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

NCT ID: NCT03974529

Last Updated: 2019-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-29

Study Completion Date

2020-12-30

Brief Summary

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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

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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.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

Intensive running

Intervention Type BEHAVIORAL

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 arm

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

Group Type ACTIVE_COMPARATOR

Physiotherapy

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hong Kong Polytechnic University

OTHER

Sponsor Role collaborator

Prince of Wales Hospital, Shatin, Hong Kong

OTHER

Sponsor Role collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Dr. Danny Tat Ming Chan

Head of Neurosurgery, Principal Investigator, Honorary Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Danny TM Chan, Dr.

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Danny TM Chan, Dr.

Role: CONTACT

85235052624

Margret Mak, PhD

Role: CONTACT

85227666708

Facility Contacts

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Danny TM Chan, MBChB FRCS

Role: primary

85235052624

Margret Mak, PhD MAppSc

Role: backup

85227666708

References

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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.

Reference Type BACKGROUND
PMID: 29027544 (View on PubMed)

Ernst 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.

Reference Type DERIVED
PMID: 38588457 (View on PubMed)

Ernst 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.

Reference Type DERIVED
PMID: 36602886 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Related Links

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https://insights.ovid.com/crossref?an=00135124-201107000-00006

Key Citation PARKINSON ' S DISEASE A Comprehensive Approach to Exercise

http://www.parkinson.org/sites/default/files/Fitness_Counts.pdf

Key Citation: Parkinson's disease: fitness counts

Other Identifiers

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NTEC-2018-0330

Identifier Type: REGISTRY

Identifier Source: secondary_id

Run for PD -v1

Identifier Type: -

Identifier Source: org_study_id

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