Lyme DiseaseNCT04867473

Feasibility of Teleyoga for Treatment of Lyme Disease

A study testing Teleyoga in people with Lyme Disease, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Lyme Disease
What is being tested?: Teleyoga
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: 1 Oct 2021to 4 Dec 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University
Palo Alto, California, 94305

Other trials in United States

About this study

Official title: 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

Read the 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

Conditions: Lyme Disease
Being tested: Teleyoga
Keywords: yoga, telehealth, chronic pain
Medical subject headings: Lyme Disease, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TeleyogaBehavioural
12 weekly 75 minute therapist-led teleyoga sessions

Study groups in NCT04867473
Study group	Role	What they receive
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 Receives: Behavioral: Teleyoga

What is being measured

The primary outcome is the main question the study is designed to answer.

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: Measured at baseline and again at the end of 12 weeks of treatment

Secondary outcomes (1)

Adherence to the Treatment Protocol
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
Measured: at study completion, an average of 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20214 Dec 2022

First posted30 Apr 2021
Study start1 Oct 2021
Primary completion10 Nov 2022
Study completion4 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Lyme DiseaseStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Participants will attend teleyoga sessions once per week, with assessments at beginning and end of treatment
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04867473
Sponsor's protocol ID: 49667
Status last verified: Aug 2023
First submitted: 16 Apr 2021
Last updated: 8 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
Trisomy 8 Mosaicism, Trisomy 8 Associated Autoinflammatory Disease
RecruitingObservational study
Evaluation, Treatment, and Follow-up of Patients With Lyme Disease
Lyme Disease
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Sana Device for Post-Treatment Lyme Disease Syndrome Chronic Pain
Post-treatment Lyme Disease Syndrome, Chronic Pain
RecruitingObservational study
FINtick - a Prospective Multicenter Study on Tick-borne Infections in Finland
Tick Borne Encephalitis (TBE), Lyme Borreliosis

All Lyme Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Teleyoga for Lyme Disease
ClinicalTrials.gov ID: NCT04867473
Acronym / sponsor ID: 49667
Conditions: Lyme Disease
Keywords: yoga, telehealth, chronic pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Study start: 1 Oct 2021 (actual)
Primary completion: 10 Nov 2022 (actual)
Study completion: 4 Dec 2022 (actual)
First posted: 30 Apr 2021 (actual)
Results: Posted 8 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Participants will attend teleyoga sessions once per week, with assessments at beginning and end of treatment

Arm	Type	Receives
Teleyoga	Experimental	Behavioral: TeleyogaLyme disease participants will attend home-based yoga sessions using HIPAA-compliant telehealth software and devices and complete pain inventory questionnaires pre and post-treatment

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Teleyoga12 weekly 75 minute therapist-led teleyoga sessions	Behavioural	Teleyoga

Primary outcome

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

1 secondary outcome

Adherence to the Treatment Protocol
Time frame: at study completion, an average of 7 months

Results and safety

Results posted to the registry on 8 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1:1 Sessions	5	5
Group Sessions	10	8

Primary outcome: Change of Pain Score From Baseline

Time frame: Measured at baseline and again at the end of 12 weeks of treatment. Number. Unit: score on a scale

Measure	1:1 Sessions n = 5	Group Sessions n = 8
Average PEG Score at Baseline	5.7	4.8
Average PEG score at end of treatment	2.9	4.6

Population analysed: 2 dyads dropped out

1 secondary outcome is reported in the full results.

Adverse events

Time frame: baseline to end of treatment (12 weeks). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1:1 Sessions	0 of 5 (0%)	0 of 5 (0%)	0 of 5
Group Sessions	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Lyme Disease

RecruitingObservational study
Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
Trisomy 8 Mosaicism, Trisomy 8 Associated Autoinflammatory Disease
RecruitingObservational study
Evaluation, Treatment, and Follow-up of Patients With Lyme Disease
Lyme Disease
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Sana Device for Post-Treatment Lyme Disease Syndrome Chronic Pain
Post-treatment Lyme Disease Syndrome, Chronic Pain
RecruitingObservational study
FINtick - a Prospective Multicenter Study on Tick-borne Infections in Finland
Tick Borne Encephalitis (TBE), Lyme Borreliosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Peter J Bayley, Ph.D. study director

VA Palo Alto Health Care System and Stanford University

Jerome A Yesavage, M.D. principal investigator

Stanford University and VA Palo Alto Health Care System

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Teleyoga in people with Lyme Disease, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Pain Score From Baseline (time frame: Measured at baseline and again at the end of 12 weeks of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04867473.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.