跳至主要内容
临床试验/NCT04665869
NCT04665869已完成不适用

Long-term Effects of Combined Balance and Brisk Walking on Alleviating Motor and Non-motor Symptoms in Parkinson's Disease: a Randomized Controlled Trial

The Hong Kong Polytechnic University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Movement Disorder Society Unified Parkinson Disease Rating Scale Part III (MDS-UPDRS-III) score

研究概览

简要总结

Parkinson's disease (PD) is a progressive neurodegenerative disease characterized with both clinical motor and non-motor features, as well as decrease in balance performance and walking endurance. The non-motor symptoms such as depression, anxiety, sleep disturbance and fatigue wound impose negative impacts on the quality of life of the individuals with PD. Aerobic endurance training can improve physical capacity and reduce those non-motor symptoms such as mood and sleep disorders. Based on the results of our recent pilot study, brisk walking is a safe and moderate-level aerobic walking exercise for improving walking capacity in the PD population up to 6 week after treatment ended. Community-based balance training could also enhance balance performance and dual-task gait performance up to 12-month follow-up for people with PD. The primary purpose of this proposed study is to investigate the short- and long-term effects of a 6-month balance and brisk walking programme in alleviating non-motor and motor symptoms in people with PD. The secondary objective is to examine the short- and long-term effects of a 6-month balance and brisk walking program on enhancing walking capacity, balance performance, and quality of life.

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)

入排标准

年龄范围
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Parkinson disease diagnosed by neurologist with Hoehn & Yahr stage 2 or 3
  • Having a 30-meter walking ability

排除标准

  • Significant neurological condition (other than Parkinson's disease)
  • Musculoskeletal conditions affecting gait, balance or functions
  • Had received deep brain stimulation surgery
  • Cognitive impairment with Montreal Cognitive Assessment score <24
  • Present with on-off motor fluctuations.

结局指标

主要结局

Movement Disorder Society Unified Parkinson Disease Rating Scale Part III (MDS-UPDRS-III) score

时间窗: 1 year

This score consists of 18 items in 33 questions examining the motor and functional capacity of people with Parkinson's disease by the assessor. Each question will be rated from 0 (normal) to 4 (severe). The MDS-UPDRS-III score ranges from 0 to 132, with higher scores indicating more severe motor and functional impairments

Movement Disorder Society Unified Parkinson Disease Rating Scale Part I (MDS-UPDRS-I) score

时间窗: 1 year

This score assesses the non-motor aspects of experiences of daily living in people with Parkinson's disease with a total of 13 questions. The score will be administered by assessor asking participants about their behaviors and non-motor symptoms such as cognitive impairment, hallucination, depressive and anxious mood, sleep, pain, urinary and constipation problems, and fatigue etc. Each question will be rated from 0 (normal) to 4 (severe). The MDS-UPDRS-I score ranges from 0 to 52, with higher scores indicating more severe non-motor impairment.

次要结局

  • Mini-Balance Evaluation Systems Test (mini-Best) total score(1-year)
  • Six-minute walking test (6MWT) distance(1 year)
  • Single-task timed-up-and-go (TUG) time(1 year)
  • Five-times-sit-to-stand (FTSTS) time(1 year)
  • Gait cycle measures by 2-minute Instrument Walk Test using mobile sensors in both comfortable and fast walking speed(1 year)
  • Activities-specific Balance Confidence (ABC) Scale score(1 year)
  • Parkinson Disease Questionnaire-39 (PDQ-39) summary index score(1 year)
  • Injurious fall rate(1 year)
  • Dual-task timed-up-and-go (DTUG) time(1 year)
  • Non-Motor Symptoms Scale for Parkinson's Disease (NMSS) total score(1 year)
  • Pittsburgh Sleep Quality Index (PSQI)(1 year)
  • Fall risk(1 year)
  • Fall rate(1 year)
  • Injurious fall risk(1 year)

研究者

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

Margaret Kit Yi Mak

Professor, Department of Rehabilitation Sciences

The Hong Kong Polytechnic University

研究点 (2)

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