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High-Speed Yoga and Executive Function

Primary Purpose

Executive Dysfunction, Parkinson Disease, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High-speed yoga multi-directional yoga
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Executive Dysfunction focused on measuring Exercise Therapy

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Max Orovitz Laboratories

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

High-Speed Multi-Directional Yoga

Waitlist control

Arm Description

The duration of the intervention is 18 weeks, with 16 weeks of training.

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.

Outcomes

Primary Outcome Measures

Change in Cognitive Dysfunction
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.
Change in Executive Function (EF)
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.
Change in Executive Function Measured by Inhibition of Cognitive Inference
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.
Change in Executive Function as Measured by Changes in Visual Spatial Ability and Task-switching
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.
Change in Distance Walked in Six Minutes
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

Changes in body weight
Body weight will be measured in kilograms using a Tanita BC-418 bioelectrical impedance scale.
Changes in fat-free mass
Fat-free mass will be measured in kilograms using a Tanita BC-418 bioelectrical impedance scale.
Changes in Dynamic Balance
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.
Changes in Functional Agility
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.
Changes in Reactive Balance Distance
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.
Changes in Reactive Balance Time
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.
Changes in Perceived Fall Risk
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.
Changes in Quality of Life
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.
Changes in Motor Function
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.

Full Information

First Posted
December 10, 2019
Last Updated
May 18, 2022
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT04215900
Brief Title
High-Speed Yoga and Executive Function
Official Title
The Impact of High-speed Yoga on Executive Function and Functional Ability in Individuals Diagnosed With Parkinson's Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 15, 2020 (Actual)
Primary Completion Date
August 30, 2021 (Actual)
Study Completion Date
August 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Executive Dysfunction, Parkinson Disease, Quality of Life
Keywords
Exercise Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-Speed Multi-Directional Yoga
Arm Type
Experimental
Arm Description
The duration of the intervention is 18 weeks, with 16 weeks of training.
Arm Title
Waitlist control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
High-speed yoga multi-directional yoga
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Cognitive Dysfunction
Description
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.
Time Frame
Baseline, Week 19
Title
Change in Executive Function (EF)
Description
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.
Time Frame
Baseline, Week 20.
Title
Change in Executive Function Measured by Inhibition of Cognitive Inference
Description
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.
Time Frame
Baseline, Week 20
Title
Change in Executive Function as Measured by Changes in Visual Spatial Ability and Task-switching
Description
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.
Time Frame
Baseline, Week 20
Title
Change in Distance Walked in Six Minutes
Description
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.
Time Frame
Baseline, Week 19
Secondary Outcome Measure Information:
Title
Changes in body weight
Description
Body weight will be measured in kilograms using a Tanita BC-418 bioelectrical impedance scale.
Time Frame
Baseline, Week 19
Title
Changes in fat-free mass
Description
Fat-free mass will be measured in kilograms using a Tanita BC-418 bioelectrical impedance scale.
Time Frame
Baseline, Week 19
Title
Changes in Dynamic Balance
Description
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.
Time Frame
Baseline, Week 19
Title
Changes in Functional Agility
Description
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.
Time Frame
Baseline, Week 19
Title
Changes in Reactive Balance Distance
Description
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.
Time Frame
Baseline, Week 19
Title
Changes in Reactive Balance Time
Description
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.
Time Frame
Baseline, Week 19
Title
Changes in Perceived Fall Risk
Description
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.
Time Frame
Baseline, Week 19
Title
Changes in Quality of Life
Description
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.
Time Frame
Baseline, Week 19
Title
Changes in Motor Function
Description
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.
Time Frame
Baseline, Week 19

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Signorile, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Max Orovitz Laboratories
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29458919
Citation
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.
Results Reference
background
PubMed Identifier
28137523
Citation
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.
Results Reference
background
PubMed Identifier
27912943
Citation
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.
Results Reference
background
PubMed Identifier
27062960
Citation
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.
Results Reference
background
PubMed Identifier
26546987
Citation
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.
Results Reference
background
PubMed Identifier
24835753
Citation
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.
Results Reference
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High-Speed Yoga and Executive Function

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