Inspiratory CapacityNCT04442542
Method JaPer. A New Strategy to Improve Inspirational Capacity
A study testing Respiratory muscle training 1 (Experimental Group) in people with Inspiratory Capacity, run by University Tolteca at 1 site in Mexico.
Trial summary
Different diseases worldwide have repercussions at the level of multiple systems; but without a doubt a higher prevalence in the cardiopulmonary system. When a patient is hospitalized, he enters a continuous and often prolonged rest stay. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Inspiratory Capacity
- What is being tested?
- Respiratory muscle training 1 (Experimental Group)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 708 participants
- Where
- 1 siteMexico
- Study dates
- 15 Dec 2018to 1 Jun 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 90 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.
About this study
Different diseases worldwide have repercussions at the level of multiple systems; but without a doubt a higher prevalence in the cardiopulmonary system. When a patient is hospitalized, he enters a continuous and often prolonged rest stay. Wherein, this physical inactivity plus its base pathology negatively impact its lung capacity. And low lung capacity has been shown to increase the risk of mortality, hospital stay, and complications. That said, the use of the device known as the "incentive inspirometer" is important, which to some extent there is no standardization of its use or applicability in a structured and planned manner. For this reason, the Japer method emerges as an idea; which, pretending through an exercise prescription through the incentive inspirometer according to 50% to 80% of the maximum inspiring capacity of the patient, improves their inspiring capacity. Having said this, the general objective was to analyze the effects of the JaPer method to improve lung capacity versus the traditional use of an inspirometer in hospitalized patients.
Read the detailed description
In 1974 the Respiratory Rehabilitation (RR) Committee of the American College of Chest Physicians defined RR as an art. It took almost 20 more years for another group of experts to describe it as a service. Moving forward in our reasoning, it is important to remember that all physical activity produces an increase in metabolic energy expenditure, as a result of body movement carried out in a specific period of time. The current literature through various organizations has been oriented to promote activities that arouse interest in generating movement and thus obtain benefits in improving health and quality of life. The respiratory physiotherapy techniques are basically divided into 2 types: facilitating techniques for expectoration and respiratory exercises. The former are indicated in hypersecretory processes, in alterations in the properties of mucus, ciliary dysfunction and alterations in the cough mechanism, to keep the airway free of secretions. The second is focused on improving a respiratory pattern, a respiratory reeducation, strengthening of respiratory muscles, preventing and / or reducing dyspnea and fatigue through the use of the inspirometer, respiratory exercises and specific techniques. In addition, it helps to decrease the hospital stay. Which, when prolonged, generates negative effects on the health system, such as: increased costs, poor accessibility to hospitalization services, saturation of emergencies and risks of adverse events. Plus all the negative effects it can generate in a hospitalized patient.
Different diseases worldwide have repercussions at the level of multiple systems; but without a doubt a higher prevalence in the cardiopulmonary system. When a patient is hospitalized, he enters a continuous and often prolonged rest stay. Wherein, this physical inactivity plus its base pathology negatively impact its lung capacity. And low lung capacity has been shown to increase the risk of mortality, hospital stay, and complications. That said, the use of the device known as the "incentive inspirometer" is important, which to some extent there is no standardization of its use or applicability in a structured and planned manner. For this reason, the Japer method emerges as an idea; which, pretending through an exercise prescription through the incentive inspirometer according to 50% to 80% of the maximum inspiring capacity of the patient, improves their inspiring capacity. Having said this, the general objective was to analyze the effects of the JaPer method to improve lung capacity versus the traditional use of an inspirometer in hospitalized patients.
- Conditions
- Inspiratory Capacity
- Being tested
- Respiratory muscle training 1 (Experimental Group), Respiratory muscle training 2 (Control Group)
- Keywords
- Inspiratory Capacity, physiotherapy, pulmonar rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory muscle training 1 (Experimental Group)Other
Also called Method JaPer
The participant must perform a series of exercises that will be the same for the two groups in this investigation. In addition to the exercises, this group will use the incentive inspirometer device with a new method created by the main author called the Method JaPer.
For the method JaPer, 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 normally until you run out of air. And after that, inhale slowly as much as possible. This maximum value will be taken as an indicative parameter of its maximum inspiratory capacity and 50 and 80% for 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
Respiratory muscle training 2 (Control Group)Other
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 the same breathing exercises that are identical for experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Respiratory exercises plus method JaPer | Experimental | Respiratory exercises plus the new intervention protocol with an inspirometer (JaPer Method) Receives: Other: Respiratory muscle training 1 (Experimental Group) |
| Protocol of use of inspirometer in a conventional way | Active comparator | Respiratory exercises plus conventional use of the inspirometer. Receives: Other: Respiratory muscle training 2 (Control Group) |
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: 2 week
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: 2 week
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: 2 week
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: 2 week
Changes in the Estimated maximum oxygen volume after 15 training sessions (ml/kg/min)
It is the maximum amount of oxygen that the body can absorb, transport and consume in a given time, is the blood that our body can transport and metabolize. To determine the Vo2 values, the 6-minute walking test is used and to determine the result of the test, formulas are used according to the meters traveled, age, sex, height and weight of the participant. The larger the meters traveled, the greater the vo2.
Measured: 2 week
Changes in the unit of measurement of the metabolic index (METs) after 15 training sessions (ml/kg/min)
It is the unit of measurement of the metabolic index (amount of energy consumed by an individual in a resting situation). To determine the METs values, the 6-minute walking test is used and to determine the result of the test, formulas are used according to the meters traveled, age, sex, height and weight of the participant. The larger the meters traveled, the greater the METs.
Measured: 2 week
Changes in the Distance traveled after 15 training sessions (m)
Distance traveled in this of 6 minute walk test. The larger the meters traveled, this will indicate better Vo2, METs and aerobic and physical capacity in the participant.
Measured: 2 week
Secondary outcomes (2)
Changes of the maximum heart rate in a effort test after 15 training sessions
It is the maximum capacity that the heart has to contract and we determine it by means of an effort test. The Maximum heart rate can be determined by formula or in a effort test (In the present investigation) which consists in mounting the participant in an endless band with an inclination and speed determined according to the protocol for said test. The test is stopped when the participant. indicates that it can not be more or there are electrocardiographic alterations that indicate that it is the participant's maximum.
Measured: 2 week
Changes in the Body weight after 15 training sessions (Kg)
How much body weight (kg) pre and post intervention
Measured: 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start15 Dec 2018
- Primary completion1 Feb 2019
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inspiratory CapacityStudies 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
- 850 hospitalized patients, who, after the exclusion criteria, 708 hospitalized patients with different diseases (mainly cancer, heart failure, COPD, postoperative gastrointestinal, fractures, pneumonia, high blood pressure, diabetes mellitus) finally began the investigation and organized into 2 groups. The present one was distributed with a basic probability sampling using a table of random numbers, the order of which was randomized through the Microsoft Excel 16.0 program, with the experimental group being 337 participants (Respiratory exercises plus new method of intervention with respiratory incentive - JaPer Method -) and the control group with 371 (Respiratory exercises plus conventional use of the respiratory incentive).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 708 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Tolteca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Eliecer Pereira Rodriguez, University Tolteca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04442542
- Sponsor's protocol ID
- JEPereiraRodriguez
- Status last verified
- Jun 2020
- First submitted
- 18 Jun 2020
- Last updated
- 22 Jun 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 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Method JaPer. A New Strategy to Improve Inspirational Capacity
- ClinicalTrials.gov ID
- NCT04442542
- Acronym / sponsor ID
- JEPereiraRodriguez
- Conditions
- Inspiratory Capacity
- Keywords
- Inspiratory Capacity, physiotherapy, pulmonar rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 708 participants (actual)
- Lead sponsor
- University ToltecaUniversity, hospital or other
- Study start
- 15 Dec 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 22 Jun 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.
Different diseases worldwide have repercussions at the level of multiple systems; but without a doubt a higher prevalence in the cardiopulmonary system. When a patient is hospitalized, he enters a continuous and often prolonged rest stay. Wherein, this physical inactivity plus its base pathology negatively impact its lung capacity. And low lung capacity has been shown to increase the risk of mortality, hospital stay, and complications. That said, the use of the device known as the "incentive inspirometer" is important, which to some extent there is no standardization of its use or applicability in a structured and planned manner. For this reason, the Japer method emerges as an idea; which, pretending through an exercise prescription through the incentive inspirometer according to 50% to 80% of the maximum inspiring capacity of the patient, improves their inspiring capacity. Having said this, the general objective was to analyze the effects of the JaPer method to improve lung capacity versus the traditional use of an inspirometer in hospitalized patients.
Detailed description
In 1974 the Respiratory Rehabilitation (RR) Committee of the American College of Chest Physicians defined RR as an art. It took almost 20 more years for another group of experts to describe it as a service. Moving forward in our reasoning, it is important to remember that all physical activity produces an increase in metabolic energy expenditure, as a result of body movement carried out in a specific period of time. The current literature through various organizations has been oriented to promote activities that arouse interest in generating movement and thus obtain benefits in improving health and quality of life. The respiratory physiotherapy techniques are basically divided into 2 types: facilitating techniques for expectoration and respiratory exercises. The former are indicated in hypersecretory processes, in alterations in the properties of mucus, ciliary dysfunction and alterations in the cough mechanism, to keep the airway free of secretions. The second is focused on improving a respiratory pattern, a respiratory reeducation, strengthening of respiratory muscles, preventing and / or reducing dyspnea and fatigue through the use of the inspirometer, respiratory exercises and specific techniques. In addition, it helps to decrease the hospital stay. Which, when prolonged, generates negative effects on the health system, such as: increased costs, poor accessibility to hospitalization services, saturation of emergencies and risks of adverse events. Plus all the negative effects it can generate in a hospitalized patient.
Different diseases worldwide have repercussions at the level of multiple systems; but without a doubt a higher prevalence in the cardiopulmonary system. When a patient is hospitalized, he enters a continuous and often prolonged rest stay. Wherein, this physical inactivity plus its base pathology negatively impact its lung capacity. And low lung capacity has been shown to increase the risk of mortality, hospital stay, and complications. That said, the use of the device known as the "incentive inspirometer" is important, which to some extent there is no standardization of its use or applicability in a structured and planned manner. For this reason, the Japer method emerges as an idea; which, pretending through an exercise prescription through the incentive inspirometer according to 50% to 80% of the maximum inspiring capacity of the patient, improves their inspiring capacity. Having said this, the general objective was to analyze the effects of the JaPer method to improve lung capacity versus the traditional use of an inspirometer in hospitalized patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 850 hospitalized patients, who, after the exclusion criteria, 708 hospitalized patients with different diseases (mainly cancer, heart failure, COPD, postoperative gastrointestinal, fractures, pneumonia, high blood pressure, diabetes mellitus) finally began the investigation and organized into 2 groups. The present one was distributed with a basic probability sampling using a table of random numbers, the order of which was randomized through the Microsoft Excel 16.0 program, with the experimental group being 337 participants (Respiratory exercises plus new method of intervention with respiratory incentive - JaPer Method -) and the control group with 371 (Respiratory exercises plus conventional use of the respiratory incentive).
| Arm | Type | Receives |
|---|---|---|
| Respiratory exercises plus method JaPer | Experimental | Other: Respiratory muscle training 1 (Experimental Group)Respiratory exercises plus the new intervention protocol with an inspirometer (JaPer Method) |
| Protocol of use of inspirometer in a conventional way | Active comparator | Other: Respiratory muscle training 2 (Control Group)Respiratory exercises plus conventional use of the inspirometer. |
Who may qualify
- Ages
- 18 to 90 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 1 (Experimental Group)Also: Method JaPerThe participant must perform a series of exercises that will be the same for the two groups in this investigation. In addition to the exercises, this group will use the incentive inspirometer device with a new method created by the main author called the Method JaPer. For the method JaPer, 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 normally until you run out of air. And after that, inhale slowly as much as possible. This maximum value will be taken as an indicative parameter of its maximum inspiratory capacity and 50 and 80% for 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 | Other | Respiratory exercises plus method JaPer |
| Respiratory muscle training 2 (Control Group)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 the same breathing exercises that are identical for experimental group. | Other | Protocol of use of inspirometer in a conventional way |
Primary outcome
Maximum inspiratory volume (ml)
Time frame: 2 week
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: 2 week
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: 2 week
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: 2 week
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.
Changes in the Estimated maximum oxygen volume after 15 training sessions (ml/kg/min)
Time frame: 2 week
It is the maximum amount of oxygen that the body can absorb, transport and consume in a given time, is the blood that our body can transport and metabolize. To determine the Vo2 values, the 6-minute walking test is used and to determine the result of the test, formulas are used according to the meters traveled, age, sex, height and weight of the participant. The larger the meters traveled, the greater the vo2.
Changes in the unit of measurement of the metabolic index (METs) after 15 training sessions (ml/kg/min)
Time frame: 2 week
It is the unit of measurement of the metabolic index (amount of energy consumed by an individual in a resting situation). To determine the METs values, the 6-minute walking test is used and to determine the result of the test, formulas are used according to the meters traveled, age, sex, height and weight of the participant. The larger the meters traveled, the greater the METs.
Changes in the Distance traveled after 15 training sessions (m)
Time frame: 2 week
Distance traveled in this of 6 minute walk test. The larger the meters traveled, this will indicate better Vo2, METs and aerobic and physical capacity in the participant.
2 secondary outcomes
Changes of the maximum heart rate in a effort test after 15 training sessions
Time frame: 2 week
Changes in the Body weight after 15 training sessions (Kg)
Time frame: 2 week
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 22 Jun 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.
Related trials for Inspiratory Capacity
Active, not recruitingPhase 2
Inhaled Treprostinil for Dyspnea and Exercise Intolerance in Mild COPD
COPD (Chronic Obstructive Pulmonary Disease)
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Active, not recruitingObservational study
Respiratory Functions in Parkinson's Disease
Parkinson Disease
Recruiting
Effects of Respiratory Muscle Strengthening and Diaphragmatic Breathing on Shoulder Pain and Disability
Shoulder Pain, Sleep Quality
Active, not recruiting
Comparative Effects of Balance and Inspiratory Muscle Training in Older Adults
Geriatric, Geriatrics Rehabilitation
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.
The record lists no contact. Use the official record to reach the sponsor.
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 (Experimental Group) in people with Inspiratory Capacity, run by University Tolteca 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: finished, as of the sponsor's last update on 22 Jun 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?
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?
Maximum inspiratory volume (ml) (time frame: 2 week). 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?
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 22 Jun 2020.