Feasibility of Teleyoga for Treatment of Lyme Disease

Study Overview
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Brief Summary
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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
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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

Official Title
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Teleyoga for Lyme Disease

Conditions
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Lyme Disease

Intervention / Treatment
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* Behavioral: Teleyoga


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Participants will attend teleyoga sessions once per week, with assessments at beginning and end of treatment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Teleyoga<br>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<br>* 12 weekly 75 minute therapist-led teleyoga sessions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Measured at baseline and again at the end of 12 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | at study completion, an average of 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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telehealth, yoga, chronic pain