Clinical trial NCT05513534: Mindfulness and Yoga or Resistance Exercise Training Fpr Parkinson's Patients
Official title: The Effects of Yoga and Power Training on Mindfulness, Psychological Wellbeing, and Functional Ability of Individuals With Parkinson's Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resistance Training
Yoga
Keywords: Parkinson's disease
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2022-08-24
Enrollment: 35
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will compare Yoga and circuit resistance tarining impacts on mindfulness, anxiety, cognition, muscle structure, and physical performance in people with Parkinson's disease.
Primary purpose: TREATMENT

Brief summary: The investigators propose to compare the effects of a 16-week specially designed yoga program to a power-based resistance training program on affect trait mindfulness, anxiety, depression, functionality, and quality of life. As secondary measures, we propose to compare the effects of these exercise programs on measures of executive function (EF), sleep, disease stage, motor symptoms, muscle quality, rigidity, strength, power, and mobility.

Detailed description: Yoga has long been recognized as a therapeutic intervention for improving mindfulness and psychological well-being. Yoga represents a unique exercise activity that employs mindfulness-based practices and various balance postures to improve physical and mental health. Yoga is a gentle form of exercise that can be easily adapted to populations suffering from physical and mental limitations and has been shown to improve physical and psychological functioning in individuals with PD. Though research continues to support the positive psychological effects of yoga, it is unclear whether this is due to the unique mindfulness-rooted approach of yoga or general increases in physical activity.

Power-based resistance training has had promising results in the PD community. Improvements in balance, gait, and increases in leg muscle power and strength have been shown in PD patients after power training interventions. Although power training is a beneficial exercise modality in the treatment of motor symptoms, the effects of power training on nonmotor symptoms have yet to be established.

Eligibility criteria: Inclusion Criteria:

* diagnosed with mild to moderate PD \[Hoehn and Yahr (H\&Y) stage 1-3\];
* over 50 years of age;
* stable use of medication;
* able to walk 15 m independently with or without an assistive device;
* the ability to get up and down from the floor with minimal assistance;
* not currently participating in yoga or resistance training more than one time per week;
* able to understand and communicate in English; and,
* able to provide informed consent.

Exclusion Criteria:

* cognitive impairment as designated by a score of less than 23 on the Montreal Cognitive Assessment (MoCA)\]; and,
* any clinically significant medical condition, such as cardiopulmonary disease and musculoskeletal problems. Subjects providing affirmative answers on a Physical Activity Readiness Questionnaire (PAR-Q) or Health Status Questionnaire related to cardiopulmonary disease or musculoskeletal impairments will be required to present a physical activity clearance from their physician.

Primary outcomes:
measure: Parkinson's Disease Questionnaire (PDQ-39)
timeFrame: 15 minutes
measure: Parkinson Anxiety Scale (PAS)
timeFrame: 2 minutes
measure: Beck Depression Inventory
timeFrame: 5 minutes
measure: Mindful Attention Awareness Scale (MAAS)
timeFrame: 5 minutes
Secondary outcomes:
measure: One-repetition maximum (1RM) testing
timeFrame: 10 minutes
measure: Timed Up & Go (TUG)
timeFrame: 3 minutes
measure: Quantitative Gait Assessment
timeFrame: 5 minutes
measure: Isokinetic Testing
timeFrame: 30 minutes
measure: Ultrasound
timeFrame: 20 minutes
measure: Power Testing
timeFrame: 15 minutes
measure: The Stroop Color Word Test
timeFrame: 5 minutes
measure: Trail-making Test (TNT)
timeFrame: 5 minutes
measure: Home Sleep Testing
timeFrame: 8 hours
measure: Actigraphy
timeFrame: 168 hours
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: Laboratory of Neruomuscular Research and Active Aging
state: Florida
Study officials:
affiliation: University of Miami
name: Joseph F Signorile, PhD
role: PRINCIPAL_INVESTIGATOR
References: