Clinical trial NCT04215900: 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
Overall status: COMPLETED
Phase: NA
Conditions: Executive Dysfunction
Parkinson Disease
Quality of Life
Keywords: Exercise Therapy
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in Cognitive Dysfunction
timeFrame: Baseline, Week 19
measure: Change in Executive Function (EF)
timeFrame: Baseline, Week 20.
measure: Change in Executive Function Measured by Inhibition of Cognitive Inference
timeFrame: Baseline, Week 20
measure: Change in Executive Function as Measured by Changes in Visual Spatial Ability and Task-switching
timeFrame: Baseline, Week 20
measure: Change in Distance Walked in Six Minutes
timeFrame: Baseline, Week 19
Secondary outcomes:
measure: Changes in body weight
timeFrame: Baseline, Week 19
measure: Changes in fat-free mass
timeFrame: Baseline, Week 19
measure: Changes in Dynamic Balance
timeFrame: Baseline, Week 19
measure: Changes in Functional Agility
timeFrame: Baseline, Week 19
measure: Changes in Reactive Balance Distance
timeFrame: Baseline, Week 19
measure: Changes in Reactive Balance Time
timeFrame: Baseline, Week 19
measure: Changes in Perceived Fall Risk
timeFrame: Baseline, Week 19
measure: Changes in Quality of Life
timeFrame: Baseline, Week 19
measure: Changes in Motor Function
timeFrame: Baseline, Week 19
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: Max Orovitz Laboratories
state: Florida
Study officials:
affiliation: University of Miami
name: Joseph Signorile, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.