Stroke RehabilitationNCT03800485
Inspiratory Muscle Training in Patients With Stroke in Subacute Phase.
A study testing IMT in people with Stroke Rehabilitation, run by Hospital Universitario Virgen de la Arrixaca at 1 site in Spain.
Trial summary
Assess the effect of inspiratory muscle training on lung function, muscle strength and trunk balance in survivors of stroke in the subacute phase of the disease Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Stroke Rehabilitation
- What is being tested?
- IMT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 20 Jan 2019to 30 Dec 2019
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sroke 6 months before of the beginning of the study
- Be able to understand simple commands
- Hemiparesis or hemiplegia
- Not have serious cardiopulmonary diseases(COPD,asthma,bronchiectasis)
Who cannot join
- Associated neurological pathology leading to muscle weakness
- Severe respiratory pathology, pulmonary embolism, presence of tracheostomy cannula,
- intracranial hypertension
- Acute retinal datachment, recent eye surgery
- Impossibility of labial occlusion
- Unstable heart disease, unstable angina, aortic aneurysm
- Recent thoracic or abdominal surgery(6 months)
- Uncontrolled arterial hypertension
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Alicia Tovar Alcaraz
Murcia, 30009
ALICIA TOVAR ALCARAZ, Pt, +34606160702, aliciatovar78@hotmail.com
SILVANA L DE OLIVEIRA SOUSA, PhD, +34687184400, soliveira@umh.es
About this study
Official title: Effects of Inspiratory Muscle Training on Lung Function, Inspiratory Muscle Strength and Trunk Balance in Patients With Stroke in Subacute Phase.
Assess the effect of inspiratory muscle training on lung function, muscle strength and trunk balance in survivors of stroke in the subacute phase of the disease
Read the detailed description
Assess the effect of inspiratory muscle training on lung function, muscle strength and trunk balance in survivors of stroke in the subacute phase of the disease. The intervention will be done in a group of patients who will be treated in the rehabilitation service at the Virgen de la Arrixaca Hospital. They will train using a threshold IMT device or a Powerbreathe device, to increase their inspiratory muscle strength in addition to a physical therapy treatment. The intervention will last eigtht weeks and the patients will be evaluated at the beginning and at the end of the intervention.
- Conditions
- Stroke Rehabilitation
- Being tested
- IMT
- Keywords
- stroke, respiratory muscles, lung, stroke rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMTDevice
A training protocol of the inspiratory muscles that goes from the 15% of the maximal inspiratory muscle preassure until the 60% of the maximal inspiratory muscle preassure during 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| IMT-GE | Experimental | the participants will perform a training protocol of the inspiratory muscles during 8 weeks with a load that will increase from the 15% of the maximal inspiratory preassure until the 60% of the maximal inspiratory preassure. Receives: Device: IMT |
| IMT-GP | Placebo comparator | The participants will perform a training protocol of the inspiratory muscles during 8 weeks with a load that will be the 10% of the maximal inspiratory preassure during all the 8 weeks Receives: Device: IMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum inspiratory pressure
The change of the maximum inspiratory pressure from the beginning, at 4 weeks and At 8 weeks
Measured: From the first day of evaluation and at eight weeks of the beginning of the intervention
Forzed vital capacity
The change of the forzed vital capacity from the beginning and at the end of the intervention
Measured: From the first day of evaluation and at eight weeks of the beginning of the intervention
Forzed espiratory volume in the first second
The change of the forzed espiratory volumen in the first second beginning and in the end of the intervention using a spirometer
Measured: From the first day of evaluation and at eight weeks of the beginning of the intervention
Voluntary maximum ventilation
The change of the voluntary maximum ventilation from the beginning and at the end of the intervention using a spirometer
Measured: From the first day of evaluation and at eight weeks of the beginning of the intervention
The "Berg balance scale" Test
The change of the balance at the beginning and in the end of the intervention using the berg balance scale tool. The máximum value of this scale is 56 points, and the mínimum is 0 points. A higher value represents a better outcome.
Measured: From the first day of evaluation and at Eight weeks of the beginning of the intervention
The postural assessment scale for stroke patients (PASS )test
The change of the balance of the trunk at the beginning and in the end of the intervention using the postural assessment scale for stroke patinents tool. The maximum value of tris scale is 36 points. The minimum is 0 points.Higher values represents a better outcome.
Measured: From the first day of evaluation and at Eight weeks of the beginning of the intervention
Trunk control test (TCT)
The change of the trunk control at the beginning and in the end of the intervention. The maximum value is 100 points, and the minimum 0 points. Higher values represents a better outcome
Measured: From the first day of evaluation and at Eight weeks of the beginning of the intervention
Secondary outcomes (4)
Quadriceps dynamometry
The change of the quadriceps´s strength with a hand held dynamometer at the beginning and in the end of the intervention. Higher values represents a better outcome
Measured: From the first day of evaluation and at eight weeks of the beginning of the intervention
"Functional ambulatory classificator" Test
The change of the walking capacity using the functional ambulatory classificator tool at the beginning and in the end of the intervention. The máximum value is 5 and the mínimum 0. Higher values represents a better outcome
Measured: From the first day of evaluation and at Eight weeks of the beginning of the intervention
"Functional ambulatory classificator Hospital de Sagunto" Test
The change of the walking capacity using the functional ambulatory classificator hospital de sagunto tool at the beginning and ni the end. The máximum value is 5 and the mínimum 0. Higher valúes represents better outcome
Measured: From the first day of evaluation and at Eight weeks of the beginning of the intervention
SF-36 health survey
The change of the quality of life related to health with the SF-36 health survey at the beginning and in the end of the intervention
Measured: From the first day of evaluation and at eight weeks of the beginning of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start20 Jan 2019 (estimated)
- Primary completion30 Nov 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
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 Stroke RehabilitationStudies 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
- There are two groups, the intervention group and the placebo group.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Virgen de la Arrixaca
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Católica San Antonio de Murcia, Universidad Miguel Hernandez de Elche
- Responsible party
- Principal investigator, Alicia Tovar Alcaraz, Hospital Universitario Virgen de la Arrixaca
- Investigators
- MARTHA C LEON GARZON, PhD, Study director, UNIVERSIDAD SAN ANTONIO DE MURCIASILVANA L DE OLIVEIRA SOUSA, PhD, Study director, Universidad Miguel Hernandez de ElcheALICIA TOVAR ALCARAZ, Pt, Principal investigator, Hospital Universitario Virgen de la Arrixaca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03800485
- Sponsor's protocol ID
- 2017-10-4-HCUVA
- Status last verified
- Jan 2019
- First submitted
- 17 Dec 2018
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The individual participant data includes the spirometry data
Publications
Messaggi-Sartor M, Guillen-Sola A, Depolo M, Duarte E, Rodriguez DA, Barrera MC, Barreiro E, Escalada F, Orozco-Levi M, Marco E. Inspiratory and expiratory muscle training in subacute stroke: A randomized clinical trial. Neurology. 2015 Aug 18;85(7):564-72. doi: 10.1212/WNL.0000000000001827. Epub 2015 Jul 15.
PubMed 26180145Sutbeyaz ST, Koseoglu F, Inan L, Coskun O. Respiratory muscle training improves cardiopulmonary function and exercise tolerance in subjects with subacute stroke: a randomized controlled trial. Clin Rehabil. 2010 Mar;24(3):240-50. doi: 10.1177/0269215509358932. Epub 2010 Feb 15.
PubMed 20156979Kulnik ST, Birring SS, Moxham J, Rafferty GF, Kalra L. Does respiratory muscle training improve cough flow in acute stroke? Pilot randomized controlled trial. Stroke. 2015 Feb;46(2):447-53. doi: 10.1161/STROKEAHA.114.007110. Epub 2014 Dec 11.
PubMed 25503549Kim CY, Lee JS, Kim HD, Kim IS. Effects of the combination of respiratory muscle training and abdominal drawing-in maneuver on respiratory muscle activity in patients with post-stroke hemiplegia: a pilot randomized controlled trial. Top Stroke Rehabil. 2015 Aug;22(4):262-70. doi: 10.1179/1074935714Z.0000000020. Epub 2015 Feb 18.
PubMed 26258451Jung KM, Bang DH. Effect of inspiratory muscle training on respiratory capacity and walking ability with subacute stroke patients: a randomized controlled pilot trial. J Phys Ther Sci. 2017 Feb;29(2):336-339. doi: 10.1589/jpts.29.336. Epub 2017 Feb 24.
PubMed 28265169
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inspiratory Muscle Training on Lung Function, Inspiratory Muscle Strength and Trunk Balance in Patients With Stroke in Subacute Phase.
- ClinicalTrials.gov ID
- NCT03800485
- Acronym / sponsor ID
- 2017-10-4-HCUVA
- Conditions
- Stroke Rehabilitation
- Keywords
- stroke, respiratory muscles, lung, stroke rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospital Universitario Virgen de la ArrixacaUniversity, hospital or other
- Collaborators
- Universidad Católica San Antonio de Murcia, Universidad Miguel Hernandez de Elche
- Study start
- 20 Jan 2019 (estimated)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 11 Jan 2019 (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.
Assess the effect of inspiratory muscle training on lung function, muscle strength and trunk balance in survivors of stroke in the subacute phase of the disease
Detailed description
Assess the effect of inspiratory muscle training on lung function, muscle strength and trunk balance in survivors of stroke in the subacute phase of the disease. The intervention will be done in a group of patients who will be treated in the rehabilitation service at the Virgen de la Arrixaca Hospital. They will train using a threshold IMT device or a Powerbreathe device, to increase their inspiratory muscle strength in addition to a physical therapy treatment. The intervention will last eigtht weeks and the patients will be evaluated at the beginning and at the end of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- There are two groups, the intervention group and the placebo group.
| Arm | Type | Receives |
|---|---|---|
| IMT-GE | Experimental | Device: IMTthe participants will perform a training protocol of the inspiratory muscles during 8 weeks with a load that will increase from the 15% of the maximal inspiratory preassure until the 60% of the maximal inspiratory preassure. |
| IMT-GP | Placebo comparator | Device: IMTThe participants will perform a training protocol of the inspiratory muscles during 8 weeks with a load that will be the 10% of the maximal inspiratory preassure during all the 8 weeks |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Sroke 6 months before of the beginning of the study
- Be able to understand simple commands
- Hemiparesis or hemiplegia
- Not have serious cardiopulmonary diseases(COPD,asthma,bronchiectasis)
Key exclusion criteria (8 listed)
- Associated neurological pathology leading to muscle weakness
- Severe respiratory pathology, pulmonary embolism, presence of tracheostomy cannula,
- intracranial hypertension
- Acute retinal datachment, recent eye surgery
- Impossibility of labial occlusion
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 |
|---|---|---|
| IMTA training protocol of the inspiratory muscles that goes from the 15% of the maximal inspiratory muscle preassure until the 60% of the maximal inspiratory muscle preassure during 8 weeks | Device | IMT-GE, IMT-GP |
Primary outcome
Maximum inspiratory pressure
Time frame: From the first day of evaluation and at eight weeks of the beginning of the intervention
The change of the maximum inspiratory pressure from the beginning, at 4 weeks and At 8 weeks
Forzed vital capacity
Time frame: From the first day of evaluation and at eight weeks of the beginning of the intervention
The change of the forzed vital capacity from the beginning and at the end of the intervention
Forzed espiratory volume in the first second
Time frame: From the first day of evaluation and at eight weeks of the beginning of the intervention
The change of the forzed espiratory volumen in the first second beginning and in the end of the intervention using a spirometer
Voluntary maximum ventilation
Time frame: From the first day of evaluation and at eight weeks of the beginning of the intervention
The change of the voluntary maximum ventilation from the beginning and at the end of the intervention using a spirometer
The "Berg balance scale" Test
Time frame: From the first day of evaluation and at Eight weeks of the beginning of the intervention
The change of the balance at the beginning and in the end of the intervention using the berg balance scale tool. The máximum value of this scale is 56 points, and the mínimum is 0 points. A higher value represents a better outcome.
The postural assessment scale for stroke patients (PASS )test
Time frame: From the first day of evaluation and at Eight weeks of the beginning of the intervention
The change of the balance of the trunk at the beginning and in the end of the intervention using the postural assessment scale for stroke patinents tool. The maximum value of tris scale is 36 points. The minimum is 0 points.Higher values represents a better outcome.
Trunk control test (TCT)
Time frame: From the first day of evaluation and at Eight weeks of the beginning of the intervention
The change of the trunk control at the beginning and in the end of the intervention. The maximum value is 100 points, and the minimum 0 points. Higher values represents a better outcome
4 secondary outcomes
Quadriceps dynamometry
Time frame: From the first day of evaluation and at eight weeks of the beginning of the intervention
"Functional ambulatory classificator" Test
Time frame: From the first day of evaluation and at Eight weeks of the beginning of the intervention
"Functional ambulatory classificator Hospital de Sagunto" Test
Time frame: From the first day of evaluation and at Eight weeks of the beginning of the intervention
SF-36 health survey
Time frame: From the first day of evaluation and at eight weeks of the beginning of the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
- Results publication: PubMed 26180145Messaggi-Sartor M, Guillen-Sola A, Depolo M, Duarte E, Rodriguez DA, Barrera MC, Barreiro E, Escalada F, Orozco-Levi M, Marco E. Inspiratory and expiratory muscle training in subacute stroke: A randomized clinical trial. Neurology. 2015 Aug 18;85(7):564-72. doi: 10.1212/WNL.0000000000001827. Epub 2015 Jul 15.
- Results publication: PubMed 20156979Sutbeyaz ST, Koseoglu F, Inan L, Coskun O. Respiratory muscle training improves cardiopulmonary function and exercise tolerance in subjects with subacute stroke: a randomized controlled trial. Clin Rehabil. 2010 Mar;24(3):240-50. doi: 10.1177/0269215509358932. Epub 2010 Feb 15.
- Results publication: PubMed 25503549Kulnik ST, Birring SS, Moxham J, Rafferty GF, Kalra L. Does respiratory muscle training improve cough flow in acute stroke? Pilot randomized controlled trial. Stroke. 2015 Feb;46(2):447-53. doi: 10.1161/STROKEAHA.114.007110. Epub 2014 Dec 11.
- Results publication: PubMed 26258451Kim CY, Lee JS, Kim HD, Kim IS. Effects of the combination of respiratory muscle training and abdominal drawing-in maneuver on respiratory muscle activity in patients with post-stroke hemiplegia: a pilot randomized controlled trial. Top Stroke Rehabil. 2015 Aug;22(4):262-70. doi: 10.1179/1074935714Z.0000000020. Epub 2015 Feb 18.
- Results publication: PubMed 28265169Jung KM, Bang DH. Effect of inspiratory muscle training on respiratory capacity and walking ability with subacute stroke patients: a randomized controlled pilot trial. J Phys Ther Sci. 2017 Feb;29(2):336-339. doi: 10.1589/jpts.29.336. Epub 2017 Feb 24.
- Individual participant dataSharing planned: Undecided. The individual participant data includes the spirometry data
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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.
MARTHA C LEON GARZON, PhD study director
UNIVERSIDAD SAN ANTONIO DE MURCIA
SILVANA L DE OLIVEIRA SOUSA, PhD study director
Universidad Miguel Hernandez de Elche
ALICIA TOVAR ALCARAZ, Pt principal investigator
Hospital Universitario Virgen de la Arrixaca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMT in people with Stroke Rehabilitation, run by Hospital Universitario Virgen de la Arrixaca at 1 site in Spain.
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 4 inclusion and 8 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 11 Jan 2019. 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 Spain. 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?
Contact ALICIA TOVAR ALCARAZ, MS (+34606160702, aliciatovar78@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum inspiratory pressure (time frame: From the first day of evaluation and at eight weeks of the beginning of the intervention). The study lists 7 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 NCT03800485, 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 11 Jan 2019.