Modified Exercise Programme in Individuals With Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Modified exercise programme
Medication
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's disease, Exercise, Rigidity, Turning
Eligibility Criteria
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
Sites / Locations
- College of Sports Science and Technology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Modified exercise programme
Parkinson's disease Medication
Arm Description
Modified exercise program is the intervention for the exercise group that they will be received this programm over 1 month.
Medication is the standard treatment for individuals with Parkinson's disease. Therefore, the control group will be received the medication only.
Outcomes
Primary Outcome Measures
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).
Functional Reach test
To assess clinical balance
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.
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).
Body Mass Index (BMI)
weight and height will be combined to report BMI in kg/m^2
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03473834
First Posted
March 7, 2018
Last Updated
November 13, 2018
Sponsor
Mahidol University
Collaborators
Liverpool John Moores University
1. Study Identification
Unique Protocol Identification Number
NCT03473834
Brief Title
Modified Exercise Programme in Individuals With Parkinson's Disease
Official Title
Responses of Modified Exercise Programme on Improvement of Axial Rigidity and Turning Dysfunction in Individuals With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
July 15, 2018 (Actual)
Study Completion Date
September 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
Collaborators
Liverpool John Moores University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
A feasibility study using measures of turning function derived from Inertial Measurement Unit sensory before, and after, a modified exercise programme approach.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson's disease, Exercise, Rigidity, Turning
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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 xIMU sensors and EOG.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Modified exercise programme
Arm Type
Experimental
Arm Description
Modified exercise program is the intervention for the exercise group that they will be received this programm over 1 month.
Arm Title
Parkinson's disease Medication
Arm Type
Active Comparator
Arm Description
Medication is the standard treatment for individuals with Parkinson's disease. Therefore, the control group will be received the medication only.
Intervention Type
Other
Intervention Name(s)
Modified exercise programme
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Medication
Intervention Description
The control group will be received the normal medication from their doctor.
Primary Outcome Measure Information:
Title
Reorientation onset of body segment
Description
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).
Time Frame
5 months
Title
Functional Reach test
Description
To assess clinical balance
Time Frame
5 months
Title
Fall Efficacy Score (FES-I)
Description
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.
Time Frame
5 months
Title
Unified Parkinson's Disease Rating Scale (UPDRS)
Description
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).
Time Frame
5 months
Title
Body Mass Index (BMI)
Description
weight and height will be combined to report BMI in kg/m^2
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Borge Scale
Description
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.
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fuengfa Khobkhun
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
College of Sports Science and Technology
City
Nakhon Pathom
ZIP/Postal Code
73170
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
The research is not finished yet when we finish it, we will decide it again.
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Modified Exercise Programme in Individuals With Parkinson's Disease
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