High-Speed Yoga and Executive Function

Not Applicable

Completed

• Conditions: Executive Dysfunction; Quality of Life; Parkinson Disease
• Interventions: Behavioral: High-speed yoga multi-directional yoga

• Registration Number: NCT04215900
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-12-10
• Study First Submitted QC: 2019-12-31
• Study First Posted: 2020-01-02
• Study Start: 2020-01-15
• Primary Completion: 2021-08-30
• Study Completion: 2021-08-30
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-18
• Last Update Posted: 2022-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-Speed Multi-Directional Yoga	High-speed yoga multi-directional yoga	The duration of the intervention is 18 weeks, with 16 weeks of training.

Primary Outcome Measures

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

Name	Time	Method
Changes in Reactive Balance Time	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.
Changes in Perceived Fall Risk	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.
Changes in Motor Function	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.
Changes in body weight	Baseline, Week 19	Body weight will be measured in kilograms using a Tanita BC-418 bioelectrical impedance scale.
Changes in Functional Agility	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.
Changes in fat-free mass	Baseline, Week 19	Fat-free mass will be measured in kilograms using a Tanita BC-418 bioelectrical impedance scale.
Changes in Dynamic Balance	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.
Changes in Quality of Life	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.
Changes in Reactive Balance Distance	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.

Trial Locations

Locations (1)

Max Orovitz Laboratories; 🇺🇸 Coral Gables, Florida, United States