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High-Speed Yoga and Executive Function

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ClinicalTrials.gov Identifier: NCT04215900
Recruitment Status : Suspended (COVID-19)
First Posted : January 2, 2020
Last Update Posted : December 16, 2020
Sponsor:
Information provided by (Responsible Party):
Joseph Signorile, University of Miami

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Executive Dysfunction Parkinson Disease Quality of Life Behavioral: High-speed yoga multi-directional yoga Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Impact of High-speed Yoga on Executive Function and Functional Ability in Individuals Diagnosed With Parkinson's Disease.
Actual Study Start Date : January 15, 2020
Estimated Primary Completion Date : October 30, 2021
Estimated Study Completion Date : October 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High-Speed Multi-Directional Yoga
The duration of the intervention is 18 weeks, with 16 weeks of training.
Behavioral: High-speed yoga multi-directional yoga
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.

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.



Primary Outcome Measures :
  1. 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.

  2. Change in Executive Function (EF) [ Time Frame: Baseline, Week 20. ]
    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.

  3. Change in Executive Function Measured by Inhibition of Cognitive Inference [ Time Frame: Baseline, Week 20 ]
    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.

  4. Change in Executive Function as Measured by Changes in Visual Spatial Ability and Task-switching [ Time Frame: Baseline, Week 20 ]
    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.

  5. Change in Distance Walked in Six Minutes [ Time Frame: Baseline, Week 19 ]
    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.


Secondary Outcome Measures :
  1. Changes in body weight [ Time Frame: Baseline, Week 19 ]
    Body weight will be measured in kilograms using a Tanita BC-418 bioelectrical impedance scale.

  2. Changes in fat-free mass [ Time Frame: Baseline, Week 19 ]
    Fat-free mass will be measured in kilograms using a Tanita BC-418 bioelectrical impedance scale.

  3. Changes in Dynamic Balance [ Time Frame: Baseline, Week 19 ]
    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.

  4. Changes in Functional Agility [ Time Frame: Baseline, Week 19 ]
    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.

  5. Changes in Reactive Balance Distance [ Time Frame: Baseline, Week 19 ]
    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.

  6. Changes in Reactive Balance Time [ Time Frame: Baseline, Week 19 ]
    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.

  7. Changes in Perceived Fall Risk [ Time Frame: Baseline, Week 19 ]
    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.

  8. Changes in Quality of Life [ Time Frame: Baseline, Week 19 ]
    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.

  9. Changes in Motor Function [ Time Frame: Baseline, Week 19 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women between 50 and 85 years of age (inclusive);
  2. Diagnosis of Parkinson's Disease (Hoehn and Yahr scale I-III);
  3. Ability to ambulate with or without an assistive device for at least 50 ft;
  4. Ability to get up and down from the floor with minimal assistance;
  5. Ability to provide informed consent;
  6. 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.);
  7. A score of 23 or above on the Montreal Cognitive Assessment;
  8. Not currently participating in yoga more than one time per week;
  9. Can understand and communicate in English.
  10. Willing and bale to provide consent.

Exclusion Criteria:

  1. Existing musculoskeletal injury.
  2. Severe freezing of gait.
  3. Enrolled in another yoga or research program.
  4. Unstable or active major medical illness.
  5. Answer "Yes" to any questions on the PAR-Q or Elder PAR-Q.
  6. Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04215900


Locations
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United States, Florida
Max Orovitz Laboratories
Coral Gables, Florida, United States, 33146
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Joseph Signorile, PhD University of Miami
Publications:

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Responsible Party: Joseph Signorile, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT04215900    
Other Study ID Numbers: 20191202
First Posted: January 2, 2020    Key Record Dates
Last Update Posted: December 16, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joseph Signorile, University of Miami:
Exercise Therapy
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases