NCT04077645

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2020

Completed
5.5 years until next milestone

Results Posted

Study results publicly available

August 24, 2025

Completed
Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

6 months

First QC Date

August 22, 2019

Results QC Date

August 24, 2022

Last Update Submit

August 21, 2025

Conditions

Keywords

physical activitywalkingmoderate intensityacute intervention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Trail Making Test A and B (Global Cognition)

    Change from baseline performance at 30 minutes

  • Digit Symbol Substitution Test (Processing Speed)

    Change from baseline performance at 30 minutes

  • State Trait Anxiety Questionnaire

    Change from baseline performance at 30 minutes

  • Visual Analog Scale for Stress

    Change from baseline performance at 30 minutes

  • Perceived Mental Fatigue

    Change from baseline performance at 30 minutes

  • +6 more secondary outcomes

Study Arms (3)

Sun salutations

EXPERIMENTAL

Sun salutations, breathing exercises, and relaxation, at a low to moderate intensity, for 30 minutes.

Behavioral: Sun salutations

Aerobic exercise

ACTIVE COMPARATOR

Walking on a treadmill at low to moderate intensity for 30 minutes.

Behavioral: Aerobic exercise

Seated rest (attentional control)

OTHER

Watching educational videos for 30 minutes.

Behavioral: Seated rest

Interventions

Sun salutationsBEHAVIORAL

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.

Sun salutations

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.

Aerobic exercise
Seated restBEHAVIORAL

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.

Seated rest (attentional control)

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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:
  • \. 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

Location

Related Links

MeSH Terms

Conditions

Stress, PsychologicalMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Dr. Sean P Mullen
Organization
University of Illinois Urbana Champaign

Study Officials

  • Sean P Mullen, PhD

    University of Illinois at Urbana-Champaign

    PRINCIPAL INVESTIGATOR
  • Madhura Phansikar, MA

    University of Illinois at Urbana-Champaign

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 22, 2019

First Posted

September 4, 2019

Study Start

September 1, 2019

Primary Completion

March 13, 2020

Study Completion

March 13, 2020

Last Updated

August 24, 2025

Results First Posted

August 24, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

De-identified individual participant data for all primary and secondary outcome measures will be made available.

Shared Documents
STUDY PROTOCOL, SAP, ICF, 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.

Locations