Modified Exercise Programme in Individuals With Parkinson's Disease

Responses of Modified Exercise Programme on Improvement of Axial Rigidity and Turning Dysfunction in Individuals With Parkinson's Disease

A feasibility study using measures of turning function derived from Inertial Measurement Unit sensory before, and after, a modified exercise programme approach.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Modified exercise programme; Behavioral: Medication

Detailed Description

Participants will be patients diagnosed as having idiopathic PD by a neurologist. Patients will be recruited from the Movement Disorder Clinic, Division of Neurology, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand. Participants will be classified into two groups; the treatment and the control groups. All participants will be asked to sign an informed consent form approved by the ethical committee of Mahidol University Institutional Review Board, Mahidol University, Thailand. Only patients with PD who meet the inclusion and exclusion criteria will be invited to participate in the study. All participants will be assessed for daily activity and motor skill using the Unified Parkinson's Disease Rating Scale (UPDRS). At pre- and post- assessments, eye movement and turning characteristics will be assessed using Inertial Measurement Unit sensors and Electroocculography (EOG). The treatment group will receive a rehabilitation program by the physiotherapist. The rehabilitation sessions will take place at the Faculty of Physical Therapy, Mahidol University, Thailand. The control group will receive a diary for recording their daily activities during the duration of participation in this study. In addition, the researcher will phone participants once per week to remind then to maintain their diary records.

Data Processing & Analysis: this study will be used the outcome measures and processing data in MATLAB.

Statistical analysis: Kolmogorov Smirnov Goodness of Fit Test will be used to test the data distribution. If the data are normal or non-normal distribution, data comparisons will be tested as the following;

• Normal distribution: Mixed model ANOVA will be used to compare outcome measures between pre- and post- and between the treatment and the control groups
• Non-normal distribution: The Mann-Whitney U test will be used to compare outcome measures between the treatment and control groups. Wilcoxon Signed-Rank test will be used to compare outcome measures between pre- and post- assessments within group.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Nakhon Pathom, Thailand, 73170
    • College of Sports Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Presenting clinical diagnosis of Parkinson's disease stage 2 to 3 by modified Hoehn and Yahr Scale assessment
• Age ranges from 50-75 years
• Having stable PD medication usage at least 1 month
• No wearing-off phenomenon
• Able to walk independently without using any assistive device
• Able to follow commands and instruction

Exclusion Criteria:

• Presenting clinical diagnosis of dementia
• Having other neurological, cardiopulmonary, or lower extremities musculoskeletal problems which influence the test performance.
• Having high blood pressure [more than 140/90 mmHg]
• Having hemodialysis
• Having visual problems which cannot be adjusted by the lens or glasses

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Modified exercise programme; Modified exercise program is the intervention for the exercise group that they will be received this programm over 1 month.	Other: Modified exercise programme; The exercise will be modified from the standardized exercise program (Schenkman, 1998) includes a series of exercises based on the concept that muscle length and coordination.; Behavioral: Medication; The control group will be received the normal medication from their doctor.
Active Comparator: Parkinson's disease Medication; Medication is the standard treatment for individuals with Parkinson's disease. Therefore, the control group will be received the medication only.	Behavioral: Medication; The control group will be received the normal medication from their doctor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reorientation onset of body segment	Previous research has shown that turning in healthy adults is a whole-body coordinated process characterized by a top-down sequence of body segments reorientation starting with the eyes and head followed by the trunk and ending with the feet (Hollands, Ziavra, & Bronstein, 2004; Mak et al., 2008). However, Lohnes and Earhart (2011) provided evidence that impaired turn performance in PD patients could be partially explained by eye movement deficits, affecting eye, head and body coordination (Lohnes & Earhart, 2011).	5 months
Functional Reach test	To assess clinical balance	5 months
Fall Efficacy Score (FES-I)	FES-I is a questionnaire to assess fear of falling (31). There is 16-item which developed by the Prevention of Falls Network Europe group (ProFaNE) to augment content covered by the original 10-item Fall Efficacy Score (FES). Participants will be asked to rate 16 items of questionnaire on a four-point Likert scale which is their concerns about the possibility of falling when performing 16 activities. A total score is 64 score, a higher score indicates a greater fear of falling.	5 months
Unified Parkinson's Disease Rating Scale (UPDRS)	The Unified Parkinson's Disease Rating Scale, abbreviated UPDRS is a scoring system widely used for the clinical evaluation of Parkinson's disease (PD). Its 42 items are evaluated by interview and clinical observation. Clinicians and researchers alike use the UPDRS and the motor section in particular to follow the progression of a person's Parkinson's disease. Scientific researchers use it to measure benefits from a given therapy in a more unified and accepted rating system. Neurologists also use it in clinical practice to follow the progression of their patients' symptoms in a more objective manner. A total of 199 points are possible (199 represents the worst disability and 0 no disability).	5 months
Body Mass Index (BMI)	weight and height will be combined to report BMI in kg/m^2	5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Borge Scale	To monitor and quantify individual's perceptions of effort during exercise. The Borge scale is used to measure the intensity of your exercise. The Borge scale runs from 0 - 10. The numbers below relate to phrases used to rate how easy or difficult you find an activity. For example, 0 (nothing at all) would be how you feel when sitting in a chair; 10 (very, very heavy) is how you feel at the end of an exercise stress test or after a very difficult activity.	5 months

Collaborators and Investigators

• Sponsor: Mahidol University
• Collaborators: Liverpool John Moores University
• Investigators: Principal Investigator: Fuengfa Khobkhun, Mahidol University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): July 15, 2018
• Study Completion (Actual): September 15, 2018

Study Registration Dates

• First Submitted: March 7, 2018
• First Submitted That Met QC Criteria: March 15, 2018
• First Posted (Actual): March 22, 2018

Study Record Updates

• Last Update Posted (Actual): November 15, 2018
• Last Update Submitted That Met QC Criteria: November 13, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Exercise; Parkinson's disease; Rigidity; Turning
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: MU-CIRB 2017/181.1210

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The research is not finished yet when we finish it, we will decide it again.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No