Breathing ExercisesINSPUL-REHABNCT04270162
New Intervention Protocol With Inspirometer Versus 2 Modalities of Pulmonary Intervention: INSPUL-REHAB
A study testing Respiratory muscle training 1, Respiratory muscle training 2 and Respiratory muscle training 3 in people with Breathing Exercises, run by Hospital Angeles Lomas at 1 site in Mexico.
Trial summary
A clinical trial will be carried out in the area of physiotherapy and rehabilitation of the "Centro Integral de Rehabilitación S.C. at the Hospital Angeles Lomas" in Mexico. Which, will have 3 arms (1. New intervention protocol created by the main author in the use of the inspirometer, 2. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Breathing Exercises
- What is being tested?
- Respiratory muscle training 1, Respiratory muscle training 2 and Respiratory muscle training 3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteMexico
- Study dates
- 10 Feb 2020to 20 Dec 2020
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized patients cardiopulmonary pathologies
- Over 18 years of age
- Patients who sign informed consent
- Possibility of performing your training for 1 month
- Participants than will can to go everyday for intervention.
- Participants do not have any inconvenience when doing the questionnaires, tests and measures that the investigation demands.
Who cannot join
- Participants who had severe pain in the lower or upper limbs.
- Unstable angina.
- Heart rate >120 bpm (beats per minute) at rest.
- Systolic blood pressure >190 mmHg.
- Diastolic blood pressure >120 mmHg.
- Participants who had a positive contraindication make exercise were not admitted in the study.
- Participants to show hemodynamic instability without improving during any test or during the intervention process.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Centro Integral de Rehabilitación S.C. en el Hospital Angeles Lomas
Estado de México, Huixquilucan, 52760
Javier Pereira Rodriguez, 2222078536, jepr87@hotmail.com
Sharon Waiss, 5545934653, sharonwaiss@yahoo.com
About this study
Official title: New Intervention Protocol With Inspirometer to Improve Lung Capacity Versus Traditional Use of Inspirometer and the Effects of Respiratory Exercises in Hospitalized Patients: INSPUL-REHAB
A clinical trial will be carried out in the area of physiotherapy and rehabilitation of the "Centro Integral de Rehabilitación S.C. at the Hospital Angeles Lomas" in Mexico. Which, will have 3 arms (1. New intervention protocol created by the main author in the use of the inspirometer, 2. Conventional use of the inspirometer, 3. breathing exercises without the use of inspirometer) with hospitalized patient population and whose purpose will be to determine the effectiveness of the new intervention protocol and compare it with the current protocol and respiratory exercises.
Read the detailed description
A clinical trial will be carried out in the area of physiotherapy and rehabilitation of the "Centro Integral de Rehabilitación S.C. at the Hospital Angeles Lomas" in Mexico. Whose population will be hospitalized patients at the angeles lomas hospital. This research is carried out with the purpose of knowing and applying the technique of contra-relax at the muscular level but in this case extrapolated in the inspirometer. This project will have 3 arms (1. New intervention protocol created by the main author in the use of the inspirometer, 2. Conventional use of the inspirometer, 3. breathing exercises) with a population of hospitalized patients and whose purpose will be to determine the effectiveness of the new intervention protocol and compare it with the current protocol and respiratory exercises.
The present project will be carried out with hospitalized patients who meet the criteria of occlusion and who, after passing the exclusion criteria, become part of a randomized clinical trial type investigation with a basic probabilistic sampling through a random number table, which Your order will be random through the Microsoft Excel 16.0 program, so we will obtain an experimental group 1, which will be the new intervention protocol for the use of the inspirometer (The maximum inspiratory capacity will be obtained and that results will be taken out 50% and 80% to have it as muscle strength training values for the respiratory muscles based on the contra-relax technique), an experimental group 2 (Conventional use of the conventional way) and a control group (breathing exercises without the use of inspirometer).
After your hospital stay, the post-training changes of the different groups will be determined taking as a reference and control value the maximum inspiratory volume and the maximum expiratory volume. The variables to be determined will be: Fatigue, dyspnea, maximum inspiratory capacity, maximum expiratory volume, quality of life, vital signs (heart rate, respiratory rate, blood pressure).
- Conditions
- Breathing Exercises
- Being tested
- Respiratory muscle training 1, Respiratory muscle training 2, Respiratory muscle training 3
- Keywords
- Inspiratory volume, expiratory volume, inspirometer.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory muscle training 1Device
Also called Inspirometer 1
For inspirometer, the participant sits and holds the device. Then put the mouthpiece of the inspirometer in the mouth. Be sure to make a good seal on the mouthpiece with your lips. And exhale (exhale) normally until you run out of air. And after that, inhale (inspire) slowly as much as possible. This maximum value will be taken as an indicative parameter of its maximum inspiratory capacity and 50 and 80% of that value will be determined so that the participant performs 1 set of 10 repetitions at 50% of their maximum value, 2 sets of 10 repetitions at 60% of its maximum capacity and ends with 1 series at 80% of its maximum capacity.
It is highlighted that in each series before finishing and without stopping to rest, the participant must do 5 repetitions at 100% maximum capacity.
In addition, the respiratory exercises that will be carried out by the 3 intervention groups.
Respiratory muscle training 2Other
Also called Inspirometer 2
Training of respiratory muscles under the protocol of conventional use. Which is that the participant sits and holds the device. Then put the mouthpiece of the inspirometer in the mouth. Be sure to make a good seal on the mouthpiece with your lips. And exhale (exhale) normally until you run out of air. And after that, inhale (inspire) slowly as much as possible. Repeat 10 times and use these indications for 3 sets.
In addition, participants must perform different breathing exercises that are identical for the 3 intervention groups.
Respiratory muscle training 3Other
Also called Respiratory exercises without inspirometer
The same exercises that apply to the participants of experimental group 1 and 2 will be performed. The only difference is that the participants of this group do not perform exercises with inspirometer.
| Study group | Role | What they receive |
|---|---|---|
| New intervention protocol with inspirometer | Experimental | Respiratory exercises without use of inspirometerwill be taken out 50% and 80% to have it as muscle strength training values for the respiratory muscles based on the contra-relax technique) Receives: Device: Respiratory muscle training 1 |
| Protocol of use of inspirometer in a conventional way | Active comparator | This gonna be a experimental group 2 with conventional use of the conventional way. Receives: Other: Respiratory muscle training 2 |
| Respiratory exercises without use of inspirometer | Active comparator | This group gonna be a control group with breathing exercises without the use of inspirometer. Receives: Other: Respiratory muscle training 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum inspiratory volume (ml)
It will be determined by using the inspirometer whose values are from 0ml to 5,000ml. This pre and post intervention value will be determined
Measured: 1 month of training
Changes in the levels of Fatigue after intervention
Fatigue was assessed using the FACT-Fatigue Scale Scale (Fatigue Scale of the Functional Evaluation of Cancer Therapy), which is an inventory of 13 items that assesses the severity of cancer-associated fatigue (FAC) in the last week. with a scale of 0 to 4 and that with higher scores reflect a lower FAC.
Measured: 1 month of training
Changes in the Dyspnoea a after intervention
Dyspnea is a respiratory difficulty that usually translates into shortness of breath. Dyspnea can be determined using the original Borg scale (Score from 0 to 20) or modified (Score from 0 to 10), in which the higher the number indicated by the participant, the higher the degree of dyspnea.
Measured: 1 month of training
Changes in the levels of Quality of life after intervention: EORTC QLQ-C30
For the quality of life, it is necessary to use the questionnaire called EORTC QLQ-C30 (Version 3), which has 30 questions, where each question will go with a score of 1 to 4 and the higher the final result the better the quality of life. participant's life.
Measured: 1 month of training
Secondary outcomes (5)
Pre and post intervention blood pressure (mmhg)
Blood pressure will be determined by using a baumanometer.
Measured: 1 month of training
Pre and post intervention heart rate (number of beats per minute)
The heart rate will be determined by using a pulse oximeter and corroborated manually.
Measured: 1 month of training
Pre and post intervention respiratory rate (breaths per minute)
Heart rate will be determined visually by the researcher.
Measured: 1 month of training
Changes in the Body Mass Index after intervention (%):
it is a mathematical reason that associates the mass and the size of an individual. it is also known as the Quetelet index. This result is determined by the formula of weight/square size.
Measured: 1 month of training
Changes in the Abdominal circumference after intervention (cm):
It is the measurement of the distance around the abdomen at a specific point. Abdominal circumference is used to diagnose and monitor abdominal obesity. The values are in centimeters and according to the population to be studied, the measurements must be less than 90cm for men and 80cm for women.
Measured: 1 month of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start10 Feb 2020
- Primary completion30 Jul 2020 (estimated)
- Study completion20 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breathing ExercisesStudies 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
- Model description
- Hospitalized patients who after the exclusion criteria will begin the investigation and organize into 3 groups. The present one will be distributed with a basic probabilistic sampling using a random number table, whose order will be randomized through the Microsoft Excel 16.0 program, being experimental group 1 (New intervention protocol with inspirometer), experimental group 2 (Use of inspirometer in a conventional way) and control group (breathing exercises without the use of inspirometer).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Angeles Lomas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Eliecer Pereira Rodriguez, Hospital Angeles Lomas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04270162
- Sponsor's protocol ID
- JEPRodriguez
- Acronym
- INSPUL-REHAB
- Status last verified
- Feb 2020
- First submitted
- 12 Feb 2020
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We don´t have any plan because The research will be carried out directly among the researchers of our center. However, it is highlighted that we will make our results available to other researchers so that they can carry out future research that supports our results and compares with other types of populations.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Intervention Protocol With Inspirometer to Improve Lung Capacity Versus Traditional Use of Inspirometer and the Effects of Respiratory Exercises in Hospitalized Patients: INSPUL-REHAB
- ClinicalTrials.gov ID
- NCT04270162
- Acronym / sponsor ID
- INSPUL-REHAB / JEPRodriguez
- Conditions
- Breathing Exercises
- Keywords
- Inspiratory volume, expiratory volume, inspirometer.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospital Angeles LomasUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 30 Jul 2020 (estimated)
- Study completion
- 20 Dec 2020 (estimated)
- First posted
- 17 Feb 2020 (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.
A clinical trial will be carried out in the area of physiotherapy and rehabilitation of the "Centro Integral de Rehabilitación S.C. at the Hospital Angeles Lomas" in Mexico. Which, will have 3 arms (1. New intervention protocol created by the main author in the use of the inspirometer, 2. Conventional use of the inspirometer, 3. breathing exercises without the use of inspirometer) with hospitalized patient population and whose purpose will be to determine the effectiveness of the new intervention protocol and compare it with the current protocol and respiratory exercises.
Detailed description
A clinical trial will be carried out in the area of physiotherapy and rehabilitation of the "Centro Integral de Rehabilitación S.C. at the Hospital Angeles Lomas" in Mexico. Whose population will be hospitalized patients at the angeles lomas hospital. This research is carried out with the purpose of knowing and applying the technique of contra-relax at the muscular level but in this case extrapolated in the inspirometer. This project will have 3 arms (1. New intervention protocol created by the main author in the use of the inspirometer, 2. Conventional use of the inspirometer, 3. breathing exercises) with a population of hospitalized patients and whose purpose will be to determine the effectiveness of the new intervention protocol and compare it with the current protocol and respiratory exercises.
The present project will be carried out with hospitalized patients who meet the criteria of occlusion and who, after passing the exclusion criteria, become part of a randomized clinical trial type investigation with a basic probabilistic sampling through a random number table, which Your order will be random through the Microsoft Excel 16.0 program, so we will obtain an experimental group 1, which will be the new intervention protocol for the use of the inspirometer (The maximum inspiratory capacity will be obtained and that results will be taken out 50% and 80% to have it as muscle strength training values for the respiratory muscles based on the contra-relax technique), an experimental group 2 (Conventional use of the conventional way) and a control group (breathing exercises without the use of inspirometer).
After your hospital stay, the post-training changes of the different groups will be determined taking as a reference and control value the maximum inspiratory volume and the maximum expiratory volume. The variables to be determined will be: Fatigue, dyspnea, maximum inspiratory capacity, maximum expiratory volume, quality of life, vital signs (heart rate, respiratory rate, blood pressure).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Hospitalized patients who after the exclusion criteria will begin the investigation and organize into 3 groups. The present one will be distributed with a basic probabilistic sampling using a random number table, whose order will be randomized through the Microsoft Excel 16.0 program, being experimental group 1 (New intervention protocol with inspirometer), experimental group 2 (Use of inspirometer in a conventional way) and control group (breathing exercises without the use of inspirometer).
| Arm | Type | Receives |
|---|---|---|
| New intervention protocol with inspirometer | Experimental | Device: Respiratory muscle training 1Respiratory exercises without use of inspirometerwill be taken out 50% and 80% to have it as muscle strength training values for the respiratory muscles based on the contra-relax technique) |
| Protocol of use of inspirometer in a conventional way | Active comparator | Other: Respiratory muscle training 2This gonna be a experimental group 2 with conventional use of the conventional way. |
| Respiratory exercises without use of inspirometer | Active comparator | Other: Respiratory muscle training 3This group gonna be a control group with breathing exercises without the use of inspirometer. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Hospitalized patients cardiopulmonary pathologies
- Over 18 years of age
- Patients who sign informed consent
- Possibility of performing your training for 1 month
- Participants than will can to go everyday for intervention.
Key exclusion criteria (7 listed)
- Participants who had severe pain in the lower or upper limbs.
- Unstable angina.
- Heart rate >120 bpm (beats per minute) at rest.
- Systolic blood pressure >190 mmHg.
- Diastolic blood pressure >120 mmHg.
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 muscle training 1Also: Inspirometer 1For inspirometer, the participant sits and holds the device. Then put the mouthpiece of the inspirometer in the mouth. Be sure to make a good seal on the mouthpiece with your lips. And exhale (exhale) normally until you run out of air. And after that, inhale (inspire) slowly as much as possible. This maximum value will be taken as an indicative parameter of its maximum inspiratory capacity and 50 and 80% of that value will be determined so that the participant performs 1 set of 10 repetitions at 50% of their maximum value, 2 sets of 10 repetitions at 60% of its maximum capacity and ends with 1 series at 80% of its maximum capacity. It is highlighted that in each series before finishing and without stopping to rest, the participant must do 5 repetitions at 100% maximum capacity. In addition, the respiratory exercises that will be carried out by the 3 intervention groups. | Device | New intervention protocol with inspirometer |
| Respiratory muscle training 2Also: Inspirometer 2Training of respiratory muscles under the protocol of conventional use. Which is that the participant sits and holds the device. Then put the mouthpiece of the inspirometer in the mouth. Be sure to make a good seal on the mouthpiece with your lips. And exhale (exhale) normally until you run out of air. And after that, inhale (inspire) slowly as much as possible. Repeat 10 times and use these indications for 3 sets. In addition, participants must perform different breathing exercises that are identical for the 3 intervention groups. | Other | Protocol of use of inspirometer in a conventional way |
| Respiratory muscle training 3Also: Respiratory exercises without inspirometerThe same exercises that apply to the participants of experimental group 1 and 2 will be performed. The only difference is that the participants of this group do not perform exercises with inspirometer. | Other | Respiratory exercises without use of inspirometer |
Primary outcome
Maximum inspiratory volume (ml)
Time frame: 1 month of training
It will be determined by using the inspirometer whose values are from 0ml to 5,000ml. This pre and post intervention value will be determined
Changes in the levels of Fatigue after intervention
Time frame: 1 month of training
Fatigue was assessed using the FACT-Fatigue Scale Scale (Fatigue Scale of the Functional Evaluation of Cancer Therapy), which is an inventory of 13 items that assesses the severity of cancer-associated fatigue (FAC) in the last week. with a scale of 0 to 4 and that with higher scores reflect a lower FAC.
Changes in the Dyspnoea a after intervention
Time frame: 1 month of training
Dyspnea is a respiratory difficulty that usually translates into shortness of breath. Dyspnea can be determined using the original Borg scale (Score from 0 to 20) or modified (Score from 0 to 10), in which the higher the number indicated by the participant, the higher the degree of dyspnea.
Changes in the levels of Quality of life after intervention: EORTC QLQ-C30
Time frame: 1 month of training
For the quality of life, it is necessary to use the questionnaire called EORTC QLQ-C30 (Version 3), which has 30 questions, where each question will go with a score of 1 to 4 and the higher the final result the better the quality of life. participant's life.
5 secondary outcomes
Pre and post intervention blood pressure (mmhg)
Time frame: 1 month of training
Pre and post intervention heart rate (number of beats per minute)
Time frame: 1 month of training
Pre and post intervention respiratory rate (breaths per minute)
Time frame: 1 month of training
Changes in the Body Mass Index after intervention (%):
Time frame: 1 month of training
Changes in the Abdominal circumference after intervention (cm):
Time frame: 1 month of training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Individual participant dataSharing planned: No. We don´t have any plan because The research will be carried out directly among the researchers of our center. However, it is highlighted that we will make our results available to other researchers so that they can carry out future research that supports our results and compares with other types of populations.
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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.
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 muscle training 1, Respiratory muscle training 2 and Respiratory muscle training 3 in people with Breathing Exercises, run by Hospital Angeles Lomas at 1 site in Mexico.
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 6 inclusion and 7 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 17 Feb 2020. 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 Mexico. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Javier Pereira Rodriguez (2222078536, jepr87@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum inspiratory volume (ml) (time frame: 1 month of training). The study lists 4 primary outcomes in all. 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 17 Feb 2020.