Long-term Effects of Combined Balance and Brisk Walking in Parkinson's Disease

June 20, 2023 updated by: Margaret Kit Yi Mak, The Hong Kong Polytechnic University

Long-term Effects of Combined Balance and Brisk Walking on Alleviating Motor and Non-motor Symptoms in Parkinson's Disease: a Randomized Controlled Trial

Parkinson's disease (PD) is a progressive neurodegenerative disease characterized with both clinical motor and non-motor features, as well as decrease in balance performance and walking endurance. The non-motor symptoms such as depression, anxiety, sleep disturbance and fatigue wound impose negative impacts on the quality of life of the individuals with PD. Aerobic endurance training can improve physical capacity and reduce those non-motor symptoms such as mood and sleep disorders. Based on the results of our recent pilot study, brisk walking is a safe and moderate-level aerobic walking exercise for improving walking capacity in the PD population up to 6 week after treatment ended. Community-based balance training could also enhance balance performance and dual-task gait performance up to 12-month follow-up for people with PD. The primary purpose of this proposed study is to investigate the short- and long-term effects of a 6-month balance and brisk walking programme in alleviating non-motor and motor symptoms in people with PD. The secondary objective is to examine the short- and long-term effects of a 6-month balance and brisk walking program on enhancing walking capacity, balance performance, and quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

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

  • Hong Kong
    • 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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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 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: Combined balance and brisk walking training
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)
Behavioral: Combined balance and brisk walking training
6-months of combined balance and brisk walking training
Active Comparator: Flexibility and strengthening 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 flexibility and strengthening exercise 2-3 times/week (to aim at 150 min of exercise per week)
Behavioral: Flexibility and strengthening exercise
6-months of flexibility and strengthening exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Mini-Balance Evaluation Systems Test (mini-Best) total score
Time Frame: 1-year
To evaluate dynamic balance in four domains: anticipatory postural adjustments, postural reactions, sensory integration and gait stability. The mini-BEST total score ranges from 0 to 28, with a higher score indicates better dynamic balance.
1-year
Single-task timed-up-and-go (TUG) time
Time Frame: 1 year
The single-task gait performance measured by the time taken to complete 3-meter timed-up-and-go (TUG) test
1 year
Dual-task timed-up-and-go (DTUG) time
Time Frame: 1 year
The dual-task gait performance measured by the time taken to complete 3-meter timed-up-and-go test with serial subtraction
1 year
Five-times-sit-to-stand (FTSTS) time
Time Frame: 1 year
The composite lower limb strength measured by the time taken to complete 5 repetitions of sitting to standing
1 year
Non-Motor Symptoms Scale for Parkinson's Disease (NMSS) total score
Time Frame: 1 year
The Non-Motor Symptoms Scale is a 30-item rater-based scale to assess a wide range of non-motor symptoms in patients with Parkinson's disease (PD). The NMSS measures the severity and frequency of non-motor symptoms across nine dimensions. The NMSS total score ranges form 0 to 360, with a higher score indicates worse PD non-motor symptoms.
1 year
Gait cycle measures by 2-minute Instrument Walk Test using mobile sensors in both comfortable and fast walking speed
Time Frame: 1 year
Spatial, gait phase, spatiotemporal and asymmetric walking variables such as gait speed, cadence, stride length, arm swing angle and velocity, and trunk movement angle and velocity will be measured by Mobility Lab system.
1 year
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 1 year
The Pittsburgh Sleep Quality Index is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month. A total score of "5" or greater is indicative of poor sleep quality.
1 year

Collaborators and Investigators

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

Sponsor

The Hong Kong Polytechnic University

Investigators

  • Principal Investigator: Margaret K Mak, PhD, 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)

November 1, 2020

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

December 7, 2020

First Submitted That Met QC Criteria

December 7, 2020

First Posted (Actual)

December 14, 2020

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 20, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSEARS20191206002

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

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.

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