Chronic Kidney Disease (Stages 4 and 5)RespDialysisNCT07811947
Inspiratory Muscle Training During Hemodialysis
A study testing Inspiratory Muscle Training in people with Chronic Kidney Disease (Stages 4 and 5) and Hemodialysis, run by Tecsam - Tecnologia e Servicos Medicos at 1 site in Portugal.
Trial summary
This study will evaluate whether inspiratory muscle training performed during hemodialysis improves inspiratory muscle strength in adults receiving regular hemodialysis. After an initial 12-week period without study-protocolized inspiratory muscle training, participants will be randomly assigned to inspiratory muscle… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease (Stages 4 and 5), Hemodialysis, Inspiratory Muscle Training
- What is being tested?
- Inspiratory Muscle Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 sitePortugal
- Study dates
- 20 Sep 2026to Sep 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Enrolled in a regular hemodialysis program for at least 3 months
- Receiving hemodialysis three times per week
- Able to understand study information
- Able to provide written informed consent
Who cannot join
- Recent history of clinically significant cardiac arrhythmia, acute myocardial infarction, unstable angina, severe valvular disease, or uncontrolled hypertension
- Medical condition that contraindicates an increase in intrathoracic negative pressure or performance of inspiratory muscle training
- Uncontrolled acute or decompensated medical condition that compromises participant safety or the validity of the assessments
- Severe cognitive impairment that prevents provision of informed consent or completion of study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site
Tecsam - Tecnologia e Serviços Médicos
Mirandela, Braganza District, 5370-530
Sónia Casado, +351965364163, soniaaccasado@gmail.com
soniaaccasado@gmail.com
About this study
Official title: Impact of Inspiratory Muscle Training on Functional Capacity, Lung Volumes, Electrical Activity and Inspiratory Muscle Strength in Hemodialysed Patients
This study will evaluate whether inspiratory muscle training performed during hemodialysis improves inspiratory muscle strength in adults receiving regular hemodialysis. After an initial 12-week period without study-protocolized inspiratory muscle training, participants will be randomly assigned to inspiratory muscle training plus usual care or usual care alone for 12 weeks. The primary outcome is the change in maximum inspiratory pressure from baseline to Week 12. The study will also assess lung function, walking capacity, handgrip strength, electrical activity of inspiratory muscles, dyspnea, body composition, health-related quality of life, and daily physical activity.
Read the detailed description
Individuals receiving regular hemodialysis may experience reduced inspiratory muscle strength, impaired lung function, dyspnea, reduced functional capacity, decreased daily physical activity, and changes in body composition. This single-center, open-label, randomized controlled study will evaluate the effect of intradialytic inspiratory muscle training on inspiratory muscle strength and related clinical and functional outcomes.
All participants will first complete a 12-week observational period without study-protocolized inspiratory muscle training. Following the T0 assessment, participants will be randomly assigned in a 1:1 ratio to inspiratory muscle training plus usual care or usual care alone for 12 weeks. Participants assigned to inspiratory muscle training will perform training during hemodialysis using the POWERbreathe KH2 device.
After the Week 12 assessment, participants initially assigned to inspiratory muscle training will undergo a second independent 1:1 randomization to either weekly maintenance inspiratory muscle training or discontinuation of study-protocolized training for 12 weeks. Participants initially assigned to usual care will continue usual care. Following the Week 24 assessment, no participant will receive study-protocolized inspiratory muscle training for 12 weeks. Follow-up assessments will be conducted through Week 52 after the initial randomization.
The primary comparison is between inspiratory muscle training plus usual care and usual care alone at Week 12. Analyses of the second randomization and later follow-up assessments are exploratory.
- Being tested
- Inspiratory Muscle Training, Usual Care
- Keywords
- hemodialysis, respiratory muscles, muscle strength, rehabilitation, functional capacity
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle TrainingBehavioural
Intradialytic inspiratory muscle training will be performed using the POWERbreathe KH2 electronic device. Training will begin approximately 30 minutes after the start of the hemodialysis session after confirmation of clinical and hemodynamic stability. Participants will be seated in the hemodialysis chair with the backrest raised to at least 45 degrees.
The initial program will be performed three times weekly for 12 weeks, for a total of 36 planned sessions. Each session will include three sets of 30 inhalations against a resistance corresponding to 50 percent of maximum inspiratory pressure, with a two-minute rest between sets. Maximum inspiratory pressure will be reassessed after every six completed sessions, and resistance will be adjusted to 50 percent of the newly measured value.
Training will be interrupted for chest pain, intolerable dyspnea, desaturation, hypotension, arrhythmia, intolerable fatigue, participant request, or any sign or symptom raising clinical concern.
Usual CareOther
Usual care consists of the regular hemodialysis schedule and the clinical and nursing care routinely provided by the hemodialysis unit. No study-protocolized inspiratory muscle training will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Inspiratory Muscle Training Plus Usual Care | Experimental | From T0 to Week 12, participants will receive intradialytic inspiratory muscle training in addition to usual hemodialysis care. After the Week 12 assessment, participants initially assigned to Group A will undergo a second randomization to either weekly maintenance inspiratory muscle training or discontinuation of study-protocolized inspiratory muscle training. Receives: Behavioral: Inspiratory Muscle Training; Other: Usual Care |
| Group B: Usual Care | Active comparator | Participants will continue regular hemodialysis and routine clinical and nursing care provided by the hemodialysis unit. They will not receive study-protocolized inspiratory muscle training during the study participation period. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maximum Inspiratory Pressure From Baseline to Week 12
Maximum inspiratory pressure will be measured using the POWERbreathe KH2 device with the participant seated with back support before the second or third weekly hemodialysis session. The outcome is the change in maximum inspiratory pressure, expressed in cmH2O.
Measured: Baseline at T0 and post-intervention at Week 12
Secondary outcomes (9)
Change in Modified Borg Dyspnea Scale Score From Baseline to Week 12
Dyspnea will be assessed using the Modified Borg Dyspnea Scale, with scores ranging from 0 to 10, at rest and after the 6-Minute Walk Test. Higher scores indicate greater perceived dyspnea. The outcome is the change in Modified Borg Dyspnea Scale score.
Measured: Baseline at T0 and post-intervention at Week 12
Change in Dominant-Hand Handgrip Strength From Baseline to Week 12
Handgrip strength will be assessed using the GripWise dynamometer with the participant seated with back support. Three attempts will be performed for each hand. The highest value obtained for the dominant hand, expressed in kilograms, will be used as the primary handgrip variable.
Measured: Baseline at T0 and post-intervention at Week 12
Change in Body Composition From Baseline to Week 12
Body composition will be assessed by bioimpedance using the InBody BWA 2.0 device at the end of the second or third weekly hemodialysis session. Outcomes are changes in fat-free mass, expressed in kilograms; skeletal muscle mass, expressed in kilograms; and fat mass, expressed as a percentage.
Measured: Baseline at T0 and post-intervention at Week 12
Change in KDQOL-SF 1.3 Health-Related Quality-of-Life Scores From Baseline to Week 12
Health-related quality of life will be assessed using the Kidney Disease Quality of Life Short Form, version 1.3 (KDQOL-SF 1.3). Scores will be calculated according to the instrument scoring instructions and converted to a 0 to 100 scale. Physical and mental summary measures derived from the SF-36 will be prioritized. Higher scores indicate better health-related quality of life in the respective domain.
Measured: Baseline at T0 and post-intervention at Week 12
Change in Forced Vital Capacity From Baseline to Week 12
Forced vital capacity will be measured by spirometry using the MIR Spirolab device with the participant seated with back support. The outcome is the change in forced vital capacity, expressed in liters and, when available, as a percentage of the predicted value.
Measured: Baseline at T0 and post-intervention at Week 12
Change in Surface Electromyography Root Mean Square Amplitude of Inspiratory Muscles From Baseline to Week 12
Surface electromyography will assess electrical activity of the scalene, sternocleidomastoid, intercostal, and diaphragm muscles using the Sessantaquattro+ system. Electromyographic signal amplitude will be quantified as root mean square amplitude and analyzed separately for each assessed muscle.
Measured: Baseline at T0 and post-intervention at Week 12
Change in Average Daily Steps From Baseline to Week 12
Daily physical activity will be assessed using a Garmin Forerunner 55 watch worn for seven consecutive days during each assessment period. The primary variable is the average number of steps per day, calculated from valid monitoring days. An assessment period requires at least four valid monitoring days.
Measured: Baseline at T0 and post-intervention at Week 12
Change in Forced Expiratory Volume in 1 Second From Baseline to Week 12
Forced expiratory volume in 1 second will be measured by spirometry using the MIR Spirolab device with the participant seated with back support. The outcome is the change in forced expiratory volume in 1 second, expressed in liters and, when available, as a percentage of the predicted value.
Measured: Baseline at T0 and post-intervention at Week 12
Change in 6-Minute Walk Test Distance From Baseline to Week 12
Functional capacity will be assessed by the distance covered during the 6-Minute Walk Test on a flat, straight 30-meter corridor. The outcome is the change in total walking distance, expressed in meters. Higher values indicate greater functional capacity. Participants may use their usual walking aid when routinely used in daily activities.
Measured: Baseline at T0 and post-intervention at Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start20 Sep 2026 (estimated)
- Primary completion21 Dec 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease (Stages 4 and 5)Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Following a 12-week observational period without study-protocolized inspiratory muscle training, participants will be randomized in a 1:1 ratio to inspiratory muscle training plus usual care or usual care alone for 12 weeks. After the Week 12 assessment, participants initially assigned to inspiratory muscle training will undergo a second independent 1:1 randomization to weekly maintenance inspiratory muscle training or discontinuation of study-protocolized training for 12 weeks. Participants initially assigned to usual care will continue usual care. All participants will subsequently undergo 12 weeks without study-protocolized inspiratory muscle training and follow-up through Week 52 after initial randomization
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tecsam - Tecnologia e Servicos Medicos
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de León, Instituto Politécnico de Bragança, Foundation for Science and Technology, Portugal
- Responsible party
- Principal investigator, Sónia Casado, Tecsam - Tecnologia e Servicos Medicos
- Investigators
- André Filipe Morais Pinto Novo, Principal investigator, Instituto Politécnico de Bragança
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07811947
- Sponsor's protocol ID
- 10.54499/2024.17137.PEX
- Other IDs
- P522771-R636876-D1882423
- Acronym
- RespDialysis
- Status last verified
- Sep 2026
- First submitted
- 16 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared, as the dataset contains sensitive health information and potentially identifiable data. Data will be used solely for the purposes of the present study, stored securely, and reported only in aggregated and anonymized form to ensure participant confidentiality and privacy.
Publications
Casado SAC, Mendes MER, Preto LSR, Vila-Cha CJF, Novo AFMP. Effect of inspiratory muscle training in hemodialysis patients: a systematic review of randomized controlled trials. Disabil Rehabil. 2026 Mar;48(5):1205-1215. doi: 10.1080/09638288.2025.2554947. Epub 2025 Sep 3.
PubMed 40901738
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Inspiratory Muscle Training on Functional Capacity, Lung Volumes, Electrical Activity and Inspiratory Muscle Strength in Hemodialysed Patients
- ClinicalTrials.gov ID
- NCT07811947
- Acronym / sponsor ID
- RespDialysis / 10.54499/2024.17137.PEX
- Keywords
- hemodialysis, respiratory muscles, muscle strength, rehabilitation, functional capacity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Tecsam - Tecnologia e Servicos MedicosUniversity, hospital or other
- Collaborators
- Universidad de León, Instituto Politécnico de Bragança, Foundation for Science and Technology, Portugal
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 21 Dec 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 10 Sep 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.
This study will evaluate whether inspiratory muscle training performed during hemodialysis improves inspiratory muscle strength in adults receiving regular hemodialysis. After an initial 12-week period without study-protocolized inspiratory muscle training, participants will be randomly assigned to inspiratory muscle training plus usual care or usual care alone for 12 weeks. The primary outcome is the change in maximum inspiratory pressure from baseline to Week 12. The study will also assess lung function, walking capacity, handgrip strength, electrical activity of inspiratory muscles, dyspnea, body composition, health-related quality of life, and daily physical activity.
Detailed description
Individuals receiving regular hemodialysis may experience reduced inspiratory muscle strength, impaired lung function, dyspnea, reduced functional capacity, decreased daily physical activity, and changes in body composition. This single-center, open-label, randomized controlled study will evaluate the effect of intradialytic inspiratory muscle training on inspiratory muscle strength and related clinical and functional outcomes.
All participants will first complete a 12-week observational period without study-protocolized inspiratory muscle training. Following the T0 assessment, participants will be randomly assigned in a 1:1 ratio to inspiratory muscle training plus usual care or usual care alone for 12 weeks. Participants assigned to inspiratory muscle training will perform training during hemodialysis using the POWERbreathe KH2 device.
After the Week 12 assessment, participants initially assigned to inspiratory muscle training will undergo a second independent 1:1 randomization to either weekly maintenance inspiratory muscle training or discontinuation of study-protocolized training for 12 weeks. Participants initially assigned to usual care will continue usual care. Following the Week 24 assessment, no participant will receive study-protocolized inspiratory muscle training for 12 weeks. Follow-up assessments will be conducted through Week 52 after the initial randomization.
The primary comparison is between inspiratory muscle training plus usual care and usual care alone at Week 12. Analyses of the second randomization and later follow-up assessments are exploratory.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Following a 12-week observational period without study-protocolized inspiratory muscle training, participants will be randomized in a 1:1 ratio to inspiratory muscle training plus usual care or usual care alone for 12 weeks. After the Week 12 assessment, participants initially assigned to inspiratory muscle training will undergo a second independent 1:1 randomization to weekly maintenance inspiratory muscle training or discontinuation of study-protocolized training for 12 weeks. Participants initially assigned to usual care will continue usual care. All participants will subsequently undergo 12 weeks without study-protocolized inspiratory muscle training and follow-up through Week 52 after initial randomization
| Arm | Type | Receives |
|---|---|---|
| Group A: Inspiratory Muscle Training Plus Usual Care | Experimental | Behavioral: Inspiratory Muscle Training, Other: Usual CareFrom T0 to Week 12, participants will receive intradialytic inspiratory muscle training in addition to usual hemodialysis care. After the Week 12 assessment, participants initially assigned to Group A will undergo a second randomization to either weekly maintenance inspiratory muscle training or discontinuation of study-protocolized inspiratory muscle training. |
| Group B: Usual Care | Active comparator | Other: Usual CareParticipants will continue regular hemodialysis and routine clinical and nursing care provided by the hemodialysis unit. They will not receive study-protocolized inspiratory muscle training during the study participation period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older
- Enrolled in a regular hemodialysis program for at least 3 months
- Receiving hemodialysis three times per week
- Able to understand study information
- Able to provide written informed consent
Key exclusion criteria (4 listed)
- Recent history of clinically significant cardiac arrhythmia, acute myocardial infarction, unstable angina, severe valvular disease, or uncontrolled hypertension
- Medical condition that contraindicates an increase in intrathoracic negative pressure or performance of inspiratory muscle training
- Uncontrolled acute or decompensated medical condition that compromises participant safety or the validity of the assessments
- Severe cognitive impairment that prevents provision of informed consent or completion of study procedures
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 |
|---|---|---|
| Inspiratory Muscle TrainingIntradialytic inspiratory muscle training will be performed using the POWERbreathe KH2 electronic device. Training will begin approximately 30 minutes after the start of the hemodialysis session after confirmation of clinical and hemodynamic stability. Participants will be seated in the hemodialysis chair with the backrest raised to at least 45 degrees. The initial program will be performed three times weekly for 12 weeks, for a total of 36 planned sessions. Each session will include three sets of 30 inhalations against a resistance corresponding to 50 percent of maximum inspiratory pressure, with a two-minute rest between sets. Maximum inspiratory pressure will be reassessed after every six completed sessions, and resistance will be adjusted to 50 percent of the newly measured value. Training will be interrupted for chest pain, intolerable dyspnea, desaturation, hypotension, arrhythmia, intolerable fatigue, participant request, or any sign or symptom raising clinical concern. | Behavioural | Group A: Inspiratory Muscle Training Plus Usual Care |
| Usual CareUsual care consists of the regular hemodialysis schedule and the clinical and nursing care routinely provided by the hemodialysis unit. No study-protocolized inspiratory muscle training will be administered. | Other | Group A: Inspiratory Muscle Training Plus Usual Care, Group B: Usual Care |
Primary outcome
Change in Maximum Inspiratory Pressure From Baseline to Week 12
Time frame: Baseline at T0 and post-intervention at Week 12
Maximum inspiratory pressure will be measured using the POWERbreathe KH2 device with the participant seated with back support before the second or third weekly hemodialysis session. The outcome is the change in maximum inspiratory pressure, expressed in cmH2O.
9 secondary outcomes
Change in Modified Borg Dyspnea Scale Score From Baseline to Week 12
Time frame: Baseline at T0 and post-intervention at Week 12
Change in Dominant-Hand Handgrip Strength From Baseline to Week 12
Time frame: Baseline at T0 and post-intervention at Week 12
Change in Body Composition From Baseline to Week 12
Time frame: Baseline at T0 and post-intervention at Week 12
Change in KDQOL-SF 1.3 Health-Related Quality-of-Life Scores From Baseline to Week 12
Time frame: Baseline at T0 and post-intervention at Week 12
Change in Forced Vital Capacity From Baseline to Week 12
Time frame: Baseline at T0 and post-intervention at Week 12
Change in Surface Electromyography Root Mean Square Amplitude of Inspiratory Muscles From Baseline to Week 12
Time frame: Baseline at T0 and post-intervention at Week 12
Change in Average Daily Steps From Baseline to Week 12
Time frame: Baseline at T0 and post-intervention at Week 12
Change in Forced Expiratory Volume in 1 Second From Baseline to Week 12
Time frame: Baseline at T0 and post-intervention at Week 12
Change in 6-Minute Walk Test Distance From Baseline to Week 12
Time frame: Baseline at T0 and post-intervention at Week 12
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 10 Sep 2026.
- Background: PubMed 40901738Casado SAC, Mendes MER, Preto LSR, Vila-Cha CJF, Novo AFMP. Effect of inspiratory muscle training in hemodialysis patients: a systematic review of randomized controlled trials. Disabil Rehabil. 2026 Mar;48(5):1205-1215. doi: 10.1080/09638288.2025.2554947. Epub 2025 Sep 3.
- Official project page with study protocol details - Official project page containing the detailed study protocol for respiratory rehabilitation in hemodialysis patients, including objectives, methodology, and implementation plan.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared, as the dataset contains sensitive health information and potentially identifiable data. Data will be used solely for the purposes of the present study, stored securely, and reported only in aggregated and anonymized form to ensure participant confidentiality and privacy.
Related trials for Chronic Kidney Disease (Stages 4 and 5)
Recruiting
Safety of a Healthy Plant-based Diet With Higher Potassium Content, Compared to a Healthy Plant-based Diet With Limited Potassium Content in Patients With Chronic Kidney Disease: A Pilot Study
Hyperkalemia, Chronic Kidney Disease (Stages 4 and 5)
Active, not recruitingObservational study
Metabolic Status and Risk of Chronic Kidney Disease in French Overseas Populations With Morbid Obesity (OBECAMcohort).
Morbid Obesity, Chronic Kidney Disease (Stage 3-4)
Recruiting
Prospective Analysis of Self Medication With Phytotherapy in Nephropatic Patients.
Chronic Kidney Disease (Stage 3-4), Chronic Kidney Disease (Stages 4 and 5)
Not yet recruiting
Feasibility of the COMFORT (COmplex Symptom Management Intervention FOR adulTs With Advanced Kidney Disease) Intervention for Adults With Advanced Kidney Disease and Their Informal Caregivers
Chronic Kidney Disease (Stages 4 and 5)
Recruiting
A Communication-Priming Intervention to Improve Shared Decision-Making Between Older Adults With Advanced CKD and Clinicians
Chronic Kidney Disease Stage 4, Chronic Kidney Disease Stage 5
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.
André Filipe Morais Pinto Novo principal investigator
Instituto Politécnico de Bragança
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Training in people with Chronic Kidney Disease (Stages 4 and 5) and Hemodialysis, run by Tecsam - Tecnologia e Servicos Medicos at 1 site in Portugal.
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 5 inclusion and 4 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 10 Sep 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 Portugal. 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. 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 Sónia Alexandra Claro Casado (+351965364163, soniaaccasado@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Maximum Inspiratory Pressure From Baseline to Week 12 (time frame: Baseline at T0 and post-intervention at Week 12). 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 NCT07811947, which also lists 1 linked publication.
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 10 Sep 2026.