Breathing ExercisesNCT06121596
Relaxation Effects of Personalized Breathing Exercises for Healthy College Students
A study testing Breathing Exercise in people with Breathing Exercises, run by Technical University of Munich at 1 site in Germany.
Trial summary
Stress plays a major role in the etiology and pathogenesis of anxiety and depression. Relaxation therapies, such as breathing exercises, can reduce stress and increase relaxation. This study has two aims. First, it aims to personalize and optimize breathing protocols. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breathing Exercises
- What is being tested?
- Breathing Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteGermany
- Study dates
- 31 Jul 2023to 27 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Above 18 years old
- University student
- Native German speaker
Who cannot join
- Any psychiatric (e.g., anxiety), neurologic (e.g., epilepsy) or cardio-pulmonary (e.g., asthma) diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relaxation Effects of Personalized Breathing Exercises for Healthy College Students: a Randomized Crossover Trial
Stress plays a major role in the etiology and pathogenesis of anxiety and depression. Relaxation therapies, such as breathing exercises, can reduce stress and increase relaxation.
This study has two aims. First, it aims to personalize and optimize breathing protocols. Second, it aims to tailor breathing protocols to subgroups based on prediction models of expected efficacy.
Read more
Three different breathing protocols, varying solely in their instructed breathing frequency with 40 percent (A), 60 percent (B), and 80 percent (C) of the interindividual spontaneous breathing frequency, are tested in a randomized, counterbalanced crossover trial. Other parameters, such as breathing quality (i.e., nasal and diaphragmatic), rhythm (i.e., prolonged exhalation without instructed pauses) and depth (i.e., increased depth due to slower breathing frequency) as well as contextual factors (e.g., posture, video-based instructions, type of pacer, etc.) are invariant between protocols.
First, this study hypothesizes a difference in the relaxation response between breathing protocols A, B, and C. This study looks at the relaxation response from three different angles (1) self-report, (2) autonomic arousal, and (3) central nervous system arousal. Second, this study explores prediction models of expected efficacy based on the interindividual variance in characteristics (i.e., depressive, anxious and stress symptoms as well as expertise in relaxation therapies) and biomarkers (e.g., heart rate variability, peripheral temperature, skin conductance, etc.). Prediction models can tailor breathing protocols to subgroups to increase expected efficacy.
- Conditions
- Breathing Exercises
- Being tested
- Breathing Exercise
- Keywords
- Relaxation therapy, Stress-management, Breathing exercise, Stress, Anxiety, Depression
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing ExerciseBehavioural
A breathing exercise is a relaxation technique (or therapy) to increase relaxation (induces a relaxation response) and decrease stress (reduces a stress response).
| Study group | Role | What they receive |
|---|---|---|
| Breathing Exercise with 40 Percent of the Spontaneous Breathing Frequency (A) | Experimental | Participants are instructed (via visual pacer) to reduce their breathing frequency to 40 percent of their spontaneous breathing frequency for a period of five minutes. In advance, participants are instructed (via pre-recorded video) to breathe nasally (if possible) and abdominally, with a prolonged exhalation (inspiration-to-expiration ratio is 1-to-2 - also instructed via visual pacer) during the breathing exercise. Receives: Behavioral: Breathing Exercise |
| Breathing Exercise with 60 Percent of the Spontaneous Breathing Frequency (B) | Experimental | Participants are instructed (via visual pacer) to reduce their breathing frequency to 60 percent of their spontaneous breathing frequency for a period of five minutes. In advance, participants are instructed (via pre-recorded video) to breathe nasally (if possible) and abdominally, with a prolonged exhalation (inspiration-to-expiration ratio is 1-to-2 - also instructed via visual pacer) during the breathing exercise. Receives: Behavioral: Breathing Exercise |
| Breathing Exercise with 80 Percent of the Spontaneous Breathing Frequency (C) | Experimental | Participants are instructed (via visual pacer) to reduce their breathing frequency to 80 percent of their spontaneous breathing frequency for a period of five minutes. In advance, participants are instructed (via pre-recorded video) to breathe nasally (if possible) and abdominally, with a prolonged exhalation (inspiration-to-expiration ratio is 1-to-2 - also instructed via visual pacer) during the breathing exercise. Receives: Behavioral: Breathing Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relaxation Sum Score
Measured with the German Version of the Relaxation State Questionnaire; Sum scores range from 10 to 50 (higher scores indicate greater relaxation).
Measured: Immediately after each 5-minute breathing exercise
Secondary outcomes (5)
Current Perceived Stress Level
Measured on a visual analog scale ranging from 0 to 100, where zero is absolutely no stress and 100 is extreme stress.
Measured: Immediately after each 5-minute breathing exercise
Heart Rate Variability
Measured via blood volume pulse with a finger clip on the middle finger
Measured: During each 5-minute breathing exercise
Peripheral Temperature
Measured via temperature sensor on the small finger
Measured: During each 5-minute breathing exercise
Skin Conductance
Measured via skin conductance sensor on the index and ring finger
Measured: During each 5-minute breathing exercise
Power in Frequency Bands
Measured via four channel EEG with linked earlobe reference and active electrode placement on F3, F4, F7, and F8 according to the international 10-20 system
Measured: During each 5-minute breathing exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start31 Jul 2023
- Primary completion27 Nov 2023
- Study completion27 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breathing ExercisesStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lukas Moebus, Technical University of Munich
- Investigators
- Lukas Moebus, M.Sc., Principal investigator, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06121596
- Sponsor's protocol ID
- P-BP-40-60-80-RCT
- Status last verified
- Mar 2025
- First submitted
- 10 Aug 2023
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relaxation Effects of Personalized Breathing Exercises for Healthy College Students: a Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT06121596
- Acronym / sponsor ID
- P-BP-40-60-80-RCT
- Conditions
- Breathing Exercises
- Keywords
- Relaxation therapy, Stress-management, Breathing exercise, Stress, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 27 Nov 2023 (actual)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stress plays a major role in the etiology and pathogenesis of anxiety and depression. Relaxation therapies, such as breathing exercises, can reduce stress and increase relaxation.
This study has two aims. First, it aims to personalize and optimize breathing protocols. Second, it aims to tailor breathing protocols to subgroups based on prediction models of expected efficacy.
Three different breathing protocols, varying solely in their instructed breathing frequency with 40 percent (A), 60 percent (B), and 80 percent (C) of the interindividual spontaneous breathing frequency, are tested in a randomized, counterbalanced crossover trial. Other parameters, such as breathing quality (i.e., nasal and diaphragmatic), rhythm (i.e., prolonged exhalation without instructed pauses) and depth (i.e., increased depth due to slower breathing frequency) as well as contextual factors (e.g., posture, video-based instructions, type of pacer, etc.) are invariant between protocols.
First, this study hypothesizes a difference in the relaxation response between breathing protocols A, B, and C. This study looks at the relaxation response from three different angles (1) self-report, (2) autonomic arousal, and (3) central nervous system arousal. Second, this study explores prediction models of expected efficacy based on the interindividual variance in characteristics (i.e., depressive, anxious and stress symptoms as well as expertise in relaxation therapies) and biomarkers (e.g., heart rate variability, peripheral temperature, skin conductance, etc.). Prediction models can tailor breathing protocols to subgroups to increase expected efficacy.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breathing Exercise with 40 Percent of the Spontaneous Breathing Frequency (A) | Experimental | Behavioral: Breathing ExerciseParticipants are instructed (via visual pacer) to reduce their breathing frequency to 40 percent of their spontaneous breathing frequency for a period of five minutes. In advance, participants are instructed (via pre-recorded video) to breathe nasally (if possible) and abdominally, with a prolonged exhalation (inspiration-to-expiration ratio is 1-to-2 - also instructed via visual pacer) during the breathing exercise. |
| Breathing Exercise with 60 Percent of the Spontaneous Breathing Frequency (B) | Experimental | Behavioral: Breathing ExerciseParticipants are instructed (via visual pacer) to reduce their breathing frequency to 60 percent of their spontaneous breathing frequency for a period of five minutes. In advance, participants are instructed (via pre-recorded video) to breathe nasally (if possible) and abdominally, with a prolonged exhalation (inspiration-to-expiration ratio is 1-to-2 - also instructed via visual pacer) during the breathing exercise. |
| Breathing Exercise with 80 Percent of the Spontaneous Breathing Frequency (C) | Experimental | Behavioral: Breathing ExerciseParticipants are instructed (via visual pacer) to reduce their breathing frequency to 80 percent of their spontaneous breathing frequency for a period of five minutes. In advance, participants are instructed (via pre-recorded video) to breathe nasally (if possible) and abdominally, with a prolonged exhalation (inspiration-to-expiration ratio is 1-to-2 - also instructed via visual pacer) during the breathing exercise. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Above 18 years old
- University student
- Native German speaker
Key exclusion criteria (1 listed)
- Any psychiatric (e.g., anxiety), neurologic (e.g., epilepsy) or cardio-pulmonary (e.g., asthma) diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathing ExerciseA breathing exercise is a relaxation technique (or therapy) to increase relaxation (induces a relaxation response) and decrease stress (reduces a stress response). | Behavioural | Breathing Exercise with 40 Percent of the Spontaneous Breathing Frequency (A), Breathing Exercise with 60 Percent of the Spontaneous Breathing Frequency (B), Breathing Exercise with 80 Percent of the Spontaneous Breathing Frequency (C) |
Primary outcome
Relaxation Sum Score
Time frame: Immediately after each 5-minute breathing exercise
Measured with the German Version of the Relaxation State Questionnaire; Sum scores range from 10 to 50 (higher scores indicate greater relaxation).
5 secondary outcomes
Current Perceived Stress Level
Time frame: Immediately after each 5-minute breathing exercise
Heart Rate Variability
Time frame: During each 5-minute breathing exercise
Peripheral Temperature
Time frame: During each 5-minute breathing exercise
Skin Conductance
Time frame: During each 5-minute breathing exercise
Power in Frequency Bands
Time frame: During each 5-minute breathing exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lukas Moebus, M.Sc. principal investigator
Technical University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing Exercise in people with Breathing Exercises, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relaxation Sum Score (time frame: Immediately after each 5-minute breathing exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.