Long-term Effects of Combined Balance and Brisk Walking in Parkinson's Disease

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04665869
• Other study ID #: HSEARS20191206002
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: June 2023
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

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 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:
• Combined balance and brisk walking training
6-months of combined balance and brisk walking training
• Flexibility and strengthening exercise
6-months of flexibility and strengthening exercise

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 (18)

Benka Wallen M, Franzen E, Nero H, Hagstromer M. Levels and Patterns of Physical Activity and Sedentary Behavior in Elderly People With Mild to Moderate Parkinson Disease. Phys Ther. 2015 Aug;95(8):1135-41. doi: 10.2522/ptj.20140374. Epub 2015 Feb 5. — View Citation

Chaudhuri KR, Martinez-Martin P. Quantitation of non-motor symptoms in Parkinson's disease. Eur J Neurol. 2008 Sep;15 Suppl 2:2-7. doi: 10.1111/j.1468-1331.2008.02212.x. — View Citation

Franchignoni F, Horak F, Godi M, Nardone A, Giordano A. Using psychometric techniques to improve the Balance Evaluation Systems Test: the mini-BESTest. J Rehabil Med. 2010 Apr;42(4):323-31. doi: 10.2340/16501977-0537. — View Citation

Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stern MB, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, — View Citation

Horvath K, Aschermann Z, Acs P, Deli G, Janszky J, Komoly S, Balazs E, Takacs K, Karadi K, Kovacs N. Minimal clinically important difference on the Motor Examination part of MDS-UPDRS. Parkinsonism Relat Disord. 2015 Dec;21(12):1421-6. doi: 10.1016/j.park — View Citation

Kletzel SL, Hernandez JM, Miskiel EF, Mallinson T, Pape TL. Evaluating the performance of the Montreal Cognitive Assessment in early stage Parkinson's disease. Parkinsonism Relat Disord. 2017 Apr;37:58-64. doi: 10.1016/j.parkreldis.2017.01.012. Epub 2017 — View Citation

Li HJ, Zhang MF, Chen MX, Hu AL, Li JB, Zhang B, Liu W. Validation of the nonmotor symptoms questionnaire for Parkinson's disease: results from a Chinese pilot study. Int J Neurosci. 2015;125(12):929-35. doi: 10.3109/00207454.2014.986573. Epub 2014 Dec 18 — View Citation

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. — View Citation

Reynolds GO, Otto MW, Ellis TD, Cronin-Golomb A. The Therapeutic Potential of Exercise to Improve Mood, Cognition, and Sleep in Parkinson's Disease. Mov Disord. 2016 Jan;31(1):23-38. doi: 10.1002/mds.26484. Epub 2015 Dec 30. — View Citation

Schenkman M, Moore CG, Kohrt WM, Hall DA, Delitto A, Comella CL, Josbeno DA, Christiansen CL, Berman BD, Kluger BM, Melanson EL, Jain S, Robichaud JA, Poon C, Corcos DM. Effect of High-Intensity Treadmill Exercise on Motor Symptoms in Patients With De Novo Parkinson Disease: A Phase 2 Randomized Clinical Trial. JAMA Neurol. 2018 Feb 1;75(2):219-226. doi: 10.1001/jamaneurol.2017.3517. — View Citation

Seppi K, Weintraub D, Coelho M, Perez-Lloret S, Fox SH, Katzenschlager R, Hametner EM, Poewe W, Rascol O, Goetz CG, Sampaio C. The Movement Disorder Society Evidence-Based Medicine Review Update: Treatments for the non-motor symptoms of Parkinson's disease. Mov Disord. 2011 Oct;26 Suppl 3(0 3):S42-80. doi: 10.1002/mds.23884. — View Citation

Stahl SE, An HS, Dinkel DM, Noble JM, Lee JM. How accurate are the wrist-based heart rate monitors during walking and running activities? Are they accurate enough? BMJ Open Sport Exerc Med. 2016 Apr 25;2(1):e000106. doi: 10.1136/bmjsem-2015-000106. eCollection 2016. — View Citation

Steffen T, Seney M. Test-retest reliability and minimal detectable change on balance and ambulation tests, the 36-item short-form health survey, and the unified Parkinson disease rating scale in people with parkinsonism. Phys Ther. 2008 Jun;88(6):733-46. — View Citation

Tsang KL, Chi I, Ho SL, Lou VW, Lee TM, Chu LW. Translation and validation of the standard Chinese version of PDQ-39: a quality-of-life measure for patients with Parkinson's disease. Mov Disord. 2002 Sep;17(5):1036-40. doi: 10.1002/mds.10249. — 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. doi: 10.1016/j.ypmed.2004.11.030. — View Citation

Tysnes OB, Storstein A. Epidemiology of Parkinson's disease. J Neural Transm (Vienna). 2017 Aug;124(8):901-905. doi: 10.1007/s00702-017-1686-y. Epub 2017 Feb 1. — View Citation

Uc EY, Doerschug KC, Magnotta V, Dawson JD, Thomsen TR, Kline JN, Rizzo M, Newman SR, Mehta S, Grabowski TJ, Bruss J, Blanchette DR, Anderson SW, Voss MW, Kramer AF, Darling WG. Phase I/II randomized trial of aerobic exercise in Parkinson disease in a community setting. Neurology. 2014 Jul 29;83(5):413-25. doi: 10.1212/WNL.0000000000000644. Epub 2014 Jul 2. — View Citation

Wong-Yu IS, Mak MK. Multi-dimensional balance training programme improves balance and gait performance in people with Parkinson's disease: A pragmatic randomized controlled trial with 12-month follow-up. Parkinsonism Relat Disord. 2015 Jun;21(6):615-21. doi: 10.1016/j.parkreldis.2015.03.022. Epub 2015 Mar 31. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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
Primary	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	Mini-Balance Evaluation Systems Test (mini-Best) total score	To evaluate dynamic balance in four domains: anticipatory postural adjustments, postural reactions, sensory integration and gait stability. The mini-BEST total score ranges from 0 to 28, with a higher score indicates better dynamic balance.	1-year
Secondary	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
Secondary	Single-task timed-up-and-go (TUG) time	The single-task gait performance measured by the time taken to complete 3-meter timed-up-and-go (TUG) test	1 year
Secondary	Dual-task timed-up-and-go (DTUG) time	The dual-task gait performance measured by the time taken to complete 3-meter timed-up-and-go test with serial subtraction	1 year
Secondary	Five-times-sit-to-stand (FTSTS) time	The composite lower limb strength measured by the time taken to complete 5 repetitions of sitting to standing	1 year
Secondary	Non-Motor Symptoms Scale for Parkinson's Disease (NMSS) total score	The Non-Motor Symptoms Scale is a 30-item rater-based scale to assess a wide range of non-motor symptoms in patients with Parkinson's disease (PD). The NMSS measures the severity and frequency of non-motor symptoms across nine dimensions. The NMSS total score ranges form 0 to 360, with a higher score indicates worse PD non-motor symptoms.	1 year
Secondary	Gait cycle measures by 2-minute Instrument Walk Test using mobile sensors in both comfortable and fast walking speed	Spatial, gait phase, spatiotemporal and asymmetric walking variables such as gait speed, cadence, stride length, arm swing angle and velocity, and trunk movement angle and velocity will be measured by Mobility Lab system.	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	Pittsburgh Sleep Quality Index (PSQI)	The Pittsburgh Sleep Quality Index is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month. A total score of "5" or greater is indicative of poor sleep quality.	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