New Intervention Protocol With Inspirometer Versus 2 Modalities of Pulmonary Intervention: INSPUL-REHAB
- Conditions
- Breathing Exercises
- Interventions
- Device: Respiratory muscle training 1Other: Respiratory muscle training 3Other: Respiratory muscle training 2
- Registration Number
- NCT04270162
- Lead Sponsor
- Hospital Angeles Lomas
- 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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description New intervention protocol with inspirometer Respiratory muscle training 1 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) Respiratory exercises without use of inspirometer Respiratory muscle training 3 This group gonna be a control group with breathing exercises without the use of inspirometer. Protocol of use of inspirometer in a conventional way Respiratory muscle training 2 This gonna be a experimental group 2 with conventional use of the conventional way.
- Primary Outcome Measures
Name Time Method Maximum inspiratory volume (ml) 1 month of training 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 Dyspnoea a after intervention 1 month of training 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 1 month of training 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 levels of Fatigue after intervention 1 month of training 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.
- Secondary Outcome Measures
Name Time Method Pre and post intervention blood pressure (mmhg) 1 month of training Blood pressure will be determined by using a baumanometer.
Pre and post intervention respiratory rate (breaths per minute) 1 month of training Heart rate will be determined visually by the researcher.
Pre and post intervention heart rate (number of beats per minute) 1 month of training The heart rate will be determined by using a pulse oximeter and corroborated manually.
Changes in the Abdominal circumference after intervention (cm): 1 month of training 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.
Changes in the Body Mass Index after intervention (%): 1 month of training 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.
Trial Locations
- Locations (1)
Centro Integral de Rehabilitación S.C. en el Hospital Angeles Lomas
🇲🇽Estado De México, Huixquilucan, Mexico