Chronic Obstructive Pulmonary DiseaseNCT02014155
Inspiratory Muscle Training and Respiratory Electromyographic Activity in COPD
A study testing Inspiratory Muscle Training and Pulmonary Rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by University of Santa Cruz do Sul at 1 site in Brazil.
Trial summary
Intended to treat disorders of the respiratory muscles can use the device Threshold IMT ® through an inspiratory muscle training (IMT) that allows training of the inspiratory muscles, the chief of these being the diaphragm which is which objectified the improvement of its function . Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Inspiratory Muscle Training and Pulmonary Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2013to 1 Jan 2015
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Will be included in the study subjects of both sexes aged between 40 and 80 years. For the control group will participate in healthy subjects, non-smokers with normal lung function. For Group TMI + Rehabilitation, Non-Rehabilitated and Rehabilitation Group participate COPD patients with GOLD staging II and III, participants and non-participants of a PR program respectively, where individuals not participating (GTMINR) will be those who will enter the PR program during the stipulated time of study and the participants have (GTMIR) should be included in the project for at least eight weeks, the time required for a program to provide RP's effects in COPD
Who cannot join
- Not participate in the study and Group TMI + Rehabilitation, Non-Rehabilitated and Rehabilitation Group, individuals who do not fit the criteria for GOLD in stages II and III, which are in acute disease, presenting hemodynamic instability, aneurysm, cognitive impairment or any other co-morbidity that prevents this study. For the GC will not participate smokers, ex-smokers or who have compromised lung function, individuals participating in regular physical activity, ie three or more times per week, and no pathology that affects the cardiorespiratory system. Also excluded are those who do not sign the consent form.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade de Santa Cruz do Sul
Santa Cruz do Sul, Rio Grande do Sul
About this study
Official title: Effects of Inspiratory Muscle Training on Respiratory Electromyographic Activity in Patients With COPD Participants and Non-participants of a Pulmonary Rehabilitation Program
Intended to treat disorders of the respiratory muscles can use the device Threshold IMT ® through an inspiratory muscle training (IMT) that allows training of the inspiratory muscles, the chief of these being the diaphragm which is which objectified the improvement of its function . To monitor the action of the respiratory muscles can be used several tools such as manometer that aims to assess respiratory pressures, ie, the strength of respiratory muscles, or the Surface Electromyography (sEMG) that allow evaluating the electromyographic activity of muscles analyzed. From a quantitative clinical trial, randomized and blinded, composed of 45 individuals obtained by random convenience and divided into three groups, COPD participating in a pulmonary rehabilitation program (RP) which will make TMI (TGR - Trained Group Rehabilitated), COPD does not participant in a PR program (TGNR - Trained Group not Rehabilitated) and a control group composed of healthy individuals (CG) that seek to analyze the electromyographic activity of sternocleidomastoid (SCM) and diaphragm muscle strength, lung volumes and breathing patterns before and after a period of eight weeks of TMI. Manual will also be held dynamometry to compare the grip strength of the CG, TGR and TGNR only at baseline.
Hypothesis:
- The Inspiratory Muscle Training (IMT) increases the maximal inspiratory pressure (MIP) in COPD patients regardless of whether they are enrolled in a program of pulmonary rehabilitation (PR).
- TMI alters the breathing pattern in COPD patients regardless of whether they were entered into a PR program.
- Patients with COPD who do not participate in a PR program have higher handgrip strength compared to patients who did not participate in a PR program.
- There is decreased activity of the sternocleidomastoid muscle due to increased activity in the diaphragmatic muscle fibers after a period of TMI.
- TMI in COPD patients participating in a program RP produces greater increase in MIP, the handgrip strength, improves breathing pattern and a greater reduction in the activity of the SCM muscle and diaphragm than in those who did not participate in a program RP.
- There will be a reduction in respiratory rate, heart rate, systolic and diastolic blood pressure and increased oxygen saturation at the end of the TMI.
- TMI reduce the degree of dyspnea reported by patients as MRC scale at the end of the training period.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Inspiratory Muscle Training, Pulmonary Rehabilitation
- Keywords
- Chronic Obstructive Pulmonary Disease,
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle TrainingOther
Will be held inspiratory muscle training associated with a pulmonary rehabilitation program. The inspiratory muscle training is performed with a load of 40 to 50% of the muscle strength of the subjects.
Pulmonary RehabilitationOther
Pulmonary Rehabilitation consists of isotonic exercises of upper and lower limbs, 20-minute workout on cycle ergometer in standard deflation (expiration at the time of muscle contraction), is performed three times a week for eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group Pulmonary Rehabilitation | Experimental | Pulmonary Rehabilitation consists of isotonic exercises of upper and lower limbs, 20-minute workout on cycle ergometer in standard desinsuflativo (expiration at the time of muscle contraction), is performed three times a week for eight weeks. Receives: Other: Pulmonary Rehabilitation |
| Group TMI + Pulmonary Rehabilitation | Experimental | Will be held inspiratory muscle training associated with a pulmonary rehabilitation program. The inspiratory muscle training is performed with a load of 40 to 50% of the muscle strength of the subjects. Pulmonary Rehabilitation consists of isotonic exercises of upper and lower limbs, 20-minute workout on cycle ergometer in standard deflation (expiration at the time of muscle contraction), is performed three times a week for eight weeks. Receives: Other: Inspiratory Muscle Training; Other: Pulmonary Rehabilitation |
| Control Group | Experimental | Inspiratory muscle training will be held three times a week for eight weeks Receives: Other: Inspiratory Muscle Training |
| COPD group not rehabilitation | Experimental | Not described Receives: Other: Inspiratory Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle electromyographic activity of the accessory Inspiration
Measured: The electromyographic activity will be evaluated during the inspiratory cycles for one minute, It will be evaluated over eight weeks
Secondary outcomes (4)
Inspiratory Muscle Training
Measured: Will be performed with frequency of three days non-consecutive week, for eight weeks
Assessment of lung volumes
Measured: will be performed previously to the study and at the end, over eight weeks
assessment of respiratory muscle strength
Measured: will be performed previously to the study and at the end, as well as weekly to adjust the pressure load, It will be evaluated over eight weeks
breathing pattern assessment
Measured: will be performed previously to the study and at the end of the same, It will be evaluated over eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2013 (estimated)
- Study startAug 2013
- Primary completion1 Nov 2014
- Study completion1 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary 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
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Santa Cruz do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diogo Fanfa Bordin, University of Santa Cruz do Sul
- Investigators
- Dulciane N Paiva, Doctor, Principal investigator, University of Santa Cruz do SulDiogo F Bordin, Academic, Principal investigator, University of Santa Cruz do SulDannuey M Cardoso, Master, Study director, University of Santa Cruz do SulAndrea LG da Silva, Doctor, Study director, University of Santa Cruz do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02014155
- Sponsor's protocol ID
- UNISC_001
- Status last verified
- Apr 2017
- First submitted
- 3 Nov 2013
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inspiratory Muscle Training on Respiratory Electromyographic Activity in Patients With COPD Participants and Non-participants of a Pulmonary Rehabilitation Program
- ClinicalTrials.gov ID
- NCT02014155
- Acronym / sponsor ID
- UNISC_001
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Santa Cruz do SulUniversity, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- 1 Nov 2014 (actual)
- Study completion
- 1 Jan 2015 (actual)
- First posted
- 18 Dec 2013 (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.
Intended to treat disorders of the respiratory muscles can use the device Threshold IMT ® through an inspiratory muscle training (IMT) that allows training of the inspiratory muscles, the chief of these being the diaphragm which is which objectified the improvement of its function . To monitor the action of the respiratory muscles can be used several tools such as manometer that aims to assess respiratory pressures, ie, the strength of respiratory muscles, or the Surface Electromyography (sEMG) that allow evaluating the electromyographic activity of muscles analyzed. From a quantitative clinical trial, randomized and blinded, composed of 45 individuals obtained by random convenience and divided into three groups, COPD participating in a pulmonary rehabilitation program (RP) which will make TMI (TGR - Trained Group Rehabilitated), COPD does not participant in a PR program (TGNR - Trained Group not Rehabilitated) and a control group composed of healthy individuals (CG) that seek to analyze the electromyographic activity of sternocleidomastoid (SCM) and diaphragm muscle strength, lung volumes and breathing patterns before and after a period of eight weeks of TMI. Manual will also be held dynamometry to compare the grip strength of the CG, TGR and TGNR only at baseline.
Hypothesis:
- The Inspiratory Muscle Training (IMT) increases the maximal inspiratory pressure (MIP) in COPD patients regardless of whether they are enrolled in a program of pulmonary rehabilitation (PR).
- TMI alters the breathing pattern in COPD patients regardless of whether they were entered into a PR program.
- Patients with COPD who do not participate in a PR program have higher handgrip strength compared to patients who did not participate in a PR program.
- There is decreased activity of the sternocleidomastoid muscle due to increased activity in the diaphragmatic muscle fibers after a period of TMI.
- TMI in COPD patients participating in a program RP produces greater increase in MIP, the handgrip strength, improves breathing pattern and a greater reduction in the activity of the SCM muscle and diaphragm than in those who did not participate in a program RP.
- There will be a reduction in respiratory rate, heart rate, systolic and diastolic blood pressure and increased oxygen saturation at the end of the TMI.
- TMI reduce the degree of dyspnea reported by patients as MRC scale at the end of the training period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group Pulmonary Rehabilitation | Experimental | Other: Pulmonary RehabilitationPulmonary Rehabilitation consists of isotonic exercises of upper and lower limbs, 20-minute workout on cycle ergometer in standard desinsuflativo (expiration at the time of muscle contraction), is performed three times a week for eight weeks. |
| Group TMI + Pulmonary Rehabilitation | Experimental | Other: Inspiratory Muscle Training, Other: Pulmonary RehabilitationWill be held inspiratory muscle training associated with a pulmonary rehabilitation program. The inspiratory muscle training is performed with a load of 40 to 50% of the muscle strength of the subjects. Pulmonary Rehabilitation consists of isotonic exercises of upper and lower limbs, 20-minute workout on cycle ergometer in standard deflation (expiration at the time of muscle contraction), is performed three times a week for eight weeks. |
| Control Group | Experimental | Other: Inspiratory Muscle TrainingInspiratory muscle training will be held three times a week for eight weeks |
| COPD group not rehabilitation | Experimental | Other: Inspiratory Muscle Training |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Will be included in the study subjects of both sexes aged between 40 and 80 years. For the control group will participate in healthy subjects, non-smokers with normal lung function. For Group TMI + Rehabilitation, Non-Rehabilitated and Rehabilitation Group participate COPD patients with GOLD staging II and III, participants and non-participants of a PR program respectively, where individuals not participating (GTMINR) will be those who will enter the PR program during the stipulated time of study and the participants have (GTMIR) should be included in the project for at least eight weeks, the time required for a program to provide RP's effects in COPD
Key exclusion criteria (1 listed)
- Not participate in the study and Group TMI + Rehabilitation, Non-Rehabilitated and Rehabilitation Group, individuals who do not fit the criteria for GOLD in stages II and III, which are in acute disease, presenting hemodynamic instability, aneurysm, cognitive impairment or any other co-morbidity that prevents this study. For the GC will not participate smokers, ex-smokers or who have compromised lung function, individuals participating in regular physical activity, ie three or more times per week, and no pathology that affects the cardiorespiratory system. Also excluded are those who do not sign the consent form.
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 TrainingWill be held inspiratory muscle training associated with a pulmonary rehabilitation program. The inspiratory muscle training is performed with a load of 40 to 50% of the muscle strength of the subjects. | Other | COPD group not rehabilitation, Control Group, Group TMI + Pulmonary Rehabilitation |
| Pulmonary RehabilitationPulmonary Rehabilitation consists of isotonic exercises of upper and lower limbs, 20-minute workout on cycle ergometer in standard deflation (expiration at the time of muscle contraction), is performed three times a week for eight weeks. | Other | Group Pulmonary Rehabilitation, Group TMI + Pulmonary Rehabilitation |
Primary outcome
Muscle electromyographic activity of the accessory Inspiration
Time frame: The electromyographic activity will be evaluated during the inspiratory cycles for one minute, It will be evaluated over eight weeks
4 secondary outcomes
Inspiratory Muscle Training
Time frame: Will be performed with frequency of three days non-consecutive week, for eight weeks
Assessment of lung volumes
Time frame: will be performed previously to the study and at the end, over eight weeks
assessment of respiratory muscle strength
Time frame: will be performed previously to the study and at the end, as well as weekly to adjust the pressure load, It will be evaluated over eight weeks
breathing pattern assessment
Time frame: will be performed previously to the study and at the end of the same, It will be evaluated over eight weeks
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 25 Apr 2017.
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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.
Dulciane N Paiva, Doctor principal investigator
University of Santa Cruz do Sul
Diogo F Bordin, Academic principal investigator
University of Santa Cruz do Sul
Dannuey M Cardoso, Master study director
University of Santa Cruz do Sul
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 and Pulmonary Rehabilitation in people with Chronic Obstructive Pulmonary Disease, run by University of Santa Cruz do Sul 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 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 25 Apr 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. 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?
Muscle electromyographic activity of the accessory Inspiration (time frame: The electromyographic activity will be evaluated during the inspiratory cycles for one minute, It will be evaluated over eight weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2017.