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Completed

NCT Number: NCT04048291

Efficacy of Brisk Walking in Parkinson's Disease

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.

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Hong Kong, Nothing Selected, 0000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brisk walking and balance training

Behavioral

6 months of combined brisk walking and balance training

Upper Limb Exercise

Behavioral

6 month of hand dexterity training

Primary outcomes

  1. Mini-Balance Evaluation Systems Test (miniBest) total scores

    Time frame: 1 year

    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.

  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. 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

Secondary outcomes

  1. Fast gait speed

    Time frame: 1 year

    The single-task gait speed measured by a 10-meter walking test in a fast pace

  2. Dual-task timed-up-and-go-time

    Time frame: 1 year

    The dual-task gait performance measured by a 3-meter timed up and go test with serial subtraction

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 7, 2019
Registry last updated
Aug 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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