Clinical trial NCT04077645: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Keywords: physical activity
walking
moderate intensity
acute intervention
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2019-09-04
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: n-back task (Working memory)
timeFrame: Change from baseline performance on the n-back at 30 minutes
Secondary outcomes:
measure: Trail Making test A and B (Global cognition)
timeFrame: Change from baseline performance at 30 minutes
measure: Digit Symbol Substitution Test (Processing Speed)
timeFrame: Change from baseline performance at 30 minutes
measure: State Trait Anxiety Questionnaire
timeFrame: Change from baseline performance at 30 minutes
measure: Visual Analog Scale for stress
timeFrame: Change from baseline performance at 30 minutes
measure: Perceived Mental Fatigue
timeFrame: Change from baseline performance at 30 minutes
measure: Focus of Attention
timeFrame: Day 1
measure: Feeling Scale
timeFrame: Change from baseline performance at 30 minutes
measure: Heart Rate
timeFrame: Change from baseline performance at 30 minutes
measure: Rating of Perceived Exertion
timeFrame: Day 1
measure: Rating of Enjoyment and Intervention
timeFrame: Day 1
measure: Rating of Technology Ease of Use and Usability
timeFrame: Day 1
Other outcomes:
Locations:
city: Urbana
country: United States
facility: University of Illinois at Urbana-Champaign
state: Illinois
Study officials:
affiliation: University of Illinois at Urbana-Champaign
name: Sean P Mullen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Illinois at Urbana-Champaign
name: Madhura Phansikar, MA
role: STUDY_DIRECTOR
References: