Pulmonary Disease, Chronic ObstructiveNCT07415746
Functional Assessment and Pulmonary Rehabilitation: Challenges and Perspectives for Comprehensive Care
A study testing Pulmonary rehabilitation combined with inspiratory muscle training in people with Pulmonary Disease, Chronic Obstructive, run by Universidade do Estado do Pará at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Pulmonary rehabilitation combined with inspiratory muscle training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2026to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Teaching and Assistance Unit in Physiotherapy and Occupational Therapy
Belém, Pará, 66093605
Gleidiane L. S. Santos, 55+ (91) 991023889, gleidianesales05@gmail.com
About this study
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.
Read the detailed description
This study aims to evaluate diaphragmatic muscle function and mobility through ultrasonography in individuals diagnosed with Chronic Obstructive Pulmonary Disease (COPD) undergoing a pulmonary rehabilitation program combined with inspiratory muscle training (IMT). The research will investigate the relationship between diaphragmatic behavior, clinical severity, and the repercussions on respiratory capacity.
Upon meeting the inclusion criteria, participants will undergo an initial clinical and sociodemographic assessment, including medical history, spirometry, manovacuometry, and the 6-Minute Walk Test (6MWT). Symptom impact and dyspnea will be measured using the COPD Assessment Test (CAT) and the mMRC scale. Participants will then be allocated into two groups:
IMT Group (IMTG): Participants will perform IMT using the PowerBreathe Classic (3 sets of 10 reps; load increasing from 50% to 60% of MIP), followed by resistance training (60-70% of 1RM) and aerobic training (20 minutes on a stationary bike at 60-80% intensity based on the Karvonen Formula and Borg Scale 4-6).
Control Group (CG): Participants will undergo the exact same resistance and aerobic training protocols as the IMTG. However, they will perform a Sham IMT using the device at its minimum load setting (3 sets of 10 reps) to maintain the same training volume and procedural consistency without the threshold training effect.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Pulmonary rehabilitation combined with inspiratory muscle training, Pulmonary rehabilitation with placebo inspiratory muscle training
- Keywords
- Pulmonary Disease, Chronic Obstructive, Rehabilitation, Ultrasonography, Breathing Exercises
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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%).
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Pulmonary rehabilitation with placebo inspiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and after 7 weeks.
Secondary outcomes (7)
Diaphragmatic Thickness (Tdi)
Diaphragm thickness will be assessed using a linear B-mode transducer, positioned between the eighth and ninth intercostal spaces in the anterior mid-axillary line, with the result expressed in centimeters (cm).
Measured: Baseline and after 7 weeks.
Diaphragmatic Thickening Fraction (DTF)
The DTF is calculated as follows: [(thickness at end-inspiration - thickness at end-expiration) / thickness at end-expiration] x 100. It is an indicator of diaphragmatic contractile activity (VIEIRA et al., 2020).
Measured: Baseline and after 7 weeks.
Lung Function Parameters (Spirometry)
Pulmonary function will be assessed using the MIR SPIRODOC spirometer with WinspiroPRO software. At least three maneuvers will be performed to obtain the best curve, following international guidelines. The following parameters will be evaluated: Forced Vital Capacity (FVC), Forced Expiratory Volume in the first second (FEV1), FEV1/FVC ratio (Tiffeneau index), Forced Expiratory Flow between 25% and 75% of FVC (FEF25-75%), and Forced Expiratory Time (FET).
Measured: Baseline and after 7 weeks.
Respiratory Muscle Strength (MIP and MEP)
Respiratory muscle strength will be assessed using the MVD300 digital manometer (Globalmed), with results expressed in cmH2O. The protocol includes measuring Maximum Inspiratory Pressure (MIP) and Maximum Expiratory Pressure (MEP). Participants will perform maneuvers until they obtain three acceptable measurements, with a variation of less than 10% between them. The highest value will be recorded for analysis. Predicted values will be calculated based on the equations proposed by Neder et al. (1999).
Measured: Baseline and after 7 weeks.
COPD Assessment Test (CAT) Score
The CAT is a validated questionnaire used to assess the impact of Chronic Obstructive Pulmonary Disease (COPD) on health status. It consists of 8 items, each scored from 0 to 5. Total scores range from 0 to 40, where higher scores indicate a greater impact of the disease on the patient's life.
Measured: Baseline and after 7 weeks
Medical Research Council (MRC) Dyspnea Scale
A scale composed of 5 items ranging from 0 to 4 points, used to grade the functional limitation caused by dyspnea in activities of daily living. As recommended by the guidelines of the Brazilian Society of Pulmonology and Phthisiology (SBPT), the scale assesses the patient's subjective perception, where higher scores indicate greater symptom severity and a worse prognosis in COPD.
Measured: Baseline and after 7 weeks of intervention.
Functional Capacity (6-Minute Walk Test - 6MWT)
The test will be applied in a standardized manner and according to the guidelines established by the American Thoracic Society (ATS), recording systemic blood pressure (BP, in mmHg), heart rate (HR, in bpm), respiratory rate (RR, in bpm), peripheral oxygen saturation (SpO2, in %), and dyspnea level at the beginning and end of the test, using the modified Borg scale (APPENDIX C). The test will be performed in a corridor at least 30 meters long, with a flat, non-slip surface. At the turnaround points, there will be cones signaling for the volunteer to complete the laps within the determined time. At the end, the distance covered in meters will be calculated (ATS, 2002; BORGES; CARVALHO, 2006).
Measured: Baseline and after 7 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Estado do Pará
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gleidiane Lorrana Sales Dos Santos, Universidade do Estado do Pará
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415746
- Sponsor's protocol ID
- 8.013.941
- Status last verified
- Feb 2026
- First submitted
- 23 Jan 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 10412550Spruit 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.
PubMed 24127811Beaumont 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.
PubMed 29371379Troosters 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.
PubMed 37286219ATS 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.
PubMed 12091180Santana 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.
PubMed 33237154Hayata 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.
PubMed 27695306
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Assessment and Pulmonary Rehabilitation: Challenges and Perspectives for Comprehensive Care
- ClinicalTrials.gov ID
- NCT07415746
- Acronym / sponsor ID
- 8.013.941
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Pulmonary Disease, Chronic Obstructive, Rehabilitation, Ultrasonography, Breathing Exercises
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Universidade do Estado do ParáUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study aims to evaluate diaphragmatic muscle function and mobility through ultrasonography in individuals diagnosed with Chronic Obstructive Pulmonary Disease (COPD) undergoing a pulmonary rehabilitation program combined with inspiratory muscle training (IMT). The research will investigate the relationship between diaphragmatic behavior, clinical severity, and the repercussions on respiratory capacity.
Upon meeting the inclusion criteria, participants will undergo an initial clinical and sociodemographic assessment, including medical history, spirometry, manovacuometry, and the 6-Minute Walk Test (6MWT). Symptom impact and dyspnea will be measured using the COPD Assessment Test (CAT) and the mMRC scale. Participants will then be allocated into two groups:
IMT Group (IMTG): Participants will perform IMT using the PowerBreathe Classic (3 sets of 10 reps; load increasing from 50% to 60% of MIP), followed by resistance training (60-70% of 1RM) and aerobic training (20 minutes on a stationary bike at 60-80% intensity based on the Karvonen Formula and Borg Scale 4-6).
Control Group (CG): Participants will undergo the exact same resistance and aerobic training protocols as the IMTG. However, they will perform a Sham IMT using the device at its minimum load setting (3 sets of 10 reps) to maintain the same training volume and procedural consistency without the threshold training effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TMI Group (GT) | Active comparator | Device: Pulmonary rehabilitation combined with inspiratory muscle trainingParticipants 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. |
| Control Group (CG) | Sham comparator | Device: Pulmonary rehabilitation with placebo inspiratory muscle trainingParticipants 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary rehabilitation combined with inspiratory muscle trainingRehabilitation 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%). | Device | TMI Group (GT) |
| Pulmonary rehabilitation with placebo inspiratory muscle trainingPulmonary 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. | Device | Control Group (CG) |
Primary outcome
Diaphragmatic Excursion (DE)
Time frame: Baseline and after 7 weeks.
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).
7 secondary outcomes
Diaphragmatic Thickness (Tdi)
Time frame: Baseline and after 7 weeks.
Diaphragmatic Thickening Fraction (DTF)
Time frame: Baseline and after 7 weeks.
Lung Function Parameters (Spirometry)
Time frame: Baseline and after 7 weeks.
Respiratory Muscle Strength (MIP and MEP)
Time frame: Baseline and after 7 weeks.
COPD Assessment Test (CAT) Score
Time frame: Baseline and after 7 weeks
Medical Research Council (MRC) Dyspnea Scale
Time frame: Baseline and after 7 weeks of intervention.
Functional Capacity (6-Minute Walk Test - 6MWT)
Time frame: Baseline and after 7 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Background: PubMed 10412550Neder 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.
- Background: PubMed 24127811Spruit 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.
- Background: PubMed 29371379Beaumont 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.
- Background: PubMed 37286219Troosters 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.
- Background: PubMed 12091180ATS 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.
- Background: PubMed 33237154Santana 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.
- Background: PubMed 27695306Hayata 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary rehabilitation combined with inspiratory muscle training in people with Pulmonary Disease, Chronic Obstructive, run by Universidade do Estado do Pará at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gleidiane L. S. Santos (55+ (91) 991023889, gleidianesales05@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragmatic Excursion (DE) (time frame: Baseline and after 7 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07415746, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.