Yoga and Aerobic Exercise Effects on Cognition

Stress, Psychological Clinical Trial

Official title:

Examining the Association of Sun Salutations and Aerobic Exercise With Cognition Among Adults With Psychosocial Stress

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04077645
• Other study ID #: 20067
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: March 13, 2020

Study information

• Verified date: April 2020
• Source: University of Illinois at Urbana-Champaign
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Participants will include individuals who are currently experiencing symptoms of psychosocial stress or general anxiety.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: March 13, 2020
• Est. primary completion date: March 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stress, Psychological

Intervention

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.
• 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
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.

Locations

Country	Name	City	State
United States	University of Illinois at Urbana-Champaign	Urbana	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline performance on the n-back at 30 minutes
Secondary	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.	Change from baseline performance at 30 minutes
Secondary	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.	Change from baseline performance at 30 minutes
Secondary	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.	Change from baseline performance at 30 minutes
Secondary	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.	Change from baseline performance at 30 minutes
Secondary	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.	Change from baseline performance at 30 minutes
Secondary	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.	Day 1
Secondary	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.	Change from baseline performance at 30 minutes
Secondary	Heart Rate	Participants' heart rate will be measured using an oxymeter	Change from baseline performance at 30 minutes
Secondary	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.	Day 1
Secondary	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?'	Day 1
Secondary	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.'	Day 1

External Links

•   Exercise, Technology, and Cognition Laboratory