Stress, PsychologicalNCT04077645
Yoga and Aerobic Exercise Effects on Cognition
A study testing Sun salutations, Aerobic exercise and Seated rest in people with Stress, Psychological, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
The purpose of this acute randomized control study is to assess the feasibility of a low-to-moderate intensity Yoga intervention (i.e. sun salutations), and examine its effect on cognitive functioning, compared to engaging in aerobic activity or seated rest. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- Sun salutations, Aerobic exercise and Seated rest
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 13 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Anyone between the ages of 18-45 years
- Anyone with a score of 3 or higher on the Generalized Anxiety Disorder symptom checklist of the Diagnostic and Statistical Manual 5. That is, anyone meeting 3 or more symptoms, on more days of the week than not, for the past 6 months:
- 1. Restlessness, feeling keyed up or on edge. 2. Being easily fatigued. 3. Difficulty concentrating or mind going blank. 4. Irritability. 5. Muscle tension. 6. Sleep disturbance (difficulty falling or staying asleep, or restless, unsatisfying sleep).
- Ability to exercise at moderate to vigorous activity levels (defined as 50%-75% of the adjusted age-predicted maximum heart rate)
- Access to a smartphone and willingness to allow research staff to install a mobile activity tracker application (and space to allow for installation)
- Willingness to be randomized into one of three groups
Who cannot join
- Anyone who is physically active (≥30 minutes, 2 or more times/week, for the last 3 months) and/or a regular practitioner of Yoga or mind-body activities (≥30 minutes, 2 or more times/week, for the last 3 months).
- Anyone with serious chronic medical conditions that would preclude them from participating without a physician present, or anyone with a risk of seizure, or anyone having psychiatric and/or neurological disorders.
- Anyone who does not consent to wearing the Fitbit, or does not have a smartphone that allows us to download an app on their phone.
- Pregnant women.
- Anyone incapable of performing the following movements at a moderate intensity- sitting, standing, kicking, pulling, pushing, bending one's elbows, bending the body forward, bending one's knees, lying down and getting up.
- Anyone with blood pressure of 200/105 or more, and anyone who scores 1 or more on the Physical Activity Readiness Questionnaire
- Anyone refusing or unwilling to be randomized into either of the conditions.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Urbana-Champaign
Urbana, Illinois, 61801
About this study
Official title: Examining the Association of Sun Salutations and Aerobic Exercise With Cognition Among Adults With Psychosocial Stress
The purpose of this acute randomized control study is to assess the feasibility of a low-to-moderate intensity Yoga intervention (i.e. sun salutations), and examine its effect on cognitive functioning, compared to engaging in aerobic activity or seated rest. Participants will include individuals who are currently experiencing symptoms of psychosocial stress or general anxiety.
Read the detailed description
Eligible participants will be randomized to one of three groups: 1. Sun salutations (Yoga), 2. Aerobic exercise (walking on a treadmill), 3. Seated rest (watching educational videos). Each activity will be 30 minutes in duration. Immediately before and after the 30 minute intervention, participants will undergo psychosocial and cognitive assessments. Prior to the intervention, participant's physical activity will be tracked for one week, via a consumer grade accelerometer.
Baseline and post-intervention testing will include a cognitive battery, psychosocial questionnaires, flexibility testing and physiological measures.
- Conditions
- Stress, Psychological
- Being tested
- Sun salutations, Aerobic exercise, Seated rest
- Keywords
- physical activity, walking, moderate intensity, acute intervention
- Medical subject headings
- Stress, Psychological, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sun salutationsBehavioural
This group will be asked to participate in 25 minutes of low-to-moderate intensity Yoga. This acute session will include engaging in sun salutations, breathing exercises and relaxation. Sun salutations involves performing 10 postures in a particular sequence, and then repeating that sequence. Some of the positions include bending over and touching one's toes, and lying belly-down on the ground and pushing up from ground while arching backwards. The activity will begin as a low intensity activity for the first 5 minutes, and the intensity will be gradually increased. Participants' heart rate will be measured before and after the intervention. The intervention will be delivered by a video displayed on a tablet device. An orientation session in the beginning will familiarize participants with the activity.
Aerobic exerciseBehavioural
This group will be asked to walk on the treadmill for the same amount of time (i.e. 25 minutes) at a moderate intensity (50-70% of their maximum heart rate). Participants will receive an initial 5-minute orientation and then begin at a self-selected speed for the first 5 minutes. Heart rate will be measured and monitored by an undergraduate research assistant. Speed will be increased after 5 minutes if participants have not reached the moderate zone. If participants still have not reached the target heart rate zone by the 10-min mark, the incline of the treadmill will be increased by a 5% grade until the zone is reached.
Seated restBehavioural
This group will be watching educational videos for the same amount of time as the intervention groups. An orientation session of 5 minutes will be held in the beginning. Participants will be watching videos on general health related topics, such as healthy eating, while being seated in a quiet room, free of distractions.
| Study group | Role | What they receive |
|---|---|---|
| Sun salutations | Experimental | Sun salutations, breathing exercises, and relaxation, at a low to moderate intensity, for 30 minutes. Receives: Behavioral: Sun salutations |
| Aerobic exercise | Active comparator | Walking on a treadmill at low to moderate intensity for 30 minutes. Receives: Behavioral: Aerobic exercise |
| Seated rest (attentional control) | Other | Watching educational videos for 30 minutes. Receives: Behavioral: Seated rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
N-back Task (Working Memory)
This is a computerized task measuring the working memory domain of cognition. The task had 3 conditions, namely, 0-back, 1-back and 2-back. Participants are presented with a series of stimuli one after the other. They have to decide whether the stimulus currently presented is the same as the stimulus presented "n" items before. For the 1-back task, participants have to decide whether the stimulus matches the stimulus presented 1 earlier. For the 2- back task, they have to decide whether the stimulus matches the stimulus presented 2 earlier. Reaction time and accuracy of the response are recorded.
Measured: Change from baseline performance on the n-back at 30 minutes
Secondary outcomes (11)
Trail Making Test A and B (Global Cognition)
This is a paper pencil task having 2 parts- Trails A and Trails B, with Trails B being more complex. In Trails A, there are 25 circles on a piece of paper numbered 1-25. Participants have to join these numbers in ascending order, as quickly as they can, without lifting their pencil. In Trails B, the participants have to join 25 circles in an ascending order, but they have to alternate between numbers and letters (1-A-2-B-3-C). Time to complete the task correctly is recorded.
Measured: Change from baseline performance at 30 minutes
Digit Symbol Substitution Test (Processing Speed)
In this task, participants are presented with a code key, in which numbers 1-9 are matched with a unique symbol. Then, they are presented with a sheet of paper having a series of symbols on it. Using the codekey, participants have to read aloud, the numbers that the symbols are associated with, in 2 minutes. The accuracy is recorded.
Measured: Change from baseline performance at 30 minutes
State Trait Anxiety Questionnaire
This questionnaire has 20 items for assessing state anxiety. Participants respond on a 4-point scale ("Not at all" to "Very much so"). Composite is calculated by summing the items. Range: 20 (min) - 80 (max). Higher scores indicate greater anxiety.
Measured: Change from baseline performance at 30 minutes
Visual Analog Scale for Stress
Participants have to indicate how stressed they are currently feeling on a scale ranging from 0 (none) to 100 (as bad as it gets). Higher scores mean more stress.
Measured: Change from baseline performance at 30 minutes
Perceived Mental Fatigue
Participants self rate their present moment feelings on a scale from 1 - 5 (1=not true at all, 5=very true) yielding a mean score across all 7 items, with higher scores indicating greater mental fatigue. Range for composite score: 1 (min) - 5 (max).
Measured: Change from baseline performance at 30 minutes
Focus of Attention
Participants are asked to self rate (1 item) their focus of attention while engaged in the previous activity. Responses range from 0 (Internal thoughts) to 10 (external thoughts), with higher scores representing external focus of attention. Range: 0 (min)- 10 (max).
Measured: Day 1
Feeling Scale
This scale measures how a participant is feeling at the present moment (valence) after a bout of exercise. It is an 11-point one-item measure ranging from +5 (very good) to -5 (very bad). Higher scores represent positive affect. Range: -55 (min) to 55 (max).
Measured: Change from baseline performance at 30 minutes
Heart Rate
Participants' heart rate will be measured using an oxymeter.
Measured: Change from baseline performance at 30 minutes
Rating of Perceived Exertion
Participants are asked to self rate their feeling of exertion on a 1-item question (11 point scale), ranging from 6 (no exertion) to 20 (maximal exertion), for the activity they were engaged in during the intervention. Range: 6 (min) to 20 (max).
Measured: Day 1
Rating of Enjoyment and Intervention
Participants will rate their enjoyment in terms of the delivery method and the intervention. This will include questions such as 'Did you like the video instruction for sun salutations?', 'Would you recommend this activity to your family and friends?' Participants had a dichotomous response choice of "yes" or "no". A composite score was calculated as an average across X items. Range of the composite score: 0 to 1. A higher score indicates higher enjoyment.
Measured: Day 1
Rating of Technology Ease of Use and Usability
Participants from the yoga group only will rate the technology used to deliver the intervention, in terms of its ease of use and usability. The items are based on the Technology Acceptance Model and will include questions such as 'The Yoga video was clear and understandable.' Response ranges from 1 to 6, and a composite score is reported as an average of the responses. Range of the composite score: 1 (min) - 6 (max). Higher scores represent better technology usability.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start1 Sep 2019
- Primary completion13 Mar 2020
- Study completion13 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sean Mullen, PhD, University of Illinois at Urbana-Champaign
- Investigators
- Sean P Mullen, PhD, Principal investigator, University of Illinois at Urbana-ChampaignMadhura Phansikar, MA, Study director, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04077645
- Sponsor's protocol ID
- 20067
- Status last verified
- Aug 2025
- First submitted
- 22 Aug 2019
- Last updated
- 24 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Association of Sun Salutations and Aerobic Exercise With Cognition Among Adults With Psychosocial Stress
- ClinicalTrials.gov ID
- NCT04077645
- Acronym / sponsor ID
- 20067
- Conditions
- Stress, Psychological
- Keywords
- physical activity, walking, moderate intensity, acute intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 4 Sep 2019 (actual)
- Results
- Posted 24 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this acute randomized control study is to assess the feasibility of a low-to-moderate intensity Yoga intervention (i.e. sun salutations), and examine its effect on cognitive functioning, compared to engaging in aerobic activity or seated rest. Participants will include individuals who are currently experiencing symptoms of psychosocial stress or general anxiety.
Detailed description
Eligible participants will be randomized to one of three groups: 1. Sun salutations (Yoga), 2. Aerobic exercise (walking on a treadmill), 3. Seated rest (watching educational videos). Each activity will be 30 minutes in duration. Immediately before and after the 30 minute intervention, participants will undergo psychosocial and cognitive assessments. Prior to the intervention, participant's physical activity will be tracked for one week, via a consumer grade accelerometer.
Baseline and post-intervention testing will include a cognitive battery, psychosocial questionnaires, flexibility testing and physiological measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sun salutations | Experimental | Behavioral: Sun salutationsSun salutations, breathing exercises, and relaxation, at a low to moderate intensity, for 30 minutes. |
| Aerobic exercise | Active comparator | Behavioral: Aerobic exerciseWalking on a treadmill at low to moderate intensity for 30 minutes. |
| Seated rest (attentional control) | Other | Behavioral: Seated restWatching educational videos for 30 minutes. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Anyone between the ages of 18-45 years
- Anyone with a score of 3 or higher on the Generalized Anxiety Disorder symptom checklist of the Diagnostic and Statistical Manual 5. That is, anyone meeting 3 or more symptoms, on more days of the week than not, for the past 6 months:
- 1. Restlessness, feeling keyed up or on edge. 2. Being easily fatigued. 3. Difficulty concentrating or mind going blank. 4. Irritability. 5. Muscle tension. 6. Sleep disturbance (difficulty falling or staying asleep, or restless, unsatisfying sleep).
- Ability to exercise at moderate to vigorous activity levels (defined as 50%-75% of the adjusted age-predicted maximum heart rate)
- Access to a smartphone and willingness to allow research staff to install a mobile activity tracker application (and space to allow for installation)
Key exclusion criteria (7 listed)
- Anyone who is physically active (≥30 minutes, 2 or more times/week, for the last 3 months) and/or a regular practitioner of Yoga or mind-body activities (≥30 minutes, 2 or more times/week, for the last 3 months).
- Anyone with serious chronic medical conditions that would preclude them from participating without a physician present, or anyone with a risk of seizure, or anyone having psychiatric and/or neurological disorders.
- Anyone who does not consent to wearing the Fitbit, or does not have a smartphone that allows us to download an app on their phone.
- Pregnant women.
- Anyone incapable of performing the following movements at a moderate intensity- sitting, standing, kicking, pulling, pushing, bending one's elbows, bending the body forward, bending one's knees, lying down and getting up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sun salutationsThis group will be asked to participate in 25 minutes of low-to-moderate intensity Yoga. This acute session will include engaging in sun salutations, breathing exercises and relaxation. Sun salutations involves performing 10 postures in a particular sequence, and then repeating that sequence. Some of the positions include bending over and touching one's toes, and lying belly-down on the ground and pushing up from ground while arching backwards. The activity will begin as a low intensity activity for the first 5 minutes, and the intensity will be gradually increased. Participants' heart rate will be measured before and after the intervention. The intervention will be delivered by a video displayed on a tablet device. An orientation session in the beginning will familiarize participants with the activity. | Behavioural | Sun salutations |
| Aerobic exerciseThis group will be asked to walk on the treadmill for the same amount of time (i.e. 25 minutes) at a moderate intensity (50-70% of their maximum heart rate). Participants will receive an initial 5-minute orientation and then begin at a self-selected speed for the first 5 minutes. Heart rate will be measured and monitored by an undergraduate research assistant. Speed will be increased after 5 minutes if participants have not reached the moderate zone. If participants still have not reached the target heart rate zone by the 10-min mark, the incline of the treadmill will be increased by a 5% grade until the zone is reached. | Behavioural | Aerobic exercise |
| Seated restThis group will be watching educational videos for the same amount of time as the intervention groups. An orientation session of 5 minutes will be held in the beginning. Participants will be watching videos on general health related topics, such as healthy eating, while being seated in a quiet room, free of distractions. | Behavioural | Seated rest (attentional control) |
Primary outcome
N-back Task (Working Memory)
Time frame: Change from baseline performance on the n-back at 30 minutes
This is a computerized task measuring the working memory domain of cognition. The task had 3 conditions, namely, 0-back, 1-back and 2-back. Participants are presented with a series of stimuli one after the other. They have to decide whether the stimulus currently presented is the same as the stimulus presented "n" items before. For the 1-back task, participants have to decide whether the stimulus matches the stimulus presented 1 earlier. For the 2- back task, they have to decide whether the stimulus matches the stimulus presented 2 earlier. Reaction time and accuracy of the response are recorded.
11 secondary outcomes
Trail Making Test A and B (Global Cognition)
Time frame: Change from baseline performance at 30 minutes
Digit Symbol Substitution Test (Processing Speed)
Time frame: Change from baseline performance at 30 minutes
State Trait Anxiety Questionnaire
Time frame: Change from baseline performance at 30 minutes
Visual Analog Scale for Stress
Time frame: Change from baseline performance at 30 minutes
Perceived Mental Fatigue
Time frame: Change from baseline performance at 30 minutes
Focus of Attention
Time frame: Day 1
Feeling Scale
Time frame: Change from baseline performance at 30 minutes
Heart Rate
Time frame: Change from baseline performance at 30 minutes
Rating of Perceived Exertion
Time frame: Day 1
Rating of Enjoyment and Intervention
Time frame: Day 1
Rating of Technology Ease of Use and Usability
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Exercise, Technology, and Cognition LaboratoryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean P Mullen, PhD principal investigator
University of Illinois at Urbana-Champaign
Madhura Phansikar, MA study director
University of Illinois at Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sun salutations, Aerobic exercise and Seated rest in people with Stress, Psychological, run by University of Illinois at Urbana-Champaign at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
N-back Task (Working Memory) (time frame: Change from baseline performance on the n-back at 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.