Back to resultsFeasibility of Teleyoga for Treatment of Lyme Disease
Primary Purpose
Lyme Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Teleyoga
Sponsored by
About this trial
This is an interventional treatment trial for Lyme Disease focused on measuring yoga, telehealth, chronic pain
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of probable Lyme disease
- Has not begun new pain medications or other treatments in the last month
- English literacy
- Wireless internet connection at home
Exclusion Criteria:
- Participation in another concurrent clinical trial
- Back surgery within the last 12 months
- Unstable, coexisting mental illness or psychiatric condition
- Active, current suicidal intent or plan
- Attended or practiced yoga ≥ 1 x in the past 12 months
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Teleyoga
Arm Description
Lyme disease participants will attend home-based yoga sessions using HIPAA-compliant telehealth software and devices and complete pain inventory questionnaires pre and post-treatment
Outcomes
Primary Outcome Measures
Change of pain score from baseline
Scores on the Pain, Enjoyment, General Activity (PEG) Scale; with values from 0 to 10 and higher scores indicating worse outcomes
Secondary Outcome Measures
Adherence to the treatment protocol
Percentage of participants who attend ≥65 percent of treatment sessions; values range from 0 percent to 100 percent with higher percentages indicative of a better outcome
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04867473
Brief Title
Feasibility of Teleyoga for Treatment of Lyme Disease
Official Title
Teleyoga for Lyme Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
November 10, 2022 (Actual)
Study Completion Date
December 4, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Primary Aims: Modify an existing teleyoga intervention to use with Lyme disease (LD) patients and address the technical challenges of at-home teleyoga
Detailed Description
Participants with symptoms of Lyme disease (n=15) will participate individually in a weekly tele-yoga class using an iPad loaned by the study. Participants will choose where to attend these remote treatment sessions. Yoga treatment will last 12 weeks. Participants' subjective pain will be rated at baseline and end-of-treatment using a standard pain scale. Also assessed will be participant adherence to study protocol by tracking treatment attendance
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lyme Disease
Keywords
yoga, telehealth, chronic pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Participants will attend teleyoga sessions once per week, with assessments at beginning and end of treatment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Teleyoga
Arm Type
Experimental
Arm Description
Lyme disease participants will attend home-based yoga sessions using HIPAA-compliant telehealth software and devices and complete pain inventory questionnaires pre and post-treatment
Intervention Type
Behavioral
Intervention Name(s)
Teleyoga
Intervention Description
12 weekly 75 minute therapist-led teleyoga sessions
Primary Outcome Measure Information:
Title
Change of pain score from baseline
Description
Scores on the Pain, Enjoyment, General Activity (PEG) Scale; with values from 0 to 10 and higher scores indicating worse outcomes
Time Frame
Measured at baseline and again at the end of 12 weeks of treatment
Secondary Outcome Measure Information:
Title
Adherence to the treatment protocol
Description
Percentage of participants who attend ≥65 percent of treatment sessions; values range from 0 percent to 100 percent with higher percentages indicative of a better outcome
Time Frame
at study completion, an average of 7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of probable Lyme disease
Has not begun new pain medications or other treatments in the last month
English literacy
Wireless internet connection at home
Exclusion Criteria:
Participation in another concurrent clinical trial
Back surgery within the last 12 months
Unstable, coexisting mental illness or psychiatric condition
Active, current suicidal intent or plan
Attended or practiced yoga ≥ 1 x in the past 12 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter J Bayley, Ph.D.
Organizational Affiliation
VA Palo Alto Health Care System and Stanford University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jerome A Yesavage, M.D.
Organizational Affiliation
Stanford University and VA Palo Alto Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Feasibility of Teleyoga for Treatment of Lyme Disease
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