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

NCT ID: NCT04665869

Last Updated: 2023-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2022-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Combined balance and brisk walking training

Week1-6: Supervised training in groups of 6-8 participant, once/week, 90 min/session 2. Week 7-26: Supervised training in groups of 6-8 participant, once/month, 90 min/session 3. Participants practice own balance exercise and brisk walking 2-3 times/week (to aim at 150 min of moderate intensity of brisk walking per week at 40-60% of heart rate reserve)

Group Type EXPERIMENTAL

Combined balance and brisk walking training

Intervention Type BEHAVIORAL

6-months of combined balance and brisk walking training

Flexibility and strengthening exercise

1. Week1-6: Supervised training in groups of 6-8 participant, once/week, 90 min/session
2. Week 7-26: Supervised training in groups of 6-8 participant, once/month, 90 min/session
3. Participants practice own flexibility and strengthening exercise 2-3 times/week (to aim at 150 min of exercise per week)

Group Type ACTIVE_COMPARATOR

Flexibility and strengthening exercise

Intervention Type BEHAVIORAL

6-months of flexibility and strengthening exercise

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Combined balance and brisk walking training

6-months of combined balance and brisk walking training

Intervention Type BEHAVIORAL

Flexibility and strengthening exercise

6-months of flexibility and strengthening exercise

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Margaret Kit Yi Mak

Professor, Department of Rehabilitation Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Margaret K Mak, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Hong Kong Polytechnic University

Hong Kong, Nothing Selected, Hong Kong

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Hong Kong

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 28150045 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29027544 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29228079 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25655884 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22021174 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26715466 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24991037 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15917061 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25899544 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27900173 (View on PubMed)

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, van Hilten JJ, LaPelle N; Movement Disorder Society UPDRS Revision Task Force. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008 Nov 15;23(15):2129-70. doi: 10.1002/mds.22340.

Reference Type RESULT
PMID: 19025984 (View on PubMed)

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. doi: 10.2522/ptj.20070214. Epub 2008 Mar 20.

Reference Type RESULT
PMID: 18356292 (View on PubMed)

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.

Reference Type RESULT
PMID: 20461334 (View on PubMed)

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 Jan 28.

Reference Type RESULT
PMID: 28189463 (View on PubMed)

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.

Reference Type RESULT
PMID: 18702736 (View on PubMed)

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.

Reference Type RESULT
PMID: 25387070 (View on PubMed)

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.parkreldis.2015.10.006. Epub 2015 Oct 22.

Reference Type RESULT
PMID: 26578041 (View on PubMed)

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.

Reference Type RESULT
PMID: 12360555 (View on PubMed)

Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

Reference Type DERIVED
PMID: 38588457 (View on PubMed)

Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

Reference Type DERIVED
PMID: 36602886 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HSEARS20191206002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Proprioception and Meditation
NCT03079817 COMPLETED NA
Chinese Exercise Modalities in Parkinson's Disease
NCT00029809 COMPLETED PHASE1/PHASE2
MOVIN' CARE for PD (Mind-body Interventions)
NCT06078046 ACTIVE_NOT_RECRUITING NA