NCT07267923

Brief Summary

This study aims to compare the effects of functional and conventional inspiratory muscle training (IMT) on post-exercise muscle deoxygenation in individuals with Chronic Obstructive Pulmonary Disease (COPD). Participants will complete both training modalities on separate days. A 2-minute walk test (2MWT) will be performed baseline, and after each session. Muscle oxygenation (SmO₂) will be assessed using near-infrared spectroscopy . Dyspnea and fatigue will be evaluated with the Modified Borg Scale, and heart rate and oxygen saturation (SpO₂) will be measured by pulse oximetry. Measurements will be recorded before, after training and at the end of the walking test.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 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

Study Start

First participant enrolled

November 11, 2025

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 5, 2025

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2026

Completed
Last Updated

April 9, 2026

Status Verified

November 1, 2025

Enrollment Period

2 months

First QC Date

November 17, 2025

Last Update Submit

April 7, 2026

Conditions

Keywords

Chronic Obstructive Pulmonary Diseaseinspiratory muscle trainingfunctional inspiratory muscle training

Outcome Measures

Primary Outcomes (1)

  • Muscle oxygenation levels (SmO₂)

    Muscle oxygenation (SmO₂) will be assessed using near-infrared spectroscopy .

    1. day - baseline measurement-before and after 2MWT , 1. day- before and after IMT and after 2MWT 2. day- before and after FIMT and after 2MWT

Secondary Outcomes (5)

  • Fatigue

    1. day - baseline measurement-before and after 2MWT , 1. day- before and after IMT and after 2MWT 2. day- before and after FIMT and after 2MWT

  • Dyspnea

    1. day - baseline measurement-before and after 2MWT , 1. day- before and after IMT and after 2MWT 2. day- before and after FIMT and after 2MWT

  • Heart rate

    1. day - baseline measurement-before and after 2MWT , 1. day- before and after IMT and after 2MWT 2. day- before and after FIMT and after 2MWT

  • Saturation (SPO2)

    1. day - baseline measurement-before and after 2MWT , 1. day- before and after IMT and after 2MWT 2. day- before and after FIMT and after 2MWT

  • hemoglobin

    1. day - baseline measurement-before and after 2MWT , 1. day- before and after IMT and after 2MWT 2. day- before and after FIMT and after 2MWT

Study Arms (1)

Chronic Obstructive Pulmonary Disease

EXPERIMENTAL
Other: Traditional inspiratory muscle trainingOther: Functional inspiratory muscle training (IMT)

Interventions

Functional inspiratory muscle training (IMT) is defined as inspiratory muscle training performed while maintaining core stabilization and postural control. Functional IMT consists of a warm-up period, core exercises, dynamic trunk activation combined with upper extremity movements, postural control exercises, and a cool-down period. The participant performs these exercises simultaneously with inspiratory muscle training.

Chronic Obstructive Pulmonary Disease

Traditional inspiratory muscle training is a form of training performed using a resistive breathing device that provides resistance to the muscles involved in inspiration. Inspiratory muscle training will be performed using a portable pressure-threshold device (POWERbreathe Classic IMT - Light Resistance). IMT will be administered in a seated position with upper extremities supported and the upper chest/shoulders relaxed. The training procedure will be explained to each participant and performed for 15 minutes at 40% of the maximal inspiratory pressure (MIP).

Chronic Obstructive Pulmonary Disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being 18 years of age or older,
  • Having a diagnosis of COPD,
  • Being in stage II-III according to the GOLD classification,
  • Being able to mobilize independently.

You may not qualify if:

  • Having a recent exacerbation or complication requiring hospitalization,
  • Having had a respiratory tract infection within the past month,
  • Having any disease or medical condition that prevents participation in exercise, -Having cognitive impairment (a score of \<24 on the Mini-Mental Test).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulhane Faculty of Physiotherapy and Rehabilitation

Ankara, Keçiören, 06018, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This study uses a crossover design with a single participant group, in which all participants receive both exercise interventions. Each participant will undergo one baseline assessment prior to any intervention. On separate days, participants will complete two different inspiratory muscle training (IMT) interventions: conventional IMT and functional IMT. A standardized outcome assessment is performed immediately after each intervention session, resulting in a total of three measurement time points (pre-intervention, post-conventional IMT, and post-functional IMT). Outcomes obtained at these three time points will be compared to determine the acute effects and relative impact of each training modality.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2025

First Posted

December 5, 2025

Study Start

November 11, 2025

Primary Completion

January 1, 2026

Study Completion

February 15, 2026

Last Updated

April 9, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations