Different Inspiratory Muscle Trainings in Patients With COPD

NCT07406659 | Recruiting

• 1 other identifier: 2025/432
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

COPD is one of the most life-threatening pulmonary diseases. According to the World Health Organization, it is expected to rise to the third leading cause of death by 2030. Smoking is the most significant contributing factor. COPD reduces lung volumes and causes dyspnea. Over time, respiratory muscle weakness develops, leading to hypercapnia, dyspnea, nocturnal oxygen desaturation, and decreased exercise performance. Pulmonary rehabilitation is the most important component of COPD treatment. Respiratory muscle training should be a mandatory component of the pulmonary rehabilitation program. Combining inspiratory muscle training with functional exercises allows the focus to be on respiratory muscle functions beyond the task of breathing. The purpose of this study was to investigate the effects of Functional Inspiratory Muscle Training on the course of the disease.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease; Respiratory Muscle Training; Lung Capacities

Outcome Measures

Primary Outcomes (11)

• Dyspnea Assessment

  Modified Medical Research Council -mMRC: The mMRC used for dyspnea assessment consists of five stages. Stage 0 represents mild dyspnea, and Stage 4 represents severe dyspnea (Bestall et al., 1999).

  Baseline and through study completion, an average of 8 weeks

• COPD Assesment Test

  COPD Assessment Test (CAT): The test consists of eight questions that examine cough, phlegm, shortness of breath, home and outdoor difficulties, sleep, and fatigue parameters. The maximum score is 40. As the score increases, symptoms worsen. The validity and reliability of the Turkish version was conducted by Yorgancıoğlu et al. (Yorgancioglu, 2012).

  Baseline and through study completion, an average of 8 weeks

• Pulmonary Function Testing

  Measurements are taken with a portable spirometer (Cosmed Pony FX, Cosmed, Rome, Italy) while the patient is in a seated position. Forced expiratory volume in one second (FEV1) is measured (Miller et al., 2005).

  Baseline and through study completion, an average of 8 weeks

• Pulmonary Function Testing

  Measurements are taken with a portable spirometer (Cosmed Pony FX, Cosmed, Rome, Italy) while the patient is in a seated position. Forced vital capacity (FVC) is measured (Miller et al., 2005).

  Baseline and through study completion, an average of 8 weeks

• Pulmonary Function Testing

  Measurements are taken with a portable spirometer (Cosmed Pony FX, Cosmed, Rome, Italy) while the patient is in a seated position. The ratio of forced expiratory volume in one second to forced vital capacity (FEV1/FVC) is measured (Miller et al., 2005).

  Baseline and through study completion, an average of 8 weeks

• Pulmonary Function Testing

  Measurements are made with a portable spirometer (Cosmed Pony FX, Cosmed, Rome, Italy) with the patient in a sitting position. Peak expiratory flow rate (PEF) are measured (Miller et al., 2005).

  Baseline and through study completion, an average of 8 weeks

• Pulmonary Function Testing

  Measurements are made with a portable spirometer (Cosmed Pony FX, Cosmed, Rome, Italy) with the patient in a sitting position. Flow rate at 25-75% of forced vital capacity (FEF 25-75%) are measured (Miller et al., 2005).

  Baseline and through study completion, an average of 8 weeks

• Pulmonary Function Testing

  Measurements are made with a portable spirometer (Cosmed Pony FX, Cosmed, Rome, Italy) with the patient in a sitting position. Vital capacity (VC) are measured (Miller et al., 2005).

  Baseline and through study completion, an average of 8 weeks

• Respiratory Muscle Strength Measurement

  Maximal inspiratory pressure measurements (MIP) will be taken. For the MIP measurement, the participant sits in a chair and, with a nose clip attached, is asked to take a maximum inspiration through the mouth for 1-3 seconds (Neder et al., 1999)..

  Baseline and through study completion, an average of 8 weeks

• Respiratory Muscle Strength Measurement

  Maximal expiratory pressure measurements (MEP) will be taken. For the MEP measurement, the participant is asked to take a maximum inspiration and then a maximum expiration for 1-3 seconds. After performing both measurements three times, the best reading is recorded (Neder et al., 1999).

  Baseline and through study completion, an average of 8 weeks

• Exercise Capacity Assessment

  Six-Minute Walk Test - 6MWT: The six-minute walk test is one of the most frequently used field tests in clinical settings due to its practicality and low cost, assessing submaximal functional capacity. The test is conducted in a 30-meter corridor. After being informed about the test, the participant is asked to walk in a marked area in the corridor for six minutes, and the total distance is recorded. It is recommended that it be performed three times at regular intervals throughout the day, and the best distance recorded. The patient may stop and rest at any time and use assistive devices if available. Blood pressure, heart rate, oxygen saturation, fatigue, and dyspnea are measured before and after the test. In individuals with COPD, a walk of \<350 meters is associated with lower exercise capacity and increased mortality risk (Ceylan, 2014). A 6-minute walk will result in a report calculating the total distance walked in meters.

  Baseline and through study completion, an average of 8 weeks

Secondary Outcomes (10)

• Cognitive Performance

  Baseline and through study completion, an average of 8 weeks

• Peripheral Muscle Strength Measurement

  Baseline and through study completion, an average of 8 weeks

• Balance Assessment (Berg Balance Scale-BDI)

  Baseline and through study completion, an average of 8 weeks

• Core Muscle Assessment

  Baseline and through study completion, an average of 8 weeks

• Lower Extremity Endurance Assessment (5-Time Sit-to-Stand Test)

  Baseline and through study completion, an average of 8 weeks

Study Arms (3)

Basic Inspiratory Muscle Training

EXPERIMENTAL

The participant will complete IMT training with a physiotherapist one day a week and without a supervisor for the remaining 6 days, 15 minutes in the morning and 15 minutes in the evening.

Other: Basic Inspiratory Muscle Training

Functional Inspiratory Muscle Training

EXPERIMENTAL

The participant will follow the same Basic IMT program for the first four weeks, and then perform the specified exercises for the remaining four weeks, 3 days a week, for 30 minutes, under the supervision of a physiotherapist. The remaining four days will include 15-minute Basic IMT training in the morning and evening, without a supervisor.

Other: Functional Inspiratory Muscle Training

Control

ACTIVE COMPARATOR

Simple upper extremity exercises and diaphragmatic breathing exercises will be given with equipment suitable for the home environment, 1 day a week accompanied by a physiotherapist for 30 minutes, and the remaining 6 days without a supervisor for 15 minutes in the morning and 15 minutes in the evening. (8-12 repetitions, 2 sets, 1-2 minute break)

Other: Control

Interventions

Control OTHER

Simple upper extremity exercises and diaphragmatic breathing exercises will be given with equipment suitable for the home environment, 1 day a week accompanied by a physiotherapist for 30 minutes, and the remaining 6 days without a supervisor for 15 minutes in the morning and 15 minutes in the evening. (8-12 repetitions, 2 sets, 1-2 minute break)

Control

Basic Inspiratory Muscle Training OTHER

The participant will complete IMT training with a physiotherapist one day a week and without a supervisor for the remaining 6 days, 15 minutes in the morning and 15 minutes in the evening.

Basic Inspiratory Muscle Training

Functional Inspiratory Muscle Training OTHER

Following 4 weeks of Basic IMT, the patient will undergo 30-minute exercises and IMT, three days a week, for 4 weeks, accompanied by a physiotherapist. The patient will continue 15-minute Basic IMT training morning and evening, four days a week, without a supervisor. Exercises will be performed 8-12 times, in 2 sets, with 1-2 minute breaks. Supine chin-up position, lowering and lifting bent legs to the side, Supine chin-up position, 90° hip flexion of one leg, then sliding the heel to extend the knee and 45° straight leg raise, Supine chin-up position, 90° hip flexion of the leg in the chin-up position, Bilateral 90° hip flexion of the legs in the chin-up position, Supine chin-up position, opposite knee extension and shoulder flexion, Cross arm-leg raises in the crawling position, shoulder flexion and extension on mobile surfaces, Back slide on the wall, Lunge by stepping forward, Lifting weight from the floor and lifting it overhead, Bridging, Crunches, Modified push-up

Functional Inspiratory Muscle Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having a COPD diagnosis according to GOLD criteria Having not had an acute exacerbation within the last month Being able to walk independently Having no communication problems Voluntarily participating in the study

You may not qualify if:

• Being in a COPD exacerbation Having an orthopedic or neurological disease that would prevent assessment and treatment Having uncontrolled hypertension and heart disease

Sponsors & Collaborators

• University of Yalova: lead

Study Sites (1)

Yalova University

Yalova, Yalova, Turkey (Türkiye)

RECRUITING

Related Publications (45)

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Erdi KAYABINAR, PhD

  University of Yalova

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erdi KAYABINAR, PhD

CONTACT

+905077692025; erdikayabinar@gmail.com

Gözde ACAR, MSc

CONTACT

+905318893236; gozde.arica@yalova.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomised, Controlled, Clinical Trial

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: February 12, 2026
• Study Start: March 11, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)