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

Study Overview
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Brief Summary
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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.

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

Conditions
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Parkinson Disease

Intervention / Treatment
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* Behavioral: Combined balance and brisk walking training
* Behavioral: Flexibility and strengthening 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 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
Maximum Age: 80 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: Combined balance and brisk walking training<br>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<br>* 6-months of combined balance and brisk walking training<br>|
| Active Comparator: Flexibility and strengthening 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 flexibility and strengthening exercise 2-3 times/week (to aim at 150 min of exercise per week) | Behavioral: Flexibility and strengthening exercise<br>* 6-months of flexibility and strengthening exercise<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini-Balance Evaluation Systems Test (mini-Best) total score | 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 | 
| 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 | 
| Single-task timed-up-and-go (TUG) time | 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 | 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 | 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 | 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 | 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 | 
| 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 | 
| Pittsburgh Sleep Quality Index (PSQI) | 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 | 
| 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, aerobic exercise, postural balance