Trial Outcomes & Findings for Feasibility of Teleyoga for Treatment of Lyme Disease (NCT NCT04867473)
NCT ID: NCT04867473
Last Updated: 2024-03-08
Results Overview
Scores on the Pain, Enjoyment, General Activity (PEG) Scale; with values from 0 to 10 and higher scores indicating worse outcomes
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
Measured at baseline and again at the end of 12 weeks of treatment
Results posted on
2024-03-08
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
10
|
|
Overall Study
COMPLETED
|
5
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
2 participants dropped out in the group format
Baseline characteristics by cohort
| Measure |
1:1 Sessions
n=5 Participants
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.
|
Group Sessions
n=10 Participants
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.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39 years
STANDARD_DEVIATION 14.3 • n=5 Participants • 2 participants dropped out in the group format
|
43.5 years
STANDARD_DEVIATION 12.6 • n=8 Participants • 2 participants dropped out in the group format
|
41.3 years
STANDARD_DEVIATION 13.5 • n=13 Participants • 2 participants dropped out in the group format
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants • 2 participants dropped out in the group format
|
8 Participants
n=8 Participants • 2 participants dropped out in the group format
|
12 Participants
n=13 Participants • 2 participants dropped out in the group format
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants • 2 participants dropped out in the group format
|
0 Participants
n=8 Participants • 2 participants dropped out in the group format
|
1 Participants
n=13 Participants • 2 participants dropped out in the group format
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • 2 participants dropped out in the group format
|
2 Participants
n=8 Participants • 2 participants dropped out in the group format
|
2 Participants
n=13 Participants • 2 participants dropped out in the group format
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants • 2 participants dropped out in the group format
|
0 Participants
n=8 Participants • 2 participants dropped out in the group format
|
0 Participants
n=13 Participants • 2 participants dropped out in the group format
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • 2 participants dropped out in the group format
|
0 Participants
n=8 Participants • 2 participants dropped out in the group format
|
0 Participants
n=13 Participants • 2 participants dropped out in the group format
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants • 2 participants dropped out in the group format
|
0 Participants
n=8 Participants • 2 participants dropped out in the group format
|
0 Participants
n=13 Participants • 2 participants dropped out in the group format
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants • 2 participants dropped out in the group format
|
6 Participants
n=8 Participants • 2 participants dropped out in the group format
|
11 Participants
n=13 Participants • 2 participants dropped out in the group format
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • 2 participants dropped out in the group format
|
0 Participants
n=8 Participants • 2 participants dropped out in the group format
|
0 Participants
n=13 Participants • 2 participants dropped out in the group format
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • 2 participants dropped out in the group format
|
0 Participants
n=8 Participants • 2 participants dropped out in the group format
|
0 Participants
n=13 Participants • 2 participants dropped out in the group format
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants • 2 participants dropped out in the group format
|
8 Participants
n=8 Participants • 2 participants dropped out in the group format
|
13 Participants
n=13 Participants • 2 participants dropped out in the group format
|
PRIMARY outcome
Timeframe: Measured at baseline and again at the end of 12 weeks of treatmentPopulation: 2 dyads dropped out
Scores on the Pain, Enjoyment, General Activity (PEG) Scale; with values from 0 to 10 and higher scores indicating worse outcomes
Outcome measures
| Measure |
1:1 Sessions
n=5 Participants
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.
|
Group Sessions
n=8 Participants
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.
|
|---|---|---|
|
Change of Pain Score From Baseline
Average PEG Score at Baseline
|
5.7 score on a scale
|
4.8 score on a scale
|
|
Change of Pain Score From Baseline
Average PEG score at end of treatment
|
2.9 score on a scale
|
4.6 score on a scale
|
SECONDARY outcome
Timeframe: at study completion, an average of 7 monthsPercentage 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
Outcome measures
| Measure |
1:1 Sessions
n=5 Participants
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.
|
Group Sessions
n=8 Participants
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.
|
|---|---|---|
|
Adherence to the Treatment Protocol
|
5 Participants
|
7 Participants
|
Adverse Events
1:1 Sessions
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group Sessions
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place