Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 4:19 AM
Study NCT ID:
NCT07406659
Status:
RECRUITING
Last Update Posted:
2026-03-16
First Post:
2025-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Different Inspiratory Muscle Trainings in Patients With COPD
Sponsor:
University of Yalova
Organization:
Study Overview
Official Title:
Early Effects of Different Inspiratory Muscle Training on Disease Clinical Course, Respiratory Parameters, Functional Capacity and Quality of Life in Patients With COPD
Status:
RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
Chronic Obstructive Pulmonary Disease (COPD) is a progressive respiratory disease with high mortality and morbidity, although it is preventable and treatable. Environmental and genetic factors, primarily smoking, play a role in the development of the disease. The most common symptom in COPD is dyspnea, which is associated with respiratory muscle dysfunction, hyperinflation, and exercise intolerance. Pulmonary rehabilitation, especially exercise training and respiratory muscle training, is a fundamental component of COPD management.
Inspiratory muscle training (IMT) aims to improve dyspnea, exercise capacity, and quality of life by increasing respiratory muscle strength and endurance. In recent years, Functional Inspiratory Muscle Training (F-IMT) has been developed, focusing on the role of respiratory muscles in postural control and trunk stabilization. However, studies on the effects of F-IMT in individuals with COPD are limited.
The aim of our study was to compare the early-term effects of basic IMT and F-IMT on the disease course in individuals with COPD. In this study, we aim to learn which training is more beneficial for individuals with COPD.
Scope: This is a prospective experimental study. The study will be conducted on total 51 individuals who meet the inclusion criteria. The study population will consist of patients admitted to Yalova Training and Research Hospital.
Inclusion Criteria:
Diagnosed with COPD according to GOLD criteria Not having had an acute exacerbation within the last month Ability to walk independently No communication problems Voluntariness to participate in the study
Exclusion Criteria:
Being in a COPD exacerbation Presence of orthopedic or neurological disease that may interfere with assessment and treatment Presence of uncontrolled hypertension and heart disease Method: The minimum sample size for the study was calculated using the GPower 3.1 program, taking into account the literature, using a 95% confidence interval, 80% power, and an effect size of 0.4823177. Accordingly, the minimum sample size for the study was calculated as 45. Considering the possibility of participant withdrawal, an additional 10% of participants will be recruited. Therefore, the study is planned to include total 51 participants. Participants will be included in the study through invitation and announcement. The study will be conducted with individuals who meet the inclusion criteria. Participants will be divided into three groups: the basic IMT group, the F-IMT group, and the control group, each containing 17 participants.
Data Collection Tools:
Demographic Information, Cognitive Performance: It will be measured using the Standardized Mini Mental Test (SMMT), Dyspnea Assessment (Modified Medical Research Council -mMRC), COPD Assessment Test (CAT), Respiratory Function Test: Measurements are taken with a portable spirometer (Cosmed Pony FX, Cosmed, Rome, Italy) while the patient is in a sitting position, Respiratory Muscle Strength Measurement: Maximal inspiratory and expiratory pressure measurements (MIP-MEP) will be taken, Exercise Capacity Assessment (Six-Minute Walk Test - 6MWT), Peripheral Muscle Strength Measurement: Participants' knee extension and grip strength will be assessed. A hand-held dynamometer (Lafayette Manual Muscle Testing System; Lafayette Instrument Company, Lafayette, Indiana, USA) will be used for knee extension strength, and a Baseline BIMS Digital 5-Position Grip Dynamometer (Baseline Evaluation Instruments, USA) will be used for grip strength, Balance Assessment (Berg Balance Scale-BBS): The BBS is used to assess dynamic balance performance, Core Muscle Assessment: The PRONE test will be performed using the Stabilizer™ (Chattanooga Group Inc., Chattanooga, TN) device, Lower Extremity Endurance Assessment (5-Time Sit-to-Stand Test), Depression Assessment (Beck Depression Inventory - BDI), Assessment of Activities of Daily Living (London Chest Activities of Daily Living Scale - LCADL), Quality of Life Assessment (St. George Respiratory Questionnaire-SGRQ), Fatigue Assessment (COPD and Asthma Fatigue Scale), Physical Activity Level Assessment (International Physical Activity Questionnaire Short Form - UFAA-SF).
Group Training Programs:
Participants will be randomized into three groups: basic IMT, functional IMT (F-IMT), and a control group. This randomization will be conducted through randomizer.org, an open-access randomization website. Participants in both groups will be assessed at the initial meeting and provided with an informed consent form. After completing the initial assessment, they will be informed about the device (in use) and the treatment process. Both groups will receive 8 weeks of treatment. IMT will be applied with a threshold pressure loading device (POWERbreathe Classic Light Resistance, PowerBreath, IMT Technologies Ltd, Birmingham, UK). Patients in both groups will receive training at 40% of the initial measured MIP and a 5-10 second rest break after 10-15 respiratory cycles.
1. Basic IMT group: They will complete IMT training once a week with a physiotherapist for 15 minutes in the morning and 15 minutes in the evening, for the remaining 6 days without a supervisor.
2. F-IMT group: After applying the same Basic IMT program for the first four weeks, the remaining four weeks will be spent 3 days a week with a physiotherapist for 30 minutes, accompanied by the specified exercises. For the remaining four days, they will continue Basic IMT training, unsupervised for 15 minutes in the morning and evening.
3. Control group: Simple upper extremity exercises and diaphragmatic breathing exercises will be performed with equipment suitable for home use, 30 minutes with a physiotherapist once a week, and 15 minutes in the morning and 15 minutes in the evening, unsupervised for the remaining six days. (8-12 repetitions, 2 sets, 1-2 minute break) F-IMT group exercises: Each exercise will be performed simultaneously with the IMT device for 8-12 repetitions, 2 sets. There will be a 1-2 minute break between exercises. -Alternating between lowering and raising bent legs while supine in a chin-up position
* Alternating between lowering and raising bent legs while supine in a chin-up position
* Alternating between 90° hip flexion of one leg, then sliding the heel to extend the knee and performing a 45° straight leg raise
* Alternating between 90° hip flexion of the opposite leg while supine in a chin-up position
* Alternating between 90° hip flexion of the legs while supine in a chin-up position
* Contralateral knee extension and shoulder flexion while supine in a chin-up position
* Crawling cross-leg raises
* Shoulder flexion and extension on unstable surfaces
* Back slides on a wall
* Lunges by stepping forward
* Lifting a weight from the floor and lifting it overhead while maintaining a neutral spine
* Bridging exercises
* Crunches
* Modified push-ups (Kisner et al., 2017)
Inspiratory muscle training (IMT) aims to improve dyspnea, exercise capacity, and quality of life by increasing respiratory muscle strength and endurance. In recent years, Functional Inspiratory Muscle Training (F-IMT) has been developed, focusing on the role of respiratory muscles in postural control and trunk stabilization. However, studies on the effects of F-IMT in individuals with COPD are limited.
The aim of our study was to compare the early-term effects of basic IMT and F-IMT on the disease course in individuals with COPD. In this study, we aim to learn which training is more beneficial for individuals with COPD.
Scope: This is a prospective experimental study. The study will be conducted on total 51 individuals who meet the inclusion criteria. The study population will consist of patients admitted to Yalova Training and Research Hospital.
Inclusion Criteria:
Diagnosed with COPD according to GOLD criteria Not having had an acute exacerbation within the last month Ability to walk independently No communication problems Voluntariness to participate in the study
Exclusion Criteria:
Being in a COPD exacerbation Presence of orthopedic or neurological disease that may interfere with assessment and treatment Presence of uncontrolled hypertension and heart disease Method: The minimum sample size for the study was calculated using the GPower 3.1 program, taking into account the literature, using a 95% confidence interval, 80% power, and an effect size of 0.4823177. Accordingly, the minimum sample size for the study was calculated as 45. Considering the possibility of participant withdrawal, an additional 10% of participants will be recruited. Therefore, the study is planned to include total 51 participants. Participants will be included in the study through invitation and announcement. The study will be conducted with individuals who meet the inclusion criteria. Participants will be divided into three groups: the basic IMT group, the F-IMT group, and the control group, each containing 17 participants.
Data Collection Tools:
Demographic Information, Cognitive Performance: It will be measured using the Standardized Mini Mental Test (SMMT), Dyspnea Assessment (Modified Medical Research Council -mMRC), COPD Assessment Test (CAT), Respiratory Function Test: Measurements are taken with a portable spirometer (Cosmed Pony FX, Cosmed, Rome, Italy) while the patient is in a sitting position, Respiratory Muscle Strength Measurement: Maximal inspiratory and expiratory pressure measurements (MIP-MEP) will be taken, Exercise Capacity Assessment (Six-Minute Walk Test - 6MWT), Peripheral Muscle Strength Measurement: Participants' knee extension and grip strength will be assessed. A hand-held dynamometer (Lafayette Manual Muscle Testing System; Lafayette Instrument Company, Lafayette, Indiana, USA) will be used for knee extension strength, and a Baseline BIMS Digital 5-Position Grip Dynamometer (Baseline Evaluation Instruments, USA) will be used for grip strength, Balance Assessment (Berg Balance Scale-BBS): The BBS is used to assess dynamic balance performance, Core Muscle Assessment: The PRONE test will be performed using the Stabilizer™ (Chattanooga Group Inc., Chattanooga, TN) device, Lower Extremity Endurance Assessment (5-Time Sit-to-Stand Test), Depression Assessment (Beck Depression Inventory - BDI), Assessment of Activities of Daily Living (London Chest Activities of Daily Living Scale - LCADL), Quality of Life Assessment (St. George Respiratory Questionnaire-SGRQ), Fatigue Assessment (COPD and Asthma Fatigue Scale), Physical Activity Level Assessment (International Physical Activity Questionnaire Short Form - UFAA-SF).
Group Training Programs:
Participants will be randomized into three groups: basic IMT, functional IMT (F-IMT), and a control group. This randomization will be conducted through randomizer.org, an open-access randomization website. Participants in both groups will be assessed at the initial meeting and provided with an informed consent form. After completing the initial assessment, they will be informed about the device (in use) and the treatment process. Both groups will receive 8 weeks of treatment. IMT will be applied with a threshold pressure loading device (POWERbreathe Classic Light Resistance, PowerBreath, IMT Technologies Ltd, Birmingham, UK). Patients in both groups will receive training at 40% of the initial measured MIP and a 5-10 second rest break after 10-15 respiratory cycles.
1. Basic IMT group: They will complete IMT training once a week with a physiotherapist for 15 minutes in the morning and 15 minutes in the evening, for the remaining 6 days without a supervisor.
2. F-IMT group: After applying the same Basic IMT program for the first four weeks, the remaining four weeks will be spent 3 days a week with a physiotherapist for 30 minutes, accompanied by the specified exercises. For the remaining four days, they will continue Basic IMT training, unsupervised for 15 minutes in the morning and evening.
3. Control group: Simple upper extremity exercises and diaphragmatic breathing exercises will be performed with equipment suitable for home use, 30 minutes with a physiotherapist once a week, and 15 minutes in the morning and 15 minutes in the evening, unsupervised for the remaining six days. (8-12 repetitions, 2 sets, 1-2 minute break) F-IMT group exercises: Each exercise will be performed simultaneously with the IMT device for 8-12 repetitions, 2 sets. There will be a 1-2 minute break between exercises. -Alternating between lowering and raising bent legs while supine in a chin-up position
* Alternating between lowering and raising bent legs while supine in a chin-up position
* Alternating between 90° hip flexion of one leg, then sliding the heel to extend the knee and performing a 45° straight leg raise
* Alternating between 90° hip flexion of the opposite leg while supine in a chin-up position
* Alternating between 90° hip flexion of the legs while supine in a chin-up position
* Contralateral knee extension and shoulder flexion while supine in a chin-up position
* Crawling cross-leg raises
* Shoulder flexion and extension on unstable surfaces
* Back slides on a wall
* Lunges by stepping forward
* Lifting a weight from the floor and lifting it overhead while maintaining a neutral spine
* Bridging exercises
* Crunches
* Modified push-ups (Kisner et al., 2017)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: