Moderate-intensity Flow-based Yoga Effects on Cognition and Stress

Study Overview
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Brief Summary
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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
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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.

Official Title
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Testing the Impact of Flow-based, Moderate-intensity Yoga on Executive Functioning and Stress Among Low Active Working Adults Having Symptoms of Stress

Conditions
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Stress, Psychological

Intervention / Treatment
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* Behavioral: Yoga


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moderate-intensity flow-based Yoga<br>The intervention will consist of participants engaging in a progressive series of moderate-intensity, flow-based yoga poses, along with breathing and relaxation, for eight weeks. The intervention will be titrated in terms of supervision, with first two weeks being completely supervised, followed by partial supervision for three weeks, and three weeks of unsupervised sessions. The sessions will be  50 minutes long, 3 times/week. All supervised sessions will be conducted online through Google Meet (GM), which is a live video interaction platform. Videos will be provided to guide unsupervised sessions. Sessions will be led by a certified yoga instructor. An orientation will be provided in the first week, given that the participants will have no or minimal experience with yoga. The intervention will consist of basic sun salutations of hatha yoga sun salutation A, sun salutation B and flow sequences, and breathing exercises, and relaxation. | Behavioral: Yoga<br>* Moderate-intensity flow-based yoga movements, breathing, and relaxation for 50 minutes, 3 times per week, for 8 weeks<br>|
| No Intervention: Waitlist control<br>Participants in this group will not receive the 8-week intervention during the course of the study, and will be asked to engage in their regular activities. They will be asked to not start any new activities during the study period. After they complete the study, they will be provided with the same intervention (live instruction, feedback and supportive videos). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Stress | The Perceived Stress Scale (PSS), developed by Cohen, Kamarck, and Mermelstein (1983) will be used to measure perceived psychosocial stress. The PSS is a 10-item scale that measures the extent to which situations are perceived as stressful. Responses range from 0 (Never) to 4 (Very often) and higher scores indicate a higher level of perceived stress. The Brief Job Stress Questionnaire, developed by Kawada and Otsuka (2011), is a 15-item scale measuring job stress. It focuses on the evaluation of job demands, job control, job support, and degree of job satisfaction. Responses range from 1 (Agree) to 4 (Disagree) and higher scores indicate a lower level of stress. | Change from baseline at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Task switching paradigm | This measures cognitive flexibility, i.e. a participant's ability to adapt quickly to changing rules and the cost associated with it. In this task, participants have to characterize the picture presented according to shape or color, with a switch in the rules occurring every two tasks. Participants are cued to the rule before the stimulus is presented. Reaction time and accuracy will be recorded, with lower reaction time and higher accuracy indicating better performance. Participants will complete 40 trials. | Change from baseline at 8 weeks | 
| Digit span forward and backward | This is a measure of the storage and manipulation capacity of working memory. The participant will be shown a series of digits presented on PowerPoint, through screen sharing. The minimum length of digits presented is 3 (e.g., 638) and the maximum length is 9 (e.g., 628295702). In the forward task, participants will be asked to recall the digits exactly as they were presented, while in the backward task, they will have to recall them in the reverse order. Digit-span backward is the more complex task of the two. Accuracy will recorded, with higher accuracy indicating better performance. | Change from baseline at 8 weeks | 
| Digit symbol substitution test (DSST) | DSST is a task measuring processing speed. Participants will be shown a code-key in which every digit matches a particular symbol. Then, they will be shown a symbol on the screen and participants will have to say the corresponding digit aloud, as quickly and accurately as possible. Participants are given 90 seconds to complete as many digit-symbol pairings as possible. The number of accurate pairings will be recorded, with a higher score indicating better performance. This task will be completed by showing the symbols to participants via screen sharing. | Change from baseline at 8 weeks | 
| Stroop task | Stroop task measures response inhibition or response interference control. Participants will be shown a series of word colors that are either congruent or incongruent with the color of the word itself. The participant will be asked to respond to the color of the word and not the word itself. Responses are made with the keyboard. The incongruent condition is the more difficult condition of the two. Reaction time is recorded and a cost score is calculated, with shorter cost scores indicating better performance. | Change from baseline at 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sun salutations, longitudinal, remote, cognition