Chronic Obstructive Pulmonary DiseaseNCT07406659
Different Inspiratory Muscle Trainings in Patients With COPD
A study testing Basic Inspiratory Muscle Training and Functional Inspiratory Muscle Training in people with Chronic Obstructive Pulmonary Disease, run by University of Yalova at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Basic Inspiratory Muscle Training and Functional Inspiratory Muscle Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Mar 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Being in a COPD exacerbation Having an orthopedic or neurological disease that would prevent assessment and treatment Having uncontrolled hypertension and heart disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Yalova University
Yalova, Yalova
Erdi KAYABINAR, PhD, +905077692025, erdikayabinar@gmail.com
Gözde ARICA, MSc, 05318893236, gozde.arica@yalova.edu.tr
About this study
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
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.
Read the 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.
- 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.
- 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.
- 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)
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Basic Inspiratory Muscle Training, Functional Inspiratory Muscle Training, Control
- Keywords
- Chronic Obstructive Pulmonary Disease, Respiratory Muscle Training, Lung Capacities
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic Inspiratory Muscle TrainingOther
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.
Functional Inspiratory Muscle TrainingOther
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
ControlOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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) Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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)..
Measured: 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).
Measured: 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.
Measured: Baseline and through study completion, an average of 8 weeks
Secondary outcomes (10)
Cognitive Performance
This will be measured with the Standardized Mini Mental Test (SMMT). The Mini Mental Test, developed by Folstein et al., is used to assess an individual's cognitive performance. The maximum score a patient can achieve on the 11-question test, which includes orientation, recording memory, attention and calculation, recall, and language sections, is 30 (Folstein et al., 1975). The higher the score, the better the situation. 0-17 points indicate severe impairment, 18-23 points indicate moderate impairment, 24-26 points indicate mild cognitive impairment, and 27-30 points indicate normal levels (Creavin et al., 2016). The Turkish validity and reliability study was conducted by Güngen et al. (Güngen et al., 2002).
Measured: Baseline and through study completion, an average of 8 weeks
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. Measurements are taken with the participant seated in a chair. Grip strength is measured in the standard position recommended by the American Association of Hand Therapists. Positions include shoulder adduction, forearm neutral position, elbow flexion at 90 degrees, wrist extension at 0-30 degrees, and ulnar deviation of 15 degrees (Tregdet and Davis, 2000). The best value after performing each measurement three times is recorded.
Measured: Baseline and through study completion, an average of 8 weeks
Balance Assessment (Berg Balance Scale-BDI)
The BDI is used to assess dynamic balance performance. It is evaluated under 14 headings, each with a score of 0-4, for a total of 0-56. 56 is the highest score and indicates complete unsupported balance performance. Scores between 0-20 represent high fall risk, 21-40 represent moderate fall risk, and 41-56 represent low fall risk. Its validity and reliability in Turkish were conducted by Şahin et al. (Sahin et al., 2008).
Measured: Baseline and through study completion, an average of 8 weeks
Core Muscle Assessment
The PRONE test will be performed using the Stabilizer™ (Chattanooga Group Inc., Chattanooga, TN) device. Before the test, the patient is instructed to perform an abdominal wall retraction. The device is placed under the abdomen with the patient lying prone. After the manometer pressure is set at 70 mmHg, the patient is asked to perform and maintain the abdominal wall retraction. The test is repeated three times, and the highest value is recorded (de Paula Lima et al., 2011).
Measured: Baseline and through study completion, an average of 8 weeks
Lower Extremity Endurance Assessment (5-Time Sit-to-Stand Test)
The 5-Time Sit-to-Stand Test is an easy-to-administer lower extremity endurance test because it only requires a chair. Patients are asked to sit down and stand up five times in a chair with a backrest and no armrests, without arm support. The total time in seconds is recorded after completing the test (Mong et al., 2010).
Measured: Baseline and through study completion, an average of 8 weeks
Depression Assessment (Beck Depression Inventory-BDI)
The BDI is a scale used to assess depression. It consists of 21 items, each with four options. The scale has a scoring system of 0-3. The lowest score a participant can receive on this scale is 0 and the highest is 63. Higher scores indicate increasing levels of depression. Total scores are divided into 4 groups: 0-9 points: "minimal depression," 10-16 points: "mild depression," 17-29 points: "moderate depression," and 30 points and above: "severe depression." The Turkish reliability study of this scale was conducted by Hisli in 1988 (Hisli, 1989).
Measured: Baseline and through study completion, an average of 8 weeks
Activity of Daily Living Assessment
London Chest Activities of Daily Living Scale - LCADL: There are four subheadings and 15 items, including personal care, housework, physical activity, and leisure time. Each item is scored between 0 and 5. The scale is scored as the total score of the subheadings and the scale. The maximum total score is 75. As the total score increases, so does dependence on activities of daily living (Janaudis-Ferreira et al., 2014). Its validity and reliability in Turkish were conducted by Saka et al.
Measured: Baseline and through study completion, an average of 8 weeks
Quality of Life Assessment
St. George Respiratory Questionnaire-SGRQ: This questionnaire is used to measure health-related quality of life in individuals with respiratory diseases. It consists of 50 items in three sections: symptoms, activities, and disease effects. Scoring ranges from 0 to 100, with higher scores indicating worsening health status. The validity and reliability of the scale was conducted by Polatlı et al. (Polatlı et al., 2013).
Measured: Baseline and through study completion, an average of 8 weeks
Fatigue Assessment
COPD and Asthma Fatigue Scale: This is a 12-item scale specifically developed for the assessment of fatigue in patients with COPD and asthma. Questions are on a five-point Likert-type scale, yielding a score between 12 and 60. The scale score is calculated out of 100 using the formula: Scale score = [(Total Raw Score-12 /48) x 100]. A higher score indicates greater fatigue (Revicki et al., 2010). The Turkish validity and reliability were made by Aslan and Öztunç (Aslan and Öztunç, 2013).
Measured: Baseline and through study completion, an average of 8 weeks
Physical Activity Level Assessment
Short Form of the International Physical Activity Questionnaire-IPAQ-SF: This questionnaire, whose validity and reliability in Turkish were developed by Sağlam et al., consists of 7 questions. It asks about vigorous and moderate physical activities, including walking and sitting activities, performed within the last week, on how many days per week and for how long. Sitting activity is not included in the scoring section (Sağlam et al., 2010). MET values of the activities were used as 8 METs for vigorous physical activities, 4 METs for moderate physical activities, and 3.3 METs for walking, and the total score was recorded as MET-min/week. The total duration (minutes) and frequency (days) of each are required for score calculation. The MET score is obtained by multiplying the MET value of the activity by the number of days and minutes. The results are evaluated in three categories: inactive, moderately active, and active: Inactive, Moderately active, Active (Craig et al., 2003).
Measured: Baseline and through study completion, an average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start11 Mar 2026
- Primary completion1 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (45)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, Controlled, Clinical Trial
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Yalova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ERDİ KAYABINAR, University of Yalova
- Investigators
- Erdi KAYABINAR, PhD, Principal investigator, University of Yalova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07406659
- Sponsor's protocol ID
- 2025/432
- Status last verified
- Mar 2026
- First submitted
- 17 Dec 2025
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ammous O, Feki W, Lotfi T, Khamis AM, Gosselink R, Rebai A, Kammoun S. Inspiratory muscle training, with or without concomitant pulmonary rehabilitation, for chronic obstructive pulmonary disease (COPD). Cochrane Database Syst Rev. 2023 Jan 6;1(1):CD013778. doi: 10.1002/14651858.CD013778.pub2.
PubMed 36606682Beaumont M, Mialon P, Le Ber C, Le Mevel P, Peran L, Meurisse O, Morelot-Panzini C, Dion A, Couturaud F. Effects of inspiratory muscle training on dyspnoea in severe COPD patients during pulmonary rehabilitation: controlled randomised trial. Eur Respir J. 2018 Jan 25;51(1):1701107. doi: 10.1183/13993003.01107-2017. Print 2018 Jan.
PubMed 29371379Ekren, P. K., Gürgün, A. 2013. "KOAH'da pulmoner rehabilitasyon: kime, ne zaman, nasıl", Güncel Göğüs Hastalıkları Serisi, 1(1), 124-35.
Ergün, P. 2019. "Pulmoner rehabilitasyon güncel yaklaşımlar" Güncel Göğüs Hastalıkları Serisi, 7, 7-18.
Firat M, Saglam M, Calik E, Inal-Ince D, Ardali-Duzgun S, Yildirim T, Ates AH, Vardar-Yagli N. Does the choice of inspiratory muscle training modality affect respiratory and peripheral muscle function in chronic kidney disease? Int Urol Nephrol. 2026 Aug 5. doi: 10.1007/s11255-026-05312-z. Online ahead of print.
PubMed 42557424Gezgen, A., Erk, M., Müsellim, B., Demir, T., Mutlu, B. 2001. "KOAH'da Üst Ekstremite Egzersizlerinin Yaşam Kalitesine ve Solunum Fonksiyonlarına Etkisi", Solunum Dergisi, 3, 60-65.
Global Initiative For Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Revised 2011.
Gökçek, Ö., Doğru Hüzmeli, E., Katayıfçı, N. 2019. "Kronik obstrüktif akciğer hastalarında dispnenin yaşam kalitesi ve depresyona etkisi", ACU Sağlık Bil Dergisi, 10(1), 84-88.
Han B, Chen Z, Ruan B, Chen Y, Lv Y, Li C, Yu L. Effects of Inspiratory Muscle Training in People with Chronic Obstructive Pulmonary Disease: A Systematic Review and Meta-Analysis. Life (Basel). 2024 Nov 12;14(11):1470. doi: 10.3390/life14111470.
PubMed 39598268Huzmeli I, Katayifci N, Abay B, Akkus O, Ozer AY. The effectiveness of functional inspiratory muscle training on exercise capacity and peripheral muscle strength in patients with essential hypertension: a three-arm randomized controlled trial. BMC Sports Sci Med Rehabil. 2025 Feb 28;17(1):29. doi: 10.1186/s13102-025-01082-w.
PubMed 40022256İnce, D., Savcı, S., Sağlam, M., Arıkan, H., Çöplü, L. 2011. "Kronik obstrüktif akciğer hastalarında sigara öyküsü ve fonksiyonel kapasite arasındaki ilişki", Fizyoterapi Rehabilitasyon, 22(1), 39-43
Keskin, T., Başkurt, Z. 2021. "KOAH Tanılı Yaşlı Bireylerde Pulmoner Rehabilitasyon", Celal Bayar Üniversitesi Sağlık Bilimleri Enstitüsü Dergisi, 8(1), 157-161.
Li Z, Liu S, Wang L, Smith L. Mind-Body Exercise for Anxiety and Depression in COPD Patients: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2019 Dec 18;17(1):22. doi: 10.3390/ijerph17010022.
PubMed 31861418McConnell, A. 2013. Respiratory Muscle Training, Theory and Practice, Edinburg: Elsevier.
Özdemir, F., Koca, T., Berber, N., Şahin, Ş. 2018. "Astım ve KOAH Hastalarının Fiziksel Aktivite Düzeylerinin Değerlendirilmesi", KSÜ Tıp Fakültesi Dergisi, 14(1), 20-23.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07406659
- Acronym / sponsor ID
- 2025/432
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, Respiratory Muscle Training, Lung Capacities
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- University of YalovaUniversity, hospital or other
- Study start
- 11 Mar 2026 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomised, Controlled, Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Basic Inspiratory Muscle Training | Experimental | Other: Basic Inspiratory Muscle TrainingThe 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. |
| Functional Inspiratory Muscle Training | Experimental | Other: Functional Inspiratory Muscle TrainingThe 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. |
| Control | Active comparator | Other: ControlSimple 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Being in a COPD exacerbation Having an orthopedic or neurological disease that would prevent assessment and treatment Having uncontrolled hypertension and heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Basic Inspiratory Muscle TrainingThe 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 TrainingFollowing 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 | Other | Functional Inspiratory Muscle Training |
| ControlSimple 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 |
Primary outcome
Dyspnea Assessment
Time frame: Baseline and through study completion, an average of 8 weeks
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).
COPD Assesment Test
Time frame: Baseline and through study completion, an average of 8 weeks
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).
Pulmonary Function Testing
Time frame: Baseline and through study completion, an average of 8 weeks
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).
Pulmonary Function Testing
Time frame: Baseline and through study completion, an average of 8 weeks
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).
Pulmonary Function Testing
Time frame: Baseline and through study completion, an average of 8 weeks
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).
Pulmonary Function Testing
Time frame: Baseline and through study completion, an average of 8 weeks
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).
Pulmonary Function Testing
Time frame: Baseline and through study completion, an average of 8 weeks
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).
Pulmonary Function Testing
Time frame: Baseline and through study completion, an average of 8 weeks
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).
Respiratory Muscle Strength Measurement
Time frame: Baseline and through study completion, an average of 8 weeks
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)..
Respiratory Muscle Strength Measurement
Time frame: Baseline and through study completion, an average of 8 weeks
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).
Exercise Capacity Assessment
Time frame: Baseline and through study completion, an average of 8 weeks
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.
10 secondary outcomes
Cognitive Performance
Time frame: Baseline and through study completion, an average of 8 weeks
Peripheral Muscle Strength Measurement
Time frame: Baseline and through study completion, an average of 8 weeks
Balance Assessment (Berg Balance Scale-BDI)
Time frame: Baseline and through study completion, an average of 8 weeks
Core Muscle Assessment
Time frame: Baseline and through study completion, an average of 8 weeks
Lower Extremity Endurance Assessment (5-Time Sit-to-Stand Test)
Time frame: Baseline and through study completion, an average of 8 weeks
Depression Assessment (Beck Depression Inventory-BDI)
Time frame: Baseline and through study completion, an average of 8 weeks
Activity of Daily Living Assessment
Time frame: Baseline and through study completion, an average of 8 weeks
Quality of Life Assessment
Time frame: Baseline and through study completion, an average of 8 weeks
Fatigue Assessment
Time frame: Baseline and through study completion, an average of 8 weeks
Physical Activity Level Assessment
Time frame: Baseline and through study completion, an average of 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Background: PubMed 36606682Ammous O, Feki W, Lotfi T, Khamis AM, Gosselink R, Rebai A, Kammoun S. Inspiratory muscle training, with or without concomitant pulmonary rehabilitation, for chronic obstructive pulmonary disease (COPD). Cochrane Database Syst Rev. 2023 Jan 6;1(1):CD013778. doi: 10.1002/14651858.CD013778.pub2.
- Background: PubMed 29371379Beaumont M, Mialon P, Le Ber C, Le Mevel P, Peran L, Meurisse O, Morelot-Panzini C, Dion A, Couturaud F. Effects of inspiratory muscle training on dyspnoea in severe COPD patients during pulmonary rehabilitation: controlled randomised trial. Eur Respir J. 2018 Jan 25;51(1):1701107. doi: 10.1183/13993003.01107-2017. Print 2018 Jan.
- BackgroundEkren, P. K., Gürgün, A. 2013. "KOAH'da pulmoner rehabilitasyon: kime, ne zaman, nasıl", Güncel Göğüs Hastalıkları Serisi, 1(1), 124-35.
- BackgroundErgün, P. 2019. "Pulmoner rehabilitasyon güncel yaklaşımlar" Güncel Göğüs Hastalıkları Serisi, 7, 7-18.
- Background: PubMed 42557424Firat M, Saglam M, Calik E, Inal-Ince D, Ardali-Duzgun S, Yildirim T, Ates AH, Vardar-Yagli N. Does the choice of inspiratory muscle training modality affect respiratory and peripheral muscle function in chronic kidney disease? Int Urol Nephrol. 2026 Aug 5. doi: 10.1007/s11255-026-05312-z. Online ahead of print.
- BackgroundGezgen, A., Erk, M., Müsellim, B., Demir, T., Mutlu, B. 2001. "KOAH'da Üst Ekstremite Egzersizlerinin Yaşam Kalitesine ve Solunum Fonksiyonlarına Etkisi", Solunum Dergisi, 3, 60-65.
- BackgroundGlobal Initiative For Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Revised 2011.
- BackgroundGökçek, Ö., Doğru Hüzmeli, E., Katayıfçı, N. 2019. "Kronik obstrüktif akciğer hastalarında dispnenin yaşam kalitesi ve depresyona etkisi", ACU Sağlık Bil Dergisi, 10(1), 84-88.
- Background: PubMed 39598268Han B, Chen Z, Ruan B, Chen Y, Lv Y, Li C, Yu L. Effects of Inspiratory Muscle Training in People with Chronic Obstructive Pulmonary Disease: A Systematic Review and Meta-Analysis. Life (Basel). 2024 Nov 12;14(11):1470. doi: 10.3390/life14111470.
- Background: PubMed 40022256Huzmeli I, Katayifci N, Abay B, Akkus O, Ozer AY. The effectiveness of functional inspiratory muscle training on exercise capacity and peripheral muscle strength in patients with essential hypertension: a three-arm randomized controlled trial. BMC Sports Sci Med Rehabil. 2025 Feb 28;17(1):29. doi: 10.1186/s13102-025-01082-w.
- Backgroundİnce, D., Savcı, S., Sağlam, M., Arıkan, H., Çöplü, L. 2011. "Kronik obstrüktif akciğer hastalarında sigara öyküsü ve fonksiyonel kapasite arasındaki ilişki", Fizyoterapi Rehabilitasyon, 22(1), 39-43
- BackgroundKeskin, T., Başkurt, Z. 2021. "KOAH Tanılı Yaşlı Bireylerde Pulmoner Rehabilitasyon", Celal Bayar Üniversitesi Sağlık Bilimleri Enstitüsü Dergisi, 8(1), 157-161.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erdi KAYABINAR, PhD principal investigator
University of Yalova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Basic Inspiratory Muscle Training and Functional Inspiratory Muscle Training in people with Chronic Obstructive Pulmonary Disease, run by University of Yalova at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erdi KAYABINAR, PhD (+905077692025, erdikayabinar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyspnea Assessment (time frame: Baseline and through study completion, an average of 8 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07406659, which also lists 45 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.