Efficacy of Brisk Walking in Parkinson's Disease

August 24, 2021 updated by: Margaret Kit Yi Mak, The Hong Kong Polytechnic University

Efficacy of Brisk Walking on Improving Balance and Gait Performance, and Functional Mobility in Parkinson's Disease - a Randomized Controlled Trial

Parkinson's disease (PD) is the second most common neuro-degenerative disease in older people. Falls are common among people PD with the incidence rate up to 70% and have strong associations with the severity of the disease, balance impairment, and freezing of gait.The abnormal gait characteristics include reduction in stride length, gait speed and arm swing, and increase in cadence. Gait training, balance training, aerobic training, Tai chi and dance training are common types of physical rehabilitation for PD. Brisk walking is a way of walking with a pace faster than normal, and it can improve dynamic balance for senior men and balance function for chronic stroke clients.

Brisk walking also promotes cardiopulmonary fitness and walking endurance in elderly women, healthy middle-age and older adults, active elderly men and chronic stroke clients. Our previous pilot randomized controlled trial on the effects of a 6-week home-based brisk walking program indicates that it is feasible and safe for the early PD population with improved walking capacity measured by 6-minute walk distance. The positive effects could carry over to 6 weeks after treatment completion. Up-to-date, the short- and long-term effects of brisk walking in improving balance and gait performance, and functional capacity in people with PD have not yet been well investigated. In order to promote their balance and functional capacity in longer term, more sustained training and better exercise adherence may be necessary.

Study Overview

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Nothing Selected
      • Hong Kong, Nothing Selected, Hong Kong, 0000
        • The Hong Kong Polytechnic University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Parkinson disease diagnosed by neurologist with Hoehn & Yahr stage 2 or 3
  • Having a 30-meter walking ability

Exclusion Criteria:

  • Significant neurological condition (other than Parkinson's disease)
  • Musculoskeletal conditions affecting gait, balance or upper limb functions
  • Had received deep brain stimulation surgery
  • Cognitive impairment with Montreal Cognitive Assessment score <24
  • Present with on-off motor fluctuations.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brisk walking and balance training
  1. Week1-6: Supervised training in groups of 6-8 participant, once/week, 90 min/session
  2. Week 7-26: Supervised training in groups of 6-8 participant, once/month, 90 min/session
  3. Participants practice own balance exercise and brisk walking 2-3 times/week (to aim at 150 min of moderate intensity of brisk walking per week at 40-60% of heart rate reserve)
6 months of combined brisk walking and balance training
Active Comparator: Upper limb exercise
  1. Week1-6: Supervised training in groups of 6-8 participant, once/week, 90 min/session
  2. Week 7-26: Supervised training in groups of 6-8 participant, once/month, 90 min/session
  3. Participants practice own upper limb exercise 2-3 times/week (to aim at 150 min of exercise per week)
6 month of hand dexterity training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mini-Balance Evaluation Systems Test (miniBest) total scores
Time Frame: 1 year
To evaluate dynamic balance in four domains: anticipatory postural adjustments, postural reactions, sensory integration and gait stability. The miniBEST scores range from 0 to 28, with a higher score indicates better dynamic balance.
1 year
Six-minute walking test (6MWT) distance
Time Frame: 1 year
The maximum walking distance covered during a validated six-minute walk test (6MWT) to document participants' aerobic endurance level and walking capacity
1 year
Movement Disorder Society Unified Parkinson Disease Rating Scale Part III (MDS-UPDRS-III) score
Time Frame: 1 year
This score consists of 18 items in 33 questions examining the motor and functional capacity of people with Parkinson's disease by the assessor. Each question will be rated from 0 (normal) to 4 (severe). The MDS-UPDRS-III score ranges from 0 to 132, with higher scores indicating more severe motor and functional impairments
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fast gait speed
Time Frame: 1 year
The single-task gait speed measured by a 10-meter walking test in a fast pace
1 year
Dual-task timed-up-and-go-time
Time Frame: 1 year
The dual-task gait performance measured by a 3-meter timed up and go test with serial subtraction
1 year
Movement Disorder Society Unified Parkinson Disease Rating Scale Part I (MDS-UPDRS-I) score
Time Frame: 1 year
This score assesses the non-motor aspects of experiences of daily living in people with Parkinson's disease with a total of 13 questions. The score will be administered by assessor asking participants about their behaviors and non-motor symptoms such as cognitive impairment, hallucination, depressive and anxious mood, sleep, pain, urinary and constipation problems, and fatigue etc. Each question will be rated from 0 (normal) to 4 (severe). The MDS-UPDRS-I score ranges from 0 to 52, with higher scores indicating more severe non-motor impairment.
1 year
Activities-specific Balance Confidence (ABC) Scale score
Time Frame: 1 year
The ABC score will be used to measure the participants' perceived level of balance confidence in 16 indoor and outdoor activities. Each activity is rated from 0-100 (0 indicates no confidence and 100 indicates full confidence, total score=1600). The total score is converted into percentage score ranging from 0 to 100%, with a higher ABC score indicating a higher level of balance confidence.
1 year
Parkinson Disease Questionnaire-39 (PDQ-39) summary index score
Time Frame: 1 year
It is a health-related quality-of-life outcome measure that contains 39 self-reported items on eight domains, i.e.: mobility [#1-10], activities of daily living [#11-16], emotional well-being [#17-22], stigma [#23-26], social support [#27-29], cognition [#30-33], communication [#34-36], and body discomfort [#37-39]. The PDQ-39 has been translated into Chinese and validated for local use. Each item is scored on 5-point Likert-type scales ranging from 0 (never), 1 (occasionally), 2 (sometimes), and 3 (often) to 4 (always) based on their perception on the item over the past month. The PDQ-39 total score is 156 and the PDQ-39 summary index is created by summing all eight of the PDQ-39 domains and standardizing the score on a scale of 0-100%. A lower PDQ-39 summary index score reflects a better health-related quality-of-life.
1 year
Fall risk
Time Frame: 1 year
The risk of falling of each group will be determined by the ratio of non-fallers to fallers at treatment completion and 6-month follow-up. A lower risk ratio indicates a lower risk of falling.
1 year
Fall rate
Time Frame: 1 year

The fall rate (times of fall per year per person) of each group at treatment completion and 6-month follow-up will be calculated with the following formula:

Number of fall events X12 / (Number of months spent to assemble fall data X number of subjects)

A lower fall rate indicates a better effect on fall reduction.

1 year
Injurious fall risk
Time Frame: 1 year
The risk of injurious falling of each group at treatment completion and 6-month follow-up will be determined by the ratio of injurious non-fallers to injurious fallers. A lower injurious risk ratio indicates a lower risk of injurious falling.
1 year
Injurious fall rate
Time Frame: 1 year

The injurious fall rate (times of injurious fall per year per person) of each group at treatment completion and 6-month follow-up will be calculated with the following formula:

Number of injurious fall events X12 / (Number of months spent to collect injurious fall data X number of subjects)

A lower injurious fall rate indicates a better effect on injurious fall reduction.

1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Margaret K Mak, Ph.D., Department of Rehabilitation Sciences,The Hong Kong Polytechnic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2018

Primary Completion (Actual)

February 28, 2020

Study Completion (Actual)

February 28, 2020

Study Registration Dates

First Submitted

October 9, 2018

First Submitted That Met QC Criteria

August 6, 2019

First Posted (Actual)

August 7, 2019

Study Record Updates

Last Update Posted (Actual)

August 30, 2021

Last Update Submitted That Met QC Criteria

August 24, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson Disease

Clinical Trials on Brisk walking and balance training

3
Subscribe