- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04048291
Efficacy of Brisk Walking in Parkinson's Disease
Efficacy of Brisk Walking on Improving Balance and Gait Performance, and Functional Mobility in Parkinson's Disease - a Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nothing Selected
-
Hong Kong, Nothing Selected, Hong Kong, 0000
- The Hong Kong Polytechnic University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Brisk walking and balance training
|
6 months of combined brisk walking and balance training
|
Active Comparator: Upper limb exercise
|
6 month of hand dexterity training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
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
|
1 year
|
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
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fast gait speed
Time Frame: 1 year
|
The single-task gait speed measured by a 10-meter walking test in a fast pace
|
1 year
|
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
|
1 year
|
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.
|
1 year
|
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.
|
1 year
|
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.
|
1 year
|
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.
|
1 year
|
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. |
1 year
|
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.
|
1 year
|
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. |
1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Margaret K Mak, Ph.D., Department of Rehabilitation Sciences,The Hong Kong Polytechnic University
Publications and helpful links
General Publications
- Bloem BR, Grimbergen YA, Cramer M, Willemsen M, Zwinderman AH. Prospective assessment of falls in Parkinson's disease. J Neurol. 2001 Nov;248(11):950-8. doi: 10.1007/s004150170047.
- Pickering RM, Grimbergen YA, Rigney U, Ashburn A, Mazibrada G, Wood B, Gray P, Kerr G, Bloem BR. A meta-analysis of six prospective studies of falling in Parkinson's disease. Mov Disord. 2007 Oct 15;22(13):1892-900. doi: 10.1002/mds.21598.
- Wood BH, Bilclough JA, Bowron A, Walker RW. Incidence and prediction of falls in Parkinson's disease: a prospective multidisciplinary study. J Neurol Neurosurg Psychiatry. 2002 Jun;72(6):721-5. doi: 10.1136/jnnp.72.6.721.
- Grimbergen YA, Munneke M, Bloem BR. Falls in Parkinson's disease. Curr Opin Neurol. 2004 Aug;17(4):405-15. doi: 10.1097/01.wco.0000137530.68867.93.
- Morris ME, Iansek R, Matyas TA, Summers JJ. The pathogenesis of gait hypokinesia in Parkinson's disease. Brain. 1994 Oct;117 ( Pt 5):1169-81. doi: 10.1093/brain/117.5.1169.
- Ebersbach G, Sojer M, Valldeoriola F, Wissel J, Muller J, Tolosa E, Poewe W. Comparative analysis of gait in Parkinson's disease, cerebellar ataxia and subcortical arteriosclerotic encephalopathy. Brain. 1999 Jul;122 ( Pt 7):1349-55. doi: 10.1093/brain/122.7.1349.
- Mak MK, Wong-Yu IS, Shen X, Chung CL. Long-term effects of exercise and physical therapy in people with Parkinson disease. Nat Rev Neurol. 2017 Nov;13(11):689-703. doi: 10.1038/nrneurol.2017.128. Epub 2017 Oct 13.
- Tully MA, Cupples ME, Chan WS, McGlade K, Young IS. Brisk walking, fitness, and cardiovascular risk: a randomized controlled trial in primary care. Prev Med. 2005 Aug;41(2):622-8. doi: 10.1016/j.ypmed.2004.11.030.
- Paillard T, Lafont C, Costes-Salon MC, Riviere D, Dupui P. Effects of brisk walking on static and dynamic balance, locomotion, body composition, and aerobic capacity in ageing healthy active men. Int J Sports Med. 2004 Oct;25(7):539-46. doi: 10.1055/s-2004-820948.
- Batcho CS, Stoquart G, Thonnard JL. Brisk walking can promote functional recovery in chronic stroke patients. J Rehabil Med. 2013 Sep;45(9):854-9. doi: 10.2340/16501977-1211.
- Blain H, Jaussent A, Picot MC, Maimoun L, Coste O, Masud T, Bousquet J, Bernard PL. Effect of a 6-Month Brisk Walking Program on Walking Endurance in Sedentary and Physically Deconditioned Women Aged 60 or Older: A Randomized Trial. J Nutr Health Aging. 2017;21(10):1183-1189. doi: 10.1007/s12603-017-0955-7.
- Mak M, Chan W, Auyeung M, Chan A, Cheung N, Mok V. Effects of a home-based brisk walking program in improving activity volume and walking capacity in people with Parkinson's disease. Fourth World Parkinson Congress Abstract; September 2016; Portland 2016.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSEARS20180507003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Parkinson Disease
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedParkinson Disease 6, Early-Onset | Parkinson Disease (Autosomal Recessive, Early Onset) 7, Human | Parkinson Disease Autosomal Recessive, Early Onset | Parkinson Disease, Autosomal Recessive Early-Onset, Digenic, Pink1/Dj1United States
-
ProgenaBiomeRecruitingParkinson Disease | Parkinsons Disease With Dementia | Parkinson-Dementia Syndrome | Parkinson Disease 2 | Parkinson Disease 3 | Parkinson Disease 4United States
-
King's College LondonGlaxoSmithKlineCompletedParkinson Disease | Idiopathic Parkinson Disease | Parkinson Disease, PARK8United Kingdom
-
Ohio State UniversityCompletedParkinson's Disease | Parkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease | Parkinson Disease, Idiopathic | Parkinson's Disease, IdiopathicUnited States
-
National Yang Ming UniversityUnknownEarly Onset Parkinson Disease | Early Stage Parkinson Disease
-
Michele Tagliati, MDRecruitingREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
-
Cedars-Sinai Medical CenterEnrolling by invitationREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
-
Mahatma Gandhi Institute of Medical SciencesCompletedStroke, Parkinson' s Disease, Neurological Impairments, Tele-rehabilitationIndia
-
Merck Sharp & Dohme LLCCompletedParkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease
-
University of DeustoCompletedPARKINSON DISEASE (Disorder)Spain
Clinical Trials on Brisk walking and balance training
-
The Hong Kong Polytechnic UniversityCompletedParkinson DiseaseHong Kong
-
University of Colorado, BoulderRecruitingHypertension | Blood Pressure | Endothelial DysfunctionUnited States
-
Bai XiaorongActive, not recruiting
-
Clinique Mutualiste Chirurgicale de la LoireUniversity Hospital of Saint-Etienne; University of LyonUnknownPhysical Activity | Autonomic Nervous System ImbalanceFrance
-
Riphah International UniversityCompleted
-
Ain Shams UniversityCompleted
-
Marquette UniversityGreater Milwaukee FoundationCompletedMultiple Sclerosis
-
Riphah International UniversityRecruiting
-
Guangdong Center for Disease Prevention and ControlUnknown
-
Chinese University of Hong KongCompletedEvaluation of Energy Expenditure and Cardiovascular Health Effects From Tai Chi and Walking ExercisePhysical ActivityHong Kong