NCT06742372

Brief Summary

This study aims to investigate the effects of combined Inspiratory Muscle Training and aerobic exercise on diaphragm and pulmonary functions, respiratory muscle function, performance, and body composition

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
active not 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 Start

First participant enrolled

December 12, 2023

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 16, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 19, 2024

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

December 19, 2024

Status Verified

December 1, 2024

Enrollment Period

1.1 years

First QC Date

December 16, 2024

Last Update Submit

December 16, 2024

Conditions

Healthy Individuals (Controls)

Outcome Measures

Primary Outcomes (3)

  • Respiratory muscle strength

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

    First day

  • diaphragm thickness

    Second day

  • diaphragm stiffness

    Second day

Secondary Outcomes (7)

  • Inspiratory muscle endurance

    First day

  • FEV1

    First day

  • FVC

    First day

  • FEV1/FVC

    First day

  • PEF

    First day

  • +2 more secondary outcomes

Study Arms (2)

combined inspiratory and aerobic exercise training

EXPERIMENTAL
Other: combined inspiratory and aerobic exercise training

aerobic exercise training

EXPERIMENTAL
Other: aerobic exercise training

Interventions

combined inspiratory and aerobic exercise trainingOTHER

combined inspiratory and aerobic exercise training will be performed in healthy individuals

combined inspiratory and aerobic exercise training
aerobic exercise trainingOTHER

aerobic exercise training will be performed in healthy individuals

aerobic exercise training

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amasya University

Amasya, Turkey (Türkiye)

Location

Related Publications (1)

  • Celik Z, Guzel NA, Allahverdiyeva S, Sendur HN, Cerit MN. Effects of simultaneous aerobic and inspiratory muscle training on diaphragm function, respiratory muscle strength, endurance, and fatigue index: randomized-controlled trial. Eur J Appl Physiol. 2025 Dec;125(12):3769-3783. doi: 10.1007/s00421-025-05868-1. Epub 2025 Jul 2.

    PMID: 40601012DERIVED

Study Design

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

Study Record Dates

First Submitted

December 16, 2024

First Posted

December 19, 2024

Study Start

December 12, 2023

Primary Completion

December 31, 2024

Study Completion

March 31, 2025

Last Updated

December 19, 2024

Record last verified: 2024-12

Locations

TU(1)