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
|Condition or disease||Intervention/treatment||Phase|
|Stress, Psychological||Behavioral: Sun salutations Behavioral: Aerobic exercise Behavioral: Seated rest||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Heart Rate [ Time Frame: Change from baseline performance at 30 minutes ]Participants' heart rate will be measured using an oxymeter
- 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.
- 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?'
- 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.'
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
|Contact: Sean P Mullen, PhDemail@example.com|
|Contact: Madhura Phansikar, MAfirstname.lastname@example.org|
|United States, Illinois|
|University of Illinois at Urbana-Champaign|
|Urbana, Illinois, United States, 61801|
|Principal Investigator:||Sean P Mullen, PhD||University of Illinois at Urbana-Champaign|
|Study Director:||Madhura Phansikar, MA||University of Illinois at Urbana-Champaign|