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

NCT04665869 | Completed

• 1 other identifier: HSEARS20191206002
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease

Keywords

rehabilitation; aerobic exercise; postural balance

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (14)

• Mini-Balance Evaluation Systems Test (mini-Best) total score

  1-year

• Six-minute walking test (6MWT) distance

  1 year

• Single-task timed-up-and-go (TUG) time

  1 year

• Dual-task timed-up-and-go (DTUG) time

  1 year

• Five-times-sit-to-stand (FTSTS) time

  1 year

Study Arms (2)

Combined balance and brisk walking training

EXPERIMENTAL

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)

Behavioral: Combined balance and brisk walking training

Flexibility and strengthening exercise

ACTIVE COMPARATOR

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)

Behavioral: Flexibility and strengthening exercise

Interventions

Combined balance and brisk walking training BEHAVIORAL

6-months of combined balance and brisk walking training

Combined balance and brisk walking training

Flexibility and strengthening exercise BEHAVIORAL

6-months of flexibility and strengthening exercise

Flexibility and strengthening exercise

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parkinson disease diagnosed by neurologist with Hoehn \& Yahr stage 2 or 3
• Having a 30-meter walking ability

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Nothing Selected, 0000, Hong Kong

Location

Related Publications (20)

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  PMID: 19025984 RESULT

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  PMID: 25387070 RESULT

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  PMID: 26578041 RESULT

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  PMID: 12360555 RESULT

• 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.

  PMID: 38588457 DERIVED

• 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.

  PMID: 36602886 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Pliability

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Mechanical Phenomena; Physical Phenomena

Study Officials

• Margaret K Mak, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Rehabilitation Sciences

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 14, 2020
• Study Start: November 1, 2020
• Primary Completion: June 30, 2022
• Study Completion: September 30, 2022
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)