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Clinical Trials/NCT04665869
NCT04665869
Completed
Not Applicable

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

The Hong Kong Polytechnic University1 site in 1 country100 target enrollmentNovember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
The Hong Kong Polytechnic University
Enrollment
100
Locations
1
Primary Endpoint
Movement Disorder Society Unified Parkinson Disease Rating Scale Part III (MDS-UPDRS-III) score
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2020
End Date
September 30, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Margaret Kit Yi Mak

Professor, Department of Rehabilitation Sciences

The Hong Kong Polytechnic University

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 functions
  • Had received deep brain stimulation surgery
  • Cognitive impairment with Montreal Cognitive Assessment score \<24
  • Present with on-off motor fluctuations.

Outcomes

Primary Outcomes

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

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 Outcomes

  • Mini-Balance Evaluation Systems Test (mini-Best) total score(1-year)
  • Six-minute walking test (6MWT) distance(1 year)
  • Single-task timed-up-and-go (TUG) time(1 year)
  • Five-times-sit-to-stand (FTSTS) time(1 year)
  • Gait cycle measures by 2-minute Instrument Walk Test using mobile sensors in both comfortable and fast walking speed(1 year)
  • Activities-specific Balance Confidence (ABC) Scale score(1 year)
  • Parkinson Disease Questionnaire-39 (PDQ-39) summary index score(1 year)
  • Injurious fall rate(1 year)
  • Dual-task timed-up-and-go (DTUG) time(1 year)
  • Non-Motor Symptoms Scale for Parkinson's Disease (NMSS) total score(1 year)
  • Pittsburgh Sleep Quality Index (PSQI)(1 year)
  • Fall risk(1 year)
  • Fall rate(1 year)
  • Injurious fall risk(1 year)

Study Sites (1)

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