Breathing ExercisesNCT07553546
THE EFFECT OF A BREATHING AND PROGRESSIVE MUSCLE RELAXATION PROGRAM
A study testing Integrated Breathing-Myofascial Program in people with Breathing Exercises and PROGRESSIVE MUSCLE RELAXATION EXERCISES, run by Marmara University.
Trial summary
This non-randomized controlled study evaluates a 10-week breathing and myofascial release program in university athletes. The intervention group receives structured training, while the control group receives only an informational brochure. Read more about this study
- Who is it for?
- Ages 18 months and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Breathing Exercises, PROGRESSIVE MUSCLE RELAXATION EXERCISES, Psychological Well-being
- What is being tested?
- Integrated Breathing-Myofascial Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 15 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 months and older
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Being between the ages of 18 and 24
- Being male
- Currently actively participating in an American football team
- Volunteering to participate in the study
Who cannot join
- Use of antiepileptic, antipsychotic, antidepressant, hormonal, or hypnotic medications Not volunteering to participate in the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: THE EFFECT OF A BREATHING AND PROGRESSIVE MUSCLE RELAXATION PROGRAM ON SLEEP QUALITY AND PSYCHOLOGICAL WELL_BEING IN UNIVERSITY ATHLETES: A NON- RANDOMIZED CONTROLLED INTERVENTION STUDY
This non-randomized controlled study evaluates a 10-week breathing and myofascial release program in university athletes. The intervention group receives structured training, while the control group receives only an informational brochure.
Read the detailed description
This study is designed as an experimental intervention trial. The intervention group will consist of players from the Marmara University American Football Team, while the control group will include players from the Boğaziçi University American Football Team. The intervention will be conducted over a 10-week period and will include a total of eight sessions.
The intervention program will comprise diaphragmatic breathing techniques, including box breathing, diaphragmatic breathing, deep breathing, and vagal stimulation, as well as self-myofascial release techniques applied using a foam roller. The program has been developed through a multidisciplinary collaboration involving a physiotherapist, a specialist physician, and a coach. Adherence to the exercise program will be monitored using structured exercise diaries.
The control group will receive only an informational brochure describing the content of the training program, without any structured practical training.
- Being tested
- Integrated Breathing-Myofascial Program
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Breathing-Myofascial ProgramBehavioural
Participants in the intervention group underwent the Integrated Diaphragmatic Breathing, Vagal Stimulation, and Self-Myofascial Release Training Program (IDBVS-MRTP) over a 10-week period. The program consisted of eight sessions delivered in a hybrid format, including four face-to-face sessions, three online sessions, and one telephone follow-up.The intervention included diaphragmatic breathing techniques (box breathing, deep breathing, and vagal stimulation) and self-myofascial release exercises using a foam roller. Adherence was monitored using structured exercise diaries. The control group received only an informational brochure without structured training.
| Study group | Role | What they receive |
|---|---|---|
| Non-intervention group | No intervention | Participants in the control group were informed solely through the distribution of an informational brochure. |
| Breathing and progressive muscle relaxation intervention group | Experimental | Over a 10-week period, participants will receive eight sessions including diaphragmatic breathing techniques (box breathing, deep breathing, and vagal stimulation) as well as self-myofascial release exercises using a foam roller. Receives: Behavioral: Integrated Breathing-Myofascial Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index,
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a validated questionnaire with scores ranging from 0 to 21, where higher scores indicate worse sleep quality.
Measured: Measurements will be collected at baseline (month 0) and at the end of the 10th week.
Ryff Psychological Well-Being Scale
Psychological well-being will be measured using the Ryff Psychological Well-Being Scale. Higher scores indicate better psychological well-being.
Measured: Measurements will be collected at baseline (month 0) and at the end of the 10th week.
Secondary outcomes (3)
Correlation Between Change in Sleep Quality (PSQI Score) and Training Intensity
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Training intensity will be recorded based on weekly training frequency and duration. Correlation between changes in PSQI scores and training intensity will be analyzed.
Measured: Measurements will be collected at baseline (month 0) and at the end of the 10th week.
Correlation Between Change in Sleep Quality (PSQI Score) and Program Adherence
Program adherence will be measured as the percentage of completed intervention sessions. Sleep quality will be assessed using PSQI. Correlation analysis will be performed between adherence rate (%) and PSQI score change.
Measured: Measurements will be collected at baseline (month 0) and at the end of the 10th week.
Correlation Between Change in Psychological Well-Being (Ryff Scale) and Program Adherence
Psychological well-being will be assessed using the Ryff Psychological Well-Being Scale. Higher scores indicate better well-being. Program adherence will be recorded as a percentage. Correlation analysis will be performed.
Measured: Measurements will be collected at baseline (month 0) and at the end of the 10th week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
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 Marmara UniversityThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study is designed as an experimental intervention trial. The intervention group will consist of players from the Marmara University American Football Team, while the control group will include players from the Boğaziçi University American Football Team. The intervention will be conducted over a 10-week period and will include a total of eight sessions.The intervention program will comprise diaphragmatic breathing techniques, including box breathing, diaphragmatic breathing, deep breathing, and vagal stimulation, as well as self- myofascial release techniques applied using a foam roller. The program has been developed through a multidisciplinary collaboration involving a physiotherapist, a specialist physician, and a coach. Adherence to the exercise program will be monitored using structured exercise diaries.The control group will receive only an informational brochure describing the content of the training program, without any structured practical training.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lacin Aksoy, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553546
- Sponsor's protocol ID
- lacinaksoy
- Status last verified
- Apr 2026
- First submitted
- 28 Mar 2026
- Last updated
- 28 Apr 2026
- 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 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF A BREATHING AND PROGRESSIVE MUSCLE RELAXATION PROGRAM ON SLEEP QUALITY AND PSYCHOLOGICAL WELL_BEING IN UNIVERSITY ATHLETES: A NON- RANDOMIZED CONTROLLED INTERVENTION STUDY
- ClinicalTrials.gov ID
- NCT07553546
- Acronym / sponsor ID
- lacinaksoy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 28 Apr 2026 (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.
This non-randomized controlled study evaluates a 10-week breathing and myofascial release program in university athletes. The intervention group receives structured training, while the control group receives only an informational brochure.
Detailed description
This study is designed as an experimental intervention trial. The intervention group will consist of players from the Marmara University American Football Team, while the control group will include players from the Boğaziçi University American Football Team. The intervention will be conducted over a 10-week period and will include a total of eight sessions.
The intervention program will comprise diaphragmatic breathing techniques, including box breathing, diaphragmatic breathing, deep breathing, and vagal stimulation, as well as self-myofascial release techniques applied using a foam roller. The program has been developed through a multidisciplinary collaboration involving a physiotherapist, a specialist physician, and a coach. Adherence to the exercise program will be monitored using structured exercise diaries.
The control group will receive only an informational brochure describing the content of the training program, without any structured practical training.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is designed as an experimental intervention trial. The intervention group will consist of players from the Marmara University American Football Team, while the control group will include players from the Boğaziçi University American Football Team. The intervention will be conducted over a 10-week period and will include a total of eight sessions.The intervention program will comprise diaphragmatic breathing techniques, including box breathing, diaphragmatic breathing, deep breathing, and vagal stimulation, as well as self- myofascial release techniques applied using a foam roller. The program has been developed through a multidisciplinary collaboration involving a physiotherapist, a specialist physician, and a coach. Adherence to the exercise program will be monitored using structured exercise diaries.The control group will receive only an informational brochure describing the content of the training program, without any structured practical training.
| Arm | Type | Receives |
|---|---|---|
| Non-intervention group | No intervention | –Participants in the control group were informed solely through the distribution of an informational brochure. |
| Breathing and progressive muscle relaxation intervention group | Experimental | Behavioral: Integrated Breathing-Myofascial ProgramOver a 10-week period, participants will receive eight sessions including diaphragmatic breathing techniques (box breathing, deep breathing, and vagal stimulation) as well as self-myofascial release exercises using a foam roller. |
Who may qualify
- Ages
- 18 months and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Being between the ages of 18 and 24
- Being male
- Currently actively participating in an American football team
- Volunteering to participate in the study
Key exclusion criteria (1 listed)
- Use of antiepileptic, antipsychotic, antidepressant, hormonal, or hypnotic medications Not volunteering to participate in the study
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 |
|---|---|---|
| Integrated Breathing-Myofascial ProgramParticipants in the intervention group underwent the Integrated Diaphragmatic Breathing, Vagal Stimulation, and Self-Myofascial Release Training Program (IDBVS-MRTP) over a 10-week period. The program consisted of eight sessions delivered in a hybrid format, including four face-to-face sessions, three online sessions, and one telephone follow-up.The intervention included diaphragmatic breathing techniques (box breathing, deep breathing, and vagal stimulation) and self-myofascial release exercises using a foam roller. Adherence was monitored using structured exercise diaries. The control group received only an informational brochure without structured training. | Behavioural | Breathing and progressive muscle relaxation intervention group |
Primary outcome
Pittsburgh Sleep Quality Index,
Time frame: Measurements will be collected at baseline (month 0) and at the end of the 10th week.
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a validated questionnaire with scores ranging from 0 to 21, where higher scores indicate worse sleep quality.
Ryff Psychological Well-Being Scale
Time frame: Measurements will be collected at baseline (month 0) and at the end of the 10th week.
Psychological well-being will be measured using the Ryff Psychological Well-Being Scale. Higher scores indicate better psychological well-being.
3 secondary outcomes
Correlation Between Change in Sleep Quality (PSQI Score) and Training Intensity
Time frame: Measurements will be collected at baseline (month 0) and at the end of the 10th week.
Correlation Between Change in Sleep Quality (PSQI Score) and Program Adherence
Time frame: Measurements will be collected at baseline (month 0) and at the end of the 10th week.
Correlation Between Change in Psychological Well-Being (Ryff Scale) and Program Adherence
Time frame: Measurements will be collected at baseline (month 0) and at the end of the 10th week.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Breathing Exercises
Not yet recruiting
Effect of Box Breathing Exercise on Anxiety, Pain, and Pulmonary Function Tests in Patients Undergoing Colonoscopy
Colonoscopy
Not yet recruiting
Home-Based Respiratory Muscle Training and Aerobic Exercise Programs to Improve Lung Health in Current and Former Cigarette Smokers
Lung Carcinoma
Active, not recruiting
Diaphragm Mobilization in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Not yet recruiting
Comparison of Functional Inspiratory Muscle Training and Combined Exercise Training in Individuals With Type 2 Diabetes
Type 2 Diabetes Mellitus
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.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Breathing-Myofascial Program in people with Breathing Exercises and PROGRESSIVE MUSCLE RELAXATION EXERCISES, run by Marmara University.
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 4 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: opening soon, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact lacin aksoy (00905543969627, drlacinaksoy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index, (time frame: Measurements will be collected at baseline (month 0) and at the end of the 10th week.). The study lists 2 primary outcomes in all. 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 28 Apr 2026.