StrokeNCT02416349
Acute Effects After Stretching Respiratory Muscles on Ventilatory Pattern and Volume Distribution of Chest Wall
A study testing Respiratory Muscles Stretching in people with Stroke, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
The purpose of study is to evaluate the acute effects of respiratory muscles stretching on ventilator pattern and volume distribution of chest wall in patients with right hemiparesis post-stroke and our hypothesis is that the use of RMS will be able to improve changes in the respiratory function. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Respiratory Muscles Stretching
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2013to Apr 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients post-stroke with right hemiparesis no more than 3 months, from both sexes, aged above 20 years, score between 1 and 3 according to Ashworth Scale for upper limbs, score above 85 according to Barthel Index and a minimum punctuation of 18 for Mini Mental State Examination.
Who cannot join
- Volunteers presenting facial paralysis; rheumatic or orthopedic diseases; spinal abnormalities or deformities that compromise the respiratory mechanics; spirometry with forced expired volume in the first second (FEV1) bellow 80% from predicted values and FEV1∕forced vital capacity (FVC) ≤ .7; presenting respiratory comorbidities; recent history of thoracic or abdominal surgery; hemodynamic instability or pregnancy.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal de Pernambuco - Laboratório de Fisiologia e Fisioterapia Cardiopulmonar - Recife - Brasil
Recife, Pernambuco, 50740 - 560
About this study
Official title: Acute Effects After Stretching Respiratory Muscles on Ventilatory Pattern and Volume Distribution of Chest Wall in Patients With Stroke: a Randomized Crossover Clinical Trial
The purpose of study is to evaluate the acute effects of respiratory muscles stretching on ventilator pattern and volume distribution of chest wall in patients with right hemiparesis post-stroke and our hypothesis is that the use of RMS will be able to improve changes in the respiratory function.
Read the detailed description
All study protocol will be performing in three different days. In the first day, the participants will undergo to the initial assessment, which consisted of anamnesis and anthropometric measurements: weight, height and body mass index (BMI). Then, they will be submitting to spirometry and respiratory muscle pressure using a manovacuometer.
All patients will submit underwent two types of intervention: respiratory muscles stretching (RMS) and remain at rest (control group). The stretching will occur throughout the expiratory phase to allow respiratory muscles to reach their maximal length, and two sets with 10 consecutive incursions will use for each stretching pattern with an interval of 30 seconds between series.
For the intervention in the control group, all volunteers will be position at rest in a comfortable in a chair during 20 minutes.
- Conditions
- Stroke
- Being tested
- Respiratory Muscles Stretching, Control Group
- Keywords
- Stroke, Stretching, Respiratory muscle, Ventilatory pattern, Optoelectronic plethysmography
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory Muscles StretchingOther
Respiratory Muscles Stretching The stretching will occur throughout the expiratory phase to allow respiratory muscles to reach their maximal length, and two sets with 10 consecutive incursions will be use for each stretching pattern with an interval of 30 seconds between series.
Pattern 1: Neck stretching Pattern 2: Upper chest stretching Pattern 3:Pectoralis major stretching Pattern 4:Lateral chest stretching
Control GroupOther
Control Group - all volunteers will be positioned at rest in a comfortable in a chair during 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Respiratory Muscles Stretching | Active comparator | Respiratory Muscles Stretching Neck stretching, upper chest stretching, pectoralis major stretching and lateral chest stretching. Receives: Other: Respiratory Muscles Stretching |
| Control Group | Placebo comparator | All volunteers will be positioned at rest in a comfortable in a chair during 20 minutes. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest Wall Volume
Vcw -Total chest wall volume by Optoelectronic Plethysmography.
Measured: During assessment and intervention, on average for an hour
Compartmental chest wall volumes (composite)
Vrcp - rib cage pulmonary volume; Vrca - rib cage abdominal volume; Vab - abdominal volume by Optoelectronic Plethysmography.
Measured: During assessment and intervention, on average for an hour
Secondary outcomes (2)
Ventilatory Pattern (Composite)
Total time (Ttot), inspiratory time (Tinsp), expiratory time (Texp), Tinsp/Ttot index, breathing rate (BR), minute volume (VE), mean inspiratory flow (MIF) and mean expiratory flow (MEF)
Measured: During assessment and intervention, on average for an hour
Lung Capacity (Composite)
VC - Vital capacity; Inspiratory Capacity by Optoelectronic Plethysmography.
Measured: During assessment and intervention, on average for an hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startNov 2013
- Primary completionMar 2015
- Study completionApr 2015
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 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Catarina Souza Ferreira Rattes Lima, Universidade Federal de Pernambuco
- Investigators
- Armele Andrade, PhD, Study director, Federal University of Pernambuco - Department of Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02416349
- Sponsor's protocol ID
- STRETCHING RESPIRATORY MUSCLES
- Status last verified
- Mar 2014
- First submitted
- 14 Mar 2014
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Rattes C, Campos SL, Morais C, Goncalves T, Sayao LB, Galindo-Filho VC, Parreira V, Aliverti A, Dornelas de Andrade A. Respiratory muscles stretching acutely increases expansion in hemiparetic chest wall. Respir Physiol Neurobiol. 2018 Aug;254:16-22. doi: 10.1016/j.resp.2018.03.015. Epub 2018 Mar 30.
PubMed 29608976
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects After Stretching Respiratory Muscles on Ventilatory Pattern and Volume Distribution of Chest Wall in Patients With Stroke: a Randomized Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT02416349
- Acronym / sponsor ID
- STRETCHING RESPIRATORY MUSCLES
- Conditions
- Stroke
- Keywords
- Stroke, Stretching, Respiratory muscle, Ventilatory pattern, Optoelectronic plethysmography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Nov 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 15 Apr 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 purpose of study is to evaluate the acute effects of respiratory muscles stretching on ventilator pattern and volume distribution of chest wall in patients with right hemiparesis post-stroke and our hypothesis is that the use of RMS will be able to improve changes in the respiratory function.
Detailed description
All study protocol will be performing in three different days. In the first day, the participants will undergo to the initial assessment, which consisted of anamnesis and anthropometric measurements: weight, height and body mass index (BMI). Then, they will be submitting to spirometry and respiratory muscle pressure using a manovacuometer.
All patients will submit underwent two types of intervention: respiratory muscles stretching (RMS) and remain at rest (control group). The stretching will occur throughout the expiratory phase to allow respiratory muscles to reach their maximal length, and two sets with 10 consecutive incursions will use for each stretching pattern with an interval of 30 seconds between series.
For the intervention in the control group, all volunteers will be position at rest in a comfortable in a chair during 20 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Respiratory Muscles Stretching | Active comparator | Other: Respiratory Muscles StretchingRespiratory Muscles Stretching Neck stretching, upper chest stretching, pectoralis major stretching and lateral chest stretching. |
| Control Group | Placebo comparator | Other: Control GroupAll volunteers will be positioned at rest in a comfortable in a chair during 20 minutes. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients post-stroke with right hemiparesis no more than 3 months, from both sexes, aged above 20 years, score between 1 and 3 according to Ashworth Scale for upper limbs, score above 85 according to Barthel Index and a minimum punctuation of 18 for Mini Mental State Examination.
Key exclusion criteria (1 listed)
- Volunteers presenting facial paralysis; rheumatic or orthopedic diseases; spinal abnormalities or deformities that compromise the respiratory mechanics; spirometry with forced expired volume in the first second (FEV1) bellow 80% from predicted values and FEV1∕forced vital capacity (FVC) ≤ .7; presenting respiratory comorbidities; recent history of thoracic or abdominal surgery; hemodynamic instability or pregnancy.
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 Muscles StretchingRespiratory Muscles Stretching The stretching will occur throughout the expiratory phase to allow respiratory muscles to reach their maximal length, and two sets with 10 consecutive incursions will be use for each stretching pattern with an interval of 30 seconds between series. Pattern 1: Neck stretching Pattern 2: Upper chest stretching Pattern 3:Pectoralis major stretching Pattern 4:Lateral chest stretching | Other | Respiratory Muscles Stretching |
| Control GroupControl Group - all volunteers will be positioned at rest in a comfortable in a chair during 20 minutes. | Other | Control Group |
Primary outcome
Chest Wall Volume
Time frame: During assessment and intervention, on average for an hour
Vcw -Total chest wall volume by Optoelectronic Plethysmography.
Compartmental chest wall volumes (composite)
Time frame: During assessment and intervention, on average for an hour
Vrcp - rib cage pulmonary volume; Vrca - rib cage abdominal volume; Vab - abdominal volume by Optoelectronic Plethysmography.
2 secondary outcomes
Ventilatory Pattern (Composite)
Time frame: During assessment and intervention, on average for an hour
Lung Capacity (Composite)
Time frame: During assessment and intervention, on average for an hour
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 15 Apr 2015.
- Derived from this study: PubMed 29608976Rattes C, Campos SL, Morais C, Goncalves T, Sayao LB, Galindo-Filho VC, Parreira V, Aliverti A, Dornelas de Andrade A. Respiratory muscles stretching acutely increases expansion in hemiparetic chest wall. Respir Physiol Neurobiol. 2018 Aug;254:16-22. doi: 10.1016/j.resp.2018.03.015. Epub 2018 Mar 30.
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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.
Armele Andrade, PhD study director
Federal University of Pernambuco - Department of Physical Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory Muscles Stretching in people with Stroke, run by Universidade Federal de Pernambuco 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 15 Apr 2015. 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?
Chest Wall Volume (time frame: During assessment and intervention, on average for an hour). The study lists 2 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 NCT02416349, 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 15 Apr 2015.