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Yoga and Aerobic Exercise Effects on Cognition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04077645
Recruitment Status : Not yet recruiting
First Posted : September 4, 2019
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
Sean Mullen, University of Illinois at Urbana-Champaign

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.

Condition or disease Intervention/treatment Phase
Stress, Psychological Behavioral: Sun salutations Behavioral: Aerobic exercise Behavioral: Seated rest Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Examining the Association of Sun Salutations and Aerobic Exercise With Cognition Among Adults With Psychosocial Stress
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sun salutations
Sun salutations, breathing exercises, and relaxation, at a low to moderate intensity, for 30 minutes.
Behavioral: Sun salutations
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.

Active Comparator: Aerobic exercise
Walking on a treadmill at low to moderate intensity for 30 minutes.
Behavioral: Aerobic exercise
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 rest (attentional control)
Watching educational videos for 30 minutes.
Behavioral: Seated rest
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 Measures :
  1. 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.


Secondary Outcome Measures :
  1. Trail Making test A and B (Global cognition) [ Time Frame: Change from baseline performance at 30 minutes ]
    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.

  2. Digit Symbol Substitution Test (Processing Speed) [ Time Frame: Change from baseline performance at 30 minutes ]
    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.

  3. State Trait Anxiety Questionnaire [ Time Frame: Change from baseline performance at 30 minutes ]
    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.

  4. Visual Analog Scale for stress [ Time Frame: Change from baseline performance at 30 minutes ]
    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.

  5. Perceived Mental Fatigue [ Time Frame: Change from baseline performance at 30 minutes ]
    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.

  6. Focus of Attention [ Time Frame: Day 1 ]
    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.

  7. Feeling Scale [ Time Frame: Change from baseline performance at 30 minutes ]
    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.

  8. Heart Rate [ Time Frame: Change from baseline performance at 30 minutes ]
    Participants' heart rate will be measured using an oxymeter

  9. Rating of Perceived Exertion [ Time Frame: Day 1 ]
    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.

  10. Rating of Enjoyment and Intervention [ Time Frame: Day 1 ]
    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?'

  11. Rating of Technology Ease of Use and Usability [ Time Frame: Day 1 ]
    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.'



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04077645


Contacts
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Contact: Sean P Mullen, PhD 217-244-4502 spmullen@illinois.edu
Contact: Madhura Phansikar, MA 217-300-7484 map7@illinois.edu

Locations
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United States, Illinois
University of Illinois at Urbana-Champaign
Urbana, Illinois, United States, 61801
Sponsors and Collaborators
University of Illinois at Urbana-Champaign
Investigators
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Principal Investigator: Sean P Mullen, PhD University of Illinois at Urbana-Champaign
Study Director: Madhura Phansikar, MA University of Illinois at Urbana-Champaign

Additional Information:
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Responsible Party: Sean Mullen, Associate Professor, University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier: NCT04077645    
Other Study ID Numbers: 20067
First Posted: September 4, 2019    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
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.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sean Mullen, University of Illinois at Urbana-Champaign:
physical activity
walking
moderate intensity
acute intervention
Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms