StrokeNCT02400138
Home-based Respiratory Training After Stroke
A study testing Respiratory training in people with Stroke, run by Federal University of Minas Gerais at 2 sites in Brazil.
Trial summary
Weakness of the respiratory muscles demonstrated by individuals with stroke, may generate important symptoms, such as fatigue and dyspnea. Since adequate strength of the inspiratory and expiratory muscles is required, mainly when performing physical activities, rehabilitation interventions for stroke subjects should… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Respiratory training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesBrazil
- Study dates
- Feb 2016to 15 Jul 2017
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stroke survivors will be eligible if they: were >3 months and <5 years after their last episode of stroke; were >20 years of age; their maximal inspiratory pressure was <80 cmH2O or maximal expiratory pressure was <90 cmH2O [18]; were not undertaking any respiratory training; and were able to provide informed consent.
Who cannot join
- Subjects will be excluded if they had cognitive deficits, facial palsy, associated respiratory diseases, or unstable conditions which might prevent measurement or training; or undergone thoracic or abdominal surgery.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Department of Physical Therapy, Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, 31270-901
NeuroGroup Laboratory
Belo Horizonte, Minas Gerais, 31270-901
About this study
Official title: Effects of Home-based Respiratory Training After Stroke: A Randomized Controlled Trial
Weakness of the respiratory muscles demonstrated by individuals with stroke, may generate important symptoms, such as fatigue and dyspnea. Since adequate strength of the inspiratory and expiratory muscles is required, mainly when performing physical activities, rehabilitation interventions for stroke subjects should include respiratory training. This study will test the hypothesis that home-based combined training of the inspiratory and expiratory muscles is effective in improving strength of the inspiratory and expiratory muscles, endurance of the inspiratory muscles, dyspnea, walking capacity, and ocurrence of respiratory complications after stroke. For this clinical trial, people after stroke will be randomly allocated into either experimental or control/sham groups. The experimental group will undertake training of the inspiratory plus expiratory muscles with the Orygen Dual Valve device, regulated at 50% of the subjects' maximal inspiratory and expíratory pressure values, seven times/week over eight weeks during 40 minutes/day. The control group will undertake the same protocol, but the participants will receive the devices without resistance. At baseline, post intervention, and four weeks after the cessation of the intervention, researchers blinded to group allocations will collect the following outcome measures: maximal inspiratory and expiratory pressures, inspiratory endurance, dyspnea, walking capacity, and ocurrence of respiratory complications.
Read the detailed description
Rationale: Weakness of the respiratory muscles demonstrated by individuals with stroke, may generate important symptoms, such as fatigue and dyspnea. Since adequate strength of the inspiratory and expiratory muscles is required, mainly when performing physical activities, rehabilitation interventions for stroke subjects should include respiratory training.
Aim: This study will test the hypothesis that home-based combined inspiratory muscular training (IMT) plus expiratory muscular training (EMT) program is effective in improving strength of the inspiratory and expiratory muscles, endurance of the inspiratory muscles, dyspnea, walking capacity, and ocurrence of respiratory complications after stroke.
Design: For this prospective, double-blinded, randomized clinical trial, people after stroke will be randomly allocated into either experimental or control/sham groups. The experimental group will undertake training of the inspiratory plus expiratory muscles with the Orygen Dual Valve, regulated at 50% of the subjects' maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) values, seven times/week over eight weeks during 40 minutes/day. The control group will undertake the same protocol, but the participants will receive the devices without resistance. At baseline, post intervention, and four weeks after the cessation of the intervention, researchers blinded to group allocations will collect all outcome measures.
Study outcomes: Primary outcomes will be MIP. Secondary outcomes will include MEP, inspiratory endurance, dyspnea, walking capacity, and ocurrence of respiratory complications.
- Conditions
- Stroke
- Being tested
- Respiratory training, Control
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory trainingOther
Respiratory training will include training of the inspiratory and expiratory muscle seven times per week over eight weeks, during 40 minutes, divided into two 20-min sessions (morning and afternoon). Each 20-min session comprised 4-min sets of respiratory training, followed by 1-min rest between the sets. The training program will be carried-out with the Orygen Dual Valve regulated at 50% of the subjects' maximal inspiratory and expiratory pressure values. Once a week, the treating physiotherapist performed a home visit, measured the current values of inspiratory and expiratory strength, and progressed the load to 50% of the new values.
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 |
|---|---|---|
| Respiratory training | Experimental | Respiratory training will include training of the inspiratory and expiratory muscles seven times per week over eight weeks, during 40 minutes per day, divided into two 20-min sessions (morning and afternoon). Each 20-min session comprised 4-min sets of respiratory training, followed by 1-min rest between the sets. The training program will be carried-out with the Orygen Dual Valve device, regulated at 50% of the subjects' maximal inspiratory and expiratory pressure values. Once a week, the treating physiotherapist performed a home visit, measured the current values of inspiratory and expiratory strength, and progressed the load to 50% of the new values. Receives: Other: Respiratory training |
| Control | Sham comparator | 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, which will be also concealed. The control group will also attend the weekly sessions and undergo the same procedures, except for the load adjustments. If the training proves to be effective, the control subjects will be informed and have the choice to receive the training with proper loads. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal inspiratory pressure
Changes in maximal inspiratory pressures will be assessed by a digital manovacuometer, following previously described protocols.
Measured: Baseline (week 0), after training (week 8) and one-month follow-up (weeks 12)
Secondary outcomes (5)
Maximal expiratory pressure
Changes in maximal expiratory pressures will be assessed by a digital manovacuometer, following previously described protocols.
Measured: Baseline (week 0), after training (week 8) and one-month follow-up (weeks 12)
Inspiratory endurance
Changes in inspiratory endurance will be assessed by the powerbreathe device, following previously described protocols.
Measured: Baseline (week 0), after training (week 8) and one-month follow-up (weeks 12)
Dyspnea
Changes in dyspnea will be assessed by the Medical Research Council Scale.
Measured: Baseline (week 0), after training (week 8) and one-month follow-up (weeks 12)
Ocurrence of respiratory complications
Changes in ocurrence of respiratory complications will be assessed by asking the participants, whether and how often they were admitted to a hospital, due to respiratory reasons.
Measured: Baseline (week 0), after training (week 8) and one-month follow-up (weeks 12)
Walking capacity
Changes in walking capacity will be evaluated by the six-minute walking test
Measured: Baseline (week 0), after training (week 8) and one-month follow-up (weeks 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startFeb 2016
- Primary completion30 Jun 2017
- Study completion15 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luci Fuscaldi Teixeira-Salmela, Federal University of Minas Gerais
- Investigators
- Fatima Rodrigues-de-Paula, Ph.D., Study director, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02400138
- Sponsor's protocol ID
- RTS-01
- Status last verified
- Oct 2017
- First submitted
- 23 Mar 2015
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sutbeyaz ST, Koseoglu F, Inan L, Coskun O. Respiratory muscle training improves cardiopulmonary function and exercise tolerance in subjects with subacute stroke: a randomized controlled trial. Clin Rehabil. 2010 Mar;24(3):240-50. doi: 10.1177/0269215509358932. Epub 2010 Feb 15.
PubMed 20156979Britto RR, Rezende NR, Marinho KC, Torres JL, Parreira VF, Teixeira-Salmela LF. Inspiratory muscular training in chronic stroke survivors: a randomized controlled trial. Arch Phys Med Rehabil. 2011 Feb;92(2):184-90. doi: 10.1016/j.apmr.2010.09.029.
PubMed 21272713Parreiras de Menezes KK, Nascimento LR, Ada L, Avelino PR, Polese JC, Mota Alvarenga MT, Barbosa MH, Teixeira-Salmela LF. High-Intensity Respiratory Muscle Training Improves Strength and Dyspnea Poststroke: A Double-Blind Randomized Trial. Arch Phys Med Rehabil. 2019 Feb;100(2):205-212. doi: 10.1016/j.apmr.2018.09.115. Epub 2018 Oct 12.
PubMed 30316960
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Home-based Respiratory Training After Stroke: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02400138
- Acronym / sponsor ID
- RTS-01
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 15 Jul 2017 (actual)
- First posted
- 26 Mar 2015 (estimated)
- 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.
Weakness of the respiratory muscles demonstrated by individuals with stroke, may generate important symptoms, such as fatigue and dyspnea. Since adequate strength of the inspiratory and expiratory muscles is required, mainly when performing physical activities, rehabilitation interventions for stroke subjects should include respiratory training. This study will test the hypothesis that home-based combined training of the inspiratory and expiratory muscles is effective in improving strength of the inspiratory and expiratory muscles, endurance of the inspiratory muscles, dyspnea, walking capacity, and ocurrence of respiratory complications after stroke. For this clinical trial, people after stroke will be randomly allocated into either experimental or control/sham groups. The experimental group will undertake training of the inspiratory plus expiratory muscles with the Orygen Dual Valve device, regulated at 50% of the subjects' maximal inspiratory and expíratory pressure values, seven times/week over eight weeks during 40 minutes/day. The control group will undertake the same protocol, but the participants will receive the devices without resistance. At baseline, post intervention, and four weeks after the cessation of the intervention, researchers blinded to group allocations will collect the following outcome measures: maximal inspiratory and expiratory pressures, inspiratory endurance, dyspnea, walking capacity, and ocurrence of respiratory complications.
Detailed description
Rationale: Weakness of the respiratory muscles demonstrated by individuals with stroke, may generate important symptoms, such as fatigue and dyspnea. Since adequate strength of the inspiratory and expiratory muscles is required, mainly when performing physical activities, rehabilitation interventions for stroke subjects should include respiratory training.
Aim: This study will test the hypothesis that home-based combined inspiratory muscular training (IMT) plus expiratory muscular training (EMT) program is effective in improving strength of the inspiratory and expiratory muscles, endurance of the inspiratory muscles, dyspnea, walking capacity, and ocurrence of respiratory complications after stroke.
Design: For this prospective, double-blinded, randomized clinical trial, people after stroke will be randomly allocated into either experimental or control/sham groups. The experimental group will undertake training of the inspiratory plus expiratory muscles with the Orygen Dual Valve, regulated at 50% of the subjects' maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) values, seven times/week over eight weeks during 40 minutes/day. The control group will undertake the same protocol, but the participants will receive the devices without resistance. At baseline, post intervention, and four weeks after the cessation of the intervention, researchers blinded to group allocations will collect all outcome measures.
Study outcomes: Primary outcomes will be MIP. Secondary outcomes will include MEP, inspiratory endurance, dyspnea, walking capacity, and ocurrence of respiratory complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Respiratory training | Experimental | Other: Respiratory trainingRespiratory training will include training of the inspiratory and expiratory muscles seven times per week over eight weeks, during 40 minutes per day, divided into two 20-min sessions (morning and afternoon). Each 20-min session comprised 4-min sets of respiratory training, followed by 1-min rest between the sets. The training program will be carried-out with the Orygen Dual Valve device, regulated at 50% of the subjects' maximal inspiratory and expiratory pressure values. Once a week, the treating physiotherapist performed a home visit, measured the current values of inspiratory and expiratory strength, and progressed the load to 50% of the new values. |
| Control | Sham comparator | Other: 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, which will be also concealed. The control group will also attend the weekly sessions and undergo the same procedures, except for the load adjustments. If the training proves to be effective, the control subjects will be informed and have the choice to receive the training with proper loads. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Stroke survivors will be eligible if they: were >3 months and <5 years after their last episode of stroke; were >20 years of age; their maximal inspiratory pressure was <80 cmH2O or maximal expiratory pressure was <90 cmH2O [18]; were not undertaking any respiratory training; and were able to provide informed consent.
Key exclusion criteria (1 listed)
- Subjects will be excluded if they had cognitive deficits, facial palsy, associated respiratory diseases, or unstable conditions which might prevent measurement or training; or undergone thoracic or abdominal surgery.
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 trainingRespiratory training will include training of the inspiratory and expiratory muscle seven times per week over eight weeks, during 40 minutes, divided into two 20-min sessions (morning and afternoon). Each 20-min session comprised 4-min sets of respiratory training, followed by 1-min rest between the sets. The training program will be carried-out with the Orygen Dual Valve regulated at 50% of the subjects' maximal inspiratory and expiratory pressure values. Once a week, the treating physiotherapist performed a home visit, measured the current values of inspiratory and expiratory strength, and progressed the load to 50% of the new values. | Other | Respiratory training |
| 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 |
Primary outcome
Maximal inspiratory pressure
Time frame: Baseline (week 0), after training (week 8) and one-month follow-up (weeks 12)
Changes in maximal inspiratory pressures will be assessed by a digital manovacuometer, following previously described protocols.
5 secondary outcomes
Maximal expiratory pressure
Time frame: Baseline (week 0), after training (week 8) and one-month follow-up (weeks 12)
Inspiratory endurance
Time frame: Baseline (week 0), after training (week 8) and one-month follow-up (weeks 12)
Dyspnea
Time frame: Baseline (week 0), after training (week 8) and one-month follow-up (weeks 12)
Ocurrence of respiratory complications
Time frame: Baseline (week 0), after training (week 8) and one-month follow-up (weeks 12)
Walking capacity
Time frame: Baseline (week 0), after training (week 8) and one-month follow-up (weeks 12)
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 Oct 2017.
- Results publication: PubMed 20156979Sutbeyaz ST, Koseoglu F, Inan L, Coskun O. Respiratory muscle training improves cardiopulmonary function and exercise tolerance in subjects with subacute stroke: a randomized controlled trial. Clin Rehabil. 2010 Mar;24(3):240-50. doi: 10.1177/0269215509358932. Epub 2010 Feb 15.
- Results publication: PubMed 21272713Britto RR, Rezende NR, Marinho KC, Torres JL, Parreira VF, Teixeira-Salmela LF. Inspiratory muscular training in chronic stroke survivors: a randomized controlled trial. Arch Phys Med Rehabil. 2011 Feb;92(2):184-90. doi: 10.1016/j.apmr.2010.09.029.
- Derived from this study: PubMed 30316960Parreiras de Menezes KK, Nascimento LR, Ada L, Avelino PR, Polese JC, Mota Alvarenga MT, Barbosa MH, Teixeira-Salmela LF. High-Intensity Respiratory Muscle Training Improves Strength and Dyspnea Poststroke: A Double-Blind Randomized Trial. Arch Phys Med Rehabil. 2019 Feb;100(2):205-212. doi: 10.1016/j.apmr.2018.09.115. Epub 2018 Oct 12.
- 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.
Fatima Rodrigues-de-Paula, Ph.D. study director
Federal University of Minas Gerais
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory training in people with Stroke, run by Federal University of Minas Gerais at 2 sites 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 1 inclusion and 1 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 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Maximal inspiratory pressure (time frame: Baseline (week 0), after training (week 8) and one-month follow-up (weeks 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 NCT02400138, which also lists 3 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 Oct 2017.