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Parkinson DiseaseNCT03473834

Modified Exercise Programme in Individuals With Parkinson's Disease

A study testing Modified exercise programme and Medication in people with Parkinson Disease, run by Mahidol University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 50 to 75 years
Conditions the study is for
Parkinson Disease
What is being tested?
Modified exercise programme and Medication
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteThailand
Study dates
1 Mar 2018to 15 Sep 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • College of Sports Science and Technology

    Nakhon Pathom, 73170

Other trials in Thailand

About this study

Official title: 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.

Read the 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.
Being tested
Modified exercise programme, Medication
Keywords
Parkinson's disease, Exercise, Rigidity, Turning
Medical subject headings
Parkinson Disease, Motor Activity, Muscle Rigidity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Modified exercise programmeOther

    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.

  • MedicationBehavioural

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

Study groups in NCT03473834
Study groupRoleWhat they receive
Modified exercise programmeExperimentalModified exercise program is the intervention for the exercise group that they will be received this programm over 1 month.
Receives: Other: Modified exercise programme; Behavioral: Medication
Parkinson's disease MedicationActive comparatorMedication is the standard treatment for individuals with Parkinson's disease. Therefore, the control group will be received the medication only.
Receives: Behavioral: Medication

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 5 months

  2. Functional Reach test

    To assess clinical balance

    Measured: 5 months

  3. 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.

    Measured: 5 months

  4. 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).

    Measured: 5 months

  5. Body Mass Index (BMI)

    weight and height will be combined to report BMI in kg/m^2

    Measured: 5 months

Secondary outcomes (1)

  1. 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.

    Measured: 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2018
  2. Study start1 Mar 2018
  3. Primary completion15 Jul 2018
  4. Study completion15 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Crossover
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)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03473834
Sponsor's protocol ID
MU-CIRB 2017/181.1210
Status last verified
Nov 2018
First submitted
7 Mar 2018
Last updated
15 Nov 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The research is not finished yet when we finish it, we will decide it again.

Questions about this trial

What is this clinical trial studying?

A study testing Modified exercise programme and Medication in people with Parkinson Disease, run by Mahidol University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reorientation onset of body segment (time frame: 5 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03473834.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2018.

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