Parkinson DiseaseNCT03443752
Comparing the Effectiveness of Shotokan-Karate vs. Tai Chi on Balance and Quality of Life in Parkinson's Disease
A study testing Shotokan-Karate and Tai-Chi in people with Parkinson Disease, run by Sun Life Financial Movement Disorders Research and Rehabilitation Centre.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Shotokan-Karate and Tai-Chi
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Feb 2018to 25 Apr 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Shotokan-Karate, Tai-Chi
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shotokan-KarateOther
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.
Tai-ChiOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Shotokan-Karate | Experimental | 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. Receives: Other: Shotokan-Karate |
| Tai-Chi | Experimental | 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. Receives: Other: Tai-Chi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the the Unified Parkinson's Disease Rating Scale (UPDRS)
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.
Measured: 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).
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study startFeb 2018 (estimated)
- Primary completion3 Apr 2018 (estimated)
- Study completion25 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will complete the experimental procedures of the present study during a 12-week training period. All participants will be asked to participate in a Shotokan-karate or Tai Chi training group. The Shotokan-karate training will involve one hour training sessions broken down into 3 components; warm-up exercises, Katas, and cool-down exercises. 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. All exercises will be administered by trained instructors throughout the 12-week training period. The 30-minute UPDRS assessment will be administered by Dr. Quincy Almeida,a movement disorder specialist.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Life Financial Movement Disorders Research and Rehabilitation Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03443752
- Sponsor's protocol ID
- MDRC1
- Status last verified
- Jan 2018
- First submitted
- 18 Jan 2018
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
PubMed 38588457Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
PubMed 36602886
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effectiveness of Shotokan-Karate vs. Tai Chi on Balance and Quality of Life in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03443752
- Acronym / sponsor ID
- MDRC1
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sun Life Financial Movement Disorders Research and Rehabilitation CentreUniversity, hospital or other
- Study start
- Feb 2018 (estimated)
- Primary completion
- 3 Apr 2018 (estimated)
- Study completion
- 25 Apr 2018 (estimated)
- First posted
- 23 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will complete the experimental procedures of the present study during a 12-week training period. All participants will be asked to participate in a Shotokan-karate or Tai Chi training group. The Shotokan-karate training will involve one hour training sessions broken down into 3 components; warm-up exercises, Katas, and cool-down exercises. 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. All exercises will be administered by trained instructors throughout the 12-week training period. The 30-minute UPDRS assessment will be administered by Dr. Quincy Almeida,a movement disorder specialist.
| Arm | Type | Receives |
|---|---|---|
| Shotokan-Karate | Experimental | Other: Shotokan-KarateThe 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. |
| Tai-Chi | Experimental | Other: Tai-ChiThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shotokan-KarateThe 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. | Other | Shotokan-Karate |
| Tai-ChiThe 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. | Other | Tai-Chi |
Primary outcome
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
- Derived from this study: PubMed 38588457Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
- Derived from this study: PubMed 36602886Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Shotokan-Karate and Tai-Chi in people with Parkinson Disease, run by Sun Life Financial Movement Disorders Research and Rehabilitation Centre.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
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.). The study lists 4 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 NCT03443752, which also lists 2 linked publications.
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 23 Feb 2018.