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Efficacy of Brisk Walking in Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Brisk walking and balance training
Upper limb exercise
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring rehabilitation, exercise, postural balance

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Brisk walking and balance training

Upper limb exercise

Arm Description

Week1-6: Supervised training in groups of 6-8 participant, once/week, 90 min/session Week 7-26: Supervised training in groups of 6-8 participant, once/month, 90 min/session 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)

Week1-6: Supervised training in groups of 6-8 participant, once/week, 90 min/session Week 7-26: Supervised training in groups of 6-8 participant, once/month, 90 min/session Participants practice own upper limb exercise 2-3 times/week (to aim at 150 min of exercise per week)

Outcomes

Primary Outcome Measures

Mini-Balance Evaluation Systems Test (miniBest) total scores
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.
Six-minute walking test (6MWT) distance
The maximum walking distance covered during a validated six-minute walk test (6MWT) to document participants' aerobic endurance level and walking capacity
Movement Disorder Society Unified Parkinson Disease Rating Scale Part III (MDS-UPDRS-III) score
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

Secondary Outcome Measures

Fast gait speed
The single-task gait speed measured by a 10-meter walking test in a fast pace
Dual-task timed-up-and-go-time
The dual-task gait performance measured by a 3-meter timed up and go test with serial subtraction
Movement Disorder Society Unified Parkinson Disease Rating Scale Part I (MDS-UPDRS-I) score
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.
Activities-specific Balance Confidence (ABC) Scale score
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.
Parkinson Disease Questionnaire-39 (PDQ-39) summary index score
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.
Fall risk
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.
Fall rate
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.
Injurious fall risk
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.
Injurious fall rate
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.

Full Information

First Posted
October 9, 2018
Last Updated
August 24, 2021
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT04048291
Brief Title
Efficacy of Brisk Walking in Parkinson's Disease
Official Title
Efficacy of Brisk Walking on Improving Balance and Gait Performance, and Functional Mobility in Parkinson's Disease - a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
February 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
rehabilitation, exercise, postural balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brisk walking and balance training
Arm Type
Experimental
Arm Description
Week1-6: Supervised training in groups of 6-8 participant, once/week, 90 min/session Week 7-26: Supervised training in groups of 6-8 participant, once/month, 90 min/session 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)
Arm Title
Upper limb exercise
Arm Type
Active Comparator
Arm Description
Week1-6: Supervised training in groups of 6-8 participant, once/week, 90 min/session Week 7-26: Supervised training in groups of 6-8 participant, once/month, 90 min/session Participants practice own upper limb exercise 2-3 times/week (to aim at 150 min of exercise per week)
Intervention Type
Behavioral
Intervention Name(s)
Brisk walking and balance training
Intervention Description
6 months of combined brisk walking and balance training
Intervention Type
Behavioral
Intervention Name(s)
Upper limb exercise
Intervention Description
6 month of hand dexterity training
Primary Outcome Measure Information:
Title
Mini-Balance Evaluation Systems Test (miniBest) total scores
Description
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.
Time Frame
1 year
Title
Six-minute walking test (6MWT) distance
Description
The maximum walking distance covered during a validated six-minute walk test (6MWT) to document participants' aerobic endurance level and walking capacity
Time Frame
1 year
Title
Movement Disorder Society Unified Parkinson Disease Rating Scale Part III (MDS-UPDRS-III) score
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Fast gait speed
Description
The single-task gait speed measured by a 10-meter walking test in a fast pace
Time Frame
1 year
Title
Dual-task timed-up-and-go-time
Description
The dual-task gait performance measured by a 3-meter timed up and go test with serial subtraction
Time Frame
1 year
Title
Movement Disorder Society Unified Parkinson Disease Rating Scale Part I (MDS-UPDRS-I) score
Description
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.
Time Frame
1 year
Title
Activities-specific Balance Confidence (ABC) Scale score
Description
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.
Time Frame
1 year
Title
Parkinson Disease Questionnaire-39 (PDQ-39) summary index score
Description
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.
Time Frame
1 year
Title
Fall risk
Description
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.
Time Frame
1 year
Title
Fall rate
Description
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.
Time Frame
1 year
Title
Injurious fall risk
Description
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.
Time Frame
1 year
Title
Injurious fall rate
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret K Mak, Ph.D.
Organizational Affiliation
Department of Rehabilitation Sciences,The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hong Kong
State/Province
Nothing Selected
ZIP/Postal Code
0000
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11757958
Citation
Bloem BR, Grimbergen YA, Cramer M, Willemsen M, Zwinderman AH. Prospective assessment of falls in Parkinson's disease. J Neurol. 2001 Nov;248(11):950-8. doi: 10.1007/s004150170047.
Results Reference
background
PubMed Identifier
17588236
Citation
Pickering RM, Grimbergen YA, Rigney U, Ashburn A, Mazibrada G, Wood B, Gray P, Kerr G, Bloem BR. A meta-analysis of six prospective studies of falling in Parkinson's disease. Mov Disord. 2007 Oct 15;22(13):1892-900. doi: 10.1002/mds.21598.
Results Reference
background
PubMed Identifier
12023412
Citation
Wood BH, Bilclough JA, Bowron A, Walker RW. Incidence and prediction of falls in Parkinson's disease: a prospective multidisciplinary study. J Neurol Neurosurg Psychiatry. 2002 Jun;72(6):721-5. doi: 10.1136/jnnp.72.6.721.
Results Reference
background
PubMed Identifier
15247535
Citation
Grimbergen YA, Munneke M, Bloem BR. Falls in Parkinson's disease. Curr Opin Neurol. 2004 Aug;17(4):405-15. doi: 10.1097/01.wco.0000137530.68867.93.
Results Reference
background
PubMed Identifier
7953597
Citation
Morris ME, Iansek R, Matyas TA, Summers JJ. The pathogenesis of gait hypokinesia in Parkinson's disease. Brain. 1994 Oct;117 ( Pt 5):1169-81. doi: 10.1093/brain/117.5.1169.
Results Reference
background
PubMed Identifier
10388800
Citation
Ebersbach G, Sojer M, Valldeoriola F, Wissel J, Muller J, Tolosa E, Poewe W. Comparative analysis of gait in Parkinson's disease, cerebellar ataxia and subcortical arteriosclerotic encephalopathy. Brain. 1999 Jul;122 ( Pt 7):1349-55. doi: 10.1093/brain/122.7.1349.
Results Reference
background
PubMed Identifier
29027544
Citation
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.
Results Reference
background
PubMed Identifier
15917061
Citation
Tully MA, Cupples ME, Chan WS, McGlade K, Young IS. Brisk walking, fitness, and cardiovascular risk: a randomized controlled trial in primary care. Prev Med. 2005 Aug;41(2):622-8. doi: 10.1016/j.ypmed.2004.11.030.
Results Reference
background
PubMed Identifier
15459836
Citation
Paillard T, Lafont C, Costes-Salon MC, Riviere D, Dupui P. Effects of brisk walking on static and dynamic balance, locomotion, body composition, and aerobic capacity in ageing healthy active men. Int J Sports Med. 2004 Oct;25(7):539-46. doi: 10.1055/s-2004-820948.
Results Reference
background
PubMed Identifier
23974944
Citation
Batcho CS, Stoquart G, Thonnard JL. Brisk walking can promote functional recovery in chronic stroke patients. J Rehabil Med. 2013 Sep;45(9):854-9. doi: 10.2340/16501977-1211.
Results Reference
background
PubMed Identifier
29188878
Citation
Blain H, Jaussent A, Picot MC, Maimoun L, Coste O, Masud T, Bousquet J, Bernard PL. Effect of a 6-Month Brisk Walking Program on Walking Endurance in Sedentary and Physically Deconditioned Women Aged 60 or Older: A Randomized Trial. J Nutr Health Aging. 2017;21(10):1183-1189. doi: 10.1007/s12603-017-0955-7.
Results Reference
background
Citation
Mak M, Chan W, Auyeung M, Chan A, Cheung N, Mok V. Effects of a home-based brisk walking program in improving activity volume and walking capacity in people with Parkinson's disease. Fourth World Parkinson Congress Abstract; September 2016; Portland 2016.
Results Reference
background

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Efficacy of Brisk Walking in Parkinson's Disease

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