Short-Term Inspiratory Muscle Training and Aerobic Exercise in Women With COPD (IMT-COPD)

Short-Term Inspiratory Muscle Training, Aerobic Exercise, and Detraining in Women With COPD: A Randomized Controlled Trial

Brief Summary:

This randomized controlled trial evaluated the short-term effects of inspiratory muscle training, aerobic exercise, combined inspiratory muscle training and aerobic exercise, placebo inspiratory muscle training, and usual care in women with stable chronic obstructive pulmonary disease (COPD). The study aimed to determine whether these interventions improve respiratory muscle strength, pulmonary function, walking capacity, dyspnea, and psychological well-being after a four-week intervention period. A secondary aim was to examine whether any improvements were maintained during a two-week detraining period after supervised training was stopped.

Participants were randomly assigned to one of five groups: control, inspiratory muscle training, aerobic exercise, combined inspiratory muscle training and aerobic exercise, or placebo inspiratory muscle training. Outcomes were assessed at baseline, after the four-week intervention, and on days 7 and 14 after the intervention. The main outcome was the change in maximal inspiratory pressure. Secondary outcomes included maximal expiratory pressure, peak inspiratory flow rate, inspiratory volume, forced vital capacity, forced expiratory volume in one second, six-minute walk distance, dyspnea, and well-being.

The study hypothesis was that inspiratory muscle training, either alone or combined with aerobic exercise, would improve respiratory muscle function, functional capacity, dyspnea, and well-being in women with COPD, and that the magnitude and persistence of these effects would differ between intervention groups.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Device: Inspiratory Muscle Training; Behavioral: Aerobic Exercise; Device: Placebo Inspiratory Muscle Training

Detailed Description

Chronic obstructive pulmonary disease (COPD) is associated with airflow limitation, respiratory symptoms, reduced exercise tolerance, dyspnea, and impaired quality of life. In women with COPD, symptom burden and dyspnea may be more pronounced even at comparable levels of airflow limitation. Inspiratory muscle dysfunction may further contribute to breathing difficulty and reduced functional capacity. Therefore, interventions targeting inspiratory muscle performance may provide clinically relevant benefits in this population.

This single-center randomized controlled trial was designed to compare the effects of different short-term rehabilitation approaches in women with stable COPD. Participants were allocated to one of five parallel groups: usual care control, inspiratory muscle training, aerobic exercise, combined inspiratory muscle training plus aerobic exercise, or placebo inspiratory muscle training. The intervention period lasted four weeks, followed by a two-week detraining period during which supervised training was discontinued.

The inspiratory muscle training intervention used individualized resistance based on each participant's maximal inspiratory pressure, while the aerobic exercise intervention consisted of supervised treadmill walking at submaximal intensity. The combined group received both inspiratory muscle training and aerobic exercise. The placebo inspiratory muscle training group followed a similar breathing exercise procedure but with a low resistance load. The control group continued usual medical care without supervised exercise training.

The study was conducted at Hitit University Çorum Erol Olçok Training and Research Hospital. Assessments were performed before the intervention, immediately after the four-week intervention, and during follow-up on days 7 and 14 after the intervention. These follow-up measurements were included to examine whether the effects of training were maintained or reduced after the supervised intervention ended. The study focused on respiratory muscle performance, pulmonary function, walking capacity, perceived dyspnea, and psychological well-being in women with stable COPD

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Çorum
    • Çorum, Çorum, Turkey (Türkiye), 1900
      • Hitit University Çorum Erol Olçok Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Female patients aged between 48 and 65 years Diagnosis of stage I or II chronic obstructive pulmonary disease according to the Global Initiative for Chronic Obstructive Lung Disease criteria Stable COPD status No acute exacerbation within the previous six weeks Attending routine follow-up at the Chest Diseases Outpatient Clinic Non-use of tobacco products, including cigarettes, hookah, and other tobacco derivatives No medical condition that could interfere with safe exercise performance, such as serious cardiovascular, neurological, rheumatologic, orthopedic, or systemic disorders Ability to understand and communicate in Turkish No regular physical activity within the preceding three months, defined as moderate- to high-intensity exercise at least three days per week Voluntary participation with signed written informed consent

Exclusion Criteria:

Unstable COPD Acute COPD exacerbation within the previous six weeks Current tobacco use Medical contraindications to exercise, such as congestive heart failure, severe osteoarthritis, or advanced neurological disease Use of long-term home oxygen therapy Difficulty reading or comprehending Turkish Previous engagement in structured exercise either professionally or recreationally, including competitive athletes or individuals with formal exercise training Failure to attend at least three scheduled intervention sessions during the study period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Participants in the control group continued their usual medical care and did not receive supervised inspiratory muscle training or aerobic exercise during the four-week intervention period. They were instructed to maintain their usual daily activities and not to start any new structured exercise program.
Experimental: Inspiratory Muscle Training; Participants performed supervised inspiratory muscle training three days per week for four weeks using the POWERbreathe Classic Light Resistance device. Training was performed at 40% of individual maximal inspiratory pressure and consisted of two sets of 30 repetitions per session.	Device: Inspiratory Muscle Training; Inspiratory muscle training was performed using the POWERbreathe Classic Light Resistance device. Participants trained three days per week for four weeks at a resistance corresponding to 40% of their individual maximal inspiratory pressure. Each session consisted of two sets of 30 repetitions in the seated position under supervision.
Experimental: Aerobic Exercise; Participants performed supervised aerobic exercise three days per week for four weeks. Each session consisted of treadmill walking at submaximal intensity, including warm-up, 30 minutes of main exercise, and cool-down. Exercise intensity was maintained at 50-65% of age-predicted maximal heart rate.	Behavioral: Aerobic Exercise; Aerobic exercise consisted of supervised treadmill walking performed three times per week for four weeks. Each session included a 5-minute warm-up with low-intensity walking and breathing exercises, a 30-minute main exercise phase, and a 5-minute cool-down with slow walking. Exercise intensity was maintained at 50-65% of the participant's age-predicted maximal heart rate and monitored using an optical heart rate sensor. Treadmill speed was adjusted to keep heart rate within the target range, and perceived exertion was maintained at 4 to 6 on the Borg scale. Oxygen saturation, heart rate, and dyspnea were monitored throughout the sessions.; Other Names: Supervised Treadmill Walking; Submaximal Aerobic Exercise
Experimental: Combined Inspiratory Muscle Training and Aerobic Exercise; Participants received both supervised inspiratory muscle training and aerobic exercise three days per week for four weeks. Inspiratory muscle training was performed at 40% of individual maximal inspiratory pressure, with one set completed before and one set after the aerobic exercise session.	Device: Inspiratory Muscle Training; Inspiratory muscle training was performed using the POWERbreathe Classic Light Resistance device. Participants trained three days per week for four weeks at a resistance corresponding to 40% of their individual maximal inspiratory pressure. Each session consisted of two sets of 30 repetitions in the seated position under supervision.; Behavioral: Aerobic Exercise; Aerobic exercise consisted of supervised treadmill walking performed three times per week for four weeks. Each session included a 5-minute warm-up with low-intensity walking and breathing exercises, a 30-minute main exercise phase, and a 5-minute cool-down with slow walking. Exercise intensity was maintained at 50-65% of the participant's age-predicted maximal heart rate and monitored using an optical heart rate sensor. Treadmill speed was adjusted to keep heart rate within the target range, and perceived exertion was maintained at 4 to 6 on the Borg scale. Oxygen saturation, heart rate, and dyspnea were monitored throughout the sessions.; Other Names: Supervised Treadmill Walking; Submaximal Aerobic Exercise
Placebo Comparator: Placebo Inspiratory Muscle Training; Participants followed the same inspiratory muscle training procedure as the true inspiratory muscle training group, using the same device and session structure. However, the device resistance was set at 15% of individual maximal inspiratory pressure.	Device: Placebo Inspiratory Muscle Training; Placebo inspiratory muscle training was performed using the same POWERbreathe Classic Light Resistance device and the same session structure as the true inspiratory muscle training intervention. The resistance was set at 15% of individual maximal inspiratory pressure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Maximal Inspiratory Pressure	Maximal inspiratory pressure was assessed as an indicator of inspiratory respiratory muscle strength. Measurements were performed using the Micro Medical/CareFusion MicroRPM device. Participants performed maximal inspiratory efforts from residual volume in a seated position while wearing nose clips. At least three trials were performed, and the highest valid value was used for analysis.	Baseline and immediately after the 4-week intervention.

Collaborators and Investigators

• Sponsor: Mehmet İsmail TOSUN

Publications and helpful links

General Publications

• Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST.
• Beaumont M, Forget P, Couturaud F, Reychler G. Effects of inspiratory muscle training in COPD patients: A systematic review and meta-analysis. Clin Respir J. 2018 Jul;12(7):2178-2188. doi: 10.1111/crj.12905. Epub 2018 May 23.
• ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
• Eser E, Cevik C, Baydur H, Gunes S, Esgin TA, Oztekin CS, Eker E, Gumussoy U, Eser GB, Ozyurt B. Reliability and validity of the Turkish version of the WHO-5, in adults and older adults for its use in primary care settings. Prim Health Care Res Dev. 2019 Jul 1;20:e100. doi: 10.1017/S1463423619000343.

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2026
• Primary Completion (Actual): May 15, 2026
• Study Completion (Actual): May 15, 2026

Study Registration Dates

• First Submitted: May 17, 2026
• First Submitted That Met QC Criteria: May 17, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 17, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Aerobic Exercise; Pulmonary Rehabilitation; Inspiratory Muscle Training; Respiratory Muscle Strength; Maximal Inspiratory Pressure; Detraining
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: 2026-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be publicly shared due to participant confidentiality and ethical restrictions. Aggregate study findings may be shared in scientific publications.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No