Effects of Inspiratory Muscle Training Combined With Circadian Rhythm-based Running Programs in Children Male Football Players

NCT07170891 | Completed DMC

• 1 other identifier: E-95674917-108.99-282503
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, a parallel two-group pre-test-post-test randomized controlled trial was conducted according to CONSORT guidelines. All participants and their parents were given detailed information about the study before it commenced, and written informed consent was obtained in accordance with the ethical principles described in the Declaration of Helsinki. Help was received from a third-level athletics coach for planning and implementing running exercises to be used in the project. The study was designed according to the rules of the Declaration of Helsinki and approved by the ethics committee for scientific research of Gümüşhane University (at its meeting on 20.09.2024 and number 2024/7; decision number E-95674917-108.99-282503). The aim of this study is to investigate the effects of additional inspiratory muscle training (IMT) on exercise tolerance, agility performance, and respiratory parameters in 10-12-year-old male football players who have been training regularly for at least two years, based on their chronotype. A power analysis was conducted using G\*Power 3.1 to determine the sample size of the study. The effect size (d) was found to be 1.12 (α = 0.05, 1-β = 0.95, η²p = 0.8). Based on this analysis, it was determined that a minimum of 20 participants per group was required. However, to mitigate potential issues, it was decided to include 25 participants, an additional 25%, in each group. Participants visited the laboratory three times. During the first visit, the familiarization procedure was performed; participants were administered the Morningness-Eveningness Scale for Children questionnaire and divided into 3 groups according to the results. Then, pulmonary function tests (PFT), maximum inspiratory pressure (MIP), expiratory pressure (MEP), six-minute walk test (6MWT), inspiratory muscle training (IMT), and running training procedures were applied. In the second visit, PFT and MIP-MEP tests, agility and 6MWT tests were performed and their performances were recorded. After the six-week training period, participants' final measurements were taken at the third and final visit. Subsequent to the completion of the six-week training period, the participants' final measurements were obtained during the final visit. The experimental trials were conducted at a consistent time each day, between 9:00 and 12:00. Prior to the commencement of the trials, participants were instructed to abstain from high-intensity physical activity. The inclusion criteria were as follows: a) Candidates must have at least two years of active football training, b) be between the ages of 10 and 13, c) be in good general health, d) have no known respiratory or cardiovascular conditions, e) provide written informed parental consent. The following criteria were used to determine exclusion from the study: The subject's medical history includes the following: a) A history of lung disease or a current upper respiratory tract infection, b) A history of current injury, c) Medication use that may affect breathing or performance, d)Individuals with FEV1/FVC\<70 e) Participation in similar studies within the last six months

Conditions

10-13 Age; Inspiratory Muscle Training; Running; Circadian Rhythm

Keywords

football players; exercise; agility; running training; circadian rhythm; inspiratory muscle training; performance; Children

Outcome Measures

Primary Outcomes (2)

• Agility (505 Agility Test)

  Agility (505 Agility Test): Change from baseline to 8 weeks.

  8 weeks.

• 6-Minute Walk Test (6MWT)

  6-Minute Walk Test (6MWT): Change from baseline to 8 weeks.

  8 weeks.

Secondary Outcomes (2)

• Respiratory Muscle Strength

  8 weeks.

• Pulmonary Function

  8 weeks.

Study Arms (3)

CONTROL

ACTIVE COMPARATOR

no exercise group

Other: Control

MORNİNG RUNNİNG+IMT

ACTIVE COMPARATOR

Inspiratory muscle training was performed in addition to morning running

Device: Morning Running and IMT

EVENİNG RUNİNG+IMT

ACTIVE COMPARATOR

Inspiratory muscle training was performed in addition to evening running

Device: Inspiratory muscle training and evening running

Interventions

Morning Running and IMT DEVICE

Inspiratory muscle training was performed in addition to morning running

MORNİNG RUNNİNG+IMT

Inspiratory muscle training and evening running DEVICE

Inspiratory muscle training was performed in addition to evening running

EVENİNG RUNİNG+IMT

Control OTHER

non-exercise group

CONTROL

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Candidates must have at least two years of active football training
• be between the ages of 10 and 13,
• be in good general health
• have no known respiratory or cardiovascular conditions,
• provide written informed parental consent.

You may not qualify if:

• A history of lung disease or a current upper respiratory tract infection,
• A history of current injury,
• Medication use that may affect breathing or performance,
• Individuals with FEV1/FVC\<70
• Participation in similar studies within the last six months

Sponsors & Collaborators

• Gümüşhane Universıty: lead

Study Sites (1)

Gumushane Univetsity

Kelkit, Gümüşhane Province, 29600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOC. PROF.

Model Details: In this study, a parallel two-group pre-test-post-test randomized controlled trial was conducted according to CONSORT guidelines \[14\]. All participants and their parents were given detailed information about the study before it commenced, and written informed consent was obtained in accordance with the ethical principles described in the Declaration of Helsinki. Help was received from a third-level athletics coach for planning and implementing running exercises to be used in the project. The aim of this study is to investigate the effects of additional inspiratory muscle training (IMT) on exercise tolerance, agility performance, and respiratory parameters in 10-12-year-old male football players who have been training regularly for at least two years, based on their chronotype. G\*Power 3.1 to determine the sample size of the study. Based on this analysis, it was determined that a minimum of 20 participants per group was required

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: September 12, 2025
• Study Start: February 5, 2025
• Primary Completion: March 15, 2025
• Study Completion: March 20, 2025
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)