Modified Exercise Programme in Individuals With Parkinson's Disease

NCT03473834 | Completed

• 1 other identifier: MU-CIRB 2017/181.1210
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Parkinson Disease

Keywords

Parkinson's disease; Exercise; Rigidity; Turning

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Borge Scale

  5 months

Study Arms (2)

Modified exercise programme

EXPERIMENTAL

Modified exercise program is the intervention for the exercise group that they will be received this programm over 1 month.

Other: Modified exercise programme; Behavioral: Medication

Parkinson's disease Medication

ACTIVE COMPARATOR

Medication is the standard treatment for individuals with Parkinson's disease. Therefore, the control group will be received the medication only.

Behavioral: Medication

Interventions

Modified exercise programme OTHER

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.

Modified exercise programme

Medication BEHAVIORAL

The control group will be received the normal medication from their doctor.

Modified exercise programme; Parkinson's disease Medication

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead
• Liverpool John Moores University: collaborator

Study Sites (1)

College of Sports Science and Technology

Nakhon Pathom, 73170, Thailand

Location

MeSH Terms

Conditions

Parkinson Disease; Motor Activity; Muscle Rigidity

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Fuengfa Khobkhun

  Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: March 22, 2018
• Study Start: March 1, 2018
• Primary Completion: July 15, 2018
• Study Completion: September 15, 2018
• Last Updated: November 15, 2018

Record last verified: 2018-11

Locations

TH (1)