Efficacy of Brisk Walking in Parkinson's Disease

Study Overview
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Brief Summary
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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.

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

Conditions
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Parkinson Disease

Intervention / Treatment
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* Behavioral: Brisk walking and balance training
* Behavioral: Upper limb exercise


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brisk walking and balance training<br>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) | Behavioral: Brisk walking and balance training<br>* 6 months of combined brisk walking and balance training<br>|
| Active Comparator: Upper limb exercise<br>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) | Behavioral: Upper limb exercise<br>* 6 month of hand dexterity training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year | 
| 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 | 1 year | 
| 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 | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fast gait speed | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rehabilitation, exercise, postural balance