Back to resultsYoga and Aerobic Exercise Effects on Cognition
Primary Purpose
Stress, Psychological
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sun salutations
Aerobic exercise
Seated rest
Sponsored by
About this trial
This is an interventional treatment trial for Stress, Psychological focused on measuring physical activity, walking, moderate intensity, acute intervention
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- University of Illinois at Urbana-Champaign
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Other
Arm Label
Sun salutations
Aerobic exercise
Seated rest (attentional control)
Arm Description
Sun salutations, breathing exercises, and relaxation, at a low to moderate intensity, for 30 minutes.
Walking on a treadmill at low to moderate intensity for 30 minutes.
Watching educational videos for 30 minutes.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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"). Higher scores indicate greater anxiety.
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.
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.
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.
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.
Heart Rate
Participants' heart rate will be measured using an oxymeter
Rating of Perceived Exertion
Participants are asked to self rate their feeling of exertion on a 11 point scale, ranging from 6 (no exertion) to 20 (maximal exertion), for the activity they were engaged in during the intervention.
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?' This will also include a semi-structured interview with those in the sun salutation group. For example, 'What about this activity did you find challenging?', 'To what extent did you enjoy the sun salutations activity?'
Rating of Technology Ease of Use and Usability
Participants 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.'
Full Information
NCT ID
NCT04077645
First Posted
August 22, 2019
Last Updated
April 8, 2020
Sponsor
University of Illinois at Urbana-Champaign
1. Study Identification
Unique Protocol Identification Number
NCT04077645
Brief Title
Yoga and Aerobic Exercise Effects on Cognition
Official Title
Examining the Association of Sun Salutations and Aerobic Exercise With Cognition Among Adults With Psychosocial Stress
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
March 13, 2020 (Actual)
Study Completion Date
March 13, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Urbana-Champaign
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological
Keywords
physical activity, walking, moderate intensity, acute intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sun salutations
Arm Type
Experimental
Arm Description
Sun salutations, breathing exercises, and relaxation, at a low to moderate intensity, for 30 minutes.
Arm Title
Aerobic exercise
Arm Type
Active Comparator
Arm Description
Walking on a treadmill at low to moderate intensity for 30 minutes.
Arm Title
Seated rest (attentional control)
Arm Type
Other
Arm Description
Watching educational videos for 30 minutes.
Intervention Type
Behavioral
Intervention Name(s)
Sun salutations
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Seated rest
Intervention Description
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.
Primary Outcome Measure Information:
Title
n-back task (Working memory)
Description
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.
Time Frame
Change from baseline performance on the n-back at 30 minutes
Secondary Outcome Measure Information:
Title
Trail Making test A and B (Global cognition)
Description
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.
Time Frame
Change from baseline performance at 30 minutes
Title
Digit Symbol Substitution Test (Processing Speed)
Description
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.
Time Frame
Change from baseline performance at 30 minutes
Title
State Trait Anxiety Questionnaire
Description
This questionnaire has 20 items for assessing state anxiety. Participants respond on a 4-point scale ("Not at all" to "Very much so"). Higher scores indicate greater anxiety.
Time Frame
Change from baseline performance at 30 minutes
Title
Visual Analog Scale for stress
Description
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.
Time Frame
Change from baseline performance at 30 minutes
Title
Perceived Mental Fatigue
Description
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.
Time Frame
Change from baseline performance at 30 minutes
Title
Focus of Attention
Description
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.
Time Frame
Day 1
Title
Feeling Scale
Description
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.
Time Frame
Change from baseline performance at 30 minutes
Title
Heart Rate
Description
Participants' heart rate will be measured using an oxymeter
Time Frame
Change from baseline performance at 30 minutes
Title
Rating of Perceived Exertion
Description
Participants are asked to self rate their feeling of exertion on a 11 point scale, ranging from 6 (no exertion) to 20 (maximal exertion), for the activity they were engaged in during the intervention.
Time Frame
Day 1
Title
Rating of Enjoyment and Intervention
Description
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?' This will also include a semi-structured interview with those in the sun salutation group. For example, 'What about this activity did you find challenging?', 'To what extent did you enjoy the sun salutations activity?'
Time Frame
Day 1
Title
Rating of Technology Ease of Use and Usability
Description
Participants 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.'
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean P Mullen, PhD
Organizational Affiliation
University of Illinois at Urbana-Champaign
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Madhura Phansikar, MA
Organizational Affiliation
University of Illinois at Urbana-Champaign
Official's Role
Study Director
Facility Information:
Facility Name
University of Illinois at Urbana-Champaign
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data for all primary and secondary outcome measures will be made available.
IPD Sharing Time Frame
Although this is not an NIH-funded study, we will update these records within 1 year of data collection completion per NIH guidelines.
IPD Sharing 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.
Links:
URL
http://exercisetechlab.com
Description
Exercise, Technology, and Cognition Laboratory
Learn more about this trial
Yoga and Aerobic Exercise Effects on Cognition
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