Yoga for Anxiety in Adults

NCT04240899 | Completed DMC

• 1 other identifier: # Pro2018002758
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Anxiety

Keywords

Yoga, anxiety, Parkinson's Disease, telerehabilitation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (11)

• Beck Depression Inventory-II (BDI-II)

  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)

  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)

  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)

  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)

  Baseline (0 weeks), timepoint-2 (6-weeks), post-intervention (12-weeks) and at follow-up (6-weeks after post-intervention testing)

Study Arms (1)

Tele-yoga

EXPERIMENTAL

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

Interventions

Tele-yoga OTHER

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.

Tele-yoga

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of Parkinson's Disease
• symptoms of anxiety as indicated by PAS (score ≥ 14)
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers University

Newark, New Jersey, 07107, United States

Location

Related Publications (1)

• 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.

  PMID: 35990111 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Anxiety Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: January 27, 2020
• Study Start: March 9, 2020
• Primary Completion: July 14, 2021
• Study Completion: July 14, 2021
• Last Updated: September 21, 2022

Record last verified: 2022-09

Locations

US (1)