Clinical trial NCT04270162: New Intervention Protocol With Inspirometer Versus 2 Modalities of Pulmonary Intervention: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Breathing Exercises
Keywords: Inspiratory volume, expiratory volume, inspirometer.
Lead sponsor: Hospital Angeles Lomas
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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).
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Maximum inspiratory volume (ml)
timeFrame: 1 month of training
measure: Changes in the levels of Fatigue after intervention
timeFrame: 1 month of training
measure: Changes in the Dyspnoea a after intervention
timeFrame: 1 month of training
measure: Changes in the levels of Quality of life after intervention: EORTC QLQ-C30
timeFrame: 1 month of training
Secondary outcomes:
measure: Pre and post intervention blood pressure (mmhg)
timeFrame: 1 month of training
measure: Pre and post intervention heart rate (number of beats per minute)
timeFrame: 1 month of training
measure: Pre and post intervention respiratory rate (breaths per minute)
timeFrame: 1 month of training
measure: Changes in the Body Mass Index after intervention (%):
timeFrame: 1 month of training
measure: Changes in the Abdominal circumference after intervention (cm):
timeFrame: 1 month of training
Other outcomes:
Locations:
city: Estado De México
country: Mexico
facility: Centro Integral de Rehabilitación S.C. en el Hospital Angeles Lomas
state: Huixquilucan
Study officials:
References: