NCT07553546

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started May 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
May 2026Jul 2026

First Submitted

Initial submission to the registry

March 28, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 28, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2026

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

March 28, 2026

Last Update Submit

April 20, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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

    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

    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

    Measurements will be collected at baseline (month 0) and at the end of the 10th week.

Study Arms (2)

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.

Behavioral: Integrated Breathing-Myofascial Program

Interventions

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.

Breathing and progressive muscle relaxation intervention group

Eligibility Criteria

Age18 Months+
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Family Medicine Specialist

Study Record Dates

First Submitted

March 28, 2026

First Posted

April 28, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

July 15, 2026

Study Completion (Estimated)

July 15, 2026

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share