NCT04215900

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2019

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

January 15, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

May 25, 2022

Status Verified

May 1, 2022

Enrollment Period

1.6 years

First QC Date

December 10, 2019

Last Update Submit

May 18, 2022

Conditions

Keywords

Exercise Therapy

Outcome Measures

Primary Outcomes (5)

  • 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.

    Baseline, Week 19

  • 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.

    Baseline, Week 20.

  • 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.

    Baseline, Week 20

  • 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.

    Baseline, Week 20

  • 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.

    Baseline, Week 19

Secondary Outcomes (9)

  • Changes in body weight

    Baseline, Week 19

  • Changes in fat-free mass

    Baseline, Week 19

  • Changes in Dynamic Balance

    Baseline, Week 19

  • Changes in Functional Agility

    Baseline, Week 19

  • Changes in Reactive Balance Distance

    Baseline, Week 19

  • +4 more secondary outcomes

Study Arms (2)

High-Speed Multi-Directional Yoga

EXPERIMENTAL

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

Behavioral: High-speed yoga multi-directional yoga

Waitlist control

NO INTERVENTION

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.

Interventions

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.

High-Speed Multi-Directional Yoga

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Max Orovitz Laboratories

Coral Gables, Florida, 33146, United States

Location

Related Publications (8)

  • 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.

    PMID: 29458919BACKGROUND
  • 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.

    PMID: 28137523BACKGROUND
  • 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.

    PMID: 27912943BACKGROUND
  • 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.

    PMID: 27062960BACKGROUND
  • 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.

    PMID: 26546987BACKGROUND
  • 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.

    PMID: 24835753BACKGROUND
  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Joseph Signorile, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 10, 2019

First Posted

January 2, 2020

Study Start

January 15, 2020

Primary Completion

August 30, 2021

Study Completion

August 30, 2021

Last Updated

May 25, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations