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

NCT04270162 | Unknown DMC

• 1 other identifier: JEPRodriguez
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Breathing Exercises

Keywords

Inspiratory volume, expiratory volume, inspirometer.

Outcome Measures

Primary Outcomes (4)

• 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

  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.

  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.

  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.

  1 month of training

Secondary Outcomes (5)

• Pre and post intervention blood pressure (mmhg)

  1 month of training

• Pre and post intervention heart rate (number of beats per minute)

  1 month of training

• Pre and post intervention respiratory rate (breaths per minute)

  1 month of training

• Changes in the Body Mass Index after intervention (%):

  1 month of training

• Changes in the Abdominal circumference after intervention (cm):

  1 month of training

Study Arms (3)

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)

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.

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.

Other: Respiratory muscle training 3

Interventions

Respiratory muscle training 1 DEVICE

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.

Also known as: Inspirometer 1

New intervention protocol with inspirometer

Respiratory muscle training 2 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 different breathing exercises that are identical for the 3 intervention groups.

Also known as: Inspirometer 2

Protocol of use of inspirometer in a conventional way

Respiratory muscle training 3 OTHER

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.

Also known as: Respiratory exercises without inspirometer

Respiratory exercises without use of inspirometer

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Angeles Lomas: lead

Study Sites (1)

Centro Integral de Rehabilitación S.C. en el Hospital Angeles Lomas

Estado de México, Huixquilucan, 52760, Mexico

RECRUITING

Central Study Contacts

Javier Pereira Rodriguez

CONTACT

2222078536; jepr87@hotmail.com

Sharon Waiss

CONTACT

5545934653; sharonwaiss@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project coordinator and Physiotherapist, specialist in cardiopulmonary rehabilitation, magister in health sciences, magister in palliative care and university professor.

Model Details: 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).

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 17, 2020
• Study Start: February 10, 2020
• Primary Completion: July 30, 2020
• Study Completion: December 20, 2020
• Last Updated: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)