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Completed

NCT Number: NCT04215900

High-Speed Yoga and Executive Function

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.

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Key information

Conditions

Executive Dysfunction Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Quality of Life Synucleinopathies

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Max Orovitz Laboratories

Coral Gables, Florida, 33146, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-speed yoga multi-directional yoga

Behavioral

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

The Impact of High-speed Yoga on Executive Function and Functional Ability in Individuals Diagnosed With Parkinson's Disease.

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 2, 2020
Registry last updated
May 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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