The Effect of Exercise Intervention on Posture, Trunk Flexibility and Spine Function in Patients With Parkinson's Disease

NCT06536478 | Recruiting

• 1 other identifier: 202307076RIND
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal of this clinical trail is to compare the effect of a five-week specific motor interventions on the postural alignment, trunk range of motion and spine function in patients with Parkinson's disease. The secondary goal is to investigate the effect of specific motor interventions on pain, balance, gait, and quality of life. Participants will: be randomly allocated to a control group or an exercise group and will perform 50 minutes of exercise twice a week, including stretching, core exercises, gross motor movements and balance exercises for 5 weeks. Each group will be assessed for posture, trunk range of motion, spine function, pain, balance, gait, and quality of life before and after the intervention.

Conditions

Parkinson Disease

Keywords

Parkinson Disease; exercise; posture

Outcome Measures

Primary Outcomes (3)

• postural alignment of frontal and sagittal plance

  The angles of Flexion and Side-bending of the trunk in degrees

  before and immediately after the intervention

• range of motion of trunk flexion and side-bending

  The range of motion of trunk flexion and side-bending will be evaluated in degrees

  before and immediately after the intervention

• Supine to and from sitting

  The time of supine to and from sitting is measured in seconds

  before and immediately after the intervention

Secondary Outcomes (6)

• Visual Analogue Scale of low back pain

  before and immediately after the intervention

• The Shortened Version of the Balance Evaluation Systems Tests (Mini-BEST)

  before and immediately after the intervention

• 10 meter gait speed

  before and immediately after the intervention

• Tinetti Mobility Test (TMT)

  before and immediately after the intervention

• the short version of the Parkinson's Disease Questionnaire (PDQ-8)

  before and immediately after the intervention

Study Arms (2)

exercise

EXPERIMENTAL

Exercise group will perform 50 minutes of exercise twice a week, including stretching, core exercises, gross motor movements and balance exercises for 5 weeks

Other: exercise

education

OTHER

The patient will be given a one-time exercise education session and a 50-minute video that included stretching, core exercises, gross motor movements and balance exercises that could be practiced at home.

Other: education

Interventions

exercise OTHER

50 minutes of exercise twice a week, including stretching, core exercises, gross motor movements and balance exercises for 5 weeks

exercise

education OTHER

The patient will be given a one-time exercise education session and a 50-minute video that included stretching, core exercises, gross motor movements and balance exercises that could be practiced at home.

education

Eligibility Criteria

• Age: 30 Years - 85 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hoehn-Yahr classification 2 to 3
• Regular compliance with medication program
• Stable medical condition and vital signs, conscious
• Be able to follow instructions.

You may not qualify if:

• Cognitive impairment or dementia who are unable to cooperate with therapy or functional assessment
• Patients with musculoskeletal injuries or surgeries that have resulted in limited mobility
• Patients with physician-diagnosed cardiorespiratory disorders with activity limitations
• Patients with acute neurological disorders.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital Hsinchu Branch

Hsinchu, Taiwan

RECRUITING

Related Publications (9)

• Barone P, Santangelo G, Amboni M, Pellecchia MT, Vitale C. Pisa syndrome in Parkinson's disease and parkinsonism: clinical features, pathophysiology, and treatment. Lancet Neurol. 2016 Sep;15(10):1063-74. doi: 10.1016/S1474-4422(16)30173-9. Epub 2016 Aug 8.

  PMID: 27571158 RESULT

• Norkin, C.C. and D.J. White, Measurement of Joint Motion: A Guide to Goniometry. 5th ed. 2017: F.A.Davis.

  RESULT

• Vaugoyeau M, Viallet F, Aurenty R, Assaiante C, Mesure S, Massion J. Axial rotation in Parkinson's disease. J Neurol Neurosurg Psychiatry. 2006 Jul;77(7):815-21. doi: 10.1136/jnnp.2004.050666. Epub 2006 Mar 30.

  PMID: 16574736 RESULT

• Schenkman M, Cutson TM, Kuchibhatla M, Chandler J, Pieper CF, Ray L, Laub KC. Exercise to improve spinal flexibility and function for people with Parkinson's disease: a randomized, controlled trial. J Am Geriatr Soc. 1998 Oct;46(10):1207-16. doi: 10.1111/j.1532-5415.1998.tb04535.x.

  PMID: 9777901 RESULT

• Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar.

  PMID: 30211382 RESULT

• Duncan RP, Leddy AL, Cavanaugh JT, Dibble LE, Ellis TD, Ford MP, Foreman KB, Earhart GM. Comparative utility of the BESTest, mini-BESTest, and brief-BESTest for predicting falls in individuals with Parkinson disease: a cohort study. Phys Ther. 2013 Apr;93(4):542-50. doi: 10.2522/ptj.20120302. Epub 2012 Nov 21.

  PMID: 23174567 RESULT

• Lindholm B, Nilsson MH, Hansson O, Hagell P. The clinical significance of 10-m walk test standardizations in Parkinson's disease. J Neurol. 2018 Aug;265(8):1829-1835. doi: 10.1007/s00415-018-8921-9. Epub 2018 Jun 6.

  PMID: 29876762 RESULT

• Kegelmeyer DA, Kloos AD, Thomas KM, Kostyk SK. Reliability and validity of the Tinetti Mobility Test for individuals with Parkinson disease. Phys Ther. 2007 Oct;87(10):1369-78. doi: 10.2522/ptj.20070007. Epub 2007 Aug 7.

  PMID: 17684089 RESULT

• Peto V, Jenkinson C, Fitzpatrick R. PDQ-39: a review of the development, validation and application of a Parkinson's disease quality of life questionnaire and its associated measures. J Neurol. 1998 May;245 Suppl 1:S10-4. doi: 10.1007/pl00007730.

  PMID: 9617716 RESULT

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Interventions

Exercise; Educational Status

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Socioeconomic Factors; Population Characteristics

Central Study Contacts

Jui-chi Hsu

CONTACT

+886-5326151; jchsu@hch.gov.tw

Jui-chi Hsu

CONTACT

+886-937138061; reachel33@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 5, 2024
• Study Start: September 28, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: August 7, 2024

Record last verified: 2023-09

Locations

TW (1)