Clinical trial NCT06194227: Yoga Training and Retinal Vasculature With Parkinson's Disease
Official title: The Impact of Cued High-speed Interval Yoga (YogaCue) on Retinal Microvasculature, Mitochondrial Function, and Cognition in Persons With Parkinson's Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Change
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 21
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare the impact of a novel high-speed, cued yoga program to a standard yoga program on retinal microvasculature, cognition and neuromuscular function in persons with Parkinson's disease.


Eligibility criteria: Inclusion Criteria:

1. Parkinson's disease (H\&Y 1, 2, and 3) confirmed by pretest administration of the UPDRS,
2. 55-90 years of age,
3. Montreal Cognitive Assessment \> 17.

Exclusion Criteria:

1. Uncontrolled cardiovascular or neuromuscular diseases that prevent participation in a training program;
2. cerebrovascular disease;
3. documented HIV infection or other immunodeficiency syndrome;
4. any systemic inflammatory or autoimmune conditions such as rheumatoid arthritis, systemic lupus erythematosus, or other serious concomitant medical illness;
5. a history of ocular surgeries (except for cataract surgery more than 6 months ago) or other ocular diseases;
6. bilateral moderate or severe cataracts;
7. refractive errors of myopia, hyperopia and/or astigmatism more than 6.0 Diopters.

Primary outcomes:
measure: Changes in Retinal measured in microliters per second (ul/s)
timeFrame: Baseline, 24 weeks
measure: Changes in Retinal vascular biomarkers
timeFrame: Baseline, 24 weeks
measure: Changes in the Hopkins Verbal Learning Test
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Changes in Executive Function using the Dimensional Card Sort Test
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Changes in Executive Function using the Flanker Test
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Changes in Executive Function using the Picture Sequence Memory Test
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Changes in Executive Function using the List Sorting Test
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Changes in Executive Function using the Pattern Comparison Test
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Changes in Executive Function: Fluid Composite Score
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Changes in the Six-Minute Walk Test
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Changes in One Repetition Maximum Strength
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Changes in Neuromuscular Power Testing
timeFrame: Baseline, 12 weeks, 24 weeks
measure: : Changes in the Ten-Meter Walk Test
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Changes in the Five Times Sit-to-Stand.
timeFrame: Baseline, 12 weeks, 24 weeks
Secondary outcomes:
measure: Changes in the Seated Medicine Ball Throw.
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Changes in the Timed Up and Go
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Changes in the Parkinson's Disease Questionnaire-39
timeFrame: Baseline, 12 weeks, 24 weeks
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Joseph F. Signorile, PhD
role: PRINCIPAL_INVESTIGATOR
References: