Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
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) |
|
| Primary |
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) |
|
| Primary |
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) |
|
| Primary |
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 |
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) |
|
| Secondary |
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) |
|
| Secondary |
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) |
|
| Secondary |
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) |
|
| Secondary |
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) |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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) |
|
| Secondary |
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) |
|
| Secondary |
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) |
|
