- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07379606
Effects of Moderate Exercise and Cyclic Sighing on Stress, Cognition and Physiological Markers in Young Adults
A Comparison of Psychophysiological Effects Between Relaxation Techniques and Physical Exercise in Young Adults
This study investigates the effects of moderate physical exercise and cyclic sighing (breathing training) on stress, cognition, and physiological markers in young adults. It is a randomized cross-over trial with two interventions. Each participant will take part in two intervention sessions:
- Moderate-intensity physical activity (PA): 15 minutes of stationary cycling at 65-75% of maximum heart rate (HRmax).
- Breathing training (CS): 15 minutes of cyclic sighing, a technique involving inhaling, pausing briefly, taking a deeper breath, and exhaling slowly.
A one-week washout period between sessions is planned to minimise carry-over effects and to ensure participants' physiological state is similar before the next session. During this week, participants will wear Polar Ignite wrist-worn devices to monitor physical activity and sleep.
A total of 30 participants (you adults) will be enrolled.
Measurements performed before and after each intervention include:
- EEG using Emotiv EPOC Flex Gel (32-channel device): 2 minutes with eyes open, 2 minutes with eyes closed, during the interventions, and while performing cognitive test (N-back).
- Heart rate variability (HRV) using the Polar H10 sensor.
- SUDS - Subjective Units of Disress Scale for perceived stress.
- N-back test for cognitive performance using Emotiv App.
- Blood pressure (systolic and diastolic) and heart rate.
- Pain threshold measured with a dolorimeter.
- PANAS-SF - Positive and Negative Affect Schedule.
Baseline questionnaires completed by participants the day before the study:
- PSS-10 - Perceived Stress Scale (Cohen, Kamarck, Mermelstein).
- MAAS - Mindful Attention Awareness Scale
- Psychological well-being - short version
- Mini-COPE - Coping with Stress Inventory
- Sleep quality and average sleep duration
- Chronotype questionnaire (morningness-eveningness)
- GPAQ - Global Physical Activity Questionnaire
- Pittsburgh Sleep Quality Index
The study aims to understand how brief interventions like moderate exercise and breathing techniques affect stress, cognitive performance, and physiological responses in young adults.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jóźwiak
- Phone Number: (61) 835 53 49
- Email: b.jozwiak@awf.poznan.pl
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- male or female participants,
- age 18-35,
- without chronic somatic diseases,
- no current episode of psychiatric disorder (no active depression, mania, or psychosis),
- regular sleep schedule in the week prior to the study,
- not taking psychotropic drugs or medications,
- non-smoker,
- not working nightshifts.
Exclusion Criteria:
- consumption of alcohol or psychoactive substances the day before or on the day of the study,
- intense physical activity less than 2 hours before the study,
- consuming coffee, black tee, energy drinks less than 2 hours before the study,
- contraindications to moderate-intensity physical activity on cycle ergometer (e.g., recent injuries),
- contraindications to EEG (e.g., scalp skin conditions preventing proper electrode placement, hypersensitivity to conductive gels or pastes).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Moderate-Intensity Physical Activity (PA)
Participants perform 15 minutes of stationary cycling at moderate intensity.
|
Participants perform 15 minutes of stationary cycling at moderate intensity.
|
|
Experimental: Breathing Training - Cyclic Sighing (CS)
Participants perform 15 minutes of cyclic sighing.
|
Participants perform 15 minutes of cyclic sighing (a breathing technique).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean EEG spectral power in theta, alpha, low beta, high beta, gamma frequency bands during resting-state (eyes-open and eyes-closed)
Time Frame: Baseline: immediately before intervention; Post-intervention: immediately after completion of the intervention period
|
Mean spectral power in theta, alpha, low beta, high beta, and gamma frequency bands derived from resting-state EEG recordings collected during eyes-open and eyes-closed conditions.
Spectral power will be calculated separately for eyes-open and eyes-closed resting-state conditions.
|
Baseline: immediately before intervention; Post-intervention: immediately after completion of the intervention period
|
|
Heart Rate Variability (HRV)
Time Frame: Baseline (average over 5-minute resting-state immediately before intervention); During intervention (average over entire session, periprocedural); Post-intervention (average over 5-minute resting-state immediately after intervention).
|
HRV will be recorded at three time points.
Baseline HRV will be calculated as the average over a 5-minute resting-state period immediately before intervention.
HRV during the intervention will be calculated as the average over the entire intervention session (periprocedural).
Post-intervention HRV will be calculated as the average over a 5-minute resting-state period immediately after intervention.
|
Baseline (average over 5-minute resting-state immediately before intervention); During intervention (average over entire session, periprocedural); Post-intervention (average over 5-minute resting-state immediately after intervention).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean EEG spectral power in theta, alpha, low beta, high beta, and gamma frequency bands during N-back task
Time Frame: Baseline (during N-back task immediately before each intervention session, periprocedural); Post-intervention (during N-back task immediately after each intervention session, periprocedural)
|
Mean spectral power in theta, alpha, low beta, high beta, and gamma frequency bands derived from EEG recordings collected during performance of the N-back cognitive task.
Spectral power will be calculated separately for each frequency band and averaged across all EEG channels.
|
Baseline (during N-back task immediately before each intervention session, periprocedural); Post-intervention (during N-back task immediately after each intervention session, periprocedural)
|
|
Mean EEG spectral power in theta, alpha, low beta, high beta, and gamma frequency bands during intervention session
Time Frame: During intervention session (periprocedural, averaged over entire session)
|
Mean spectral power in theta, alpha, low beta, high beta, and gamma frequency bands derived from EEG recordings collected during the intervention session.
Spectral power will be calculated separately for each frequency band and averaged across all EEG channels.
|
During intervention session (periprocedural, averaged over entire session)
|
|
Perceived Stress measured with the Subjective Units of Distress Scale (SUDS)
Time Frame: Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session
|
Participants rate their perceived stress using the Subjective Units of Distress Scale (SUDS), a self-reported scale ranging from 0 (no stress) to 100 (extreme stress), where higher scores indicate higher perceived stress.
|
Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session
|
|
Cognitive Performance (N-back)
Time Frame: Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session
|
Working memory assessed using N-back test with Emotiv app.
|
Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session
|
|
Blood Pressure
Time Frame: Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session
|
Systolic and diastolic blood pressure measured using standard protocols.
|
Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session
|
|
Pain Threshold
Time Frame: Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session
|
Pain threshold measured using a dolorimeter (algorimeter)
|
Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session
|
|
Positive and Negative Affect measured with the Positive and Negative Affect Schedule - Short Form (PANAS-SF)
Time Frame: Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session
|
Participants complete the Positive and Negative Affect Schedule - Short Form (PANAS-SF), a self-reported scale assessing positive and negative affect.
Each subscale contains 10 items rated from 1 (very slightly or not at all) to 5 (extremely), giving a possible score range of 10-50 for each subscale.
Higher scores indicate higher levels of positive or negative affect, depending on the subscale.
|
Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session
|
|
Heart Rate
Time Frame: Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session
|
Heart rate measured using standard protocols.
|
Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychological Well-Being measured with the Short Version of Ryff's Psychological Well-Being Scale
Time Frame: Day before first intervention.
|
Participants complete the Short Version of Ryff's Psychological Well-Being Scale, a self-reported questionnaire assessing psychological well-being across multiple dimensions.
Items are rated on a scale from 1 (strongly disagree) to 6 (strongly agree), giving a total possible score range of 18-108, where higher scores indicate higher levels of psychological well-being.
|
Day before first intervention.
|
|
Trait Mindfulness measured with the Mindful Attention Awareness Scale (MAAS)
Time Frame: Day before first intervention.
|
Participants complete the Mindful Attention Awareness Scale (MAAS), a self-reported questionnaire measuring trait mindfulness.
Items are rated on a scale from 1 (almost always) to 6 (almost never), with total scores ranging from 15 to 90.
Higher scores indicate higher levels of trait mindfulness.
|
Day before first intervention.
|
|
Coping with Stress measured with the Brief COPE Inventory (mini-COPE)
Time Frame: Day before first intervention.
|
Participants complete the Brief COPE Inventory (mini-COPE), a self-reported questionnaire assessing coping strategies and stress management.
Each item is rated on a scale from 1 (I haven't been doing this at all) to 4 (I've been doing this a lot), with total subscale scores ranging from 2 to 8, depending on the subscale.
Higher scores indicate greater use of the specific coping strategy.
|
Day before first intervention.
|
|
Chronotype measured with the Morningness-Eveningness Questionnaire (MEQ)
Time Frame: Day before first intervention.
|
Participants complete the Morningness-Eveningness Questionnaire (MEQ) to assess chronotype, indicating morningness-eveningness preference.
Items are scored to give a total score ranging from 16 to 86, where higher scores indicate greater morningness and lower scores indicate greater eveningness.
|
Day before first intervention.
|
|
Global Physical Activity measured with the Global Physical Activity Questionnaire (GPAQ)
Time Frame: Day before first session.
|
Participants complete the Global Physical Activity Questionnaire (GPAQ) to assess baseline physical activity levels.
Responses are used to calculate total physical activity expressed in MET-minutes per week, with higher scores indicating higher levels of physical activity.
|
Day before first session.
|
|
Sleep Quality and Duration (Pittsburgh Sleep Quality Index)
Time Frame: Day before first session.
|
Participants complete the Pittsburgh Sleep Quality Index (PSQI) to assess sleep quality and average sleep duration.
|
Day before first session.
|
|
Objective Sleep and Physical Activity (Polar Ignite)
Time Frame: During the 1-week washout period between intervention sessions.
|
Participants wear Polar Ignite wrist-worn devices to monitor sleep quality and duration, as well as daily physical activity levels.
|
During the 1-week washout period between intervention sessions.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 716/25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stress
-
Massachusetts General HospitalCompletedStress | Emotional Stress | Psychological Stress | Social Stress | Life StressUnited States
-
Center for Advanced Facial Plastic SurgeryCompletedStress | Stress, Physiological | Stress Response | Stress (Psychology) | Healthy Adult Female Participants | Stress, Psychologic | Stress Perception | Stress Levels | Stress, Psychological CumulativeUnited States
-
Amsterdam UMC, location VUmcRigshospitalet, Denmark; Universitätsklinikum Hamburg-EppendorfNot yet recruitingStress | Stress and Burnout | Stress BiomarkersGermany, Denmark
-
University of California, Los AngelesUniversity of California, San Francisco; Stanford University; California Initiative...CompletedStress | Stress, Psychological | Stress, Emotional | Stress, Physiological | Stress ReactionUnited States
-
Canterbury Christ Church UniversitySussex Partnership NHS Foundation TrustEnrolling by invitationOccupational Stress or Workplace StressUnited Kingdom
-
University of PadovaCompletedStress | Stress Disorder | Work Related StressItaly
-
Amasya UniversityCompletedThe Effect of Online Stress Management Program on Nurses' Individual Workload Perception, and StressStress | Nursing | Stress ManagementTurkey (Türkiye)
-
University of Thi-QarCompletedPsychological Stress | Academic StressIraq
-
University of North Carolina, Chapel HillWashington University School of Medicine; United States Department of Defense; University of Florida and other collaboratorsRecruitingPost-traumatic Stress Disorder | Acute Stress Disorder | Acute Stress ReactionUnited States
-
K.G. Razumovsky Moscow State University of Technologies...RecruitingStress | Stress (Psychology)Russia
Clinical Trials on Moderate-Intensity Physical Activity (PA)
-
Anne Birgitte RabenUniversity of Nottingham; University of Helsinki; Wageningen University; University... and other collaboratorsCompletedObesity | Pre-diabetesSpain, Denmark, Australia, Bulgaria, Finland, Netherlands, New Zealand, United Kingdom
-
Brown UniversityNational Institute on Aging (NIA)Active, not recruitingPhysical InactivityUnited States
-
Western University, CanadaEast Elgin Family Health TeamRecruiting
-
Hasselt UniversityNot yet recruitingHealthy Adult ParticipantsBelgium
-
George MakrydimasRecruiting
-
University of Vic - Central University of CataloniaIRIS-CC; AGAURActive, not recruitingMental Health IssueSpain
-
University of GuadalajaraCompleted
-
University of Sao PauloUnknownSedentary LifestyleBrazil
-
Riphah International UniversityCompletedQuality of Life | AnemiaPakistan
-
University GhentCompleted