NCT06494930

Brief Summary

The study aims to investigate the effects of core stabilization exercise, which includes functional respiratory muscle training, on respiratory function, aerobic capacity, trunk stabilization, and physical performance in football players. Licensed athletes who actively engage in sports and play football will be included in the project. Volunteers included in the study will be randomly divided into two groups: study and control groups. Different methods will be used in the study for respiratory function testing, respiratory muscle strength measurement, trunk stabilization evaluation, and performance evaluation. To apply these methods, a spirometer device (according to ATS/ERS criteria with Cosmed Pony FX, Italy), portable, electronic oral pressure measurement device (with Micro Medical Micro RPM, Rochester, England), Plank and Sorenson tests will be used. A core stabilization exercise protocol including functional respiratory muscle training will be applied to the study group. The control group will only apply the same core stabilization exercise protocol as the study group. This study aims to investigate the effects of functional respiratory muscle training and to add it to the training program of athletes according to the results.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

June 2, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 10, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

July 15, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2025

Completed
Last Updated

April 17, 2025

Status Verified

April 1, 2025

Enrollment Period

5 months

First QC Date

June 2, 2024

Last Update Submit

April 14, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • İnspiratory muscle strength measurement

    The athletes' maximum inspiratory intraoral pressure (MIP) will be measured by a portable, electronic oral pressure measuring device, and the values will be recorded in cmH2O.

    6 week

  • Plank Test

    Subjects are asked to lie face down, stand on their toes with their forearms and elbows bilaterally shoulder-width apart, lift the pelvis, and form a straight line parallel to the floor with their neck, shoulders, back, hips, and legs, and the subject maintains this posture. Once the time starts, the time until the subject gets tired and/or breaks his posture is recorded in seconds.

    6 week

  • Sorenson Test

    For this test, the athlete will be laid face down with his body hanging off the bed from the anterior superior iliac spine. The athlete is asked to keep his body parallel to the ground against gravity, with his legs fixed at the gastrocnemius muscle level and his hands clasped on his chest. Partial trunk extension is allowed. When posture is impaired and/or the athlete quits the experiment due to fatigue and pain, the time is stopped and the score in seconds is recorded.

    6 week

  • Y Balance Test

    The "Y Balance Test" platform will be used to measure dynamic postural control. Each participant's leg length will be recorded in centimeters by measuring bilaterally in the supine position from the anterior superior iliac point to the distal part of the medial malleolus. Measurements will be tested barefoot, in 3 directions, with ANT reaching as the distance between the participant's central toe tip and PL and PM as the distance between the farthest point the participant can reach from the heel of the foot.

    6 week

  • Ekspiratory muscle strength measurement

    The athletes' maximum expiratory intraoral pressure (MEP) will be measured by a portable, electronic oral pressure measuring device, and the values will be recorded in cmH2O.

    6 week

Secondary Outcomes (4)

  • The forced vital capacity (FVC)

    6 week

  • The forced expiratory volume in the first second (FEV1)

    6 week

  • The forced expiratory volume in the first second to forced vital capacity (FEV1/FVC)

    6 week

  • The peak flow rate (PEF)

    6 week

Study Arms (2)

F-IMT Group

EXPERIMENTAL

Participants in this group will perform functional IMT under supervision 5 days a week. In functional IMT, the core stabilization exercise protocol will be applied at the same time as the participants practice the breathing exercise with the device.

Other: F-IMT

Control Group

ACTIVE COMPARATOR

Participants in this group will also apply a core stabilization exercise protocol under supervision 5 days a week.

Other: Core Stabilization Exercise

Interventions

F-IMTOTHER

A core stabilization exercise protocol including functional respiratory muscle training will be applied to the F-IMT group. IMT will be provided with the red Powerbreath Plus MR exercise device. Initial training intensity will be set at 50% of the MIP value measured at the athlete's first evaluation. Every two weeks, the athlete will be re-evaluated the new MIP value will be measured, and the training intensity will be adjusted to 50% of the newly measured MIP value. After the nose clip is attached, the athlete will be asked to take the device's mouthpiece into his mouth, close his lips tightly, and take a deep, fast, and powerful breath, then exhale slowly and completely with minimal effort. While the athlete does breathing exercises with the device, he will also do core stabilization exercises. Athletes will be asked to train 30 minutes daily, five days a week, for six weeks.

F-IMT Group

Only the core stabilization exercise protocol will be applied to the control group. Athletes will be asked to train 30 minutes a day, five days a week, for six weeks.

Control Group

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Professional or recreational athlete Must be approved participation Must be ability to cooperate with the exercise training and evaluation methods to be applied

You may not qualify if:

  • Have surgery within the last six months Cardiovascular or pulmonary disease Taking a break from sports

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yunus Emre TÜTÜNEKEN

Istanbul, Zeytinburnu, 34010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 2, 2024

First Posted

July 10, 2024

Study Start

July 15, 2024

Primary Completion

December 15, 2024

Study Completion

February 15, 2025

Last Updated

April 17, 2025

Record last verified: 2025-04

Locations