NCT07200895

Brief Summary

Acute IMT Intensity Effects in Male Smokers

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2025

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 1, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

September 23, 2025

Last Update Submit

February 16, 2026

Conditions

Smokers

Keywords

Inspiratory muscle trainingbreathing exerciserespiratory muscle strengthsmoking

Outcome Measures

Primary Outcomes (1)

  • Change in Maximal Inspiratory Pressure (MIP), cmH₂O and % predicted

    MIP will be measured using a calibrated mouth pressure meter/threshold device per standard procedures with a nose clip and from residual volume. The primary endpoint is the within-participant change (post-pre) expressed in cmH₂O and as % predicted based on reference equations. Higher values indicate greater inspiratory muscle strength.

    Baseline (pre-session) to immediately post-session (within ~5 minutes after IMT)

Secondary Outcomes (3)

  • Change in Maximal Expiratory Pressure (MEP), cmH₂O and % predicted

    Baseline to immediately post-session

  • Change in Handgrip Strength (dominant and non-dominant), kg

    Baseline to immediately post-session

  • Change in Heart Rate, Change in Respiratory Rate, Change in Oxygen Saturation, Change in Systolic and Diastolic Blood Pressure, Change in Perceived Exertion

    Baseline to immediately post-session

Study Arms (2)

30% MIP IMT

EXPERIMENTAL

Single supervised session of inspiratory muscle training at 30% of maximal inspiratory pressure (MIP) using a threshold device; 3 sets × 30 breaths (\~15 minutes) following a standardized diaphragmatic-breathing warm-up.

Device: Inspiratory Muscle Training (30% MIP)

60% MIP IMT

EXPERIMENTAL

Single supervised session of inspiratory muscle training at 60% of maximal inspiratory pressure (MIP) using a threshold device; 3 sets × 30 breaths (\~15 minutes) following the same standardized warm-up.

Device: Inspiratory Muscle Training (60% MIP)

Interventions

Inspiratory Muscle Training (30% MIP)DEVICE

Single supervised session of threshold-loaded inspiratory muscle training set at 30% of baseline maximal inspiratory pressure (MIP); 3 sets × 30 breaths (\~15 minutes) following a standardized diaphragmatic-breathing warm-up.

30% MIP IMT
Inspiratory Muscle Training (60% MIP)DEVICE

Single supervised session of threshold-loaded inspiratory muscle training set at 60% of baseline maximal inspiratory pressure (MIP); 3 sets × 30 breaths (\~15 minutes) following the same standardized warm-up.

60% MIP IMT

Eligibility Criteria

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

You may qualify if:

  • Male, 18-25 years of age.
  • Current cigarette smoker for ≥1 year (regular use).
  • No known acute or chronic medical condition.

You may not qualify if:

  • History of any musculoskeletal injury that may limit participation.
  • History of chest pain during physical activity.
  • Current use of any medication.
  • Symptoms of dizziness or balance loss.
  • Diagnosis of hemophilia or history of vascular/cardiovascular disease affecting circulation.
  • Presence of any acute illness at screening or on the test day.
  • Inability to complete the procedures due to physical limitation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biruni University

Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

  • Tanriverdi A, Kahraman BO, Ozsoy I, Ozpelit E, Savci S. Acute effects of inspiratory muscle training at different intensities in healthy young people. Ir J Med Sci. 2021 May;190(2):577-585. doi: 10.1007/s11845-020-02353-w. Epub 2020 Aug 26.

    PMID: 32851483RESULT

  • Rodrigues F, Araujo AA, Mostarda CT, Ferreira J, de Barros Silva MC, Nascimento AM, Lira FS, De Angelis K, Irigoyen MC, Rodrigues B. Autonomic changes in young smokers: acute effects of inspiratory exercise. Clin Auton Res. 2013 Aug;23(4):201-7. doi: 10.1007/s10286-013-0202-1. Epub 2013 Jun 28.

    PMID: 23812534RESULT

MeSH Terms

Conditions

Smoking

Interventions

Maximal Respiratory Pressures

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Respiratory Function TestsDiagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 23, 2025

First Posted

October 1, 2025

Study Start

October 1, 2025

Primary Completion

December 1, 2025

Study Completion

January 1, 2026

Last Updated

February 18, 2026

Record last verified: 2026-02

Locations

TU(1)