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

NCT07604961 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2026-05-22

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

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.

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.

Sponsors & Collaborators

  • Mehmet İsmail TOSUN

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
48 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-06
Primary Completion
2026-05-15
Completion
2026-05-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07604961 on ClinicalTrials.gov