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

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ClinicalTrials.gov Identifier: NCT03974529
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Collaborators:
The Hong Kong Polytechnic University
Prince of Wales Hospital, Shatin, Hong Kong
Information provided by (Responsible Party):
Dr. Danny Tat Ming Chan, Chinese University of Hong Kong

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Parkinson Disease Behavioral: Intensive running Behavioral: Physiotherapy Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

This is a prospective randomized controlled single-blinded study. 30 patients will be included and randomized to intervention arm or control arm in a ratio of 2 to 1. Informed consent will be signed after the patient is fully informed about the procedures and prior to the baseline assessments.

Intervention arm

  • Number of participants: 20
  • Venue: Shatin playground
  • Supervisors: licensed coaches (2 to 4 per session)
  • Training session: 30 minutes of warm-up stretching + 60 minutes supervised progressive aerobic endurance track running
  • Targeted intensity: 60-75% of maximum heart rate (HR max = 220 - age) OR 40-50% heart rate reserve (HRR= HR max - HR rest)
  • Frequency and training period: 2 sessions per week, for 24 weeks

Control arm

  • Number of participants: 10
  • Venue: Indoor gymnasium
  • Supervisor: a physiotherapist
  • Training session: 60 minutes of physical stretching
  • Frequency and training period: 1 session per week, for 24 weeks
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Intensive Running Exercise Improves Parkinson's Motor and Non-motor Symptoms
Actual Study Start Date : December 29, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intensive running arm
20 patients will be assigned randomly to intensive running arm (intervention arm). They will be required to complete a designed training protocol.
Behavioral: Intensive running
The patients who are assigned to this group will be required to finish a 90 minutes of training protocol, containing 30 minutes' warm-up stretching, and 60 minutes of supervised progressive aerobic endurance track running. The training takes place two time per week, for 24 weeks.

Active Comparator: Physiotherapy arm
10 patients will be assigned randomly to physiotherapy arm. They will be required to complete a designed training protocol.
Behavioral: Physiotherapy
The patients who are assigned to this group will be required to finish a 60 minutes of physiotherapy session. The training takes place once per week, for 24 weeks.




Primary Outcome Measures :
  1. Unified Parkinson's disease rating scale Overall Score [ Time Frame: 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).


  2. Parkinson's Disease Questionnaire - 39 (PDQ39) Quality of Life Score [ Time Frame: 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.



Secondary Outcome Measures :
  1. Endurance [ Time Frame: Six months after finishing the trainingBaseline, one month after finishing the training, and six months after finishing the training ]
    The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. It is suitable in assessing endurance in patients with Parkinson's disease

  2. Gait performance [ Time Frame: Six months after finishing the training ]
    Fastest walking speed: Duration for individual walks without assistance for 10 meters

  3. MiniBest Test Score [ Time Frame: Six months after finishing the training ]
    MiniBest test is an evaluation system focusing on the balance of patients with Parkinson's disease. The maximum score for the system is 28 whereas the minimum score is 0. The higher the score is, the better the patient's function.

  4. Mood [ Time Frame: Six months after finishing the training ]
    Symptoms related to anxiety and depression measured with Anxiety and depression Hospital Anxiety and Depression Scale (HADS). It is a commonly used tools in hospital settings to determine the level of depression and anxiety. There are 14 questions in total, with 7 items assessing level of depression whereas 7 for the level of anxiety. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The higher the score, the higher level of depression/ anxiety patient is experiencing.The HADS uses a scale and therefore the data returned from the HADS is ordinal.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974529


Contacts
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Contact: Danny TM Chan, Dr. 85235052624 tmdanny@surgery.cuhk.edu.hk
Contact: Margret Mak, PhD 85227666708 margret.mak@polyu.edu.hk

Locations
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Hong Kong
The Chinese University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Danny TM Chan, MBChB FRCS    85235052624    tmdanny@surgery.cuhk.edu.hk   
Contact: Margret Mak, PhD MAppSc    85227666708    margret.mak@polyu.edu.hk   
Sub-Investigator: Margret Mak, PhD MAppSc         
Sponsors and Collaborators
Chinese University of Hong Kong
The Hong Kong Polytechnic University
Prince of Wales Hospital, Shatin, Hong Kong
Investigators
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Principal Investigator: Danny TM Chan, Dr. Chinese University of Hong Kong
  Study Documents (Full-Text)

Documents provided by Dr. Danny Tat Ming Chan, Chinese University of Hong Kong:
Study Protocol  [PDF] December 1, 2018
Informed Consent Form  [PDF] December 1, 2018


Additional Information:
Publications:
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Responsible Party: Dr. Danny Tat Ming Chan, Head of Neurosurgery, Principal Investigator, Honorary Clinical Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03974529     History of Changes
Other Study ID Numbers: Run for PD -v1
NTEC-2018-0330 ( Registry Identifier: Joint CUHK-NTEC Clinical Research Ethics Committee (CREC) )
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Patient do not consent for sharing the data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Danny Tat Ming Chan, Chinese University of Hong Kong:
Intensive running
Gait
Balance
Motor symptoms of Parkinson's disease
Non-motor symptoms of Parkinson's disease
UPDRS score
Physiotherapy
Quality of life

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases