Intensive Running Exercise Improves Parkinson's Motor and Non-motor Symptoms
2 other identifiers
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable parkinson-disease
Started Dec 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 29, 2018
CompletedFirst Submitted
Initial submission to the registry
April 17, 2019
CompletedFirst Posted
Study publicly available on registry
June 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2020
CompletedJune 5, 2019
June 1, 2019
1.5 years
April 17, 2019
June 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Unified Parkinson's disease rating scale Overall Score
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).
Six months after finishing the training
Parkinson's Disease Questionnaire - 39 (PDQ39) Quality of Life Score
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.
Six months after finishing the training
Secondary Outcomes (4)
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
Study Arms (2)
Intensive running arm
EXPERIMENTAL20 patients will be assigned randomly to intensive running arm (intervention arm). They will be required to complete a designed training protocol.
Physiotherapy arm
ACTIVE COMPARATOR10 patients will be assigned randomly to physiotherapy arm. They will be required to complete a designed training protocol.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chinese University of Hong Konglead
- The Hong Kong Polytechnic Universitycollaborator
- Prince of Wales Hospital, Shatin, Hong Kongcollaborator
Study Sites (1)
The Chinese University of Hong Kong
Hong Kong, Hong Kong
Related Publications (3)
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.
PMID: 29027544BACKGROUNDErnst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
PMID: 38588457DERIVEDErnst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
PMID: 36602886DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Danny TM Chan, Dr.
Chinese University of Hong Kong
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Neurosurgery, Principal Investigator, Honorary Clinical Professor
Study Record Dates
First Submitted
April 17, 2019
First Posted
June 5, 2019
Study Start
December 29, 2018
Primary Completion
June 30, 2020
Study Completion
December 30, 2020
Last Updated
June 5, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share
Patient do not consent for sharing the data.