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临床试验/NCT04442542
NCT04442542已完成不适用

Method JaPer. A New Strategy to Improve Inspirational Capacity

University Tolteca2 个研究点 分布在 1 个国家目标入组 708 人开始时间: 2018年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
708
试验地点
2
主要终点
Changes in the Distance traveled after 15 training sessions (m)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

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

时间窗: 2 week

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.

Maximum inspiratory volume (ml)

时间窗: 2 week

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 levels of Fatigue after intervention

时间窗: 2 week

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.

Changes in the Dyspnoea a after intervention

时间窗: 2 week

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

时间窗: 2 week

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 Estimated maximum oxygen volume after 15 training sessions (ml/kg/min)

时间窗: 2 week

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.

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

时间窗: 2 week

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.

次要结局

  • 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)

研究者

发起方
University Tolteca
申办方类型
Other
责任方
Principal Investigator
主要研究者

Javier Eliecer Pereira Rodriguez

Physiotherapist, specialist in cardiopulmonary rehabilitation, master in palliative care

University Tolteca

研究点 (2)

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