Feasibility of Teleyoga for Treatment of Lyme Disease

August 10, 2023 updated by: Peter Bayley, Stanford University

Teleyoga for Lyme Disease

Primary Aims: Modify an existing teleyoga intervention to use with Lyme disease (LD) patients and address the technical challenges of at-home teleyoga

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Actual)

November 10, 2022

Study Completion (Actual)

December 4, 2022

Study Registration Dates

First Submitted

April 16, 2021

First Submitted That Met QC Criteria

April 26, 2021

First Posted (Actual)

April 30, 2021

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

August 10, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 49667

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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