Parkinson DiseaseNCT04240899
Yoga for Anxiety in Adults
A study testing Tele-yoga in people with Parkinson Disease and Anxiety, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson Disease, Anxiety
- What is being tested?
- Tele-yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2020to 14 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
Show all 9Show fewer
- willing to be video recorded during the yoga session
- willing to open Zoom on their technological device
- demonstrates self-reported technological literacy.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tele- Yoga for Adults With Anxiety: a Pilot Study
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.
Read the 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.
- Conditions
- Parkinson Disease, Anxiety
- Being tested
- Tele-yoga
- Keywords
- Yoga, anxiety, Parkinson's Disease, telerehabilitation
- Medical subject headings
- Parkinson Disease, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-yogaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Tele-yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: follow-up (at 18 weeks)
Secondary outcomes (11)
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.
Measured: 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)
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.
Measured: 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)
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).
Measured: 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)
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.
Measured: 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)
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.
Measured: Baseline (0 weeks), timepoint-2 (6-weeks), post-intervention (12-weeks) and at follow-up (6-weeks after post-intervention testing)
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.
Measured: Between week 6 to week 12
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.
Measured: Between week 6 to week 12
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).
Measured: Between week 6 to week 12
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.
Measured: Post-intervention testing (at 12-weeks)
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.
Measured: Post-intervention testing (at 12-weeks)
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.
Measured: Follow-up (6-weeks after post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start9 Mar 2020
- Primary completion14 Jul 2021
- Study completion14 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Francois Daneault, Ph.D., Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240899
- Sponsor's protocol ID
- # Pro2018002758
- Status last verified
- Sep 2022
- First submitted
- 16 Jan 2020
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35990111
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele- Yoga for Adults With Anxiety: a Pilot Study
- ClinicalTrials.gov ID
- NCT04240899
- Acronym / sponsor ID
- # Pro2018002758
- Conditions
- Parkinson Disease, Anxiety
- Keywords
- Yoga, anxiety, Parkinson's Disease, telerehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 14 Jul 2021 (actual)
- Study completion
- 14 Jul 2021 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Tele-yoga | Experimental | Other: Tele-yogaThis 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele-yogaSubjects 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. | Other | Tele-yoga |
Primary outcome
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.
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.
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.
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.
11 secondary outcomes
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)
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 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)
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)
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)
Adherence will be assessed by calculating the total number of yoga sessions attended.
Time frame: Between week 6 to week 12
Adverse Events
Time frame: Between week 6 to week 12
Technical Difficulties Encountered
Time frame: Between week 6 to week 12
Enjoyment/Feedback
Time frame: Post-intervention testing (at 12-weeks)
Usability
Time frame: Post-intervention testing (at 12-weeks)
Yoga Status at Follow-up
Time frame: Follow-up (6-weeks after post-intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Derived from this study: PubMed 35990111James-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-yoga in people with Parkinson Disease and Anxiety, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parkinson's Anxiety Scale (PAS) (time frame: Baseline (at 0 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04240899, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.