Feasibility of Teleyoga for Treatment of Lyme Disease

NCT ID: NCT04867473

Last Updated: 2024-03-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2022-12-04

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

Conditions

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Lyme Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Participants will attend teleyoga sessions once per week, with assessments at beginning and end of treatment
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Teleyoga

Intervention Type BEHAVIORAL

12 weekly 75 minute therapist-led teleyoga sessions

Interventions

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Teleyoga

12 weekly 75 minute therapist-led teleyoga sessions

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Peter Bayley

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter J Bayley, Ph.D.

Role: STUDY_DIRECTOR

VA Palo Alto Health Care System and Stanford University

Jerome A Yesavage, M.D.

Role: PRINCIPAL_INVESTIGATOR

Stanford University and VA Palo Alto Health Care System

Locations

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Stanford University

Palo Alto, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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49667

Identifier Type: -

Identifier Source: org_study_id

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