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 |
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Parkinson Disease | Behavioral: Intensive running Behavioral: Physiotherapy | Not Applicable |
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.
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
Control arm
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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 |
Arm | Intervention/treatment |
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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.
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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.
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Active Comparator: Physiotherapy arm
10 patients will be assigned randomly to physiotherapy arm. They will be required to complete a designed training protocol.
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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.
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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).
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.
Ages Eligible for Study: | 40 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Danny TM Chan, Dr. | 85235052624 | tmdanny@surgery.cuhk.edu.hk | |
Contact: Margret Mak, PhD | 85227666708 | margret.mak@polyu.edu.hk |
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 |
Principal Investigator: | Danny TM Chan, Dr. | Chinese University of Hong Kong |
Tracking Information | |||||
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First Submitted Date ICMJE | April 17, 2019 | ||||
First Posted Date ICMJE | June 5, 2019 | ||||
Last Update Posted Date | June 5, 2019 | ||||
Actual Study Start Date ICMJE | December 29, 2018 | ||||
Estimated Primary Completion Date | June 30, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Intensive Running Exercise Improves Parkinson's Motor and Non-motor Symptoms | ||||
Official Title ICMJE | Intensive Running Exercise Improves Parkinson's Motor and Non-motor Symptoms | ||||
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. |
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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 ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | 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
Control arm
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
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Condition ICMJE | Parkinson Disease | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Mak MK, Wong-Yu IS, Shen X, Chung CL. Long-term effects of exercise and physical therapy in people with Parkinson disease. Nat Rev Neurol. 2017 Nov;13(11):689-703. doi: 10.1038/nrneurol.2017.128. Epub 2017 Oct 13. Review. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
30 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 30, 2020 | ||||
Estimated Primary Completion Date | June 30, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 40 Years to 60 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Hong Kong | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03974529 | ||||
Other Study ID Numbers ICMJE | Run for PD -v1 NTEC-2018-0330 ( Registry Identifier: Joint CUHK-NTEC Clinical Research Ethics Committee (CREC) ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Dr. Danny Tat Ming Chan, Chinese University of Hong Kong | ||||
Study Sponsor ICMJE | Chinese University of Hong Kong | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Chinese University of Hong Kong | ||||
Verification Date | June 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |