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临床试验/NCT03974529
NCT03974529Unknown不适用

Intensive Running Exercise Improves Parkinson's Motor and Non-motor Symptoms

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年12月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Parkinson's Disease Questionnaire - 39 (PDQ39) Quality of Life Score

研究概览

简要总结

High quality clinical trial and meta-analysis have demonstrated short term, and to a lesser extent, long term benefits in various outcome measures. To achieve positive effects, supervised progressive strength and aerobic endurance training program of 12 weeks was required. Extended progressive strength training improved muscle strength for up to 24 months. While aerobic endurance training would increase walking capacity up to 16 months. 1 There are data suggesting a threshold of intensity of exercise to be reached for the positive effect. This overall body of evidence suggests that regular vigorous exercise should be accorded a central place in the treatment of Parkinson's disease.

However, there was no evidence about regular intensive exercise of running in Parkinson's disease. And most of the studies were not randomized with a control group.

In this study, the investigators are to investigate the effect of regular vigorous aerobic exercise training of running on motor and non-motor symptoms, and quality-of-life of people with Parkinson's disease.

详细描述

There is growing volume of evidences support the positive effect of exercise and physical therapy to Parkinson's disease. Various exercise types have shown different positive effects. Gait training for 4 weeks showed a moderate improvement in balancing while balance training of 8 to 26 weeks decreased fall rate. Cued exercise would mildly increase the speed of the gait. Complementary exercises, such as Tai Chi and dancing, have shown improvement in balancing of the patients.

One of the main complaints of Parkinson's disease is rigidity. It is because of the musculoskeletal impairments which compromise the flexibility and stability of both axial structure (spine) and the extremities. Truncal stiffness and rigidity results in a stooped posture, which further undermines one's balance and agility. Flexibility training (stretching) is shown to be beneficial to all stages of patients with Parkinson's disease, in terms of improved both range of movement in joints and spinal stability. It is recommended that regular stretching should be the first step in one's exercise program to combat the muscle rigidity. High quality clinical trial and meta-analysis have demonstrated short term, and to a lesser extent, long term benefits in various outcome measures. To achieve positive effects, supervised progressive strength and aerobic endurance training program of 12 weeks was required. Extended progressive strength training improved muscle strength for up to 24 months. While aerobic endurance training would increase walking capacity up to 16 months.

There are data suggested a threshold of intensity of exercise to be reached for the positive effect. This overall body of evidence suggests that regular vigorous exercise should be accorded a central place in the treatment of Parkinson's disease.

In this study, the investigators are to investigate the effect of regular vigorous aerobic exercise training of running on motor and non-motor symptoms, and quality-of-life of people with Parkinson's disease.

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)

盲法说明

The assessment will be taken by three blinded assessors (one occupational therapist, a registered research nurse and a research assistant) at baseline, at completion of the training and 6 months after, at Prince of Wales Hospital.

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with idiopathic Parkinson's disease, aging from 40 years to 60 years old.
  • Patient who are able to walk independently without walking aids for a distance of 30 meters.

排除标准

  • Previous history of other neuro-degenerative diseases
  • Presence of ischemic heart disease or musculoskeletal and cardiopulmonary diseases
  • Presence of physical disability
  • History of regular running practice in the past 6 months.

研究组 & 干预措施

Intensive running arm

Experimental

20 patients will be assigned randomly to intensive running arm (intervention arm). They will be required to complete a designed training protocol.

干预措施: Intensive running (Behavioral)

Physiotherapy arm

Active Comparator

10 patients will be assigned randomly to physiotherapy arm. They will be required to complete a designed training protocol.

干预措施: Physiotherapy (Behavioral)

结局指标

主要结局

Parkinson's Disease Questionnaire - 39 (PDQ39) Quality of Life Score

时间窗: Six months after finishing the training

The PDQ39 is a 39-item self-reporting questionnaire which assess the Parkinson's disease associated health related quality over the last month. PDQ-39 There are 39 questions in the long form Parkinson's Disease Questionnaire, with 8 discrete scales: mobility (10 items) activities of daily living (6 items) emotional well-being (6 items) stigma (4 items) social support (3 items) cognitions (4 items) communication (3 items) bodily discomfort (3 items) Patients are asked to think about their health and general well-being and to consider how often in the last month they have experienced certain events (e.g. difficulty walking 100 yards). Patients are asked to indicate the frequency of each event by selecting one of 5 options (likert Scale): never/occasionally/sometimes/often/always or cannot do at all.

Unified Parkinson's disease rating scale Overall Score

时间窗: Six months after finishing the training

A comprehensive 50 question assessment of both motor and non-motor symptoms associated with Parkinson's. The MDS-UPDRS features sections that require independent completion by people affected by Parkinson's and their carers, and sections to be completed by the clinician. Part 1: non-motor experiences of daily living Part 2: motor experiences of daily living Part 3: motor examination Part 4: motor complications. Some sections of the UPDRS scale require multiple grades assigned to each extremity with a possible maximum of 199 points. A score of 199 on the UPDRS scale represents the worst (total disability) with a score of zero representing (no disability).

次要结局

  • Endurance(Six months after finishing the trainingBaseline, one month after finishing the training, and six months after finishing the training)
  • Gait performance(Six months after finishing the training)
  • MiniBest Test Score(Six months after finishing the training)
  • Mood(Six months after finishing the training)

研究者

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

Dr. Danny Tat Ming Chan

Head of Neurosurgery, Principal Investigator, Honorary Clinical Professor

Chinese University of Hong Kong

研究点 (1)

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