance of another person
  • Usual 4 meter gait speed > 0.60 m/s and < 1.2 m/s
  • Physician clearance to participate in a moderate intensity exercise program
  • Not meeting physical activity recommendations defined as reporting less than 150 minutes of moderate intensity activity per week in the past month.7

排除标准

  • persistent lower extremity pain that is present on most days of the week
  • back pain that is present on most days of the weeks and interferes with walking and activities of daily living or back pain that increases with walking
  • refuse to walk on a treadmill
  • plans to move out of the area in the next 5 years
  • dyspnea at rest or during activities of daily living or use supplemental oxygen (CHF, COPD)
  • any acute illness or medical condition that is not stable according to the approving physician
  • resting systolic blood pressure ≥ 200 mm Hg or diastolic blood pressure ≥ 100 mm Hg or resting heart rate > 100 or < 40 beats per minute
  • diagnosed dementia or cognitive impairment defined as modified Mini-Mental State (3MS) examination <79
  • hospitalized in the past 6 months for acute illness or surgery, other than minor surgical procedures
  • severe visual impairment
  • fixed or fused lower extremity joints such as hip, knee or ankle
  • lower extremity strength <3/5 on manual muscle testing
  • lower extremity amputation
  • progressive movement disorder such as Multiple Sclerosis, Amyotrophic Lateral Sclerosis or Parkinson's disease

研究组 & 干预措施

Standard

Active Comparator

The standard arm consists of strength, endurance and flexibility exercises 2 times per week for 12 weeks. Will also receive a physical activity behavioral intervention.

干预措施: Strength training (Behavioral)

Standard

Active Comparator

The standard arm consists of strength, endurance and flexibility exercises 2 times per week for 12 weeks. Will also receive a physical activity behavioral intervention.

干预措施: Endurance training (Behavioral)

Standard

Active Comparator

The standard arm consists of strength, endurance and flexibility exercises 2 times per week for 12 weeks. Will also receive a physical activity behavioral intervention.

干预措施: Flexibility training (Behavioral)

Standard

Active Comparator

The standard arm consists of strength, endurance and flexibility exercises 2 times per week for 12 weeks. Will also receive a physical activity behavioral intervention.

干预措施: Physical activity behavioral intervention (Behavioral)

Standard-plus

Experimental

The standard-plus arm consists of strength, endurance and flexibility exercises plus task specific timing and coordination exercises to improve gait 2 times per week for 12 weeks. Will also receive a physical activity behavioral intervention.

干预措施: Strength training (Behavioral)

Standard-plus

Experimental

The standard-plus arm consists of strength, endurance and flexibility exercises plus task specific timing and coordination exercises to improve gait 2 times per week for 12 weeks. Will also receive a physical activity behavioral intervention.

干预措施: Endurance training (Behavioral)

Standard-plus

Experimental

The standard-plus arm consists of strength, endurance and flexibility exercises plus task specific timing and coordination exercises to improve gait 2 times per week for 12 weeks. Will also receive a physical activity behavioral intervention.

干预措施: Flexibility training (Behavioral)

Standard-plus

Experimental

The standard-plus arm consists of strength, endurance and flexibility exercises plus task specific timing and coordination exercises to improve gait 2 times per week for 12 weeks. Will also receive a physical activity behavioral intervention.

干预措施: Task Specific timing and coordination training (Behavioral)

Standard-plus

Experimental

The standard-plus arm consists of strength, endurance and flexibility exercises plus task specific timing and coordination exercises to improve gait 2 times per week for 12 weeks. Will also receive a physical activity behavioral intervention.

干预措施: Physical activity behavioral intervention (Behavioral)

结局指标

主要结局

Gait speed

时间窗: 12 weeks

Usual walking speed over a short distance. A physiologic measure recorded in m/s.

次要结局

  • Smoothness of walking(12, 24, and 36 weeks)
  • gait variability(12, 24, 36 weeks)
  • Late Life Function and Disability Instrument - function subscale(12, 24, and 36 weeks)
  • Late Life Function and Disability Instrument - disability subscale(12, 24, and 36 weeks)
  • Lower extremity muscle power(12, 24, and 36 weeks)
  • Lower extremity strength(12, 24, and 36 weeks)
  • Six minute walk test(12, 24, and 36 weeks)
  • Chair sit and reach test(12, 24, and 36 weeks)
  • Physical activity(12, 24, and 36 weeks)

研究者

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

Jennifer S. Brach

PhD

University of Pittsburgh

研究点 (1)

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