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Yoga for Anxiety in Adults

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ClinicalTrials.gov Identifier: NCT04240899
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : April 1, 2020
Sponsor:
Information provided by (Responsible Party):
Jean-Francois Daneault, Ph.D., Rutgers, The State University of New Jersey

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Anxiety Other: Tele-yoga Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Tele- Yoga for Adults With Anxiety: a Pilot Study
Actual Study Start Date : March 9, 2020
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tele-yoga
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
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 Measures :
  1. Parkinson's Anxiety Scale (PAS) [ Time Frame: Baseline (at 0 weeks) ]
    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.

  2. Parkinson's Anxiety Scale (PAS) [ Time Frame: timepoint-2 (at 6-weeks) ]
    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.

  3. Parkinson's Anxiety Scale (PAS) [ Time Frame: post-intervention (at 12-weeks) ]
    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.

  4. Parkinson's Anxiety Scale (PAS) [ Time Frame: follow-up (at 18 weeks) ]
    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 :
  1. Beck Depression Inventory-II (BDI-II) [ Time Frame: Baseline (0 weeks), timepoint-2 (6-weeks), post-intervention (12-weeks) and at follow-up (6-weeks after post-intervention testing) ]
    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.

  2. Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: Baseline (0 weeks), timepoint-2 (6-weeks), post-intervention (12-weeks) and at follow-up (6-weeks after post-intervention testing) ]
    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.

  3. The Parkinson's Disease Questionnaire-39 (PDQ-39) [ Time Frame: Baseline (0 weeks), timepoint-2 (6-weeks), post-intervention (12-weeks) and at follow-up (6-weeks after post-intervention testing) ]
    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).

  4. Five Times Sit to Stand Test (FTST) [ Time Frame: Baseline (0 weeks), timepoint-2 (6-weeks), post-intervention (12-weeks) and at follow-up (6-weeks after post-intervention testing) ]
    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.

  5. Parkinson's Disease Sleep Scale-version 2 (PDSS-2) [ Time Frame: Baseline (0 weeks), timepoint-2 (6-weeks), post-intervention (12-weeks) and at follow-up (6-weeks after post-intervention testing) ]
    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.

  6. Adherence will be assessed by calculating the total number of yoga sessions attended. [ Time Frame: Between week 6 to week 12 ]
    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.

  7. Adverse Events [ Time Frame: Between week 6 to week 12 ]
    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.

  8. Technical Difficulties Encountered [ Time Frame: Between week 6 to week 12 ]
    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).

  9. Enjoyment/Feedback [ Time Frame: Post-intervention testing (at 12-weeks) ]
    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.

  10. Usability [ Time Frame: Post-intervention testing (at 12-weeks) ]
    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.

  11. Yoga Status at Follow-up [ Time Frame: Follow-up (6-weeks after post-intervention) ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04240899


Contacts
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Contact: Jean-Francois Daneault, PhD 973-972-8482 jf.daneault@rutgers.edu

Locations
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United States, New Jersey
Rutgers University Recruiting
Newark, New Jersey, United States, 07107
Contact: Jean-Francois Daneault    973-972-8482    jf.daneault@rutgers.edu   
Sponsors and Collaborators
Rutgers, The State University of New Jersey
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Responsible Party: Jean-Francois Daneault, Ph.D., Assistant Professor, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT04240899    
Other Study ID Numbers: # Pro2018002758
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: April 1, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jean-Francois Daneault, Ph.D., Rutgers, The State University of New Jersey:
Yoga, anxiety, Parkinson's Disease, telerehabilitation
Additional relevant MeSH terms:
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Parkinson Disease
Anxiety Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Mental Disorders