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

NCT07604961 | Completed

• 1 other identifier: 2026-08
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Inspiratory Muscle Training; Aerobic Exercise; Detraining; Respiratory Muscle Strength; Maximal Inspiratory Pressure; Pulmonary Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (5)

Control

NO INTERVENTION

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.

Inspiratory Muscle Training

EXPERIMENTAL

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

Aerobic Exercise

EXPERIMENTAL

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

Combined Inspiratory Muscle Training and Aerobic Exercise

EXPERIMENTAL

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; Behavioral: Aerobic Exercise

Placebo Inspiratory Muscle Training

PLACEBO COMPARATOR

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

Interventions

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.

Combined Inspiratory Muscle Training and Aerobic Exercise; Inspiratory Muscle Training

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.

Also known as: Supervised Treadmill Walking, Submaximal Aerobic Exercise

Aerobic Exercise; Combined Inspiratory Muscle Training and 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.

Placebo Inspiratory Muscle Training

Eligibility Criteria

• Age: 48 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mehmet İsmail TOSUN: lead

Study Sites (1)

Hitit University Çorum Erol Olçok Training and Research Hospital

Çorum, Çorum, 1900, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 32800004 BACKGROUND

• 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.

  PMID: 12091180 BACKGROUND

• 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.

  PMID: 31613151 BACKGROUND

• 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.

  PMID: 29665262 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants and intervention practitioners were blinded to the resistance level in the true inspiratory muscle training and placebo inspiratory muscle training groups. The device resistance was preset by the principal investigator before each session and concealed from the practitioners. Due to the nature of aerobic exercise, masking was not feasible for participants and supervising staff in the aerobic and combined exercise groups. Researchers responsible for data analysis remained blinded to group allocation until completion of the post-test assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants were randomly assigned to one of five parallel groups: control, inspiratory muscle training, aerobic exercise, combined inspiratory muscle training and aerobic exercise, or placebo inspiratory muscle training. Each group followed its assigned condition during the four-week intervention period, followed by a two-week detraining period.

Study Record Dates

• First Submitted: May 17, 2026
• First Posted: May 22, 2026
• Study Start: April 6, 2026
• Primary Completion: May 15, 2026
• Study Completion: May 15, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)