New Intervention Protocol With Inspirometer Versus 2 Modalities of Pulmonary Intervention: INSPUL-REHAB (INSPUL-REHAB)
Primary Purpose
Breathing Exercises
Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Respiratory muscle training 1
Respiratory muscle training 2
Respiratory muscle training 3
Sponsored by
About this trial
This is an interventional treatment trial for Breathing Exercises focused on measuring Inspiratory volume, expiratory volume, inspirometer.
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Centro Integral de Rehabilitación S.C. en el Hospital Angeles LomasRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
New intervention protocol with inspirometer
Protocol of use of inspirometer in a conventional way
Respiratory exercises without use of inspirometer
Arm Description
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)
This gonna be a experimental group 2 with conventional use of the conventional way.
This group gonna be a control group with breathing exercises without the use of inspirometer.
Outcomes
Primary Outcome Measures
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
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.
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.
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.
Secondary Outcome Measures
Pre and post intervention blood pressure (mmhg)
Blood pressure will be determined by using a baumanometer.
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.
Pre and post intervention respiratory rate (breaths per minute)
Heart rate will be determined visually by the researcher.
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.
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.
Full Information
NCT ID
NCT04270162
First Posted
February 12, 2020
Last Updated
February 13, 2020
Sponsor
Hospital Angeles Lomas
1. Study Identification
Unique Protocol Identification Number
NCT04270162
Brief Title
New Intervention Protocol With Inspirometer Versus 2 Modalities of Pulmonary Intervention: INSPUL-REHAB
Acronym
INSPUL-REHAB
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 10, 2020 (Actual)
Primary Completion Date
July 30, 2020 (Anticipated)
Study Completion Date
December 20, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Angeles Lomas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breathing Exercises
Keywords
Inspiratory volume, expiratory volume, inspirometer.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
New intervention protocol with inspirometer
Arm Type
Experimental
Arm Description
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)
Arm Title
Protocol of use of inspirometer in a conventional way
Arm Type
Active Comparator
Arm Description
This gonna be a experimental group 2 with conventional use of the conventional way.
Arm Title
Respiratory exercises without use of inspirometer
Arm Type
Active Comparator
Arm Description
This group gonna be a control group with breathing exercises without the use of inspirometer.
Intervention Type
Device
Intervention Name(s)
Respiratory muscle training 1
Other Intervention Name(s)
Inspirometer 1
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Respiratory muscle training 2
Other Intervention Name(s)
Inspirometer 2
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Respiratory muscle training 3
Other Intervention Name(s)
Respiratory exercises without inspirometer
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximum inspiratory volume (ml)
Description
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
Time Frame
1 month of training
Title
Changes in the levels of Fatigue after intervention
Description
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.
Time Frame
1 month of training
Title
Changes in the Dyspnoea a after intervention
Description
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.
Time Frame
1 month of training
Title
Changes in the levels of Quality of life after intervention: EORTC QLQ-C30
Description
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.
Time Frame
1 month of training
Secondary Outcome Measure Information:
Title
Pre and post intervention blood pressure (mmhg)
Description
Blood pressure will be determined by using a baumanometer.
Time Frame
1 month of training
Title
Pre and post intervention heart rate (number of beats per minute)
Description
The heart rate will be determined by using a pulse oximeter and corroborated manually.
Time Frame
1 month of training
Title
Pre and post intervention respiratory rate (breaths per minute)
Description
Heart rate will be determined visually by the researcher.
Time Frame
1 month of training
Title
Changes in the Body Mass Index after intervention (%):
Description
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.
Time Frame
1 month of training
Title
Changes in the Abdominal circumference after intervention (cm):
Description
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.
Time Frame
1 month of training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Javier Pereira Rodriguez
Phone
2222078536
Email
jepr87@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sharon Waiss
Phone
5545934653
Email
sharonwaiss@yahoo.com
Facility Information:
Facility Name
Centro Integral de Rehabilitación S.C. en el Hospital Angeles Lomas
City
Estado De México
State/Province
Huixquilucan
ZIP/Postal Code
52760
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier Pereira Rodriguez
Phone
2222078536
Email
jepr87@hotmail.com
First Name & Middle Initial & Last Name & Degree
Sharon Waiss
Phone
5545934653
Email
sharonwaiss@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
Learn more about this trial
New Intervention Protocol With Inspirometer Versus 2 Modalities of Pulmonary Intervention: INSPUL-REHAB
We'll reach out to this number within 24 hrs