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

17. Mai 2026 aktualisiert von: Mehmet İsmail TOSUN

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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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

Studientyp

Interventionell

Einschreibung (Tatsächlich)

68

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Türkei (türkiye)
    • Çorum
      • Çorum, Çorum, Türkei (türkiye), 1900
        • Hitit University Corum Erol Olçok Training and Research Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: 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.
Gerät: 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.
Verhalten: 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.
Andere Namen:
  • 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.
Gerät: 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.
Verhalten: 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.
Andere Namen:
  • Supervised Treadmill Walking
  • Submaximal Aerobic Exercise
Placebo-Komparator: 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.
Gerät: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Maximal Inspiratory Pressure
Zeitfenster: 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.
Baseline and immediately after the 4-week intervention.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Mehmet İsmail TOSUN

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

6. April 2026

Primärer Abschluss (Tatsächlich)

15. Mai 2026

Studienabschluss (Tatsächlich)

15. Mai 2026

Studienanmeldedaten

Zuerst eingereicht

17. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

17. Mai 2026

Zuerst gepostet (Tatsächlich)

22. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

22. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

17. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2026-08

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Individual participant data will not be publicly shared due to participant confidentiality and ethical restrictions. Aggregate study findings may be shared in scientific publications.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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