Trial Outcomes & Findings for Feasibility of At-Home Telehealth Yoga for Treating Chronic Pain (NCT NCT04074109)

NCT ID: NCT04074109

Last Updated: 2023-04-18

Results Overview

A participant satisfaction measure \[score range: 0 to 4\]. The higher the value, the greater the treatment satisfaction

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 34 participants
• Primary outcome timeframe: after 12 weeks of treatment
• Results posted on: 2023-04-18

Participant Flow

Participant milestones

Measure	Teleyoga group will receive instruction via computer tablet Teleyoga: the yoga protocol will be delivered via a tablet computer to groups of participants	In-person Yoga group will receive instruction in-person In-person yoga: the yoga protocol will be delivered by a yoga instructor in the room to group of participants
Overall Study STARTED	18	16
Overall Study COMPLETED	13	8
Overall Study NOT COMPLETED	5	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Feasibility of At-Home Telehealth Yoga for Treating Chronic Pain

Baseline characteristics by cohort

Measure	Teleyoga n=18 Participants group will receive instruction via computer tablet Teleyoga: the yoga protocol will be delivered via a tablet computer to groups of participants	In-person Yoga n=16 Participants group will receive instruction in-person In-person yoga: the yoga protocol will be delivered by a yoga instructor in the room to group of participants	Total n=34 Participants Total of all reporting groups
Age, Continuous	61 years STANDARD_DEVIATION 18.9 • n=5 Participants	62 years STANDARD_DEVIATION 15.1 • n=7 Participants	61.06 years STANDARD_DEVIATION 17.21 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	12 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	4 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants	16 participants n=7 Participants	34 participants n=5 Participants

PRIMARY outcome

Timeframe: after 12 weeks of treatment

A participant satisfaction measure [score range: 0 to 4]. The higher the value, the greater the treatment satisfaction

Outcome measures

Measure	Teleyoga n=13 Participants group will receive instruction via computer tablet Teleyoga: the yoga protocol will be delivered via a tablet computer to groups of participants	In-person Yoga n=8 Participants group will receive instruction in-person In-person yoga: the yoga protocol will be delivered by a yoga instructor in the room to group of participants
Multi-Dimensional Treatment Satisfaction Measure	3.2 score on a scale Standard Deviation 0.36	3.6 score on a scale Standard Deviation 0.19

PRIMARY outcome

Timeframe: during 12 weeks of treatment

% of randomized patients who attend ≥65% of treatment sessions

Outcome measures

Measure	Teleyoga n=18 Participants group will receive instruction via computer tablet Teleyoga: the yoga protocol will be delivered via a tablet computer to groups of participants	In-person Yoga n=16 Participants group will receive instruction in-person In-person yoga: the yoga protocol will be delivered by a yoga instructor in the room to group of participants
Adherence to the Treatment Protocol	10 Participants	7 Participants

PRIMARY outcome

Timeframe: during 12 weeks of treatment

number of randomized patients who drop out of treatment

Outcome measures

Measure	Teleyoga n=18 Participants group will receive instruction via computer tablet Teleyoga: the yoga protocol will be delivered via a tablet computer to groups of participants	In-person Yoga n=16 Participants group will receive instruction in-person In-person yoga: the yoga protocol will be delivered by a yoga instructor in the room to group of participants
Attrition	5 Participants	8 Participants

Adverse Events

Teleyoga

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

In-person Yoga

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

Peter Bayley, PhD

VA Palo Alto Health Care System

Phone: 650-493-5000

Email: peter.bayley@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place