Healthy LifestylebreathingNCT04950387
Impact of Breathing Exercise Intervention on Breathing Sectors Engagement in Adolescent Runners During Load
A study testing Breathing exercises in people with Healthy Lifestyle, run by University of South Bohemia at 1 site in Czechia.
Trial summary
Forty-six endurance runners, 23 males (age = 16.4±1.1) and 23 females (age=16.8±1.1) participated in our study. The contribution of abdominal, thoracic, and subclavian musculature to respiration and ventilation parameters during three different intensities on a cycle ergometer was assessed pre- and post-intervention. Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Lifestyle
- What is being tested?
- Breathing exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jul 2020to 15 Mar 2021
- 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 14 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- healthy runners
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Forty-six endurance runners, 23 males (age = 16.4±1.1) and 23 females (age=16.8±1.1) participated in our study. The contribution of abdominal, thoracic, and subclavian musculature to respiration and ventilation parameters during three different intensities on a cycle ergometer was assessed pre- and post-intervention.
Read the detailed description
Subjects Forty six distance runners (14-18 years) participated in our study, 23 males (age = 16.4±1.1, height = 177.1±5.8 cm, weight = 62.4±5.8 kg) and 23 females (age = 16.8±1.1, height = 168.5±4.4 cm, weight = 55.9±4.0 kg). All participants reported a history of endur-ance running of at least six times a week for the past year. Participants were randomly al-located to an experimental group (n=23), which took part in an eight-week breathing in-tervention, or a control group (n=23), which continued training but did not carry out any breathing exercises. One participant did not complete the intervention for medical rea-sons, so was excluded from the study. The two groups, both experimental and control, followed the same training program, the only difference being that the experimental group performed breathing exercises. A randomization sequence has been generated using Randomization.org. An independent person not involved in this study made the comput-er-generated randomization sequence. The study protocol was reviewed and approved by the local Ethics Committee on October 19, 2018 (002/2018) and followed the guidelines of the World Medical Assembly Declaration of Helsinki. Written informed consent to partic-ipate was provided by guardians and verbal assessment was provided by the partici-pants.
Study design We evaluated ventilatory musculature involvement in three basic areas using a muscle dynamometer MD03 as previously described. The device is a four-channel digital muscle dynamometer that, by design, al-lows instantaneous values of muscle force to be measured in relation to time (i.e., both the force size and its dynamics can be evaluated). In general, different muscles and muscle groups on the human body can be measured. MD03 is made up of four muscle probes (we used three probes) that attach themselves to the human body with belts. The probes contain a strain transducer to a digital signal that is transmitted to a microprocessor evalua-tion unit that adjusts digital signals from the probes into a compatible form with a USB input to a notebook. Two software levels (SW1 and SW2) are part of MD03. Probe attachment sites were selected based on the kinematics of the aforementioned thoracic sectors. The first probe was placed in the lower respiratory sector on the ventral side of the level L4-5. In the middle wind sector at the level of 8.-9. ribs, on the ventral side below the sternum, a second probe was placed. A third level probe was placed in the upper respiratory sector 3.-4. ribs on the ventral side in the sternal area. Chest compression and expansion during respiration change the force applied to the individual sensors in the attached belt.
Inspiratory and expiratory forces exerted on individual probes located in the given breathing sectors were recorded for 60-sec and minute averages were determined for each probe. After 60-sec of resting data acquisition using spontaneous breathing and deep breathing, participants underwent an incremental test on a cycle ergometer (Lode, Gro-ningen, The Netherlands) and oxygen consumption, tidal volume, respiratory rate and minute ventilatory volume were continuously monitored (Metalyzer B3, Cortex, Leipzig, Germany). The testing protocol was made relative to participant body weight (i.e., W·kg-1) and began with a 4-min stage at 1 W·kg-1 followed by three, two-minute stages at progres-sive intensities (2, 3, 4 W·kg-1) and cadence was standardized to 95-100 rev·min-1. Ventilatory muscular involvement of the abdominal, thoracic, and subclavian body sectors was monitored during the last minute of each of the three submaximal intensities.
The training program lasted eight weeks. The experimental group performed breath-ing exercises daily. In the first week of the breathing intervention, training of breathing ex-ercises took place in the form of three supervised as group breathing sessions. In the following weeks, there were always two group training sessions, each last ~30 minutes. They practiced right on the schedule. On unsupervised days, participants were asked to perform exercises individually at home for at least 10 minutes. Information about the length of each individuals training session was recorded in a diary by the participant.
The set of breathing exercises was based on yoga, the aim was to activate the dia-phragm and become aware of individual breathing sectors. As such, breath training in-cluded a variety of exercises such as breathing wave training, full breathing (breathing in-to all sectors) and paced breathing (breathing in a specified rhythm). The exercises were performed in various positions, including lying down, sitting in the kneeling position, sit-ting, kneeling, and standing. All breathing was performed through the nose. At the begin-ning of the intervention, the participants breathed spontaneously, later switching to pro-longing the inspiratory and expiratory phases. They started with a 1: 1 ratio of inhale to exhale length. Gradually, the pre-exhalation and pre-exhalation phases of breath holding were included: inspiration - 6 periods, holding breath - 3 periods, exhaling - 6 periods, holding breath - 3 periods. Each of the participants adapted the exercise to their individual respiratory rate. Each of the exercises was repeated 6 times. The exercises were slow, with a deep focus on breathing, in line with the movement. Very important was the perception of the direction of movement and expansion of the chest, the behavior of the axis of the body (head, spine, pelvis), which they learned during the introductory meetings. The control group did not participate in any form of breathing training and were told to go about their lives as usual.
The follow-up testing, which was the same as the aforementioned described graded maximal test on the cycle ergometer, was performed after 8 weeks of intervention. The control group was always tested at the same time as the members of the intervention group.
- Conditions
- Healthy Lifestyle
- Being tested
- Breathing exercises
- Keywords
- breathing pattern, breathing exercise, load, adolescents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing exercisesOther
Based in yoga, common load
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Participants took part in breathing exercises Receives: Other: Breathing exercises |
| Control group | No intervention | Participant did not take part in intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Ratio of breathing sectors
pressure in particular sectors
Measured: 8 weeks
Secondary outcomes (1)
Change of ventilatory parameters
Tidal volume, respiratory rate, minute ventilatory volume
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start1 Jul 2020
- Primary completion10 Jan 2021
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy LifestyleStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Bohemia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petr Bahensky, University of South Bohemia
- Investigators
- Petr Bahenský, Principal investigator, University of South Bohemia in České Budějovice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950387
- Sponsor's protocol ID
- LzdKtvsPfJu2014
- Acronym
- breathing
- Status last verified
- Jun 2021
- First submitted
- 21 Jun 2021
- Last updated
- 6 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Breathing Exercise Intervention on Breathing Sectors Engagement in Adolescent Runners During Load
- ClinicalTrials.gov ID
- NCT04950387
- Acronym / sponsor ID
- breathing / LzdKtvsPfJu2014
- Conditions
- Healthy Lifestyle
- Keywords
- breathing pattern, breathing exercise, load, adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of South BohemiaUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 10 Jan 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 6 Jul 2021 (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.
Forty-six endurance runners, 23 males (age = 16.4±1.1) and 23 females (age=16.8±1.1) participated in our study. The contribution of abdominal, thoracic, and subclavian musculature to respiration and ventilation parameters during three different intensities on a cycle ergometer was assessed pre- and post-intervention.
Detailed description
Subjects Forty six distance runners (14-18 years) participated in our study, 23 males (age = 16.4±1.1, height = 177.1±5.8 cm, weight = 62.4±5.8 kg) and 23 females (age = 16.8±1.1, height = 168.5±4.4 cm, weight = 55.9±4.0 kg). All participants reported a history of endur-ance running of at least six times a week for the past year. Participants were randomly al-located to an experimental group (n=23), which took part in an eight-week breathing in-tervention, or a control group (n=23), which continued training but did not carry out any breathing exercises. One participant did not complete the intervention for medical rea-sons, so was excluded from the study. The two groups, both experimental and control, followed the same training program, the only difference being that the experimental group performed breathing exercises. A randomization sequence has been generated using Randomization.org. An independent person not involved in this study made the comput-er-generated randomization sequence. The study protocol was reviewed and approved by the local Ethics Committee on October 19, 2018 (002/2018) and followed the guidelines of the World Medical Assembly Declaration of Helsinki. Written informed consent to partic-ipate was provided by guardians and verbal assessment was provided by the partici-pants.
Study design We evaluated ventilatory musculature involvement in three basic areas using a muscle dynamometer MD03 as previously described. The device is a four-channel digital muscle dynamometer that, by design, al-lows instantaneous values of muscle force to be measured in relation to time (i.e., both the force size and its dynamics can be evaluated). In general, different muscles and muscle groups on the human body can be measured. MD03 is made up of four muscle probes (we used three probes) that attach themselves to the human body with belts. The probes contain a strain transducer to a digital signal that is transmitted to a microprocessor evalua-tion unit that adjusts digital signals from the probes into a compatible form with a USB input to a notebook. Two software levels (SW1 and SW2) are part of MD03. Probe attachment sites were selected based on the kinematics of the aforementioned thoracic sectors. The first probe was placed in the lower respiratory sector on the ventral side of the level L4-5. In the middle wind sector at the level of 8.-9. ribs, on the ventral side below the sternum, a second probe was placed. A third level probe was placed in the upper respiratory sector 3.-4. ribs on the ventral side in the sternal area. Chest compression and expansion during respiration change the force applied to the individual sensors in the attached belt.
Inspiratory and expiratory forces exerted on individual probes located in the given breathing sectors were recorded for 60-sec and minute averages were determined for each probe. After 60-sec of resting data acquisition using spontaneous breathing and deep breathing, participants underwent an incremental test on a cycle ergometer (Lode, Gro-ningen, The Netherlands) and oxygen consumption, tidal volume, respiratory rate and minute ventilatory volume were continuously monitored (Metalyzer B3, Cortex, Leipzig, Germany). The testing protocol was made relative to participant body weight (i.e., W·kg-1) and began with a 4-min stage at 1 W·kg-1 followed by three, two-minute stages at progres-sive intensities (2, 3, 4 W·kg-1) and cadence was standardized to 95-100 rev·min-1. Ventilatory muscular involvement of the abdominal, thoracic, and subclavian body sectors was monitored during the last minute of each of the three submaximal intensities.
The training program lasted eight weeks. The experimental group performed breath-ing exercises daily. In the first week of the breathing intervention, training of breathing ex-ercises took place in the form of three supervised as group breathing sessions. In the following weeks, there were always two group training sessions, each last ~30 minutes. They practiced right on the schedule. On unsupervised days, participants were asked to perform exercises individually at home for at least 10 minutes. Information about the length of each individuals training session was recorded in a diary by the participant.
The set of breathing exercises was based on yoga, the aim was to activate the dia-phragm and become aware of individual breathing sectors. As such, breath training in-cluded a variety of exercises such as breathing wave training, full breathing (breathing in-to all sectors) and paced breathing (breathing in a specified rhythm). The exercises were performed in various positions, including lying down, sitting in the kneeling position, sit-ting, kneeling, and standing. All breathing was performed through the nose. At the begin-ning of the intervention, the participants breathed spontaneously, later switching to pro-longing the inspiratory and expiratory phases. They started with a 1: 1 ratio of inhale to exhale length. Gradually, the pre-exhalation and pre-exhalation phases of breath holding were included: inspiration - 6 periods, holding breath - 3 periods, exhaling - 6 periods, holding breath - 3 periods. Each of the participants adapted the exercise to their individual respiratory rate. Each of the exercises was repeated 6 times. The exercises were slow, with a deep focus on breathing, in line with the movement. Very important was the perception of the direction of movement and expansion of the chest, the behavior of the axis of the body (head, spine, pelvis), which they learned during the introductory meetings. The control group did not participate in any form of breathing training and were told to go about their lives as usual.
The follow-up testing, which was the same as the aforementioned described graded maximal test on the cycle ergometer, was performed after 8 weeks of intervention. The control group was always tested at the same time as the members of the intervention group.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Breathing exercisesParticipants took part in breathing exercises |
| Control group | No intervention | –Participant did not take part in intervention |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- healthy runners
Key exclusion criteria (1 listed)
- -
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 exercisesBased in yoga, common load | Other | Experimental group |
Primary outcome
Change of Ratio of breathing sectors
Time frame: 8 weeks
pressure in particular sectors
1 secondary outcome
Change of ventilatory parameters
Time frame: 8 weeks
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 6 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Petr Bahenský principal investigator
University of South Bohemia in České Budějovice
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 exercises in people with Healthy Lifestyle, run by University of South Bohemia at 1 site in Czechia.
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 1 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 6 Jul 2021. 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 Czechia. 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?
Change of Ratio of breathing sectors (time frame: 8 weeks). 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 6 Jul 2021.