Clinical trial NCT04665869: Long-term Effects of Combined Balance and Brisk Walking in Parkinson's Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: rehabilitation
aerobic exercise
postural balance
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2020-12-14
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Movement Disorder Society Unified Parkinson Disease Rating Scale Part III (MDS-UPDRS-III) score
timeFrame: 1 year
measure: Movement Disorder Society Unified Parkinson Disease Rating Scale Part I (MDS-UPDRS-I) score
timeFrame: 1 year
Secondary outcomes:
measure: Mini-Balance Evaluation Systems Test (mini-Best) total score
timeFrame: 1-year
measure: Six-minute walking test (6MWT) distance
timeFrame: 1 year
measure: Single-task timed-up-and-go (TUG) time
timeFrame: 1 year
measure: Dual-task timed-up-and-go (DTUG) time
timeFrame: 1 year
measure: Five-times-sit-to-stand (FTSTS) time
timeFrame: 1 year
measure: Non-Motor Symptoms Scale for Parkinson's Disease (NMSS) total score
timeFrame: 1 year
measure: Gait cycle measures by 2-minute Instrument Walk Test using mobile sensors in both comfortable and fast walking speed
timeFrame: 1 year
measure: Activities-specific Balance Confidence (ABC) Scale score
timeFrame: 1 year
measure: Parkinson Disease Questionnaire-39 (PDQ-39) summary index score
timeFrame: 1 year
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 1 year
measure: Fall risk
timeFrame: 1 year
measure: Fall rate
timeFrame: 1 year
measure: Injurious fall risk
timeFrame: 1 year
measure: Injurious fall rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
state: Nothing Selected
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Margaret K Mak, PhD
role: PRINCIPAL_INVESTIGATOR
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