Clinical trial NCT04442542: Method JaPer. A New Strategy to Improve Inspirational Capacity
Official title: Method JaPer. A New Strategy to Improve Inspirational Capacity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inspiratory Capacity
Keywords: Inspiratory Capacity
physiotherapy
pulmonar rehabilitation
Lead sponsor: University Tolteca
Sponsor class: OTHER
First posted: 2020-06-22
Enrollment: 708
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 850 hospitalized patients, who, after the exclusion criteria, 708 hospitalized patients with different diseases (mainly cancer, heart failure, COPD, postoperative gastrointestinal, fractures, pneumonia, high blood pressure, diabetes mellitus) finally began the investigation and organized into 2 groups. The present one was distributed with a basic probability sampling using a table of random numbers, the order of which was randomized through the Microsoft Excel 16.0 program, with the experimental group being 337 participants (Respiratory exercises plus new method of intervention with respiratory incentive - JaPer Method -) and the control group with 371 (Respiratory exercises plus conventional use of the respiratory incentive).
Primary purpose: TREATMENT

Brief summary: Different diseases worldwide have repercussions at the level of multiple systems; but without a doubt a higher prevalence in the cardiopulmonary system. When a patient is hospitalized, he enters a continuous and often prolonged rest stay. Wherein, this physical inactivity plus its base pathology negatively impact its lung capacity. And low lung capacity has been shown to increase the risk of mortality, hospital stay, and complications. That said, the use of the device known as the "incentive inspirometer" is important, which to some extent there is no standardization of its use or applicability in a structured and planned manner. For this reason, the Japer method emerges as an idea; which, pretending through an exercise prescription through the incentive inspirometer according to 50% to 80% of the maximum inspiring capacity of the patient, improves their inspiring capacity. Having said this, the general objective was to analyze the effects of the JaPer method to improve lung capacity versus the traditional use of an inspirometer in hospitalized patients.

Detailed description: In 1974 the Respiratory Rehabilitation (RR) Committee of the American College of Chest Physicians defined RR as an art. It took almost 20 more years for another group of experts to describe it as a service. Moving forward in our reasoning, it is important to remember that all physical activity produces an increase in metabolic energy expenditure, as a result of body movement carried out in a specific period of time. The current literature through various organizations has been oriented to promote activities that arouse interest in generating movement and thus obtain benefits in improving health and quality of life. The respiratory physiotherapy techniques are basically divided into 2 types: facilitating techniques for expectoration and respiratory exercises. The former are indicated in hypersecretory processes, in alterations in the properties of mucus, ciliary dysfunction and alterations in the cough mechanism, to keep the airway free of secretions. The second is focused on improving a respiratory pattern, a respiratory reeducation, strengthening of respiratory muscles, preventing and / or reducing dyspnea and fatigue through the use of the inspirometer, respiratory exercises and specific techniques. In addition, it helps to decrease the hospital stay. Which, when prolonged, generates negative effects on the health system, such as: increased costs, poor accessibility to hospitalization services, saturation of emergencies and risks of adverse events. Plus all the negative effects it can generate in a hospitalized patient.

Different diseases worldwide have repercussions at the level of multiple systems; but without a doubt a higher prevalence in the cardiopulmonary system. When a patient is hospitalized, he enters a continuous and often prolonged rest stay. Wherein, this physical inactivity plus its base pathology negatively impact its lung capacity. And low lung capacity has been shown to increase the risk of mortality, hospital stay, and complications. That said, the use of the device known as the "incentive inspirometer" is important, which to some extent there is no standardization of its use or applicability in a structured and planned manner. For this reason, the Japer method emerges as an idea; which, pretending through an exercise prescription through the incentive inspirometer according to 50% to 80% of the maximum inspiring capacity of the patient, improves their inspiring capacity. Having said this, the general objective was to analyze the effects of the JaPer method to improve lung capacity versus the traditional use of an inspirometer in hospitalized patients.

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: 2 week
measure: Changes in the levels of Fatigue after intervention
timeFrame: 2 week
measure: Changes in the Dyspnoea a after intervention
timeFrame: 2 week
measure: Changes in the levels of Quality of life after intervention: EORTC QLQ-C30
timeFrame: 2 week
measure: Changes in the Estimated maximum oxygen volume after 15 training sessions (ml/kg/min)
timeFrame: 2 week
measure: Changes in the unit of measurement of the metabolic index (METs) after 15 training sessions (ml/kg/min)
timeFrame: 2 week
measure: Changes in the Distance traveled after 15 training sessions (m)
timeFrame: 2 week
Secondary outcomes:
measure: Changes of the maximum heart rate in a effort test after 15 training sessions
timeFrame: 2 week
measure: Changes in the Body weight after 15 training sessions (Kg)
timeFrame: 2 week
Other outcomes:
Locations:
city: Puebla
country: Mexico
facility: Universidad Tolteca - Puebla
Study officials:
References: