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RecruitingNCT06973876

Examining the Effectiveness of Asynchronous Versus Synchronous Yoga for Veterans With Chronic Pain

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
Portland VA Medical Center · Federal
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The goal of this clinical trial is to see if pre-recorded yoga videos are as helpful for chronic pain as online yoga sessions taught in real time. The main questions it aims to answer are: Are pre-recorded yoga videos an acceptable and practical tool and could they be used more broadly? Are pre-recorded yoga videos no worse than online yoga sessions taught in real time for managing chronic pain? Researchers will compare changes in chronic pain, mental health, and quality of life outcomes for participants who attend pre-recorded yoga videos versus online yoga sessions taught in real time. Over the course of 4 months, participants will: Attend a 5-session virtual yoga course. Continue virtual yoga practice for 12-weeks on their own or in a VA online class. Complete 3 online assessments and a brief exit interview.

Detailed description

The overarching goals of the proposed research are to pilot test feasibility and acceptability of a 5-session yoga primer to the mindful practice of pain-sensitive teleyoga and its impact on subsequent teleyoga practice delivered either synchronously or asynchronously. The research will also test the preliminary effectiveness of teleyoga practice on outcomes related to chronic pain, mental health, and quality of life. * Aim 1: Assess acceptability and feasibility of trial methodology to inform future larger-scale trials. * Aim 2: Use intent-to-treat analysis and random effect regression models to compare changes in pain interference, pain severity, physical function, quality of life, depression, and anxiety between participants who attend synchronous vs. asynchronous teleyoga. The primary purpose of a pilot study is to assess feasibility of methods to inform future larger studies. However, inferential analyses may be appropriate to help ascertain estimates of variability for the primary and secondary outcomes that can be used to power larger trials. To that end, the investigators will use intent-to-treat procedures and random effect regression models to compare changes in the outcome variables between patients who receive asynchronous vs. synchronous teleyoga. Hypothesis: The investigators predict that asynchronous teleyoga will be non-inferior to synchronous teleyoga in reducing the primary outcome of pain interference, as well as across secondary outcomes

Conditions

Interventions

TypeNameDescription
BEHAVIORALPain-Sensitive Teleyoga PrimerThe 5-session Pain-Sensitive Teleyoga Primer will be delivered synchronously to participants who will practice from their home. The purpose of the 5-session primer is two-fold: (1) it allows trained yoga instructors to determine physical abilities and limitations of patient participants so that pose modifications may be taught and (2) it provides education to participants on pain neuroscience, breathwork, relaxation, mindfulness, and interoception so that they may apply this knowledge to maximize the benefits of whichever yoga condition they are randomized to. Each session will last approximately 75 minutes. Participants will be provided with a supplementary handout to reinforce content from the sessions.
BEHAVIORALSynchronous TeleyogaParticipants randomized to receive synchronous teleyoga will be provided information so that they can attend VAPORHCS virtual yoga offerings. They will be encouraged to attend one class per week during the 12 weeks between randomization and follow-up assessment. Attendance will be tracked via a signed note in the medical record. Each session will last approximately 30-60 minutes.
BEHAVIORALAsynchronous TeleyogaParticipants randomized to receive asynchronous teleyoga will be provided information so that they can access to the digital library of yoga videos on Ompractice, an existing partner with VA Medical Centers. Ompractice contains a suite of yoga video content, and participants will be encouraged to complete one class per week during the 12 weeks between randomization and follow-up assessment. Attendance will be tracked by Ompractice and shared with VAPORHCS.

Timeline

Start date
2025-01-10
Primary completion
2025-09-30
Completion
2025-09-30
First posted
2025-05-15
Last updated
2025-06-04

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06973876. Inclusion in this directory is not an endorsement.