search
Back to results

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

Primary Purpose

Parkinson Disease

Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Intensive running
Physiotherapy
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Intensive running, Gait, Balance, Motor symptoms of Parkinson's disease, Non-motor symptoms of Parkinson's disease, UPDRS score, Physiotherapy, Quality of life

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Chinese University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intensive running arm

Physiotherapy arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

Endurance
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
Gait performance
Fastest walking speed: Duration for individual walks without assistance for 10 meters
MiniBest Test Score
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.
Mood
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.

Full Information

First Posted
April 17, 2019
Last Updated
June 3, 2019
Sponsor
Chinese University of Hong Kong
Collaborators
The Hong Kong Polytechnic University, Prince of Wales Hospital, Shatin, Hong Kong
search

1. Study Identification

Unique Protocol Identification Number
NCT03974529
Brief Title
Intensive Running Exercise Improves Parkinson's Motor and Non-motor Symptoms
Official Title
Intensive Running Exercise Improves Parkinson's Motor and Non-motor Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 29, 2018 (Actual)
Primary Completion Date
June 30, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
Collaborators
The Hong Kong Polytechnic University, Prince of Wales Hospital, Shatin, Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Intensive running, Gait, Balance, Motor symptoms of Parkinson's disease, Non-motor symptoms of Parkinson's disease, UPDRS score, Physiotherapy, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intensive running arm
Arm Type
Experimental
Arm Description
20 patients will be assigned randomly to intensive running arm (intervention arm). They will be required to complete a designed training protocol.
Arm Title
Physiotherapy arm
Arm Type
Active Comparator
Arm Description
10 patients will be assigned randomly to physiotherapy arm. They will be required to complete a designed training protocol.
Intervention Type
Behavioral
Intervention Name(s)
Intensive running
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physiotherapy
Intervention Description
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 Measure Information:
Title
Unified Parkinson's disease rating scale Overall Score
Description
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).
Time Frame
Six months after finishing the training
Title
Parkinson's Disease Questionnaire - 39 (PDQ39) Quality of Life Score
Description
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.
Time Frame
Six months after finishing the training
Secondary Outcome Measure Information:
Title
Endurance
Description
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
Time Frame
Six months after finishing the trainingBaseline, one month after finishing the training, and six months after finishing the training
Title
Gait performance
Description
Fastest walking speed: Duration for individual walks without assistance for 10 meters
Time Frame
Six months after finishing the training
Title
MiniBest Test Score
Description
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.
Time Frame
Six months after finishing the training
Title
Mood
Description
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.
Time Frame
Six months after finishing the training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Danny TM Chan, Dr.
Phone
85235052624
Email
tmdanny@surgery.cuhk.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Margret Mak, PhD
Phone
85227666708
Email
margret.mak@polyu.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danny TM Chan, Dr.
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danny TM Chan, MBChB FRCS
Phone
85235052624
Email
tmdanny@surgery.cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Margret Mak, PhD MAppSc
Phone
85227666708
Email
margret.mak@polyu.edu.hk
First Name & Middle Initial & Last Name & Degree
Margret Mak, PhD MAppSc

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Patient do not consent for sharing the data.
Citations:
PubMed Identifier
29027544
Citation
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.
Results Reference
background
Links:
URL
https://insights.ovid.com/crossref?an=00135124-201107000-00006
Description
Key Citation PARKINSON ' S DISEASE A Comprehensive Approach to Exercise
URL
http://www.parkinson.org/sites/default/files/Fitness_Counts.pdf
Description
Key Citation: Parkinson's disease: fitness counts
URL
https://www.acsm.org/read-research/books/acsms-guidelines-for-exercise-testing-and-prescription
Description
Key Citation: American College of Sports Medicine. Cardiorespiratory exercise prescription. In: Ehrman JK, editor. , editor. ACSM's Guidelines for Exercise Testing and Prescription, 6th ed Baltimore: Lippincott Williams & Wilkins; 2010:448-462

Learn more about this trial

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

We'll reach out to this number within 24 hrs