跳至主要内容
临床试验/NCT04302831
NCT04302831撤回不适用

Restoring Central Motor Control to Improve Community Mobility of Older Adults

University of Pittsburgh1 个研究点 分布在 1 个国家开始时间: 2020年3月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Change in oxygenated hemoglobin at the prefrontal cortex from standing to walking

研究概览

简要总结

Motor skill training therapy aims to improve the brain's control of walking and can improve clinic-based measures of walking in older adults. However, it is unknown whether the benefits of motor skill training extend to real world mobility measures. The investigators will test the effects of motor skill training on measures of community mobility of older adults and assess the mechanisms through improved motor control at the level of the brain. These results will inform intervention approaches to maintain community mobility of older adults and prevent disability and institutionalization.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
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
是

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.

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 f- ixed 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-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)

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)

结局指标

主要结局

Change in oxygenated hemoglobin at the prefrontal cortex from standing to walking

时间窗: change from baseline to 36 weeks

Physiologic measure indicative of usage of the prefrontal cortex during a task recorded by optical imaging (near infrared spectroscopy).

Change in oxygenated hemoglobin at the prefrontal cortex from standing to walking

时间窗: change from baseline to 12 weeks

Physiologic measure indicative of usage of the prefrontal cortex during a task recorded by optical imaging (near infrared spectroscopy).

次要结局

  • Gait speed(12, 24, and 36 weeks)
  • Gait variability(12, 24, and 36 weeks)

研究者

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

Andrea Rosso

Assistant Professor

University of Pittsburgh

研究点 (1)

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