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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teleyoga | Behavioral | 12 weekly 75 minute therapist-led teleyoga sessions |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at study completion, an average of 7 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1:1 Sessions | Yoga will be delivered in either a 1-on-1 format between the yoga therapist and the participant. Participants will receive at-home teleyoga classes via video conferencing. |
| FG001 | Group Sessions | Yoga will be delivered in a group format between the yoga therapist and the participant. Participants will receive at-home teleyoga classes via video conferencing. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1:1 Sessions | Yoga will be delivered in either a 1-on-1 format between the yoga therapist and the participant. Participants will receive at-home teleyoga classes via video conferencing. |
| BG001 | Group Sessions |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 2 participants dropped out in the group format |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 2 dyads dropped out | Posted | Number | score on a scale | Measured at baseline and again at the end of 12 weeks of treatment |
|
baseline to end of treatment (12 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1:1 Sessions | Yoga will be delivered in either a 1-on-1 format between the yoga therapist and the participant. Participants will receive at-home teleyoga classes via video conferencing. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Bayley, PhD | Stanford University | 650-493-5000 | 68653 | peter.bayley@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 21, 2023 | Jun 21, 2023 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D008193 | Lyme Disease |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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Participants will attend teleyoga sessions once per week, with assessments at beginning and end of treatment
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Yoga will be delivered in a group format between the yoga therapist and the participant.
Participants will receive at-home teleyoga classes via video conferencing.
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | 2 participants dropped out in the group format | Count of Participants | Participants |
|
| Race (NIH/OMB) | 2 participants dropped out in the group format | Count of Participants | Participants |
|
| Region of Enrollment | 2 participants dropped out in the group format | Count of Participants | Participants |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | at study completion, an average of 7 months |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Group Sessions | Yoga will be delivered in a group format between the yoga therapist and the participant. Participants will receive at-home teleyoga classes via video conferencing. | 0 | 10 | 0 | 10 | 0 | 10 |
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| D001899 | Borrelia Infections |
| D013145 | Spirochaetales Infections |
| D017282 | Tick-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|