Comparing the Effectiveness of Shotokan-Karate vs. Tai Chi on Balance and Quality of Life in Parkinson's Disease

February 21, 2018 updated by: Sun Life Financial Movement Disorders Research and Rehabilitation Centre
The following study will be a comparison of balance and quality of life in Tai Chi training programs and Shotokan-Karate training programs in individuals with Parkinson's Disease. The following study will be a 12-week program which will assess whether or not Shotokan-Karate betters balance and quality of life even more than Tai Chi. Both Tai Chi and Karate will be taught by a professional instruction at the Sun Life Financial Movement Disorders and Rehabilitation Centre located in Waterloo, Ontario.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Parkinson's disease is a progressive disorder of the central nervous system which affects movement. Some signs and symptoms of PD include; tremors, rigidity, gait impairments, and balance disruption. Individuals with PD experience substantially impaired balance ultimately affecting their functional abilities. With this, individuals with PD may also experience lower quality of life due to these diminished determinants. Currently, there are medications which have proven to mask the symptoms of Parkinson's such as levodopa. There are also exercise programs which have proven to improve the symptoms of Parkinson's disease such as resistance based exercises and Tai Chi.based on the proven benefits of balance and overall quality of life through Shotokan-karate training, the purpose of this study will be to compare Shotokan-karate training versus Tai Chi on balance and quality of life in individuals with Parkinson's disease. Based on the literature available on the benefits of shotokan-karate on balance and quality of life in the elderly, it is hypothesized that shotokan-karate will improve balance and quality of life due to its high intensity, increased engagement and similarities to everyday movements. If the following hypothesis is supported, the present study will allow for individuals with Parkinson's disease to engage in an exercise program that shows vast improvements in their postural stability and overall quality of life. In addition, participants will be able to engage in an exercise program which will provide them with long term benefits and they will be able to implement this in their everyday lifestyle.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Eligibility criteria involved a clinical diagnosis of Parkinson's disease, stable medication use, ability to comprehend English, ability to stand without aid and walk with or without assisted aids.

Exclusion Criteria:

  • Exclusion criteria for participating in this study included any participation in current studies, which involve behavioural, cognitive or pharmacological interventions. In addition, individuals with impaired vision, impaired behavioural and cognitive abilities, and those who are unable to participate in this study due to unavailability and those with scheduling conflicts will also be apart of the exclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Shotokan-Karate
The protocol for Shotokan-karate training will involve a one hour training session which will be broken down into 3 major components. The training program will consist of warm-up exercises, katas (choreographed karate movements), and cool-down exercise.
Other: Shotokan-Karate
The Shotokan-Karate training program will be ran over a period of 12 weeks. Classes will be conducted 3 times per week at the Movement Disorders Rehabilitation Centre in Waterloo, Ontario. The program will be conducted by a trained professional (principal investigator), and there will be volunteers who ensure the safety and well-being of participants.
Experimental: Tai-Chi
The protocol for Tai Chi will involve a one-hour training session which will be conducted by an instructor at the Sun Life Financial Movement Disorders and Rehabilitation Centre.The following program will be held three times per week.
Other: Tai-Chi
The Tai-Chi training program will be ran over a period of 12 weeks. Classes will be conducted 3 times per week at the Movement Disorders Rehabilitation Centre in Waterloo, Ontario. The program will be conducted by a trained professional (principal investigator), and there will be volunteers who ensure the safety and well-being of participants.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in the the Unified Parkinson's Disease Rating Scale (UPDRS)
Time Frame: Pre-Test (week prior), Post-Test (after 12-week training program), concluding it with a one month washout period after the completion of the study.
Participants will be asked to complete the motor section of the Unified Parkinson's Disease Rating Scale (UPDRS-II) which will be assessed by the supervisor (Quincy J. Almeida). UPDRS-II will be assessed during the pre-testing period and the post-testing period which will be after the 12 week training program. UPDRS-II will be reassessed once again after a one month wash out period after the completion of the study. It will assess the progression of Parkinson's over the course of the exercise program and will look into how the disease has changed over time.
Pre-Test (week prior), Post-Test (after 12-week training program), concluding it with a one month washout period after the completion of the study.
Change in the Parkinson's Disease Questionnaire-39 (PDQ-39).
Time Frame: Pre-Test (week prior), Post-Test (after 12-week training program), concluding it with a one month washout period after the completion of the study.
PDQ-39 (Parkinson's Disease Questionnaire) is a self-reported questionnaire, which assesses a given individuals quality of life while living with Parkinson's Disease. The assessment is usually done within the ending of the designated training program. PDQ-39 assesses the experiences the participant has experienced in the training program (positive or negative), and its impact on the eight quality of life dimensions on specific areas of wellbeing in Parkinson's.
Pre-Test (week prior), Post-Test (after 12-week training program), concluding it with a one month washout period after the completion of the study.
Change in the Timed Up-and-Go (TUG) Test
Time Frame: Pre-Test (week prior), Post-Test (after 12-week training program), concluding it with a one month washout period after the completion of the study.
The first condiition in which balance will be measured on individuals with Parkinson's disease will be through the use of the "Timed-up-and-Go" (TUG) Test. The (TUG) Test is performed on a 4.27m long and 1.22m wide ProtoKinetics Movement Analysis Software^TM electronic walkway carpet (Zeno Walkway- Protokinetics, Haverton, PA, USA) that will capture spatiotemporal aspects of the participant's gait. The participants will begin the task by sitting on a chair placed on the Zeno Walkway. Participants will then be asked to stand up and walk to a pylon 3 meters away, then turn around at the pylon and walk back to the chair to sit down. A stopwatch will be used to record time in which it takes the participants to perform the task. The Timed Up-and-Go (TUG) Test will measure balance, ability to walk, and the risk of falls in older adults.
Pre-Test (week prior), Post-Test (after 12-week training program), concluding it with a one month washout period after the completion of the study.
Change in the Gait Analysis
Time Frame: Pre-Test (week prior), Post-Test (after 12-week training program), concluding it with a one month washout period after the completion of the study.
Change in Gait Analysis will be assessed through the Gait Mat which will measure an individual's step length, stride length, step variability, and the centre of pressure. Obtained results will be analyzed and calculated through a software which provides results after the completion of each trial.
Pre-Test (week prior), Post-Test (after 12-week training program), concluding it with a one month washout period after the completion of the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Life Financial Movement Disorders Research and Rehabilitation Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 3, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 25, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MDRC1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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