Efficacy of Brisk Walking in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04048291
• Other study ID #: HSEARS20180507003
• Status: Completed
• Phase: N/A
• Start date: October 15, 2018
• Est. completion date: February 28, 2020

Study information

• Verified date: August 2021
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Behavioral:
• Brisk walking and balance training
6 months of combined brisk walking and balance training
• Upper limb exercise
6 month of hand dexterity training

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University	Hong Kong	Nothing Selected

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

Ebersbach G, Sojer M, Valldeoriola F, Wissel J, Müller 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. — View Citation

Grimbergen YA, Munneke M, Bloem BR. Falls in Parkinson's disease. Curr Opin Neurol. 2004 Aug;17(4):405-15. Review. — View Citation

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.

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. Review. — View Citation

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. — View Citation

Paillard T, Lafont C, Costes-Salon MC, Rivière 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mini-Balance Evaluation Systems Test (miniBest) total scores	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
Primary	Six-minute walking test (6MWT) distance	The maximum walking distance covered during a validated six-minute walk test (6MWT) to document participants' aerobic endurance level and walking capacity	1 year
Primary	Movement Disorder Society Unified Parkinson Disease Rating Scale Part III (MDS-UPDRS-III) score	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	Fast gait speed	The single-task gait speed measured by a 10-meter walking test in a fast pace	1 year
Secondary	Dual-task timed-up-and-go-time	The dual-task gait performance measured by a 3-meter timed up and go test with serial subtraction	1 year
Secondary	Movement Disorder Society Unified Parkinson Disease Rating Scale Part I (MDS-UPDRS-I) score	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
Secondary	Activities-specific Balance Confidence (ABC) Scale score	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
Secondary	Parkinson Disease Questionnaire-39 (PDQ-39) summary index score	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
Secondary	Fall risk	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
Secondary	Fall rate	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
Secondary	Injurious fall risk	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
Secondary	Injurious fall rate	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