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

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.

Study Overview

• Status: Unknown
• Conditions: Parkinson Disease
• Intervention / Treatment: Behavioral: Intensive running; Behavioral: Physiotherapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • The Chinese University of Hong Kong
    • Contact: Danny TM Chan, MBChB FRCS; Phone Number: 85235052624; Email: tmdanny@surgery.cuhk.edu.hk
    • Contact: Margret Mak, PhD MAppSc; Phone Number: 85227666708; Email: margret.mak@polyu.edu.hk
    • Sub-Investigator: Margret Mak, PhD MAppSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Six months after finishing the trainingBaseline, one month after finishing the training, and six months after finishing the training
Gait performance	Fastest walking speed: Duration for individual walks without assistance for 10 meters	Six months after finishing the training
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.	Six months after finishing the training
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.	Six months after finishing the training

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Collaborators: The Hong Kong Polytechnic University; Prince of Wales Hospital, Shatin, Hong Kong
• Investigators: Principal Investigator: Danny TM Chan, Dr., Chinese University of Hong Kong

Publications and helpful links

General 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.

Helpful Links

• Key Citation PARKINSON ' S DISEASE A Comprehensive Approach to Exercise
• Key Citation: Parkinson's disease: fitness counts
• 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

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2018
• Primary Completion (Anticipated): June 30, 2020
• Study Completion (Anticipated): December 30, 2020

Study Registration Dates

• First Submitted: April 17, 2019
• First Submitted That Met QC Criteria: June 3, 2019
• First Posted (Actual): June 5, 2019

Study Record Updates

• Last Update Posted (Actual): June 5, 2019
• Last Update Submitted That Met QC Criteria: June 3, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Balance; Gait; Quality of life; Physiotherapy; Intensive running; Motor symptoms of Parkinson's disease; Non-motor symptoms of Parkinson's disease; UPDRS score
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: Run for PD -v1; NTEC-2018-0330 (Registry Identifier: Joint CUHK-NTEC Clinical Research Ethics Committee (CREC))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Patient do not consent for sharing the data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No