Respiratory InsufficiencyNCT04915170
Inspiratory Muscle Training in Cerebral Palsy Patients
A study testing Inspiratory muscle training in people with Respiratory Insufficiency, run by University of Salamanca at 1 site in Spain.
Trial summary
To evaluate the effectiveness of two protocols of inspiratory muscle training (IMT) in cerebral palsy patients to improve respiratory strength and spirometric parameters. Low-intensity vs high-intensity resistance training programs. Read more about this study
- Who is it for?
- Ages 35 to 64 years
- Conditions the study is for
- Respiratory Insufficiency
- What is being tested?
- Inspiratory muscle training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2022to 1 Feb 2023
- 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 35 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Cerebral palsy patients
- Understand the objectives and be able to complete questionaires
- Exclusion criteria: the presence of a respiratory disease in the previous month, inability to understand assessment tests or intervention or hemodynamic alterations (heart rate > 150 beats per minute (bpm), systolic blood pressure > 140 millimeters mercury (mmHg) or diastolic blood pressure > 90 mmHg).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Inspiratory Muscle Training in Adult Patients With Cerebral Palsy
To evaluate the effectiveness of two protocols of inspiratory muscle training (IMT) in cerebral palsy patients to improve respiratory strength and spirometric parameters. Low-intensity vs high-intensity resistance training programs. Evaluations: Determination of the maximum inspiratory pressure (MIP) and the maximum expiratory pressure (MEP); spirometry - peak expiratory flow (PEF), forced expiratory volume in first second (FEV1) and clinical evaluations. The participants will be evaluated at the beginning and end of the intervention period. Intervention: There are two groups of patients, one works with low loads (20% MIP) and another with high loads (40% MIP). They train 5 days/week 10 cycles lasting 1 minute. There is a rest of 1 minute between each cycle.
Read the detailed description
The study was a controlled, randomised, double-blind trial and with allocation concealment. The study protocol was approved by the Bioethics Committee of the University of Salamanca (number of registry 678, 6th October 2021).
Participants:
Institutionalized people with cerebral palsy between 35 and 64 years were included, they were all members of ASPACE Salamanca.
All patients will be asked to carry out the 5-day weekly program, and a recording sheet will be provided to each participant so they will can record the time of each daily respiratory training session. All participants signed an informed consent form.
The patients will be assigned to the two groups randomly. The main researcher doesn´t meet any of the participants until the initial assessment will be carried out.
Intervention:
"High-intensity group". The device incorporates a unidirectional valve independent of flow to guarantee constant resistance and includes a specific pressure setting (in cm H2O).
The intensity of the device will be 40% of MIP. The protocol includes 10 cycles lasting 1 minute. The participants rest for 1 minute between each cycle. In total, the protocol includes 10 minutes of daily respiratory training. The patients will be instructed to inhale with enough force to reach the opening of the valve.
"Low-intensity group".The device incorporates a unidirectional valve independent of flow to guarantee constant resistance and includes a specific pressure setting (in cm H2O).
The intensity of the device will be 20% of MIP. The protocol includes 10 cycles lasting 1 minute. The participants rest for 1 minute between each cycle. In total, the protocol includes 10 minutes of daily respiratory training. The patients will be instructed to inhale with enough force to reach the opening of the valve.
- Conditions
- Respiratory Insufficiency
- Being tested
- Inspiratory muscle training
- Keywords
- aging, cerebral palsy, MANOVA, muscle strength, older adults, physical activity, respiratory exercises
- Medical subject headings
- Respiratory Insufficiency, Cerebral Palsy, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle trainingDevice
The device incorporate a unidirectional valve independent of flow to guarantee constant resistance and included a specific pressure setting (in cm H2O)
| Study group | Role | What they receive |
|---|---|---|
| High intensity group | Experimental | Intervention is administrated with an inspiratory muscle trainer (IMT). High intensity group: 10 cycles, 1 minute each one, 40% MIP with IMT. 1 minute to rest between cycles. Receives: Device: Inspiratory muscle training |
| Low intensity group | Experimental | Intervention is administrated with an inspiratory muscle trainer (IMT). Low intensity group: 10 cycles, 1 minute each one, 20% MIP with IMT. 1 minute to rest between cycles. Receives: Device: Inspiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal inspiratory pressure
The evaluation is performed using a pressure transducer, Elka 15, which obtainer each measurement in millibar and converted it into the reference unit of centimeter of water (cm H2O) (1 mbar = 1.01973 cm H2O), following the rules of the American Thoracic Society/European Respiratory Society (ATS / ERS). The procedure was repeated until 3 values were obtained with a difference of less than 5%, and the highest value was used for the analysis.
Measured: 2 minutes
Maximal expiratory pressure
The evaluation is performed using a pressure transducer, Elka 15, which obtainer each measurement in millibar and converted it into the reference unit of centimeter of water (cm H2O) (1 mbar = 1.01973 cm H2O), following the rules of the American Thoracic Society/European Respiratory Society (ATS / ERS). The procedure was repeated until 3 values were obtained with a difference of less than 5%, and the highest value was used for the analysis.
Measured: 2 minutes
Secondary outcomes (2)
Pulmonary volume
The evaluation is performed collecting forced expiratory volume in 1 second (FEV1). It was measured using the peak flow device (Asma-1, Vitalograph Ltd, Buckingham, England)
Measured: 1 minute
Pulmonary flow
The evaluation is performed collecting peak expiratory flow (PEF). It was measured using the peak flow device (Asma-1, Vitalograph Ltd, Buckingham, England)
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start1 Jun 2022
- Primary completion1 Aug 2022
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory InsufficiencyStudies 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
- Patients are assigned randomly to the 2 working groups, each patient only receives one of the two protocols.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CARLOS MARTIN SANCHEZ, University of Salamanca
- Investigators
- CARLOS MARTIN SANCHEZ, PhD, Principal investigator, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915170
- Sponsor's protocol ID
- 31052021
- Status last verified
- Feb 2024
- First submitted
- 31 May 2021
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared after approving.
Publications
Martin-Sanchez C, Barbero-Iglesias FJ, Amor-Esteban V, Martin-Sanchez M, Martin-Nogueras AM. Inspiratory Muscle Training in Adults With Cerebral Palsy: Long Term Effects: A Double-Blind Randomized, Controlled Trial. Res Nurs Health. 2025 Oct;48(5):545-558. doi: 10.1002/nur.70000. Epub 2025 Jun 20.
PubMed 40539466Martin-Sanchez C, Barbero-Iglesias FJ, Amor-Esteban V, Martin-Sanchez M, Martin-Nogueras AM. Benefits of inspiratory muscle training therapy in institutionalized adult people with cerebral palsy: A double-blind randomized controlled trial. Brain Behav. 2024 Sep;14(9):e70044. doi: 10.1002/brb3.70044.
PubMed 39295105
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inspiratory Muscle Training in Adult Patients With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04915170
- Acronym / sponsor ID
- 31052021
- Conditions
- Respiratory Insufficiency
- Keywords
- aging, cerebral palsy, MANOVA, muscle strength, older adults, physical activity, respiratory exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 7 Jun 2021 (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 effectiveness of two protocols of inspiratory muscle training (IMT) in cerebral palsy patients to improve respiratory strength and spirometric parameters. Low-intensity vs high-intensity resistance training programs. Evaluations: Determination of the maximum inspiratory pressure (MIP) and the maximum expiratory pressure (MEP); spirometry - peak expiratory flow (PEF), forced expiratory volume in first second (FEV1) and clinical evaluations. The participants will be evaluated at the beginning and end of the intervention period. Intervention: There are two groups of patients, one works with low loads (20% MIP) and another with high loads (40% MIP). They train 5 days/week 10 cycles lasting 1 minute. There is a rest of 1 minute between each cycle.
Detailed description
The study was a controlled, randomised, double-blind trial and with allocation concealment. The study protocol was approved by the Bioethics Committee of the University of Salamanca (number of registry 678, 6th October 2021).
Participants:
Institutionalized people with cerebral palsy between 35 and 64 years were included, they were all members of ASPACE Salamanca.
All patients will be asked to carry out the 5-day weekly program, and a recording sheet will be provided to each participant so they will can record the time of each daily respiratory training session. All participants signed an informed consent form.
The patients will be assigned to the two groups randomly. The main researcher doesn´t meet any of the participants until the initial assessment will be carried out.
Intervention:
"High-intensity group". The device incorporates a unidirectional valve independent of flow to guarantee constant resistance and includes a specific pressure setting (in cm H2O).
The intensity of the device will be 40% of MIP. The protocol includes 10 cycles lasting 1 minute. The participants rest for 1 minute between each cycle. In total, the protocol includes 10 minutes of daily respiratory training. The patients will be instructed to inhale with enough force to reach the opening of the valve.
"Low-intensity group".The device incorporates a unidirectional valve independent of flow to guarantee constant resistance and includes a specific pressure setting (in cm H2O).
The intensity of the device will be 20% of MIP. The protocol includes 10 cycles lasting 1 minute. The participants rest for 1 minute between each cycle. In total, the protocol includes 10 minutes of daily respiratory training. The patients will be instructed to inhale with enough force to reach the opening of the valve.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Patients are assigned randomly to the 2 working groups, each patient only receives one of the two protocols.
| Arm | Type | Receives |
|---|---|---|
| High intensity group | Experimental | Device: Inspiratory muscle trainingIntervention is administrated with an inspiratory muscle trainer (IMT). High intensity group: 10 cycles, 1 minute each one, 40% MIP with IMT. 1 minute to rest between cycles. |
| Low intensity group | Experimental | Device: Inspiratory muscle trainingIntervention is administrated with an inspiratory muscle trainer (IMT). Low intensity group: 10 cycles, 1 minute each one, 20% MIP with IMT. 1 minute to rest between cycles. |
Who may qualify
- Ages
- 35 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Cerebral palsy patients
- Understand the objectives and be able to complete questionaires
- Exclusion criteria: the presence of a respiratory disease in the previous month, inability to understand assessment tests or intervention or hemodynamic alterations (heart rate > 150 beats per minute (bpm), systolic blood pressure > 140 millimeters mercury (mmHg) or diastolic blood pressure > 90 mmHg).
Key exclusion criteria (0 listed)
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 trainingThe device incorporate a unidirectional valve independent of flow to guarantee constant resistance and included a specific pressure setting (in cm H2O) | Device | High intensity group, Low intensity group |
Primary outcome
Maximal inspiratory pressure
Time frame: 2 minutes
The evaluation is performed using a pressure transducer, Elka 15, which obtainer each measurement in millibar and converted it into the reference unit of centimeter of water (cm H2O) (1 mbar = 1.01973 cm H2O), following the rules of the American Thoracic Society/European Respiratory Society (ATS / ERS). The procedure was repeated until 3 values were obtained with a difference of less than 5%, and the highest value was used for the analysis.
Maximal expiratory pressure
Time frame: 2 minutes
The evaluation is performed using a pressure transducer, Elka 15, which obtainer each measurement in millibar and converted it into the reference unit of centimeter of water (cm H2O) (1 mbar = 1.01973 cm H2O), following the rules of the American Thoracic Society/European Respiratory Society (ATS / ERS). The procedure was repeated until 3 values were obtained with a difference of less than 5%, and the highest value was used for the analysis.
2 secondary outcomes
Pulmonary volume
Time frame: 1 minute
Pulmonary flow
Time frame: 1 minute
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 12 Feb 2024.
- Derived from this study: PubMed 40539466Martin-Sanchez C, Barbero-Iglesias FJ, Amor-Esteban V, Martin-Sanchez M, Martin-Nogueras AM. Inspiratory Muscle Training in Adults With Cerebral Palsy: Long Term Effects: A Double-Blind Randomized, Controlled Trial. Res Nurs Health. 2025 Oct;48(5):545-558. doi: 10.1002/nur.70000. Epub 2025 Jun 20.
- Derived from this study: PubMed 39295105Martin-Sanchez C, Barbero-Iglesias FJ, Amor-Esteban V, Martin-Sanchez M, Martin-Nogueras AM. Benefits of inspiratory muscle training therapy in institutionalized adult people with cerebral palsy: A double-blind randomized controlled trial. Brain Behav. 2024 Sep;14(9):e70044. doi: 10.1002/brb3.70044.
- Individual participant dataSharing planned: Yes. Data will be shared after approving.
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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.
CARLOS MARTIN SANCHEZ, PhD principal investigator
University of Salamanca
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 in people with Respiratory Insufficiency, run by University of Salamanca 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 3 inclusion and 0 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 12 Feb 2024. 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. 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?
Maximal inspiratory pressure (time frame: 2 minutes). 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 NCT04915170, which also lists 2 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 12 Feb 2024.