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Yoga for Anxiety in Adults

Primary Purpose

Parkinson Disease, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tele-yoga
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Yoga, anxiety, Parkinson's Disease, telerehabilitation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Rutgers University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tele-yoga

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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).
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.
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.
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.
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.
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).
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.
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.
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.

Full Information

First Posted
January 16, 2020
Last Updated
September 19, 2022
Sponsor
Rutgers, The State University of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT04240899
Brief Title
Yoga for Anxiety in Adults
Official Title
Tele- Yoga for Adults With Anxiety: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
March 9, 2020 (Actual)
Primary Completion Date
July 14, 2021 (Actual)
Study Completion Date
July 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Anxiety
Keywords
Yoga, anxiety, Parkinson's Disease, telerehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tele-yoga
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Tele-yoga
Intervention Description
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.
Primary Outcome Measure Information:
Title
Parkinson's Anxiety Scale (PAS)
Description
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.
Time Frame
Baseline (at 0 weeks)
Title
Parkinson's Anxiety Scale (PAS)
Description
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.
Time Frame
timepoint-2 (at 6-weeks)
Title
Parkinson's Anxiety Scale (PAS)
Description
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.
Time Frame
post-intervention (at 12-weeks)
Title
Parkinson's Anxiety Scale (PAS)
Description
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.
Time Frame
follow-up (at 18 weeks)
Secondary Outcome Measure Information:
Title
Beck Depression Inventory-II (BDI-II)
Description
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.
Time Frame
Baseline (0 weeks), timepoint-2 (6-weeks), post-intervention (12-weeks) and at follow-up (6-weeks after post-intervention testing)
Title
Unified Parkinson's Disease Rating Scale (UPDRS)
Description
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.
Time Frame
Baseline (0 weeks), timepoint-2 (6-weeks), post-intervention (12-weeks) and at follow-up (6-weeks after post-intervention testing)
Title
The Parkinson's Disease Questionnaire-39 (PDQ-39)
Description
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).
Time Frame
Baseline (0 weeks), timepoint-2 (6-weeks), post-intervention (12-weeks) and at follow-up (6-weeks after post-intervention testing)
Title
Five Times Sit to Stand Test (FTST)
Description
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.
Time Frame
Baseline (0 weeks), timepoint-2 (6-weeks), post-intervention (12-weeks) and at follow-up (6-weeks after post-intervention testing)
Title
Parkinson's Disease Sleep Scale-version 2 (PDSS-2)
Description
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.
Time Frame
Baseline (0 weeks), timepoint-2 (6-weeks), post-intervention (12-weeks) and at follow-up (6-weeks after post-intervention testing)
Title
Adherence will be assessed by calculating the total number of yoga sessions attended.
Description
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.
Time Frame
Between week 6 to week 12
Title
Adverse Events
Description
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.
Time Frame
Between week 6 to week 12
Title
Technical Difficulties Encountered
Description
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).
Time Frame
Between week 6 to week 12
Title
Enjoyment/Feedback
Description
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.
Time Frame
Post-intervention testing (at 12-weeks)
Title
Usability
Description
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.
Time Frame
Post-intervention testing (at 12-weeks)
Title
Yoga Status at Follow-up
Description
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.
Time Frame
Follow-up (6-weeks after post-intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Rutgers University
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07107
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35990111
Citation
James-Palmer AM, Daneault JF. Tele-yoga for the management of Parkinson disease: A safety and feasibility trial. Digit Health. 2022 Aug 15;8:20552076221119327. doi: 10.1177/20552076221119327. eCollection 2022 Jan-Dec.
Results Reference
derived

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Yoga for Anxiety in Adults

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