Feasibility of Teleyoga for Treatment of Lyme Disease

Sponsor

Stanford University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04867473

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Anticipated 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 treatmentParticipants 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 :

Oct 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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

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

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Palo Alto	California	United States	94305

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peter Bayley, Investigator, Stanford University

ClinicalTrials.gov Identifier:

NCT04867473

Other Study ID Numbers:

49667

First Posted:

Apr 30, 2021

Last Update Posted:

Jan 26, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Peter Bayley, Investigator, Stanford University

yoga

telehealth

chronic pain

Additional relevant MeSH terms:

Lyme Disease

Study Results

No Results Posted as of Jan 26, 2022