Amyotrophic Lateral SclerosisNCT04226144
Breath Stacking Technique Associated With Expiratory Muscle Training in Amyotrophic Lateral Sclerosis Patients
A study testing Breath Stacking Group and Breath stacking and EMT in people with Amyotrophic Lateral Sclerosis and Neuromuscular Diseases, run by Escola Superior de Ciencias da Saude at 1 site in Brazil.
Trial summary
it will be conducted a randomized parallel controlled trial with patients diagnosed with Amyotrophic Lateral Sclerosis (ALS) to compare two techniques to lung recruitment and cough augmentation, to assess their effects on pulmonary function, global functionally, swallowing and ability to speech in these population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Neuromuscular Diseases
- What is being tested?
- Breath Stacking Group and Breath stacking and EMT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 6 Jan 2020to 1 Dec 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of neuromuscular disease confirmed by neurologists at the referral center for neuromuscular diseases at Brasília prior to screening for recruitment
- age over 18 years
- preserved cognition, evidenced by a score greater than or equal to 24 points in the Mini-Mental Status Exam;
- no barium allergies
- without tracheostomy or invasive mechanical ventilation
- no diaphragmatic pacemaker
- without associated respiratory disease
Who cannot join
- pregnancy
- previous kidney disease or other concomitant diseases .respiratory diseases and hospitalization in intensive care units (ICUs) during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Breath Stacking Technique Associated With Expiratory Muscle Training and Breath Stacking Technique in Amyotrophic Lateral Sclerosis Patients: a Randomized Single Blind Trial
it will be conducted a randomized parallel controlled trial with patients diagnosed with Amyotrophic Lateral Sclerosis (ALS) to compare two techniques to lung recruitment and cough augmentation, to assess their effects on pulmonary function, global functionally, swallowing and ability to speech in these population.
Read the detailed description
age over 18 years preserved cognition, evidenced by a score greater than or equal to 24 points in the Mini-Mental Status Exam; no barium allergies; without tracheostomy or invasive mechanical ventilation; no diaphragmatic pacemaker and without associated respiratory disease.Participants are excluded if they have pregnancy; previous kidney disease or other concomitant diseases; respiratory diseases and hospitalization in intensive care units (ICUs) during the study.
- Being tested
- Breath Stacking Group, Breath stacking and EMT
- Keywords
- respiratory function tests, deglution disorders
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath Stacking GroupDevice
Also called lung recruitment technique
Lung recruitment technique using manual bag resuscitation with oronasal mask interface
Breath stacking and EMTDevice
Also called VUP
Lung recruitment technique with one way valve with counter resistance during all expiratory phase
| Study group | Role | What they receive |
|---|---|---|
| Breath Stacking Group | Active comparator | The lungs are inflated as fully as possible by stacking successive breaths without expiration until the patients' maximal inspiratory capacity (MIC). The participant will be instructed to sustain the air in the lung, closing the glottis. Once the lungs are maximally inflated, the compressed air volume is released under expiratory muscle force, thus generating a cough with lung and chest wall recoil. They will perform 5-8 cycles of breath stacking per session, stacking 3-5 breaths per cycle. Receives: Device: Breath Stacking Group |
| Breath stacking and EMT | Experimental | This group will perform the breath stacking technique in addiction with EMT. It will change the one-way valve in this group to VUP (Lumiar, Sao Paulo, Brazil) one-way valve, which allows the patients blow out the air with a counter resistance during all expiratory phase. The initial expiratory pressure will be 8 cmH2O, and could be changed at each visit according to participants' tolerance (either report easy or difficult to exhale assessed by research coordinators. The participants are encouraged to blow out the most slowly that they can do it. Receives: Device: Breath stacking and EMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximal respiratory pressures
change of decline rate of maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) assessed by digital pressure (MVD-500 V.1.1 Microhard System,Porto Alegre, Brazil).
Measured: from baseline to 24 weeks
Peak cough flow
change of decline rate of peak cough flow (PCF) assessed by analogic peak cough flow meter (Respironics-Philips Health Care,PA,USA)
Measured: from baseline to 24 weeks
Forced Vital Capacity and Slow Vital Capacity
Change of decline rate of Forced Vital Capacity (FVC) and Slow Vital Capacity (SVC) predicted by brazilian population assessed by digital spirometer (Vitalgraph, London, UK)
Measured: from baseline to 24 weeks
Secondary outcomes (3)
ALSFR-BR
change of decline rate of Amyotrofic Lateral Sclerosis Functional Revised Scale Brazil (ALSFR-BR)
Measured: from baseline to 24 weeks
Voice parameters
change of Maximum Phonation Time
Measured: from baseline to 24 weeks
swalloing function
change of The Eating Assessment Tool-10 (EAT-10)
Measured: from baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start6 Jan 2020
- Primary completion31 Aug 2021
- Study completion1 Dec 2022
Why it stopped: COVID 19 pandemy
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 Amyotrophic Lateral SclerosisStudies 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
- Model description
- two-arm, parallel (1:1), superiority, blinded-assessor randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Escola Superior de Ciencias da Saude
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vinicius Zacarias Maldaner da silva, Escola Superior de Ciencias da Saude
- Investigators
- Vinicius Maldaner, Principal investigator, Hospital de Apoio de Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04226144
- Sponsor's protocol ID
- EMTBTALS
- Status last verified
- Apr 2023
- First submitted
- 9 Jan 2020
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dorca A, Alcantara LA, Diniz DS, Sarmet M, Menezes Mateus SR, Franco Oliveira LV, Franco H, Maldaner V. Comparison between breath stacking technique associated with expiratory muscle training and breath stacking technique in amyotrophic lateral sclerosis patients: Protocol for randomized single blind trial. Contemp Clin Trials Commun. 2020 Sep 2;19:100647. doi: 10.1016/j.conctc.2020.100647. eCollection 2020 Sep.
PubMed 33005816
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Breath Stacking Technique Associated With Expiratory Muscle Training and Breath Stacking Technique in Amyotrophic Lateral Sclerosis Patients: a Randomized Single Blind Trial
- ClinicalTrials.gov ID
- NCT04226144
- Acronym / sponsor ID
- EMTBTALS
- Keywords
- respiratory function tests, deglution disorders
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID 19 pandemy
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Escola Superior de Ciencias da SaudeUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 13 Jan 2020 (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.
it will be conducted a randomized parallel controlled trial with patients diagnosed with Amyotrophic Lateral Sclerosis (ALS) to compare two techniques to lung recruitment and cough augmentation, to assess their effects on pulmonary function, global functionally, swallowing and ability to speech in these population.
Detailed description
age over 18 years preserved cognition, evidenced by a score greater than or equal to 24 points in the Mini-Mental Status Exam; no barium allergies; without tracheostomy or invasive mechanical ventilation; no diaphragmatic pacemaker and without associated respiratory disease.Participants are excluded if they have pregnancy; previous kidney disease or other concomitant diseases; respiratory diseases and hospitalization in intensive care units (ICUs) during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- two-arm, parallel (1:1), superiority, blinded-assessor randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Breath Stacking Group | Active comparator | Device: Breath Stacking GroupThe lungs are inflated as fully as possible by stacking successive breaths without expiration until the patients' maximal inspiratory capacity (MIC). The participant will be instructed to sustain the air in the lung, closing the glottis. Once the lungs are maximally inflated, the compressed air volume is released under expiratory muscle force, thus generating a cough with lung and chest wall recoil. They will perform 5-8 cycles of breath stacking per session, stacking 3-5 breaths per cycle. |
| Breath stacking and EMT | Experimental | Device: Breath stacking and EMTThis group will perform the breath stacking technique in addiction with EMT. It will change the one-way valve in this group to VUP (Lumiar, Sao Paulo, Brazil) one-way valve, which allows the patients blow out the air with a counter resistance during all expiratory phase. The initial expiratory pressure will be 8 cmH2O, and could be changed at each visit according to participants' tolerance (either report easy or difficult to exhale assessed by research coordinators. The participants are encouraged to blow out the most slowly that they can do it. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- diagnosis of neuromuscular disease confirmed by neurologists at the referral center for neuromuscular diseases at Brasília prior to screening for recruitment
- age over 18 years
- preserved cognition, evidenced by a score greater than or equal to 24 points in the Mini-Mental Status Exam;
- no barium allergies
- without tracheostomy or invasive mechanical ventilation
Key exclusion criteria (2 listed)
- pregnancy
- previous kidney disease or other concomitant diseases .respiratory diseases and hospitalization in intensive care units (ICUs) during the study.
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 |
|---|---|---|
| Breath Stacking GroupAlso: lung recruitment techniqueLung recruitment technique using manual bag resuscitation with oronasal mask interface | Device | Breath Stacking Group |
| Breath stacking and EMTAlso: VUPLung recruitment technique with one way valve with counter resistance during all expiratory phase | Device | Breath stacking and EMT |
Primary outcome
maximal respiratory pressures
Time frame: from baseline to 24 weeks
change of decline rate of maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) assessed by digital pressure (MVD-500 V.1.1 Microhard System,Porto Alegre, Brazil).
Peak cough flow
Time frame: from baseline to 24 weeks
change of decline rate of peak cough flow (PCF) assessed by analogic peak cough flow meter (Respironics-Philips Health Care,PA,USA)
Forced Vital Capacity and Slow Vital Capacity
Time frame: from baseline to 24 weeks
Change of decline rate of Forced Vital Capacity (FVC) and Slow Vital Capacity (SVC) predicted by brazilian population assessed by digital spirometer (Vitalgraph, London, UK)
3 secondary outcomes
ALSFR-BR
Time frame: from baseline to 24 weeks
Voice parameters
Time frame: from baseline to 24 weeks
swalloing function
Time frame: from baseline to 24 weeks
Results and safety
The study was stopped early (reason given: COVID 19 pandemy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Derived from this study: PubMed 33005816Dorca A, Alcantara LA, Diniz DS, Sarmet M, Menezes Mateus SR, Franco Oliveira LV, Franco H, Maldaner V. Comparison between breath stacking technique associated with expiratory muscle training and breath stacking technique in amyotrophic lateral sclerosis patients: Protocol for randomized single blind trial. Contemp Clin Trials Commun. 2020 Sep 2;19:100647. doi: 10.1016/j.conctc.2020.100647. eCollection 2020 Sep.
- 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.
Vinicius Maldaner principal investigator
Hospital de Apoio de Brasilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breath Stacking Group and Breath stacking and EMT in people with Amyotrophic Lateral Sclerosis and Neuromuscular Diseases, run by Escola Superior de Ciencias da Saude 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 7 inclusion and 2 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: stopped early, as of the sponsor's last update on 4 Apr 2023. 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. 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 was stopped early (reason given: COVID 19 pandemy). Results are not available in the source record.
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 respiratory pressures (time frame: from baseline to 24 weeks). The study lists 3 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 NCT04226144, 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 4 Apr 2023.