- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04215900
High-Speed Yoga and Executive Function
May 18, 2022 updated by: Joseph Signorile, University of Miami
The Impact of High-speed Yoga on Executive Function and Functional Ability in Individuals Diagnosed With Parkinson's Disease.
The purpose of this research study is to establish if a novel high-speed yoga program which incorporates visual cues can make a positive change in the participant's ability to make decisions and move as measured by several cognitive, balance and functional tests.
It has been shown that yoga can improve balance and movement in those diagnosed with Parkinson's disease.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
The purpose of this research study is to establish if a novel high-speed yoga program which incorporates visual cues can make a positive change in the participant's ability to make decisions and move as measured by several cognitive, balance and functional tests.
It has been shown that yoga can improve balance and movement in those diagnosed with Parkinson's disease.
Subjects will be randomly assigned to either the high-speed yoga group or an inactive control group.
All subjects will be tested before and after the 16 week training period using tests of balance, cognition and functional movement.
The high-speed yoga group will receive yoga sequences lead by a certified yoga instructor during each of the 32 visits to the yoga studio.
Each session will last one hour and be conducted two times per week.
The program will consist of several different balance poses and movements where participants are encouraged to move quickly.
Participants will also be asked to move in different directions based on colored lines placed on the yoga mat.
To ensure a safe environment, several assistants will be present to help participants move into each pose.
In addition, several assistive devices such as chairs and yoga blocks will be available if participants chose to use them.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Coral Gables, Florida, United States, 33146
- Max Orovitz Laboratories
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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
Ages Eligible for Study
50 years to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Men and women between 50 and 85 years of age (inclusive);
- Diagnosis of Parkinson's Disease (Hoehn and Yahr scale I-III);
- Ability to ambulate with or without an assistive device for at least 50 ft;
- Ability to get up and down from the floor with minimal assistance;
- Ability to provide informed consent;
- No medical contraindication to participation in an exercise program including unstable or active untreated major medical illness (i.e., cardiovascular disease, neurological or neuromuscular diseases, stroke, cancer, etc.);
- A score of 23 or above on the Montreal Cognitive Assessment;
- Not currently participating in yoga more than one time per week;
- Can understand and communicate in English.
- Willing and bale to provide consent.
Exclusion Criteria:
- Existing musculoskeletal injury.
- Severe freezing of gait.
- Enrolled in another yoga or research program.
- Unstable or active major medical illness.
- Answer "Yes" to any questions on the PAR-Q or Elder PAR-Q.
- Pregnancy
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
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: High-Speed Multi-Directional Yoga
The duration of the intervention is 18 weeks, with 16 weeks of training.
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The yoga training will be performed over a 4-month period where classes will be held two times per week.
Each session will include a warm-up, speed and balance training section, and cooldown phase.
The yoga program will include four separate progressions with the first four weeks serving as a familiarization phase, where the participants will be introduced to the poses and proper technique will be demonstrated.
The second four-week phase will emphasize a speed component used to target improvements in aerobic capacity.
The same poses previously learned will be used.
The final two phases will increase in intensity maintaining the speed element and include skill-based training, where the participants will be asked to complete each pose moving as quickly as possible in response to visual and auditory cues.
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NO_INTERVENTION: Waitlist control
During the course of the 18 week study this arm will receive no intervention.
Participants will be encouraged to maintain their daily schedules.Following the completion of the study the participants will be offered eight yoga sessions over a one month period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Cognitive Dysfunction
Time Frame: Baseline, Week 19
|
The Montreal Cognitive Assessment (MoCA) is a rapid screening instrument for mild cognitive dysfunction.
A total possible score is 30 points with a range of 0-30.
A score of 26 or above is considered normal.
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Baseline, Week 19
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Change in Executive Function (EF)
Time Frame: Baseline, Week 20.
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The Wisconsin Card Sort task evaluates executive function with correct scores and errors associated with previously used rules known as preservative errors.
Scores (t-scores) on the Wisconsin Card Sort task (total error) at study endpoint adjusted for education are min=0 and max=100.
Higher scores indicate better outcomes.
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Baseline, Week 20.
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Change in Executive Function Measured by Inhibition of Cognitive Inference
Time Frame: Baseline, Week 20
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The Stroop color word test evaluates the participant's ability to inhibit cognitive inference.
This is a cognitive domain of executive function and involves the processing of a stimulus where one feature of a previous stimulus may affect the simultaneous processing of a new stimulus.
The total score can range from 0 to 100 with higher scores indicating better memory function.
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Baseline, Week 20
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Change in Executive Function as Measured by Changes in Visual Spatial Ability and Task-switching
Time Frame: Baseline, Week 20
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The Trail Making Test Part A & B measures visuospatial abilities, working memory and task switching abilities associated with EF domains.
Lower times to completion and fewer errors indicate better performance.
Scores for Part A typically can range from 20 to 90 seconds.
Scores for Part B can range from 60 seconds to 180 seconds.
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Baseline, Week 20
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Change in Distance Walked in Six Minutes
Time Frame: Baseline, Week 19
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The six-minute walk test measures cardiovascular performance.
The test measures how far you can walk in 6 minutes.
Scores typically range from 200 to 500 meters in Parkinson's disease (PD) patients.
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Baseline, Week 19
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in body weight
Time Frame: Baseline, Week 19
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Body weight will be measured in kilograms using a Tanita BC-418 bioelectrical impedance scale.
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Baseline, Week 19
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Changes in fat-free mass
Time Frame: Baseline, Week 19
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Fat-free mass will be measured in kilograms using a Tanita BC-418 bioelectrical impedance scale.
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Baseline, Week 19
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Changes in Dynamic Balance
Time Frame: Baseline, Week 19
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The Mini-BESTest measures dynamic balance deficits in persons with mild to moderate PD.
The assessment has 14 items.
Each item is rated on a 0-2 point scale, where a score of 0 indicates that the participant is unable to complete the task, and a score of 2 indicates normal performance.
The score can range from 0 to 28.
Higher score indicates better dynamic balance.
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Baseline, Week 19
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Changes in Functional Agility
Time Frame: Baseline, Week 19
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The Timed Up-and-Go measures a participant's ability to rise from a standard chair walk 3 meters, walk around a cone, walk back 3 meters and sit down in the chair.
The measure is how long it takes to complete the task.
The range of scores is 6.5 seconds to 20.3 seconds.
A lower score indicates better agility.
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Baseline, Week 19
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Changes in Reactive Balance Distance
Time Frame: Baseline, Week 19
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Reactive balance testing measures the ability of the participant to maintain balance on a moving platform.
The dynamic balance score can range from 1440 centimeters to 0 centimeters, with the lower score indicating better performance.
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Baseline, Week 19
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Changes in Reactive Balance Time
Time Frame: Baseline, Week 19
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Reactive balance testing measures the ability of the participant to maintain balance on a moving platform.
The time-on-test score can range from 0-120 seconds with the higher score indicating better performance.
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Baseline, Week 19
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Changes in Perceived Fall Risk
Time Frame: Baseline, Week 19
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The Modified Fall Efficacy Scale measures perceived balance ability and fall risk.
The instrument consists of 14 self-report items which are scored on a 10-point Likert based scale.
A score of 0 indicates not confident at all and a score of 10 indicates complete confidence.
The test can range from 0 to 140.
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Baseline, Week 19
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Changes in Quality of Life
Time Frame: Baseline, Week 19
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The Parkinson's Disease Questionnaire (PDQ-39) measures self-reported quality of life in Parkinson's patients.
It has 39 items with an overall score range from 20 to 56 with the lower score indicating better quality of life.
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Baseline, Week 19
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Changes in Motor Function
Time Frame: Baseline, Week 19
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The Unified Parkinson's Disease Rating Scale-III motor scale is an examination of motor dysfunction in Parkinson's disease patients.
The score can range from 0 to 108 with the higher score indicating greater dysfunction.
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Baseline, Week 19
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Wooten SV, Signorile JF, Desai SS, Paine AK, Mooney K. Yoga meditation (YoMed) and its effect on proprioception and balance function in elders who have fallen: A randomized control study. Complement Ther Med. 2018 Feb;36:129-136. doi: 10.1016/j.ctim.2017.12.010. Epub 2017 Dec 29.
- Potiaumpai M, Martins MC, Wong C, Desai T, Rodriguez R, Mooney K, Signorile JF. Difference in muscle activation patterns during high-speed versus standard-speed yoga: A randomized sequence crossover study. Complement Ther Med. 2017 Feb;30:24-29. doi: 10.1016/j.ctim.2016.11.002. Epub 2016 Nov 18.
- Potiaumpai M, Martins MC, Rodriguez R, Mooney K, Signorile JF. Differences in energy expenditure during high-speed versus standard-speed yoga: A randomized sequence crossover trial. Complement Ther Med. 2016 Dec;29:169-174. doi: 10.1016/j.ctim.2016.10.002. Epub 2016 Oct 15.
- Ni M, Mooney K, Signorile JF. Controlled pilot study of the effects of power yoga in Parkinson's disease. Complement Ther Med. 2016 Apr;25:126-31. doi: 10.1016/j.ctim.2016.01.007. Epub 2016 Feb 10.
- Ni M, Signorile JF, Mooney K, Balachandran A, Potiaumpai M, Luca C, Moore JG, Kuenze CM, Eltoukhy M, Perry AC. Comparative Effect of Power Training and High-Speed Yoga on Motor Function in Older Patients With Parkinson Disease. Arch Phys Med Rehabil. 2016 Mar;97(3):345-354.e15. doi: 10.1016/j.apmr.2015.10.095. Epub 2015 Nov 4.
- Ni M, Mooney K, Richards L, Balachandran A, Sun M, Harriell K, Potiaumpai M, Signorile JF. Comparative impacts of Tai Chi, balance training, and a specially-designed yoga program on balance in older fallers. Arch Phys Med Rehabil. 2014 Sep;95(9):1620-1628.e30. doi: 10.1016/j.apmr.2014.04.022. Epub 2014 May 14.
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 (ACTUAL)
January 15, 2020
Primary Completion (ACTUAL)
August 30, 2021
Study Completion (ACTUAL)
August 30, 2021
Study Registration Dates
First Submitted
December 10, 2019
First Submitted That Met QC Criteria
December 31, 2019
First Posted (ACTUAL)
January 2, 2020
Study Record Updates
Last Update Posted (ACTUAL)
May 25, 2022
Last Update Submitted That Met QC Criteria
May 18, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20191202
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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