THE EFFECT OF A BREATHING AND PROGRESSIVE MUSCLE RELAXATION PROGRAM

April 20, 2026 updated by: Lacin Aksoy, Marmara University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being between the ages of 18 and 24
  • Being male
  • Currently actively participating in an American football team
  • Volunteering to participate in the study

Exclusion Criteria:

  • Use of antiepileptic, antipsychotic, antidepressant, hormonal, or hypnotic medications Not volunteering to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Non-intervention group
Participants in the control group were informed solely through the distribution of an informational brochure.
Experimental: Breathing and progressive muscle relaxation intervention group
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.
Behavioral: Integrated Breathing-Myofascial Program
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measurements will be collected at baseline (month 0) and at the end of the 10th week.
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.
Measurements will be collected at baseline (month 0) and at the end of the 10th week.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
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.
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.
Measurements will be collected at baseline (month 0) and at the end of the 10th week.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

July 15, 2026

Study Completion (Estimated)

July 15, 2026

Study Registration Dates

First Submitted

March 28, 2026

First Submitted That Met QC Criteria

April 20, 2026

First Posted (Actual)

April 28, 2026

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • lacinaksoy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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