Feasibility of Teleyoga for Treatment of Lyme Disease

Not Applicable

Completed

• Conditions: Lyme Disease
• Interventions: Behavioral: Teleyoga

• Registration Number: NCT04867473
• Lead Sponsor: Stanford University

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-04-16
• Study First Submitted QC: 2021-04-26
• Study First Posted: 2021-04-30
• Study Start: 2021-10-01
• Primary Completion: 2022-11-10
• Study Completion: 2022-12-04
• Status Verified: 2023-08
• Results First Submitted: 2023-08-10
• Results First Submitted QC: 2023-08-10
• Last Update Submitted: 2023-08-10
• Results First Posted: 2024-03-08
• Last Update Posted: 2024-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Teleyoga	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

Primary Outcome Measures

Name	Time	Method
Change of Pain Score From Baseline	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

Name	Time	Method
Adherence to the Treatment Protocol	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

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States