Muscle WeaknessIMTNCT02459444
Inspiratory Muscle Training and Hospital Complications
A study testing Powerbreathe and Physiotherapy in people with Muscle Weakness, run by Federal University of Bahia at 1 site in Brazil.
Trial summary
The inspiratory muscle training (IMT) is a feasible and safe strategy for patients and athletes, your goal is to recondition the respiratory muscles, providing optimization of lung capacity, either for high performance sport as to support metabolic wear caused by illness. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Muscle Weakness
- What is being tested?
- Powerbreathe and Physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteBrazil
- Study dates
- May 2015to Aug 2016
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Admission to the hospital ward;
- At least two of the following risk factors for prolonged hospitalization: two or more comorbidities; sepsis; liver, lung, or kidney diseases; neoplasia; mechanical ventilation; and use of vasopressor or dialysis therapy.
Who cannot join
- Patients with a cognitive disability that made them unable to perform the respiratory training;
- Uncontrolled cardiac arrhythmias;
- Circulatory shock;
- Acute ischemic heart disease;
- acute respiratory failure (characterised by a partial pressure of arterial oxygen < 60 mmHg or a partial pressure of arterial carbon dioxide > 50 mmHg);
- neuromuscular disease or myopathies;
- diaphragmatic paresis or paralysis were excluded from the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Inspiratory Muscle Training for Preventing Adverse Outcomes in Patients at Risk of Prolonged Hospitalization
The inspiratory muscle training (IMT) is a feasible and safe strategy for patients and athletes, your goal is to recondition the respiratory muscles, providing optimization of lung capacity, either for high performance sport as to support metabolic wear caused by illness. It is generally agreed the positive impact of the application of a TMI Protocol on maximal inspiratory pressure (MIP), this benefit encourages individuals sick since weaning from mechanical ventilation (MV), to the optimization of physical performance in cardiac and / or pulmonary rehabilitation. The TMI is based on the principles: the burden imposed on the muscle; the specificity of training; the reversibility of the gain and muscle atrophy.
Read the detailed description
This prospective double-blind (patient and evaluator) randomised controlled trial compared the efficacy of inspiratory muscle training and inspiratory muscle training. The study protocol for this trial was described elsewhere. This study was conducted in accordance with Consolidated Standards of Reporting Trials recommendations. The trial was performed at the Roberto Santos General Hospital in Salvador, Bahia, Brazil. This study was approved by the institutional hospital ethics committee (approval reference number 03/2014). Before enrolment, written informed consent was obtained from participants or their legal guardians.
- Conditions
- Muscle Weakness
- Being tested
- Powerbreathe, Physiotherapy
- Keywords
- Respiratory Muscles, Muscle Weakness, Hospitalization, Length of Stay, Mortality
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PowerbreatheDevice
Also called MODEL: CLASSIC LIGHT RESISTANCE, ANVISA: CLASS I 81001390001, MANUFACTURER: HAB INTERNATIONAL LTD - UNITED KINGDOM
Respiratory equipment for physiotherapy, offering to load muscles inspiratory
PhysiotherapyOther
Also called Concurrent training
This was contemplated cinesioterapia unloaded, muscle stretching, coughing technique, sedestração and ambulation if the participant was fit.
| Study group | Role | What they receive |
|---|---|---|
| IMT group and physiotherapy | Experimental | Inspiratory muscle training with POWERBREATHE an approximate load of 50 % of MIP , for 1 set of 30 breaths twice a day, 7 days a week for 4 weeks ( total 56 sessions). Associated with physiotherapy program. Receives: Device: Powerbreathe; Other: Physiotherapy |
| Sham IMT group | Placebo comparator | Inspiratory muscle training with the same device in the experimental group , however without charge , for 1 set of 30 breaths twice a day, 7 days a week for 4 weeks ( total 56 sessions). Associated with physiotherapy program. Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
hospital inpatient complications
Follow-up during hospitalization
Measured: Discharge from hospital
Secondary outcomes (1)
respiratory muscle strength
Measured with manometer for 3 reps.
Measured: After 4 weeks follow
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionFeb 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Muscle WeaknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Bahia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mansueto Gomes Neto, Federal University of Bahia
- Investigators
- Balbino V Nepomuceno, MD, Study director, Federal University of Bahia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02459444
- Sponsor's protocol ID
- U1111-1163-0679
- Acronym
- IMT
- Status last verified
- Mar 2017
- First submitted
- 19 May 2015
- Last updated
- 20 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Gosselink R, Bott J, Johnson M, Dean E, Nava S, Norrenberg M, Schonhofer B, Stiller K, van de Leur H, Vincent JL. Physiotherapy for adult patients with critical illness: recommendations of the European Respiratory Society and European Society of Intensive Care Medicine Task Force on Physiotherapy for Critically Ill Patients. Intensive Care Med. 2008 Jul;34(7):1188-99. doi: 10.1007/s00134-008-1026-7. Epub 2008 Feb 19.
PubMed 18283429Griffiths LA, McConnell AK. The influence of inspiratory and expiratory muscle training upon rowing performance. Eur J Appl Physiol. 2007 Mar;99(5):457-66. doi: 10.1007/s00421-006-0367-6. Epub 2006 Dec 22.
PubMed 17186299Hogan MC, Welch HG. Effect of altered arterial O2 tensions on muscle metabolism in dog skeletal muscle during fatiguing work. Am J Physiol. 1986 Aug;251(2 Pt 1):C216-22. doi: 10.1152/ajpcell.1986.251.2.C216.
PubMed 3740252Martin AD, Smith BK, Davenport PD, Harman E, Gonzalez-Rothi RJ, Baz M, Layon AJ, Banner MJ, Caruso LJ, Deoghare H, Huang TT, Gabrielli A. Inspiratory muscle strength training improves weaning outcome in failure to wean patients: a randomized trial. Crit Care. 2011;15(2):R84. doi: 10.1186/cc10081. Epub 2011 Mar 7.
PubMed 21385346Nepomuceno BRV Jr, Barreto MS, Almeida NC, Guerreiro CF, Xavier-Souza E, Neto MG. Safety and efficacy of inspiratory muscle training for preventing adverse outcomes in patients at risk of prolonged hospitalisation. Trials. 2017 Dec 28;18(1):626. doi: 10.1186/s13063-017-2372-y.
PubMed 29282152
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Inspiratory Muscle Training for Preventing Adverse Outcomes in Patients at Risk of Prolonged Hospitalization
- ClinicalTrials.gov ID
- NCT02459444
- Acronym / sponsor ID
- IMT / U1111-1163-0679
- Conditions
- Muscle Weakness
- Keywords
- Respiratory Muscles, Muscle Weakness, Hospitalization, Length of Stay, Mortality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Federal University of BahiaUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 2 Jun 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.
The inspiratory muscle training (IMT) is a feasible and safe strategy for patients and athletes, your goal is to recondition the respiratory muscles, providing optimization of lung capacity, either for high performance sport as to support metabolic wear caused by illness. It is generally agreed the positive impact of the application of a TMI Protocol on maximal inspiratory pressure (MIP), this benefit encourages individuals sick since weaning from mechanical ventilation (MV), to the optimization of physical performance in cardiac and / or pulmonary rehabilitation. The TMI is based on the principles: the burden imposed on the muscle; the specificity of training; the reversibility of the gain and muscle atrophy.
Detailed description
This prospective double-blind (patient and evaluator) randomised controlled trial compared the efficacy of inspiratory muscle training and inspiratory muscle training. The study protocol for this trial was described elsewhere. This study was conducted in accordance with Consolidated Standards of Reporting Trials recommendations. The trial was performed at the Roberto Santos General Hospital in Salvador, Bahia, Brazil. This study was approved by the institutional hospital ethics committee (approval reference number 03/2014). Before enrolment, written informed consent was obtained from participants or their legal guardians.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMT group and physiotherapy | Experimental | Device: Powerbreathe, Other: PhysiotherapyInspiratory muscle training with POWERBREATHE an approximate load of 50 % of MIP , for 1 set of 30 breaths twice a day, 7 days a week for 4 weeks ( total 56 sessions). Associated with physiotherapy program. |
| Sham IMT group | Placebo comparator | Other: PhysiotherapyInspiratory muscle training with the same device in the experimental group , however without charge , for 1 set of 30 breaths twice a day, 7 days a week for 4 weeks ( total 56 sessions). Associated with physiotherapy program. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Admission to the hospital ward;
- At least two of the following risk factors for prolonged hospitalization: two or more comorbidities; sepsis; liver, lung, or kidney diseases; neoplasia; mechanical ventilation; and use of vasopressor or dialysis therapy.
Key exclusion criteria (7 listed)
- Patients with a cognitive disability that made them unable to perform the respiratory training;
- Uncontrolled cardiac arrhythmias;
- Circulatory shock;
- Acute ischemic heart disease;
- acute respiratory failure (characterised by a partial pressure of arterial oxygen < 60 mmHg or a partial pressure of arterial carbon dioxide > 50 mmHg);
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 |
|---|---|---|
| PowerbreatheAlso: MODEL: CLASSIC LIGHT RESISTANCE, ANVISA: CLASS I 81001390001, MANUFACTURER: HAB INTERNATIONAL LTD - UNITED KINGDOMRespiratory equipment for physiotherapy, offering to load muscles inspiratory | Device | IMT group and physiotherapy |
| PhysiotherapyAlso: Concurrent trainingThis was contemplated cinesioterapia unloaded, muscle stretching, coughing technique, sedestração and ambulation if the participant was fit. | Other | IMT group and physiotherapy, Sham IMT group |
Primary outcome
hospital inpatient complications
Time frame: Discharge from hospital
Follow-up during hospitalization
1 secondary outcome
respiratory muscle strength
Time frame: After 4 weeks follow
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 20 Mar 2017.
- Background: PubMed 18283429Gosselink R, Bott J, Johnson M, Dean E, Nava S, Norrenberg M, Schonhofer B, Stiller K, van de Leur H, Vincent JL. Physiotherapy for adult patients with critical illness: recommendations of the European Respiratory Society and European Society of Intensive Care Medicine Task Force on Physiotherapy for Critically Ill Patients. Intensive Care Med. 2008 Jul;34(7):1188-99. doi: 10.1007/s00134-008-1026-7. Epub 2008 Feb 19.
- Results publication: PubMed 17186299Griffiths LA, McConnell AK. The influence of inspiratory and expiratory muscle training upon rowing performance. Eur J Appl Physiol. 2007 Mar;99(5):457-66. doi: 10.1007/s00421-006-0367-6. Epub 2006 Dec 22.
- Results publication: PubMed 3740252Hogan MC, Welch HG. Effect of altered arterial O2 tensions on muscle metabolism in dog skeletal muscle during fatiguing work. Am J Physiol. 1986 Aug;251(2 Pt 1):C216-22. doi: 10.1152/ajpcell.1986.251.2.C216.
- Results publication: PubMed 21385346Martin AD, Smith BK, Davenport PD, Harman E, Gonzalez-Rothi RJ, Baz M, Layon AJ, Banner MJ, Caruso LJ, Deoghare H, Huang TT, Gabrielli A. Inspiratory muscle strength training improves weaning outcome in failure to wean patients: a randomized trial. Crit Care. 2011;15(2):R84. doi: 10.1186/cc10081. Epub 2011 Mar 7.
- Derived from this study: PubMed 29282152Nepomuceno BRV Jr, Barreto MS, Almeida NC, Guerreiro CF, Xavier-Souza E, Neto MG. Safety and efficacy of inspiratory muscle training for preventing adverse outcomes in patients at risk of prolonged hospitalisation. Trials. 2017 Dec 28;18(1):626. doi: 10.1186/s13063-017-2372-y.
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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.
Balbino V Nepomuceno, MD study director
Federal University of Bahia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Powerbreathe and Physiotherapy in people with Muscle Weakness, run by Federal University of Bahia 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 2 inclusion and 7 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 20 Mar 2017. 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?
hospital inpatient complications (time frame: Discharge from hospital). 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 NCT02459444, which also lists 5 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 20 Mar 2017.