Mindfulness and Yoga or Resistance Exercise Training Fpr Parkinson's Patients

NCT05513534 | Completed

• 1 other identifier: 20220477
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Resistance Training; Yoga

Keywords

Parkinson's disease

Outcome Measures

Primary Outcomes (4)

• Parkinson's Disease Questionnaire (PDQ-39)

  The PDQ-39 is one of the most widely used self-reported questionnaires designed to assess QoL in Parkinson's patients. It is composed of 39 items which are distributed over 8 separate scales including mobility, activities of daily living, emotional wellbeing, stigma, social support, cognition, communication, and bodily discomfort (Jenkinson et al., 1997). All items are answered on a 5-point Likert type scale (0= never, 1=occasionally, 2=sometimes, 3=often, 4=always). In addition, a summary index can be computed to assess the overall impact of PD on the responder.

  15 minutes

• Parkinson Anxiety Scale (PAS)

  The Parkinson Anxiety Scale (PAS) is a frequently used observer or patient-rated anxiety measurement tool designed specifically for PD patients. The exam consists of three sub-scales for persistent anxiety (dimension A), episodic anxiety (dimension B), and avoidance behavior (dimension C), with 5, 4, and 3 items, respectively. All items are scored on a 5-point Likert type scale (0=not or never, 4=severe or almost always). A cut-off point of 14 is optimal to detect anxiety. Self-administered, the test takes approximately 2 minutes.

  2 minutes

• Beck Depression Inventory

  The Beck Depression Inventory is a widely used self-report inventory to assess the severity of depressive symptoms in adults in the past two weeks. The BDI-II has been validated in patients with PD. It includes both cognitive and somatic symptoms of depression and consists of 21 items using a 4-point Likert scale. A maximum score is 63 with 0-13 indicating none or minimal range depression, 14-19 mild, 20-28 moderate, and 29-63 severe.

  5 minutes

• Mindful Attention Awareness Scale (MAAS)

  The Mindful Attention Awareness Scale is a single-factor measure of trait mindfulness comprised of 15 items. The scale evaluates attentiveness and awareness of the present moment with higher scores indicating a greater degree of mindfulness trait. All questions are answered on a 6-point Likert scale with a range from 1 to 6. The total possible score is 90 points with a minimum score of 15

  5 minutes

Secondary Outcomes (10)

• One-repetition maximum (1RM) testing

  10 minutes

• Timed Up & Go (TUG)

  3 minutes

• Quantitative Gait Assessment

  5 minutes

• Isokinetic Testing

  30 minutes

• Ultrasound

  20 minutes

Study Arms (2)

Standard Hatha Yoga

EXPERIMENTAL

A yoga program adapted for those with PD will be used in the current study. It will be conducted over a 16-week period and consists of twice-weekly sessions lasting approximately one hour. The program will be based on principles of Hatha yoga which incorporate longer holds and deep breathing. Each session will include a warm-up, three yoga flows, a balance training section, and a cooldown phase. The first four weeks will emphasize proper alignment, breathing, and technique. Additionally, the classes will be led by a certified yoga instructor and include multiple on-site assistants to ensure a safe training environment. Participants will also be provided with assistive devices (i.e. chairs, yoga blocks, and blankets) if they are required.

Other: Yoga

Power Resisatnce Training

EXPERIMENTAL

: A high-velocity resistance (power) will be conducted over a 16-week period and consists of twice-weekly sessions lasting approximately one hour. Each training session will begin with a brief warm-up. Each session will consist of three sets of 10 repetitions each with 1.5 to 2- to minute rest periods between sets. Participants will be instructed to control the concentric and eccentric velocity of each exercise, with each phase lasting approximately two to three seconds. Exercise order will be randomized during each session and upper and lower body exercises will be alternated whenever possible.

Other: High-speed Resistance Training

Interventions

Yoga OTHER

A standard yoga program will be provided using Hatha poses.

Standard Hatha Yoga

High-speed Resistance Training OTHER

Each session will consist of three sets of 10 repetitions each with 1.5 to 2-minute rest periods between sets. Participants will be instructed to control the concentric and eccentric velocity of each exercise, with each phase lasting approximately two to three seconds

Power Resisatnce Training

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

Laboratory of Neruomuscular Research and Active Aging

Coral Gables, Florida, 33147, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Yoga

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Joseph F Signorile, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors will be masked concerning the intervention provided.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: We will compare Yoga and circuit resistance tarining impacts on mindfulness, anxiety, cognition, muscle structure, and physical performance in people with Parkinson's disease.

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 24, 2022
• Study Start: August 18, 2022
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)