Clinical trial NCT04240899: Yoga for Anxiety in Adults
Official title: Tele- Yoga for Adults With Anxiety: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Anxiety
Keywords: Yoga, anxiety, Parkinson's Disease, telerehabilitation
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Parkinson's Anxiety Scale (PAS)
timeFrame: Baseline (at 0 weeks)
measure: Parkinson's Anxiety Scale (PAS)
timeFrame: timepoint-2 (at 6-weeks)
measure: Parkinson's Anxiety Scale (PAS)
timeFrame: post-intervention (at 12-weeks)
measure: Parkinson's Anxiety Scale (PAS)
timeFrame: follow-up (at 18 weeks)
Secondary outcomes:
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: Baseline (0 weeks), timepoint-2 (6-weeks), post-intervention (12-weeks) and at follow-up (6-weeks after post-intervention testing)
measure: Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: Baseline (0 weeks), timepoint-2 (6-weeks), post-intervention (12-weeks) and at follow-up (6-weeks after post-intervention testing)
measure: The Parkinson's Disease Questionnaire-39 (PDQ-39)
timeFrame: Baseline (0 weeks), timepoint-2 (6-weeks), post-intervention (12-weeks) and at follow-up (6-weeks after post-intervention testing)
measure: Five Times Sit to Stand Test (FTST)
timeFrame: Baseline (0 weeks), timepoint-2 (6-weeks), post-intervention (12-weeks) and at follow-up (6-weeks after post-intervention testing)
measure: Parkinson's Disease Sleep Scale-version 2 (PDSS-2)
timeFrame: Baseline (0 weeks), timepoint-2 (6-weeks), post-intervention (12-weeks) and at follow-up (6-weeks after post-intervention testing)
measure: Adherence will be assessed by calculating the total number of yoga sessions attended.
timeFrame: Between week 6 to week 12
measure: Adverse Events
timeFrame: Between week 6 to week 12
measure: Technical Difficulties Encountered
timeFrame: Between week 6 to week 12
measure: Enjoyment/Feedback
timeFrame: Post-intervention testing (at 12-weeks)
measure: Usability
timeFrame: Post-intervention testing (at 12-weeks)
measure: Yoga Status at Follow-up
timeFrame: Follow-up (6-weeks after post-intervention)
Other outcomes:
Locations:
city: Newark
country: United States
facility: Rutgers University
state: New Jersey
Study officials:
References:
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.