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临床试验/NCT06576817
NCT06576817招募中不适用

Comparison of High-intensity Interval Circuit Training With Upper Extremity and Lower Extremity Training Versus Lower Extremity Training Alone in People With Parkinson Disease

Pacific Northwest University of Health Sciences2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
64
试验地点
2
主要终点
Trail making Test Parts A and B (timed, higher scores mean worse outcome)

研究概览

简要总结

The goal of the study is to compare different types of high intensity circuit exercises over an 8-class training series in people with Parkinson disease. The main question it aims to answer is:

-Does including arm and hand exercises with leg exercises improve reaction time, balance, functional measures, gait speed and quality of life? This group will be compared to a group that only does leg exercises. Participants will be asked to participate in 8 high intensity circuit exercise classes.

详细描述

People with Parkinson disease will be recruited from the community and randomized into 2 equal groups: high intensity interval circuit training with lower extremity (LE) and lower and upper extremity (LEUE) training. The study will be composed of a baseline assessment, 8 group class sessions, and a post-intervention assessment. The baseline assessment will include demographics, disease and fall history and outcome measure collection. Group class sessions will include concurrent group warmup, followed by an 8-station circuit performed with high intensity intervals, and a cool-down. The circuit will include 4 stations performed by both the LE and LEUE groups and 4 stations specific to each intervention group, including 4 additional LE exercise stations for the LE group and 4 UE specific stations for the LEUE group. The stations that differ will not be adjacent to one another nor specifically indicated as different. The stations that differ will mirror similar aspects of function (ie, strength, reaction time, etc.) for the UE and LE stations. Participants will be told exercise stations may vary within-session and week to week but will not be informed that only one group has UE exercise interventions. After conclusion of the class series, post-intervention balance and stepping outcomes will be reassessed.

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 (Participant, Outcomes Assessor)

盲法说明

Participants will be told exercise stations may vary within-session and week to week but will not be informed that only one group has UE exercise interventions.

Assessors are blinded to group allocation.

入排标准

性别
All
接受健康志愿者

入选标准

  • diagnosis of Parkinson's disease
  • Hoehn and Yahr level of 1 to 3
  • ability to walk independently with or without an assistive device
  • obtain medical clearance to participate in moderate or vigorous exercise.

排除标准

  • diagnosis of any neurological disease other than PD (including but not limited to stroke, dementia, and multiple sclerosis; mild cognitive impairment is not excluded)
  • bone instability (non-consolidated fractures, unstable spinal column, severe osteoporosis)
  • muscle or ligament tears
  • uncontrolled hypertension
  • uncontrolled diabetes
  • severe cardiovascular disease that impairs walking or exercise
  • a major change in medication during the study training period (pre-test to post-test)

结局指标

主要结局

Trail making Test Parts A and B (timed, higher scores mean worse outcome)

时间窗: 8-10 weeks

Cognitive and fine motor skills

Activity-specific Balance Confidence Scale (0-100%, higher scores mean better outcome)

时间窗: 8-10 weeks

Balance confidence self-report

Timed Up and Go

时间窗: 8-10 weeks

Balance and function

10 meter Walk Test

时间窗: 8-10 weeks

Gait Speed

6 minute walk test

时间窗: 8-10 weeks

endurance

9-hole peg test (timed, higher scores mean worse outcome)

时间窗: 8-10 weeks

fine motor

Parkinson's Disease Questionnaire - Short Form (8) (Score 0-32, higher scores mean worse outcome)

时间窗: 8-10 weeks

Quality of Life

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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