NCT06759779

Brief Summary

This study will investigate the effects of inspiratory and expiratory muscle training on respiratory muscle strength, pulmonary function, and performance status in adolescent athletes

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2024

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 6, 2025

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

January 8, 2025

Status Verified

January 1, 2025

Enrollment Period

1.6 years

First QC Date

December 13, 2024

Last Update Submit

January 7, 2025

Conditions

Adolescent Development

Keywords

pulmonary functionsmuscle trainingadolescent healthvolleyball players

Outcome Measures

Primary Outcomes (1)

  • Respiratory muscle strength

    Maximal inspiratory and expiratory muscle strength will be evaluated using mouth pressure device .

    First day

Secondary Outcomes (10)

  • Constant load-inspiratory muscle endurance test

    First day

  • FEV1

    First day

  • FVC

    First day

  • FEV1/FVC

    First day

  • PEF

    First day

  • +5 more secondary outcomes

Study Arms (2)

inspiratory muscle training group

EXPERIMENTAL
Device: inspiratory muscle training

expiratory muscle training group

EXPERIMENTAL
Device: expiratory muscle training

Interventions

inspiratory muscle trainingDEVICE

Inspiratory muscle training will be performed

inspiratory muscle training group
expiratory muscle trainingDEVICE

Expiratory muscle training will be performed

expiratory muscle training group

Eligibility Criteria

Age12 Years - 18 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Athletes aged 12-18 who train at a submaximal level at least 3 days a week

You may not qualify if:

  • Adolescents with any history of chronic lung disease
  • unable to comply with the test and training
  • unwilling to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Emek, 06490, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Zeliha ÇELİK, Asst.Prof.

CONTACT

+90 (358) 218 17 67zelihacelik1@hotmail.com

Study Design

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

Study Record Dates

First Submitted

December 13, 2024

First Posted

January 6, 2025

Study Start

July 1, 2023

Primary Completion

February 1, 2025

Study Completion

March 1, 2025

Last Updated

January 8, 2025

Record last verified: 2025-01

Locations

TU(1)