Clinical trial NCT04740229: Moderate-intensity Flow-based Yoga Effects on Cognition and Stress
Official title: Testing the Impact of Flow-based, Moderate-intensity Yoga on Executive Functioning and Stress Among Low Active Working Adults Having Symptoms of Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Psychological
Keywords: sun salutations
longitudinal
remote
cognition
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the efficacy of an 8-week, remotely-delivered, flow-based and moderate-intensity yoga intervention (vs. waitlist control), on stress and cognitive functioning. Participants will include individuals who are full-time working adults between the ages of 18 and 64, and currently experiencing symptoms of psychosocial stress or anxiety.

Detailed description: Participants who pass a telephone screening, electronically sign our informed consent agreement, and complete baseline testing, will be randomized to one of two groups: yoga intervention or a waitlist control group. Before and after the 8-week intervention, participants will complete psychosocial questionnaires and computerized cognitive testing. The remote intervention will be delivered via Google Meet and will be led by a certified yoga instructor. During the course of the intervention, participants will be wearing a consumer grade accelerometer to track heart rate during yoga sessions and physical activity during the 8 weeks.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 64 years.
* Full-time working adults, defined as working \>35 hrs/week in any industry, and not currently enrolled as a full-time student.
* Presence of at least three symptoms of stress or anxiety as measured by the symptom checklist from the Diagnostic and Statistical Manual VI.
* Low active, i.e. participating in physical activity and/or mind-body activities such as yoga and tai-chi less than 3 times/week for 30 minutes, in the last three months.
* Ability to exercise at a moderate intensity, and perform movements including sitting, standing, kicking, pulling, pushing, bending one's elbows, bending the body forward, bending one's knees, lying down and getting up without difficulty.
* No engagement in mindful activities, such as meditation, or brain training games, for greater than 3 times/week for 30 minutes, in the last three months.
* Currently not involved in any other research study or structured program related to physical activity, mind-body activities, or brain training games.
* Access to a yoga mat, and a smartphone with a data plan or access to WiFi, on which an application could be downloaded.
* Access to a laptop or desktop with an attached keyboard
* Willingness to be randomized to one of two conditions

Exclusion Criteria:

* Age below 18 years or above 64 years
* Students or non full-time working adults, such as part-time working adults
* Presence of two or less symptoms of stress or anxiety as measured by the symptom checklist from the Diagnostic and Statistical Manual VI.
* Engaging in high levels of physical activity (≥ 30 minutes, two or more times/week, for the last three months) and/or a regular practitioner of Yoga or mind-body activities such as tai-chi and mindfulness meditation (≥ 30 minutes, two or more times/week, for the last three months) and/or a certified yoga teacher.
* Mobility impairment restricting ability to engage in moderate intensity activity.
* Engagement in mindful activities, such as meditation, or brain training games, for greater than 3 times/week for 30 minutes, in the last three months
* Currently involved in research study or structured program related to physical activity, mind-body activities, or brain training games
* No access to yoga mat or a smartphone with data or WiFi, as well as refusal to download a health application on their smartphone.
* Refusal or unwillingness to be randomized into either of the conditions.
* Having any of the following medical conditions, including risk of seizure, psychiatric and/or neurological disorders, or diagnosed hypertension or blood pressure of 200/105 or more.
* Score of \>1 on the Physical Activity Readiness Questionnaire.
* Unavailable for \>one week in the 10-week study
* Prior yoga experience in the last 10 years. i.e. those who have engaged in 50 consecutive weeks of yoga sessions each lasting 60 minutes, without missing 12 weeks or more

Primary outcomes:
measure: Perceived Stress
timeFrame: Change from baseline at 8 weeks
Secondary outcomes:
measure: Task switching paradigm
timeFrame: Change from baseline at 8 weeks
measure: Digit span forward and backward
timeFrame: Change from baseline at 8 weeks
measure: Digit symbol substitution test (DSST)
timeFrame: Change from baseline at 8 weeks
measure: Stroop task
timeFrame: Change from baseline at 8 weeks
Other outcomes:
measure: Self-Compassion
timeFrame: Change from baseline at 8 weeks
measure: Personal optimism and self-efficacy optimism
timeFrame: Change from baseline at 8 weeks
measure: Covid-related stress
timeFrame: Change from baseline at 8 weeks
measure: Self-efficacy
timeFrame: Change from baseline at 8 weeks
measure: Mindfulness and Attention
timeFrame: Change from baseline at 8 weeks
measure: Positive and Negative Affect
timeFrame: Change from baseline at 8 weeks
measure: Experienced Bodily Changes Scale (EBCS)
timeFrame: Change from baseline at 8 weeks
measure: Physical activity
timeFrame: Change from baseline at 8 weeks
measure: Outcome expectations
timeFrame: Change from baseline at 8 weeks
measure: Self-regulation
timeFrame: Change from baseline at 8 weeks
measure: Bodily pain
timeFrame: Change from baseline at 8 weeks
measure: Anxiety and Depression
timeFrame: Change from baseline at 8 weeks
measure: Rating of Perceived Exertion (RPE)
timeFrame: Change from baseline at 50 minutes (post-session)
measure: Focus of Attention
timeFrame: Change from baseline at 50 minutes (post-session)
measure: Affect
timeFrame: Change from baseline at 50 minutes (post-session)
measure: Heart rate
timeFrame: Change from baseline at 50 minutes (post-session)
Locations:
city: Urbana
country: United States
facility: University of Illinois at Urbana-Champaign
state: Illinois
Study officials:
affiliation: University of Illinois, Urbana-Champaign
name: Sean P Mullen, PhD
role: PRINCIPAL_INVESTIGATOR
References: