Parkinson DiseaseNCT05608941
High-Intensity Respiratory Muscle Training in Individuals With Parkinson's Disease
A study testing Respiratory muscle training in people with Parkinson Disease, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
Background: Individuals with PD commonly have a significant reduction in respiratory muscle strength and inspiratory muscle endurance, and it can intensify with the disease progression. Respiratory muscle training has shown to increase respiratory muscle strength in individuals with Parkinson's Disease (PD). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Respiratory muscle training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Dec 2022to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson's disease diagnosed by a neurologist
- Ability to walk independently, with or without assistive devices
- Taking anti parkinsonian medication, and who have been medically stable for at least six months
- Classified between stages 1-3 of the modified Hoehn \& Yahr Scale (Schenkman et al., 2001)
- Maximum inspiratory pressure less or equal to -80 cmH2O or maximum expiratory pressure less or equal to 90 cmH2O
Who cannot join
- Possible cognitive impairment as determined by cutoff scores (in points) of the Mini-Mental Status Examination
- Use deep brain stimulation (DBS)
- Smokers or who stopped smoking less than six months ago; have been affected by respiratory or cardiac infections in the last month
- Had any other neurological, musculoskeletal, cardiovascular or respiratory disorders that could affect their ability to perform the tests
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Minas Gerais
Belo Horizonte, Minas Gerais, 31270-901
About this study
Official title: Effects of High-Intensity Respiratory Muscle Training on Respiratory Muscle Strength, Functional Outcomes and Quality of Life in Individuals With Parkinson's Disease: A Randomized Clinical Trial
Background: Individuals with PD commonly have a significant reduction in respiratory muscle strength and inspiratory muscle endurance, and it can intensify with the disease progression. Respiratory muscle training has shown to increase respiratory muscle strength in individuals with Parkinson's Disease (PD). However, the effect size on other functional outcomes has not been determined and/or investigated. In addition, no studies have investigated the effects of high-intensity respiratory muscle training (inspiratory and expiratory) in this population.
Objectives: The primary aim of this study will be to investigate the effects of high-intensity respiratory muscle training on inspiratory and expiratory muscle strength in individuals with PD. The secondary aim of this study will be to investigate the efficacy of high-intensity respiratory muscle training in improving inspiratory muscle endurance, peak cough flow, dyspnea, fatigue, exercise capacity, and quality of life in this population.
Read more
Design: A randomized controlled trial with blinded assessment will assign eligible participants to either: high-intensity respiratory muscle training (experimental group) or sham training (control group). Individuals will perform a home-based intervention, not directly supervised, consisted of two daily 20-min sessions (morning and afternoon), seven times a week, during eight weeks.
Study Outcomes: Primary outcomes are inspiratory and expiratory muscle strength (MIP and MEP). Secondary outcomes are respiratory muscle endurance, peak cough flow, dyspnea, fatigue, exercise capacity, and quality of life.The outcomes will be measured at baseline, post-intervention (after the 8-week intervention), and one month after the cessation of the intervention (12-week follow-up).
Conclusion: The results of this trial will provide valuable new information on the efficacy of high-intensity respiratory muscle training in improving muscle strength and other functional outcomes in individuals with PD.
Read the detailed description
Sample size calculation: The sample size calculation was performed considering the primary outcome measures (inspiratory and expiratory muscle strength). The effect size for inspiratory muscle training was derived from a RCT with a similar population and intervention. Considering a significance level (α) of 5% and a power of 0.80, thirteen participants per group are required (a total of 26 participants). The effect size for expiratory muscle training was also derived from a RCT with a similar population and intervention. Considering a significance level (α) of 5% and a power of 0.80, fourteen participants per group are required (a total of 28 participants). Therefore, a sample size of 28 individuals (14 in each group) was defined (largest sample size calculated). Assuming an expected dropout rate of 20%, a total sample size of 34 individuals was set (17 in each group).
Statistical analyzes: All statistical analyzes will be performed by an independent examiner, blinded to the group allocation. Each participant will assigned a unique code. All analyzes will be performed using SPSS (SPSS Inc., Chicago, IL, USA). The normality of data distribution will be for all continuous numeric variables. Descriptive statistics will be calculated for all outcomes.The effects of the interventions will be analyzed from the collected data using intention-to-treat. Data from the last available assessment will be used for missed sessions. Two-way ANOVA with repeated measures (2*3) will be used to evaluate the differences between groups, considering the time factor (considering baseline, post-intervention, and 4-week follow-up), for the variables: inspiratory and expiratory muscle strength, respiratory muscle endurance, peak cough flow and exercise capacity. The level of significance will be set at 5% and adjusted for multiple comparisons. Data distribution and equality of variance will also be analyzed, to ensure the parametric analysis has been applied correctly. The effect sizes will be calculated to determine the magnitude of the differences between the groups. The differences between the two mean values will be expressed in units of their SD, expressed as Cohen's d, or mean results for the experimental group minus the mean results for the control group, divided by the SD of the control group. Effect sizes between 0.2 and 0.5 will be considered small; between 0.5 and 0.8, medium; and above 0.8, large.
- Conditions
- Parkinson Disease
- Being tested
- Respiratory muscle training, Control
- Keywords
- Breathing exercises, Clinical trial, Exercise, Muscle strength, Parkinson's disease, Rehabilitation
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory muscle trainingOther
The training program will be carried-out with the Orygen Dual Valve. Individuals will perform a home-based intervention, split into two daily 20-min sessions (morning and afternoon), totaling 40 min per day, seven times a week, during eight weeks. Each daily session will be composed into four blocks of three minutes, with a two-minute rest between blocks. The initial training load for each participant will be set at 60% of his/her maximal baseline MIP and MEP for both inspiratory and expiratory strength training, respectively. Borg score of dyspnea and effort was also considered for adjusting training intensity, and scores from 4 to 6 were targeted. Once a week, a trained researcher will visit their homes, the MIP and MEP will be evaluated and the training load will be progressed to ensure that 60% of the new pressure values are maintained.
ControlOther
The control/sham group will underwent exactly the same protocol and weekly monitoring at home, but the participants will receive the devices without resistance of the spring.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The training program will be carried-out with the Orygen Dual Valve. Individuals will perform a home-based intervention, split into two daily 20-min sessions (morning and afternoon), totaling 40 min per day, seven times a week, during eight weeks. Each daily session will be composed into four blocks of three minutes, with a two-minute rest between blocks. The initial training load for each participant will be set at 60% of his/her maximal baseline MIP and MEP for both inspiratory and expiratory strength training, respectively. Borg score of dyspnea and effort was also considered for adjusting training intensity, and scores from 4 to 6 were targeted. Once a week, a trained researcher will visit their homes, the MIP and MEP will be evaluated and the training load will be progressed to ensure that 60% of the new pressure values are maintained. Receives: Other: Respiratory muscle training |
| Control Group | Sham comparator | The control group will also perform the exercises using the Orygen Dual Valve device. A sham intervention will be implemented: the initial resistance of the device will be 0cmH2O, and will be maintained throughout the intervention period - there will be no load progression. All procedures adopted with experimental group, including the weekly home visit, will also be performed with individuals in the control group. However, there will be no real change in the training load. All devices will be wrapped with an opaque material so that the load or possible respiratory training load is not visualized. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Maximal inspiratory pressure (MIP)
Maximum inspiratory pressure will be measured using a digital manovacuometer (LEB-LabCare/UFMG, Brazil) , following previously described protocols.
Measured: At baseline, post-intervention (after the 8-week intervention), and one month after the cessation of the intervention (12-week follow-up).
Change from baseline in Maximal expiratory pressure (MEP)
Maximum expiratory pressure will be measured using a digital manovacuometer (LEB-LabCare/UFMG, Brazil) , following previously described protocols.
Measured: At baseline, post-intervention (after the 8-week intervention), and one month after the cessation of the intervention (12-week follow-up).
Secondary outcomes (6)
Change from baseline in Inspiratory muscle endurance
Inspiratory endurance will be assessed by the powerbreathe device. The measurement will be carried out following the recommended guideline for the flow-resistive loading tests.
Measured: At baseline, post-intervention (after the 8-week intervention), and one month after the cessation of the intervention (12-week follow-up).
Change from baseline in Peak cough flow
Peak cough flow measurement will be performed with the with peak expiratory flow meter (Mini-Wright Peak Expiratory Flow Meter), following previously described protocols.
Measured: At baseline, post-intervention (after the 8-week intervention), and one month after the cessation of the intervention (12-week follow-up).
Change from baseline in perception of Dyspnea
Dyspnea will be measured using the instrument of the Medical Research Council (MRC). This is a 5-point scale, in which 0 indicates 'breathless only with strenuous exercise' and 4 indicates 'too breathless to leave the house'.
Measured: At baseline, post-intervention (after the 8-week intervention), and one month after the cessation of the intervention (12-week follow-up).
Change from baseline in Fatigue
Fatigue will be measured using the Fatigue Severity Scale. The scale consists of 9 items, for each item the scores range from 1 (strongly disagree) to 7 (strongly agree). A higher score indicates a higher level of fatigue.
Measured: At baseline, post-intervention (after the 8-week intervention), and one month after the cessation of the intervention (12-week follow-up).
Change from baseline in Exercise capacity
Exercise capacity will be measured using the Six-minute Walk Test (6MWT), following previously described protocols.
Measured: At baseline, post-intervention (after the 8-week intervention), and one month after the cessation of the intervention (12-week follow-up).
Change from baseline in Quality of life
Quality of life will be measured using the Parkinson's Disease Questionnaire-39. This instrument is composed of 39 items divided into eight dimensions. The score for each domain ranges from 0 (zero) to 100 (one hundred), where zero means better and one hundred means worse quality of life.
Measured: At baseline, post-intervention (after the 8-week intervention), and one month after the cessation of the intervention (12-week follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start1 Dec 2022
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do estado de Minas Gerais, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Christina Danielli Coelho de Morais Faria, Federal University of Minas Gerais
- Investigators
- Christina CM Faria, Doctor, Principal investigator, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608941
- Sponsor's protocol ID
- CAAE: 53970421.0.0000.5149
- Status last verified
- Sep 2024
- First submitted
- 27 Oct 2022
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brito SAF, Scianni AA, Silveira BMF, Oliveira ERM, Mateus ME, Faria CDCM. Effects of high-intensity respiratory muscle training on respiratory muscle strength in individuals with Parkinson's disease: Protocol of a randomized clinical trial. PLoS One. 2023 Sep 8;18(9):e0291051. doi: 10.1371/journal.pone.0291051. eCollection 2023.
PubMed 37682839Brito SAF, Scianni AA, Silveira BMF, de Oliveira ERM, Faria CDCM. High-intensity respiratory muscle training improves maximal respiratory pressures, breathing endurance, dyspnoea and exercise capacity in people with Parkinson's disease: a randomised trial. J Physiother. 2026 Apr;72(2):128-136. doi: 10.1016/j.jphys.2026.03.006. Epub 2026 Apr 2.
PubMed 41933952
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-Intensity Respiratory Muscle Training on Respiratory Muscle Strength, Functional Outcomes and Quality of Life in Individuals With Parkinson's Disease: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05608941
- Acronym / sponsor ID
- CAAE: 53970421.0.0000.5149
- Conditions
- Parkinson Disease
- Keywords
- Breathing exercises, Clinical trial, Exercise, Muscle strength, Parkinson's disease, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do estado de Minas Gerais, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 8 Nov 2022 (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.
Background: Individuals with PD commonly have a significant reduction in respiratory muscle strength and inspiratory muscle endurance, and it can intensify with the disease progression. Respiratory muscle training has shown to increase respiratory muscle strength in individuals with Parkinson's Disease (PD). However, the effect size on other functional outcomes has not been determined and/or investigated. In addition, no studies have investigated the effects of high-intensity respiratory muscle training (inspiratory and expiratory) in this population.
Objectives: The primary aim of this study will be to investigate the effects of high-intensity respiratory muscle training on inspiratory and expiratory muscle strength in individuals with PD. The secondary aim of this study will be to investigate the efficacy of high-intensity respiratory muscle training in improving inspiratory muscle endurance, peak cough flow, dyspnea, fatigue, exercise capacity, and quality of life in this population.
Design: A randomized controlled trial with blinded assessment will assign eligible participants to either: high-intensity respiratory muscle training (experimental group) or sham training (control group). Individuals will perform a home-based intervention, not directly supervised, consisted of two daily 20-min sessions (morning and afternoon), seven times a week, during eight weeks.
Study Outcomes: Primary outcomes are inspiratory and expiratory muscle strength (MIP and MEP). Secondary outcomes are respiratory muscle endurance, peak cough flow, dyspnea, fatigue, exercise capacity, and quality of life.The outcomes will be measured at baseline, post-intervention (after the 8-week intervention), and one month after the cessation of the intervention (12-week follow-up).
Conclusion: The results of this trial will provide valuable new information on the efficacy of high-intensity respiratory muscle training in improving muscle strength and other functional outcomes in individuals with PD.
Detailed description
Sample size calculation: The sample size calculation was performed considering the primary outcome measures (inspiratory and expiratory muscle strength). The effect size for inspiratory muscle training was derived from a RCT with a similar population and intervention. Considering a significance level (α) of 5% and a power of 0.80, thirteen participants per group are required (a total of 26 participants). The effect size for expiratory muscle training was also derived from a RCT with a similar population and intervention. Considering a significance level (α) of 5% and a power of 0.80, fourteen participants per group are required (a total of 28 participants). Therefore, a sample size of 28 individuals (14 in each group) was defined (largest sample size calculated). Assuming an expected dropout rate of 20%, a total sample size of 34 individuals was set (17 in each group).
Statistical analyzes: All statistical analyzes will be performed by an independent examiner, blinded to the group allocation. Each participant will assigned a unique code. All analyzes will be performed using SPSS (SPSS Inc., Chicago, IL, USA). The normality of data distribution will be for all continuous numeric variables. Descriptive statistics will be calculated for all outcomes.The effects of the interventions will be analyzed from the collected data using intention-to-treat. Data from the last available assessment will be used for missed sessions. Two-way ANOVA with repeated measures (2*3) will be used to evaluate the differences between groups, considering the time factor (considering baseline, post-intervention, and 4-week follow-up), for the variables: inspiratory and expiratory muscle strength, respiratory muscle endurance, peak cough flow and exercise capacity. The level of significance will be set at 5% and adjusted for multiple comparisons. Data distribution and equality of variance will also be analyzed, to ensure the parametric analysis has been applied correctly. The effect sizes will be calculated to determine the magnitude of the differences between the groups. The differences between the two mean values will be expressed in units of their SD, expressed as Cohen's d, or mean results for the experimental group minus the mean results for the control group, divided by the SD of the control group. Effect sizes between 0.2 and 0.5 will be considered small; between 0.5 and 0.8, medium; and above 0.8, large.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Respiratory muscle trainingThe training program will be carried-out with the Orygen Dual Valve. Individuals will perform a home-based intervention, split into two daily 20-min sessions (morning and afternoon), totaling 40 min per day, seven times a week, during eight weeks. Each daily session will be composed into four blocks of three minutes, with a two-minute rest between blocks. The initial training load for each participant will be set at 60% of his/her maximal baseline MIP and MEP for both inspiratory and expiratory strength training, respectively. Borg score of dyspnea and effort was also considered for adjusting training intensity, and scores from 4 to 6 were targeted. Once a week, a trained researcher will visit their homes, the MIP and MEP will be evaluated and the training load will be progressed to ensure that 60% of the new pressure values are maintained. |
| Control Group | Sham comparator | Other: ControlThe control group will also perform the exercises using the Orygen Dual Valve device. A sham intervention will be implemented: the initial resistance of the device will be 0cmH2O, and will be maintained throughout the intervention period - there will be no load progression. All procedures adopted with experimental group, including the weekly home visit, will also be performed with individuals in the control group. However, there will be no real change in the training load. All devices will be wrapped with an opaque material so that the load or possible respiratory training load is not visualized. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Parkinson's disease diagnosed by a neurologist
- Ability to walk independently, with or without assistive devices
- Taking anti parkinsonian medication, and who have been medically stable for at least six months
- Classified between stages 1-3 of the modified Hoehn \& Yahr Scale (Schenkman et al., 2001)
- Maximum inspiratory pressure less or equal to -80 cmH2O or maximum expiratory pressure less or equal to 90 cmH2O
Key exclusion criteria (4 listed)
- Possible cognitive impairment as determined by cutoff scores (in points) of the Mini-Mental Status Examination
- Use deep brain stimulation (DBS)
- Smokers or who stopped smoking less than six months ago; have been affected by respiratory or cardiac infections in the last month
- Had any other neurological, musculoskeletal, cardiovascular or respiratory disorders that could affect their ability to perform the tests
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 |
|---|---|---|
| Respiratory muscle trainingThe training program will be carried-out with the Orygen Dual Valve. Individuals will perform a home-based intervention, split into two daily 20-min sessions (morning and afternoon), totaling 40 min per day, seven times a week, during eight weeks. Each daily session will be composed into four blocks of three minutes, with a two-minute rest between blocks. The initial training load for each participant will be set at 60% of his/her maximal baseline MIP and MEP for both inspiratory and expiratory strength training, respectively. Borg score of dyspnea and effort was also considered for adjusting training intensity, and scores from 4 to 6 were targeted. Once a week, a trained researcher will visit their homes, the MIP and MEP will be evaluated and the training load will be progressed to ensure that 60% of the new pressure values are maintained. | Other | Experimental Group |
| ControlThe control/sham group will underwent exactly the same protocol and weekly monitoring at home, but the participants will receive the devices without resistance of the spring. | Other | Control Group |
Primary outcome
Change from baseline in Maximal inspiratory pressure (MIP)
Time frame: At baseline, post-intervention (after the 8-week intervention), and one month after the cessation of the intervention (12-week follow-up).
Maximum inspiratory pressure will be measured using a digital manovacuometer (LEB-LabCare/UFMG, Brazil) , following previously described protocols.
Change from baseline in Maximal expiratory pressure (MEP)
Time frame: At baseline, post-intervention (after the 8-week intervention), and one month after the cessation of the intervention (12-week follow-up).
Maximum expiratory pressure will be measured using a digital manovacuometer (LEB-LabCare/UFMG, Brazil) , following previously described protocols.
6 secondary outcomes
Change from baseline in Inspiratory muscle endurance
Time frame: At baseline, post-intervention (after the 8-week intervention), and one month after the cessation of the intervention (12-week follow-up).
Change from baseline in Peak cough flow
Time frame: At baseline, post-intervention (after the 8-week intervention), and one month after the cessation of the intervention (12-week follow-up).
Change from baseline in perception of Dyspnea
Time frame: At baseline, post-intervention (after the 8-week intervention), and one month after the cessation of the intervention (12-week follow-up).
Change from baseline in Fatigue
Time frame: At baseline, post-intervention (after the 8-week intervention), and one month after the cessation of the intervention (12-week follow-up).
Change from baseline in Exercise capacity
Time frame: At baseline, post-intervention (after the 8-week intervention), and one month after the cessation of the intervention (12-week follow-up).
Change from baseline in Quality of life
Time frame: At baseline, post-intervention (after the 8-week intervention), and one month after the cessation of the intervention (12-week follow-up).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Results publication: PubMed 37682839Brito SAF, Scianni AA, Silveira BMF, Oliveira ERM, Mateus ME, Faria CDCM. Effects of high-intensity respiratory muscle training on respiratory muscle strength in individuals with Parkinson's disease: Protocol of a randomized clinical trial. PLoS One. 2023 Sep 8;18(9):e0291051. doi: 10.1371/journal.pone.0291051. eCollection 2023.
- Derived from this study: PubMed 41933952Brito SAF, Scianni AA, Silveira BMF, de Oliveira ERM, Faria CDCM. High-intensity respiratory muscle training improves maximal respiratory pressures, breathing endurance, dyspnoea and exercise capacity in people with Parkinson's disease: a randomised trial. J Physiother. 2026 Apr;72(2):128-136. doi: 10.1016/j.jphys.2026.03.006. Epub 2026 Apr 2.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Christina CM Faria, Doctor principal investigator
Federal University of Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory muscle training in people with Parkinson Disease, run by Federal University of Minas Gerais 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 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: finished, as of the sponsor's last update on 26 Sep 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Maximal inspiratory pressure (MIP) (time frame: At baseline, post-intervention (after the 8-week intervention), and one month after the cessation of the intervention (12-week follow-up).). The study lists 2 primary outcomes in all. 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 NCT05608941, which also lists 2 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 26 Sep 2024.