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

NCT04740229 | Completed

• 1 other identifier: 21584
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Psychological

Keywords

sun salutations; longitudinal; remote; cognition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Task switching paradigm

  Change from baseline at 8 weeks

• Digit span forward and backward

  Change from baseline at 8 weeks

• Digit symbol substitution test (DSST)

  Change from baseline at 8 weeks

• Stroop task

  Change from baseline at 8 weeks

Other Outcomes (16)

• Self-Compassion

  Change from baseline at 8 weeks

• Personal optimism and self-efficacy optimism

  Change from baseline at 8 weeks

• Covid-related stress

  Change from baseline at 8 weeks

Study Arms (2)

Moderate-intensity flow-based Yoga

EXPERIMENTAL

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

Waitlist control

NO INTERVENTION

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).

Interventions

Yoga BEHAVIORAL

Moderate-intensity flow-based yoga movements, breathing, and relaxation for 50 minutes, 3 times per week, for 8 weeks

Moderate-intensity flow-based Yoga

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead

Study Sites (1)

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

Location

Related Publications (1)

• Phansikar M, Gothe N, Hernandez R, Lara-Cinisomo S, Mullen SP. Feasibility and impact of a remote moderate-intensity yoga intervention on stress and executive functioning in working adults: a randomized controlled trial. J Behav Med. 2023 Oct;46(5):720-731. doi: 10.1007/s10865-022-00385-4. Epub 2023 Feb 8.

  PMID: 36754937 DERIVED

Related Links

• Full-time working adults interested in participating in the study should fill out the interest survey at this link

MeSH Terms

Interventions

Yoga

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Sean P Mullen, PhD

  University of Illinois, Urbana-Champaign

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 5, 2021
• Study Start: February 10, 2021
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: June 6, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: We will update these records once the data has been processed and published. We hope to do so within 1 year of data collection completion per NIH guidelines.
• Access Criteria: Data will be accessible on an open site (e.g., Open Science Framework https://osf.io/) with a request to interested parties to engage with the investigative team about any publication of these data in an effort to avoid redundancy. Appropriate authorship crediting investigators involved in the parent study conceptualization, and any consultation regarding data interpretation should be sought by any researchers interested in publishing these data.

Locations

US (1)