Feasibility of Teleyoga for Treatment of Lyme Disease

NCT04867473 | Completed Results

• 1 other identifier: 49667
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Lyme Disease

Keywords

yoga; telehealth; chronic pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adherence to the Treatment Protocol

  at study completion, an average of 7 months

Study Arms (1)

Teleyoga

EXPERIMENTAL

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

Interventions

Teleyoga BEHAVIORAL

12 weekly 75 minute therapist-led teleyoga sessions

Teleyoga

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94305, United States

Location

MeSH Terms

Conditions

Lyme Disease; Chronic Pain

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Borrelia Infections; Spirochaetales Infections; Tick-Borne Diseases; Vector Borne Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Peter Bayley, PhD
• Organization: Stanford University

peter.bayley@va.gov

650-493-5000

Study Officials

• Peter J Bayley, Ph.D.

  VA Palo Alto Health Care System and Stanford University

  STUDY DIRECTOR

• Jerome A Yesavage, M.D.

  Stanford University and VA Palo Alto Health Care System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Model Details: Participants will attend teleyoga sessions once per week, with assessments at beginning and end of treatment

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 30, 2021
• Study Start: October 1, 2021
• Primary Completion: November 10, 2022
• Study Completion: December 4, 2022
• Last Updated: March 8, 2024
• Results First Posted: March 8, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)