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

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ClinicalTrials.gov Identifier: NCT04665869
Recruitment Status : Recruiting
First Posted : December 14, 2020
Last Update Posted : August 25, 2021
Sponsor:
Information provided by (Responsible Party):
Margaret Kit Yi Mak, The Hong Kong Polytechnic University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Behavioral: Combined balance and brisk walking training Behavioral: Flexibility and strengthening exercise Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Long-term Effects of Combined Balance and Brisk Walking on Alleviating Motor and Non-motor Symptoms in Parkinson's Disease: a Randomized Controlled Trial
Actual Study Start Date : March 15, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.


  13. 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.

  14. 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.



Eligibility Criteria
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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 functions
  • Had received deep brain stimulation surgery
  • Cognitive impairment with Montreal Cognitive Assessment score <24
  • Present with on-off motor fluctuations.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04665869


Contacts
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Contact: Margaret K Mak, PhD +852 27666708 margaret.mak@polyu.edu.hk

Locations
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Hong Kong
The Hong Kong Polytechnic University Recruiting
Hong Kong, Nothing Selected, Hong Kong, 0000
Contact: Margaret K Mak, Ph.D.    +85227666708    margaret.mak@polyu.edu.hk   
Sponsors and Collaborators
The Hong Kong Polytechnic University
Investigators
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Principal Investigator: Margaret K Mak, PhD The Hong Kong Polytechnic University
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Margaret Kit Yi Mak, Professor, Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT04665869    
Other Study ID Numbers: HSEARS20191206002
First Posted: December 14, 2020    Key Record Dates
Last Update Posted: August 25, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Margaret Kit Yi Mak, The Hong Kong Polytechnic University:
rehabilitation
aerobic exercise
postural balance
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases