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Feasibility of Teleyoga for Treatment of Lyme Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04867473
Recruitment Status : Recruiting
First Posted : April 30, 2021
Last Update Posted : January 26, 2022
Sponsor:
Information provided by (Responsible Party):
Peter Bayley, Stanford University

Study Description
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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

Condition or disease Intervention/treatment Phase
Lyme Disease Behavioral: Teleyoga Not Applicable

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Participants will attend teleyoga sessions once per week, with assessments at beginning and end of treatment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Teleyoga for Lyme Disease
Actual Study Start Date : October 1, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lyme Disease

Arms and Interventions
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Arm Intervention/treatment
Experimental: Teleyoga
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
 Behavioral: Teleyoga
12 weekly 75 minute therapist-led teleyoga sessions


Outcome Measures
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Primary Outcome Measures :
  1. Change of pain score from baseline [ Time Frame: Measured at baseline and again at the end of 12 weeks of treatment ]
    Scores on the Pain, Enjoyment, General Activity (PEG) Scale; with values from 0 to 10 and higher scores indicating worse outcomes


Secondary Outcome Measures :
  1. Adherence to the treatment protocol [ Time Frame: at study completion, an average of 7 months ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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): NCT04867473


Contacts
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Contact: Erika S Tomlinson, Psy.D. 4152363905 Erika.Tomlinson@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Study Director: Peter J Bayley, Ph.D. VA Palo Alto Health Care System and Stanford University
Principal Investigator: Jerome A Yesavage, M.D. Stanford University and VA Palo Alto Health Care System
More Information
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Responsible Party: Peter Bayley, Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT04867473    
Other Study ID Numbers: 49667
First Posted: April 30, 2021    Key Record Dates
Last Update Posted: January 26, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Peter Bayley, Stanford University:
yoga
telehealth
chronic pain
Additional relevant MeSH terms:
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Lyme Disease
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
 Borrelia Infections
Spirochaetales Infections
Tick-Borne Diseases
Vector Borne Diseases