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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03974529
• Other study ID #: Run for PD -v1
• Secondary ID: NTEC-2018-0330
• Status: Recruiting
• Phase: N/A
• Start date: December 29, 2018
• Est. completion date: December 30, 2020

Study information

• Verified date: June 2019
• Source: Chinese University of Hong Kong
• Contact: Danny TM Chan, Dr.
• Phone: 85235052624
• Email: tmdanny[@]surgery.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Hong Kong

Sponsors (3)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Prince of Wales Hospital, Shatin, Hong Kong, The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Gait performance	Fastest walking speed: Duration for individual walks without assistance for 10 meters	Six months after finishing the training
Secondary	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
Secondary	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

External Links

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