Method JaPer. A New Strategy to Improve Inspirational Capacity

NCT04442542 | Completed DMC

• 1 other identifier: JEPereiraRodriguez
• Study Type: interventional
• Target: 708
• Locations: 1 country
• Sites: 1

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.

Conditions

Inspiratory Capacity

Keywords

Inspiratory Capacity; physiotherapy; pulmonar rehabilitation

Outcome Measures

Primary Outcomes (7)

• 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

  2 week

• 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.

  2 week

• 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.

  2 week

• 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.

  2 week

• Changes in the Estimated maximum oxygen volume after 15 training sessions (ml/kg/min)

  It is the maximum amount of oxygen that the body can absorb, transport and consume in a given time, is the blood that our body can transport and metabolize. To determine the Vo2 values, the 6-minute walking test is used and to determine the result of the test, formulas are used according to the meters traveled, age, sex, height and weight of the participant. The larger the meters traveled, the greater the vo2.

  2 week

• Changes in the unit of measurement of the metabolic index (METs) after 15 training sessions (ml/kg/min)

  It is the unit of measurement of the metabolic index (amount of energy consumed by an individual in a resting situation). To determine the METs values, the 6-minute walking test is used and to determine the result of the test, formulas are used according to the meters traveled, age, sex, height and weight of the participant. The larger the meters traveled, the greater the METs.

  2 week

• Changes in the Distance traveled after 15 training sessions (m)

  Distance traveled in this of 6 minute walk test. The larger the meters traveled, this will indicate better Vo2, METs and aerobic and physical capacity in the participant.

  2 week

Secondary Outcomes (2)

• Changes of the maximum heart rate in a effort test after 15 training sessions

  2 week

• Changes in the Body weight after 15 training sessions (Kg)

  2 week

Study Arms (2)

Respiratory exercises plus method JaPer

EXPERIMENTAL

Respiratory exercises plus the new intervention protocol with an inspirometer (JaPer Method)

Other: Respiratory muscle training 1 (Experimental Group)

Protocol of use of inspirometer in a conventional way

ACTIVE COMPARATOR

Respiratory exercises plus conventional use of the inspirometer.

Other: Respiratory muscle training 2 (Control Group)

Interventions

Respiratory muscle training 1 (Experimental Group) OTHER

The participant must perform a series of exercises that will be the same for the two groups in this investigation. In addition to the exercises, this group will use the incentive inspirometer device with a new method created by the main author called the Method JaPer. For the method JaPer, 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 normally until you run out of air. And after that, inhale slowly as much as possible. This maximum value will be taken as an indicative parameter of its maximum inspiratory capacity and 50 and 80% for 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

Also known as: Method JaPer

Respiratory exercises plus method JaPer

Respiratory muscle training 2 (Control Group) 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 the same breathing exercises that are identical for experimental group.

Protocol of use of inspirometer in a conventional way

Eligibility Criteria

• Age: 18 Years - 90 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

• University Tolteca: lead

Study Sites (1)

Universidad Tolteca - Puebla

Puebla City, 72280, Mexico

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist, specialist in cardiopulmonary rehabilitation, master in palliative care

Model Details: 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).

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: June 22, 2020
• Study Start: December 15, 2018
• Primary Completion: February 1, 2019
• Study Completion: June 1, 2020
• Last Updated: June 22, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)