Yoga for Anxiety in Adults

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effect of a telerehabilitation-yoga intervention delivered remotely via videoconferencing on adults with Parkinson's Disease and anxiety symptoms.

Detailed Description
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A single group intervention study of adults (18-80 years-old) with Parkinson's Disease and anxiety symptoms undergoing a 6-week intervention of 30-minute yoga classes delivered remotely through videoconferencing 2-3 times per week. Subjects with symptoms of anxiety as indicated by their score on the Parkinson's Anxiety Scale will complete yoga classes delivered at-home with videoconferencing, receiving one-on-one yoga instruction including breathing, postures, and meditation/relaxation for two-three times a week. Data collection will occur remotely via videoconferencing at 0-weeks, 6-weeks after a waiting period, 12-weeks after the intervention, and 6-weeks after the last lab visit. Data collection will include demographics, mental health questionnaires, motor assessments, enjoyment, usability, and follow-up yoga status. Each yoga session will be video recorded to aide in recording adherence, adverse events, and challenges.

Official Title
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Tele- Yoga for Adults With Anxiety: a Pilot Study

Conditions
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Parkinson Disease, Anxiety

Intervention / Treatment
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* Other: Tele-yoga


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of Parkinson's Disease symptoms of anxiety as indicated by PAS (score ≥ 14) 18-80 years old ability to communicate verbally and follow directions English-speaking access to WiFi and applicable technological device (computer, laptop, tablet, smartphone etc.) willing to be video recorded during the yoga session willing to open Zoom on their technological device demonstrates self-reported technological literacy. Exclusion Criteria: major depressive disorder (self-report medical history) injury or condition that could prevent engagement in yoga poses cognitive impairment or condition that would prevent the participant from understanding the tasks or communicating with the research team past yoga experience exceeding 5 or more times within the last 2 months pregnant women (self-report)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is a single group intervention study of adults (18-80 years-old) with Parkinson's Disease and anxiety symptoms undergoing a 6-week intervention of 30-minute yoga classes delivered remotely through videoconferencing 2-3 times per week. There will be baseline testing, a 6-week waiting period, timepoint-two testing, a 6-week intervention, post-intervention testing, and 6-week follow-up testing.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tele-yoga<br>This is a single group study, therefore all subjects will be included in this single arm and will undergo the same telerehabilitation yoga intervention delivered through videoconferencing. | Other: Tele-yoga<br>* Subjects will undergo 30-minute yoga sessions delivered remotely 2-3 times/week for 6-weeks. The yoga sessions will be delivered one-on-one and will include 5-7 minutes of breathing exercises 15-20 minutes of postures, and 5-7 minutes of relaxation and meditation exercises.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parkinson's Anxiety Scale (PAS) | The 12-item self-report PAS will be used to assess anxiety symptoms. It takes approximately 2-minutes to complete and is a 12-item scale with three sub-scales assessing 1. Persistent anxiety, episodic anxiety, and avoidance behavior. Participants answer questions on a scale from not or never (0) to severe or almost always (4) with a potential score range of 0-48. Higher score indicates greater symptoms of anxiety. | Baseline (at 0 weeks) | 
| Parkinson's Anxiety Scale (PAS) | The 12-item self-report PAS will be used to assess anxiety symptoms. It takes approximately 2-minutes to complete and is a 12-item scale with three sub-scales assessing 1. Persistent anxiety, episodic anxiety, and avoidance behavior. Participants answer questions on a scale from not or never (0) to severe or almost always (4) with a potential score range of 0-48. Higher score indicates greater symptoms of anxiety. | timepoint-2 (at 6-weeks) | 
| Parkinson's Anxiety Scale (PAS) | The 12-item self-report PAS will be used to assess anxiety symptoms. It takes approximately 2-minutes to complete and is a 12-item scale with three sub-scales assessing 1. Persistent anxiety, episodic anxiety, and avoidance behavior. Participants answer questions on a scale from not or never (0) to severe or almost always (4) with a potential score range of 0-48. Higher score indicates greater symptoms of anxiety. | post-intervention (at 12-weeks) | 
| Parkinson's Anxiety Scale (PAS) | The 12-item self-report PAS will be used to assess anxiety symptoms. It takes approximately 2-minutes to complete and is a 12-item scale with three sub-scales assessing 1. Persistent anxiety, episodic anxiety, and avoidance behavior. Participants answer questions on a scale from not or never (0) to severe or almost always (4) with a potential score range of 0-48. Higher score indicates greater symptoms of anxiety. | follow-up (at 18 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Inventory-II (BDI-II) | The 21- item self-report BDI-II will be used to measure symptoms of depression. For each item the subject must choose one out of 4 statements of increasing severity regarding a specific symptom of depression. It is written approximately at a 5th grade reading level and takes about 5-10 minutes to complete. Potential scores range from 0-63 with higher scores indicating greater severity of depressive symptoms. | Baseline (0 weeks), timepoint-2 (6-weeks), post-intervention (12-weeks) and at follow-up (6-weeks after post-intervention testing) | 
| Unified Parkinson's Disease Rating Scale (UPDRS) | The 50 item UPDRS will be used to assess motor and non-motor symptoms of Parkinson's Disease. It contains four sections 1. Mentation, Behavior, Mood; 2. Activities of Daily Living; 3. Motor Examination; and 4. Complications of Therapy. We will administer a modified version of this assessment in order to administer it remotely via videoconferencing. The hands on rigidity assessment will be excluded. Potential scores range from 0-179 (with rigidity components excluded), with higher scores indicating greater symptoms. | Baseline (0 weeks), timepoint-2 (6-weeks), post-intervention (12-weeks) and at follow-up (6-weeks after post-intervention testing) | 
| The Parkinson's Disease Questionnaire-39 (PDQ-39) | The 39-item self-report questionnaire will be used to asses quality of life. 8 domains (e.g. mobility, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort). It contains questions asking how often certain difficulties/problems have occurred within the last month with answers ranging from never to always. Each dimension total score ranges from 0 (never have difficulty) to 100 (always have difficulty). | Baseline (0 weeks), timepoint-2 (6-weeks), post-intervention (12-weeks) and at follow-up (6-weeks after post-intervention testing) | 
| Five Times Sit to Stand Test (FTST) | The FTST, functional measure, will be administered to assess physical function. It will be administered using a chair in the participants' homes over a one-on-one Zoom videoconference. Participants will be encouraged to have another adult present during this portion of the data collection in case there is any loss of balance. Participants will be encouraged to use an armless chair approximately 63 centimeters from the ground and any deviation from this standard procedure will be documented. Time in seconds it takes the participant to raise from the chair 5 times will be recorded. Longer times will indicate poorer physical function. | Baseline (0 weeks), timepoint-2 (6-weeks), post-intervention (12-weeks) and at follow-up (6-weeks after post-intervention testing) | 
| Parkinson's Disease Sleep Scale-version 2 (PDSS-2) | The 15-item self report PDSS-2 measure will be used to assess sleep dysfunction. It contains questions about the participant's sleep experience during the past week with answers on a likert scale of 0-very often to 4-never. Scores can range from 0-60 with higher scores indicating greater sleep impairment. | Baseline (0 weeks), timepoint-2 (6-weeks), post-intervention (12-weeks) and at follow-up (6-weeks after post-intervention testing) | 
| Adherence will be assessed by calculating the total number of yoga sessions attended. | Adherence to the yoga classes will be recorded each class including if a class is rescheduled. The occurrence, frequency, and brief description of any home yoga practice will also be recorded. | Between week 6 to week 12 | 
| Adverse Events | All adverse events will be documented with a brief description of each adverse event, the potential relationship to the study, and the severity of each event. | Between week 6 to week 12 | 
| Technical Difficulties Encountered | Anything perceived has a challenge by the yoga instructor or participant will be will be documented with severity of the challenge measured by time disrupted at an event level (time disrupted by the single event) and time disrupted from an entire session (time disrupted cumulatively). | Between week 6 to week 12 | 
| Enjoyment/Feedback | Enjoyment/feedback will be assessed via a Qualtrics questionnaire created by the study team inquiring about the subject's opinions about the intervention and a 10-point enjoyment scale. | Post-intervention testing (at 12-weeks) | 
| Usability | The systems usability scale, a 10-item scale that will be used to assess how usable the subjects feel that the tele-yoga intervention was. Scores are calculated such that a toal score of 100 is possible. Higher scores indicate higher usability. | Post-intervention testing (at 12-weeks) | 
| Yoga Status at Follow-up | Yoga status at follow-up will be assessed via a Qualtrics questionnaire created by the study team asking questions about the subject's current involvement in yoga and other related topics. | Follow-up (6-weeks after post-intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Yoga, anxiety, Parkinson's Disease, telerehabilitation