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NCT Number: NCT07604961

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

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.

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Key information

Age range

48 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hitit University Çorum Erol Olçok Training and Research Hospital

Çorum, 1900, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inspiratory muscle training

Device

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.

Aerobic Exercise

Behavioral

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 inspiratory muscle training

Device

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.

Primary outcomes

  1. Change in Maximal Inspiratory Pressure

    Time frame: Baseline and immediately after the 4-week intervention.

    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.

Sponsors and collaborators

Lead sponsor

Mehmet İsmail TOSUN

Other

Registry information

Official study title

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

Acronym: IMT-COPD

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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