NCT07415746

Brief Summary

Individuals with Chronic Obstructive Pulmonary Disease (COPD) present with respiratory muscle dysfunction, characterized by reduced diaphragmatic contractility and mobility due to pulmonary hyperinflation, oxidative stress, and systemic inflammation. Effective assessment of diaphragmatic function is crucial for monitoring progress in pulmonary rehabilitation programs. This study aims to evaluate diaphragmatic function and mobility in COPD patients undergoing pulmonary rehabilitation with inspiratory muscle training, using ultrasound, and to identify associations between diaphragmatic dysfunction and clinical symptoms such as dyspnea and fatigue. A randomized clinical trial will be conducted to investigate the impact of rehabilitation on diaphragmatic function, correlating it with pulmonary function and physical performance.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress72%
Mar 2026Oct 2026

First Submitted

Initial submission to the registry

January 23, 2026

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

7 months

First QC Date

January 23, 2026

Last Update Submit

February 9, 2026

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Pulmonary Disease, Chronic ObstructiveRehabilitationUltrasonographyBreathing Exercises

Outcome Measures

Primary Outcomes (1)

  • Diaphragmatic Excursion (DE)

    Diaphragmatic excursion will be assessed by visualizing the right hemidiaphragm via an anterior subcostal approach between the midclavicular and anterior axillary lines, using a convex transducer in M-mode, with results expressed in millimeters (mm).

    Baseline and after 7 weeks.

Secondary Outcomes (7)

  • Diaphragmatic Thickness (Tdi)

    Baseline and after 7 weeks.

  • Diaphragmatic Thickening Fraction (DTF)

    Baseline and after 7 weeks.

  • Lung Function Parameters (Spirometry)

    Baseline and after 7 weeks.

  • Respiratory Muscle Strength (MIP and MEP)

    Baseline and after 7 weeks.

  • COPD Assessment Test (CAT) Score

    Baseline and after 7 weeks

  • +2 more secondary outcomes

Study Arms (2)

TMI Group (GT)

ACTIVE COMPARATOR

Participants in this arm will undergo an intervention consisting of resistance and aerobic exercises, combined with inspiratory muscle training. The protocol will be conducted over 7 weeks, comprising 20 sessions performed 3 times per week.

Device: Pulmonary rehabilitation combined with inspiratory muscle training

Control Group (CG)

SHAM COMPARATOR

Participants in this arm will undergo an intervention consisting of resistance and aerobic exercises, combined with sham inspiratory muscle training (IMT). The sham IMT protocol will utilize only the minimum load of the device. The protocol will be conducted over 7 weeks, comprising 20 sessions performed 3 times per week.

Device: Pulmonary rehabilitation with placebo inspiratory muscle training

Interventions

Pulmonary rehabilitation combined with inspiratory muscle trainingDEVICE

Rehabilitation will begin with diaphragmatic breathing and Inspiratory Muscle Training (IMT) with the Powerbreathe Classic device (3 sets of 10 repetitions, 1 min rest). The initial load will be 50% of PImáx, progressing 10% every 10 sessions until reaching 60%, with monitoring for fatigue and dyspnea. Resistance Training (RT) will utilize lat pulldown, bench press, and leg press on the weight training station. The load is based on the 1RM test, starting at 60% and progressing to 70% after 10 sessions. Aerobic Training (AT) will take place on a stationary bike for 20 min (5 min warm-up and 15 min workout). To calculate the Training Heart Rate (THR), the Karvonen formula will be used: THR = (HRmax - HRrest) x % target intensity + HRrest, followed by the calculation of the Maximum Heart Rate (HRmax) using the Tanaka formula: HRmax = 208 - (0.7 x age). The target intensity will be set between moderate (60% - 70%) and high (70% - 80%).

TMI Group (GT)
Pulmonary rehabilitation with placebo inspiratory muscle trainingDEVICE

Pulmonary rehabilitation will consist of resistance and aerobic training protocols with the same specifications as the TMI Group. The placebo TMI will be performed on the Powerbreathe device with minimal load, consisting of 3 sets of 10 repetitions interspersed with 1 minute of rest.

Control Group (CG)

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 40 years or older.
  • Both sexes are eligible (men and women).
  • Clinically diagnosed COPD, clinically stable, classified in Stages I, II, III or IV of GOLD (Global Initiative for Chronic Obstructive Lung Disease).
  • Ability to understand and provide the signed Informed Consent Form to participate in the study.

You may not qualify if:

  • Physical limitations and/or cognitive impairment that prevent the execution of the study protocol.
  • Currently engaged in physical therapy treatment and/or physical activity that may interfere with the study results.
  • Presence of severe, uncontrolled, or disabling comorbidities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Teaching and Assistance Unit in Physiotherapy and Occupational Therapy

Belém, Pará, 66093605, Brazil

Location

Related Publications (7)

  • Neder JA, Andreoni S, Lerario MC, Nery LE. Reference values for lung function tests. II. Maximal respiratory pressures and voluntary ventilation. Braz J Med Biol Res. 1999 Jun;32(6):719-27. doi: 10.1590/s0100-879x1999000600007.

    PMID: 10412550BACKGROUND

  • Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Molken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST.

    PMID: 24127811BACKGROUND

  • Beaumont M, Mialon P, Le Ber C, Le Mevel P, Peran L, Meurisse O, Morelot-Panzini C, Dion A, Couturaud F. Effects of inspiratory muscle training on dyspnoea in severe COPD patients during pulmonary rehabilitation: controlled randomised trial. Eur Respir J. 2018 Jan 25;51(1):1701107. doi: 10.1183/13993003.01107-2017. Print 2018 Jan.

    PMID: 29371379BACKGROUND

  • Troosters T, Janssens W, Demeyer H, Rabinovich RA. Pulmonary rehabilitation and physical interventions. Eur Respir Rev. 2023 Jun 7;32(168):220222. doi: 10.1183/16000617.0222-2022. Print 2023 Jun 30.

    PMID: 37286219BACKGROUND

  • 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: 12091180BACKGROUND

  • Santana PV, Cardenas LZ, Albuquerque ALP, Carvalho CRR, Caruso P. Diaphragmatic ultrasound: a review of its methodological aspects and clinical uses. J Bras Pneumol. 2020 Nov 20;46(6):e20200064. doi: 10.36416/1806-3756/e20200064. eCollection 2020.

    PMID: 33237154BACKGROUND

  • Hayata A, Minakata Y, Matsunaga K, Nakanishi M, Yamamoto N. Differences in physical activity according to mMRC grade in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2016 Sep 13;11:2203-2208. doi: 10.2147/COPD.S109694. eCollection 2016.

    PMID: 27695306BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Gleidiane L. S. Santos

CONTACT

55+ (91) 991023889gleidianesales05@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's Student

Study Record Dates

First Submitted

January 23, 2026

First Posted

February 17, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

February 17, 2026

Record last verified: 2026-02

Locations

BR(1)