New Intervention Protocol With Inspirometer Versus 2 Modalities of Pulmonary Intervention: INSPUL-REHAB

Hospital Angeles Lomas

Status: Unknown

Conditions: Breathing Exercises

Treatments: Other: Respiratory muscle training 2; Other: Respiratory muscle training 3; Device: Respiratory muscle training 1

Study type: Interventional

Funder types: Other

Identifiers

NCT04270162

JEPRodriguez

Details and patient eligibility

About

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.

Full 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).

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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200 participants in 3 patient groups

New intervention protocol with inspirometer

Experimental group

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)

Treatment:

Device: Respiratory muscle training 1

Protocol of use of inspirometer in a conventional way

Active Comparator group

Description:

This gonna be a experimental group 2 with conventional use of the conventional way.

Treatment:

Other: Respiratory muscle training 2

Respiratory exercises without use of inspirometer

Active Comparator group

Description:

This group gonna be a control group with breathing exercises without the use of inspirometer.

Treatment:

Other: Respiratory muscle training 3