NCT07763002

Brief Summary

This randomized controlled trial evaluates the acute effects of a single session of functional inspiratory muscle training on muscle oxygenation, exercise capacity, dynamic balance, and agility in elite male volleyball players aged 18 to 25 years. Thirty participants will be randomly assigned in a 1:1 ratio to an intervention group or a no-intervention control group. The intervention group will perform 60 resisted breaths at 50% of maximal inspiratory pressure using a POWERbreathe device during a sport-specific fixed-ball throwing drill. Both groups will complete assessments before and immediately after the intervention period on the same day. Quadriceps muscle oxygen saturation and total hemoglobin will be measured using a Moxy near-infrared spectroscopy monitor during the Incremental Shuttle Walk Test. Exercise capacity, dynamic balance, and agility will be assessed using the Incremental Shuttle Walk Test, Star Excursion Balance Test, and T-Test, respectively.

Trial Health

77
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
8mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
May 2026Jun 2027

Study Start

First participant enrolled

May 1, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 13, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

August 13, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 10, 2026

Last Update Submit

August 10, 2026

Conditions

Keywords

functional inspiratory muscle traininginspiratory muscle trainingelite volleyball playersmuscle oxygenationnear-infrared spectroscopyMoxy MonitorIncremental Shuttle Walk Testdynamic balanceagility

Outcome Measures

Primary Outcomes (2)

  • Change in Quadriceps Total Hemoglobin During the Incremental Shuttle Walk Test

    Total hemoglobin (THb, g/dL) will be recorded continuously using a Moxy near-infrared spectroscopy monitor positioned over the midpoint of the right quadriceps femoris. Mean THb will be summarized separately for the pre-exercise rest, exercise, and recovery phases of the Incremental Shuttle Walk Test. For each phase, change will be calculated as the post-intervention value minus the pre-intervention value. The primary comparison will be the difference in pre-to-post change between the intervention and control groups.

    Baseline and immediately after the single-session intervention or control period, within the same day

  • Change in Quadriceps Muscle Oxygen Saturation During the Incremental Shuttle Walk Test

    Muscle oxygen saturation (SmO2, %) will be recorded continuously using a Moxy near-infrared spectroscopy monitor positioned over the midpoint of the right quadriceps femoris. Mean SmO2 will be summarized separately for the pre-exercise rest, exercise, and recovery phases of the Incremental Shuttle Walk Test. For each phase, change will be calculated as the post-intervention value minus the pre-intervention value. The primary comparison will be the difference in pre-to-post change between the intervention and control groups.

    Baseline and immediately after the single-session intervention or control period, within the same day

Secondary Outcomes (3)

  • Change in Incremental Shuttle Walk Test Distance

    Baseline and immediately after the single-session intervention or control period, within the same day

  • Change in Normalized Star Excursion Balance Test Reach Distance

    Baseline and immediately after the single-session intervention or control period, within the same day

  • Change in T-Test Agility Completion Time

    Baseline and immediately after the single-session intervention or control period, within the same day

Study Arms (2)

Functional Inspiratory Muscle Training

EXPERIMENTAL

Fifteen participants are planned for this arm. After warm-up, participants perform a sport-specific fixed-ball throwing drill while completing a single session of functional inspiratory muscle training using a POWERbreathe device. The resistance is set at 50% of the individual's maximal inspiratory pressure. Training consists of two sets of 30 resisted breaths, for a total of 60 breaths over approximately 10 to 12 minutes.

Device: Functional Inspiratory Muscle Training With POWERbreathe

No-Intervention Control

NO INTERVENTION

Fifteen participants are planned for this arm. Participants receive no inspiratory muscle training and complete the same pre-intervention and post-intervention outcome assessments as the intervention group on the same day.

Interventions

A POWERbreathe pressure-threshold inspiratory muscle training device is used during a sport-specific fixed-ball throwing drill after warm-up. Before training, maximal inspiratory pressure is measured using a mouth pressure meter. The device resistance is individualized at 50% of maximal inspiratory pressure. Participants complete two sets of 30 resisted inspirations, totaling 60 breaths, over approximately 10 to 12 minutes. Expiration is unrestricted. The intervention is delivered once.

Functional Inspiratory Muscle Training

Eligibility Criteria

Age18 Years - 25 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male, aged 18 to 25 years
  • Regular participation in volleyball training
  • University student actively playing on an elite-level volleyball team
  • Regular training during the previous 3 months
  • Willing and able to provide written informed consent

You may not qualify if:

  • Current smoking or regular alcohol use
  • Regular use of medication or vitamin supplements
  • History of upper respiratory tract infection or COVID-19 within the previous 3 months
  • Lower-extremity or shoulder surgery within the previous 6 months
  • An acute respiratory or musculoskeletal condition that prevents safe completion of the protocol
  • Inability to complete the assessment or training procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University Faculty of Health Sciences Department of Cardiopulmonary Physiotherapy and Rehabilitation, Ankara, Çankaya 06490

Ankara, Ankara, 06560, Turkey (Türkiye)

RECRUITING

Related Publications (8)

  • Vivas-Mateos G, Livingstone IAT, Hamilton R, Cheema A, Giardini ME. Too Many Shades of Grey: Photometrically and Spectrally Mismatched Targets and Backgrounds in Printed Acuity Tests for Infants and Young Children. Transl Vis Sci Technol. 2020 Nov 6;9(12):12. doi: 10.1167/tvst.9.12.12. eCollection 2020 Nov.

    PMID: 33240565BACKGROUND
  • Gribble PA, Hertel J, Plisky P. Using the Star Excursion Balance Test to assess dynamic postural-control deficits and outcomes in lower extremity injury: a literature and systematic review. J Athl Train. 2012 May-Jun;47(3):339-57. doi: 10.4085/1062-6050-47.3.08.

    PMID: 22892416BACKGROUND
  • Probst VS, Hernandes NA, Teixeira DC, Felcar JM, Mesquita RB, Goncalves CG, Hayashi D, Singh S, Pitta F. Reference values for the incremental shuttle walking test. Respir Med. 2012 Feb;106(2):243-8. doi: 10.1016/j.rmed.2011.07.023. Epub 2011 Aug 23.

    PMID: 21865021BACKGROUND
  • Singh SJ, Morgan MD, Scott S, Walters D, Hardman AE. Development of a shuttle walking test of disability in patients with chronic airways obstruction. Thorax. 1992 Dec;47(12):1019-24. doi: 10.1136/thx.47.12.1019.

    PMID: 1494764BACKGROUND
  • Crum EM, O'Connor WJ, Van Loo L, Valckx M, Stannard SR. Validity and reliability of the Moxy oxygen monitor during incremental cycling exercise. Eur J Sport Sci. 2017 Sep;17(8):1037-1043. doi: 10.1080/17461391.2017.1330899. Epub 2017 May 30.

    PMID: 28557670BACKGROUND
  • Feldmann A, Schmitz R, Erlacher D. Near-infrared spectroscopy-derived muscle oxygen saturation on a 0% to 100% scale: reliability and validity of the Moxy Monitor. J Biomed Opt. 2019 Nov;24(11):1-11. doi: 10.1117/1.JBO.24.11.115001.

    PMID: 31741352BACKGROUND
  • Laveneziana P, Albuquerque A, Aliverti A, Babb T, Barreiro E, Dres M, Dube BP, Fauroux B, Gea J, Guenette JA, Hudson AL, Kabitz HJ, Laghi F, Langer D, Luo YM, Neder JA, O'Donnell D, Polkey MI, Rabinovich RA, Rossi A, Series F, Similowski T, Spengler CM, Vogiatzis I, Verges S. ERS statement on respiratory muscle testing at rest and during exercise. Eur Respir J. 2019 Jun 13;53(6):1801214. doi: 10.1183/13993003.01214-2018. Print 2019 Jun.

    PMID: 30956204BACKGROUND
  • American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.

    PMID: 12186831BACKGROUND

Study Officials

  • Meral BOŞNAK GÜÇLÜ, PhD

    Gazi University

    STUDY DIRECTOR
  • Betül Yoleri, MSc

    Gazi University

    STUDY CHAIR
  • Mücahit Şahin, Pt

    Gazi University

    PRINCIPAL INVESTIGATOR
  • Ece Demirkılınç, Pt

    Gazi University

    PRINCIPAL INVESTIGATOR
  • İrem Acar, Pt

    Gazi University

    PRINCIPAL INVESTIGATOR
  • Ebrar Tarhan, Pt

    Gazi University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Meral BOŞNAK GÜÇLÜ, Prof. Dr

CONTACT

Betül YOLERİ, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessments are performed by physiotherapists who are not informed of participant allocation. The intervention is not masked to participants or personnel administering the training because the intervention group uses a POWERbreathe device and the control group receives no sham intervention. Group labels will be coded for statistical analysis when feasible.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

August 10, 2026

First Posted

August 13, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

August 13, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations