COPDNCT03417908
Respiratory Muscle Stretching Effect on Functional and Electromyographic Parameters of Patients With and Without COPD
A study testing PNF in people with COPD, run by Universidade Federal do Pampa at 1 site in Brazil.
Trial summary
To evaluate the activation of accessory respiratory muscles and the effects of stretching these muscles in patients with COPD. Read more about this study
- Who is it for?
- Ages 40 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- COPD
- What is being tested?
- PNF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 4 Dec 2017to 14 Dec 2018
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Control group: Men without respiratory symptoms and lung disease, with normal spirometry.
- Interventional group: Men diagnosed with severe to very severe COPD (forced expiratory volume in one second / forced vital capacity - FEV1/FVC <0.7 and FEV1 <50% predicted after bronchodilator use); clinically stable over the past 4 weeks.
Who cannot join
- History of fracture in the spine and / or upper limb
- Herniated disc
- Connective tissue disease
- Ischemic heart disease or uncontrolled hypertension
- Obesity (BMI> 30 kg/m2)
- Aortic aneurysm
Show all 9Show fewer
- Recent abdominal or thoracic surgery
- Glaucoma
- Retinal detachment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Proprioceptive Neuromuscular Facilitation Applied to the Accessory Respiratory Muscles on Functional and Electromyographic Parameters in Patients With and Without COPD
To evaluate the activation of accessory respiratory muscles and the effects of stretching these muscles in patients with COPD.
Read the detailed description
All subjects (sixty men) will perform spirometry, measure of inspiratory capacity (IC) and maximal inspiratory and expiratory pressures (MIP and MEP). Baseline blood pressure (BP), respiratory rate (RR), heart rate (HR), sensation of dyspnea (Borg Scale) and oxygen saturation (pulse oximetry, SpO2) will be collected prior to the performance of pulmonary function tests.
The electrical activity of the scalene (ESC), sternocleidomastoid (SCM) and external intercostal muscles (INTER) will be measured by surface electromyography (sEMG) at rest and during the maneuvers of IC, MIP and MEP.
Control group: The control group will perform isotonic concentric contraction of the biceps (two sets of five push-ups elbow in both arms) with the individual sitting in a chair with back support.
Intervention group: The contract-relax method of proprioceptive neuromuscular facilitation (PNF) technique will be used for stretching of ESC, ECM and external intercostals muscles. The contraction of agonist muscles against the resistance imposed by the physiotherapist (isometric contraction) is maintained for 6 seconds. After that, the patient will be asked to relax the muscles for 6 seconds without losing range of motion, and then the muscle will be lengthened. This procedure is repeated until the maximum amplitude of motion of the neck and upper limb is reached. The stretching will be performed on the right and left sides of the body.
Statistical analysis will be carried out with the Statistical Package for the Social Sciences, version 18.0 (SPSS Inc., Chicago, IL, USA). Normality of data distribution will be assessed by the Shapiro-Wilk test.
Values will be presented as mean ± standard deviation (SD) or median (25-75%). To compare the differences between the baseline characteristics between the groups the t test for independent samples will be used. The effect of the intervention will be evaluated by paired t test. For the analysis of the electromyographic signal will be use the Wilcoxon T test. Statistical significance is accepted at p < 0.05.
- Conditions
- COPD
- Being tested
- PNF, Sham
- Keywords
- Proprioceptive neuromuscular facilitation, Pulmonary Rehabilitation, muscle activation, COPD
- 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.
PNFProcedure or surgery
The contract-relax method of proprioceptive neuromuscular facilitation (PNF) technique will be used for stretching of ESC, ECM and external intercostals muscles. The contraction of agonist muscles against the resistance imposed by the physiotherapist (isometric contraction) will be maintained for 6 seconds. After that, the patient is oriented to relax the muscles for 6 seconds without losing range of motion, and then the muscle will be lengthened. This procedure is repeated until the maximum amplitude of motion of the neck and upper limb is reached. The stretching will be performed on the right and left sides of the body.
ShamProcedure or surgery
Isotonic concentric contraction of the biceps (two sets of five push-ups elbow in both arms) with the individual sitting in a chair with back support.
| Study group | Role | What they receive |
|---|---|---|
| COPD - PNF | Active comparator | COPD - PNF Receives: Procedure: PNF |
| COPD - sham | Sham comparator | COPD - sham Receives: Procedure: Sham |
| Individuals Without COPD - PNF | Active comparator | Individuals Without COPD - PNF Receives: Procedure: PNF |
| Individuals Without COPD - sham | Sham comparator | Individuals Without COPD - sham Receives: Procedure: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in inspiratory capacity
Change in inspiratory capacity
Measured: One day
Secondary outcomes (2)
Change in maximal respiratory pressure (MIP and MEP)
Change in maximal respiratory pressure (MIP and MEP)
Measured: One day
Change in electromyographic activity of accessory respiratory muscles
Change in electromyographic activity of accessory respiratory muscles
Measured: One Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start4 Dec 2017
- Primary completion14 Dec 2018 (estimated)
- Study completion14 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Pampa
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Responsible party
- Principal investigator, Anelise Dumke, Universidade Federal do Pampa
- Investigators
- Anelise Dumke, Principal investigator, Federal University of Rio Grande do SulMarli M. Knorst, Study director, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03417908
- Sponsor's protocol ID
- 09-411
- Status last verified
- Feb 2018
- First submitted
- 24 Jan 2018
- Last updated
- 26 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Proprioceptive Neuromuscular Facilitation Applied to the Accessory Respiratory Muscles on Functional and Electromyographic Parameters in Patients With and Without COPD
- ClinicalTrials.gov ID
- NCT03417908
- Acronym / sponsor ID
- 09-411
- Conditions
- COPD
- Keywords
- Proprioceptive neuromuscular facilitation, Pulmonary Rehabilitation, muscle activation, COPD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidade Federal do PampaUniversity, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 14 Dec 2018 (estimated)
- Study completion
- 14 Dec 2018 (estimated)
- First posted
- 31 Jan 2018 (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.
To evaluate the activation of accessory respiratory muscles and the effects of stretching these muscles in patients with COPD.
Detailed description
All subjects (sixty men) will perform spirometry, measure of inspiratory capacity (IC) and maximal inspiratory and expiratory pressures (MIP and MEP). Baseline blood pressure (BP), respiratory rate (RR), heart rate (HR), sensation of dyspnea (Borg Scale) and oxygen saturation (pulse oximetry, SpO2) will be collected prior to the performance of pulmonary function tests.
The electrical activity of the scalene (ESC), sternocleidomastoid (SCM) and external intercostal muscles (INTER) will be measured by surface electromyography (sEMG) at rest and during the maneuvers of IC, MIP and MEP.
Control group: The control group will perform isotonic concentric contraction of the biceps (two sets of five push-ups elbow in both arms) with the individual sitting in a chair with back support.
Intervention group: The contract-relax method of proprioceptive neuromuscular facilitation (PNF) technique will be used for stretching of ESC, ECM and external intercostals muscles. The contraction of agonist muscles against the resistance imposed by the physiotherapist (isometric contraction) is maintained for 6 seconds. After that, the patient will be asked to relax the muscles for 6 seconds without losing range of motion, and then the muscle will be lengthened. This procedure is repeated until the maximum amplitude of motion of the neck and upper limb is reached. The stretching will be performed on the right and left sides of the body.
Statistical analysis will be carried out with the Statistical Package for the Social Sciences, version 18.0 (SPSS Inc., Chicago, IL, USA). Normality of data distribution will be assessed by the Shapiro-Wilk test.
Values will be presented as mean ± standard deviation (SD) or median (25-75%). To compare the differences between the baseline characteristics between the groups the t test for independent samples will be used. The effect of the intervention will be evaluated by paired t test. For the analysis of the electromyographic signal will be use the Wilcoxon T test. Statistical significance is accepted at p < 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| COPD - PNF | Active comparator | Procedure: PNFCOPD - PNF |
| COPD - sham | Sham comparator | Procedure: ShamCOPD - sham |
| Individuals Without COPD - PNF | Active comparator | Procedure: PNFIndividuals Without COPD - PNF |
| Individuals Without COPD - sham | Sham comparator | Procedure: ShamIndividuals Without COPD - sham |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Control group: Men without respiratory symptoms and lung disease, with normal spirometry.
- Interventional group: Men diagnosed with severe to very severe COPD (forced expiratory volume in one second / forced vital capacity - FEV1/FVC <0.7 and FEV1 <50% predicted after bronchodilator use); clinically stable over the past 4 weeks.
Key exclusion criteria (9 listed)
- History of fracture in the spine and / or upper limb
- Herniated disc
- Connective tissue disease
- Ischemic heart disease or uncontrolled hypertension
- Obesity (BMI> 30 kg/m2)
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 |
|---|---|---|
| PNFThe contract-relax method of proprioceptive neuromuscular facilitation (PNF) technique will be used for stretching of ESC, ECM and external intercostals muscles. The contraction of agonist muscles against the resistance imposed by the physiotherapist (isometric contraction) will be maintained for 6 seconds. After that, the patient is oriented to relax the muscles for 6 seconds without losing range of motion, and then the muscle will be lengthened. This procedure is repeated until the maximum amplitude of motion of the neck and upper limb is reached. The stretching will be performed on the right and left sides of the body. | Procedure or surgery | COPD - PNF, Individuals Without COPD - PNF |
| ShamIsotonic concentric contraction of the biceps (two sets of five push-ups elbow in both arms) with the individual sitting in a chair with back support. | Procedure or surgery | COPD - sham, Individuals Without COPD - sham |
Primary outcome
Change in inspiratory capacity
Time frame: One day
Change in inspiratory capacity
2 secondary outcomes
Change in maximal respiratory pressure (MIP and MEP)
Time frame: One day
Change in electromyographic activity of accessory respiratory muscles
Time frame: One Day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2018.
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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.
Anelise Dumke principal investigator
Federal University of Rio Grande do Sul
Marli M. Knorst study director
Federal University of Rio Grande 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 PNF in people with COPD, run by Universidade Federal do Pampa 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 9 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: status not confirmed, as of the sponsor's last update on 26 Nov 2018. 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?
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?
Change in inspiratory capacity (time frame: One day). 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 26 Nov 2018.