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临床试验/NCT04678700
NCT04678700Unknown不适用

Implementation of a Respiratory Physiotherapy Program in Post COVID-19 Patients Through Tele-assistance

European University of Madrid2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
2
主要终点
Respiratory rate

研究概览

简要总结

The objective of this research project is to scientifically evidence a pulmonary rehabilitation program that was initiated altruistically during the confinement of those patients who had suffered from COVID-19, through an online platform.

Patients are connected telematically 3 times a week from April 6, 2020 to perform the physical therapy program. Due to the clinical improvements that have been referred by patients, they began to take objective data.

Our goal is to know if a telematic respiratory therapy program in post-covid 19 patient, improves the level of anxiety, dyspnea on effort, improves quality of life and oxygenation.

详细描述

Patients affected by COVID- 19 have long periods of convalescence at home. This fact, together with the measures of social isolation, has contributed to act from a new therapeutic paradigm with the implementation of telematic rehabilitation programs.

On April 6, 2020 the online platform was born under the name "Respiratory Physiotherapy; telematic assistance in patients with COVID-19 sequelae".

We want to quantify the Chest Physiotherapy online program.

Hypothesis; An online respiratory physiotherapy program offers improvements in quality of life, dyspnea and anxiety to patients who have suffered COVID-19.

Objectives; General objective; To improve the pulmonary function of patients who have suffered from COVID-19 infection through an online respiratory physiotherapy program.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients in the recovery phase, hospitalised or at home.
  • Patients diagnosed with positive PCR for COVID-19
  • Patient with sensation of dyspnea
  • Patient able to sit still

排除标准

  • Patients admitted to intensive care and/or hemodynamically unstable
  • Patients connected to mechanical ventilation
  • Patients who do not have integrated cognitive abilities
  • Patients who are receiving other respiratory rehabilitation programs
  • Patients without adecuate technologies ( WIFI, computer, email, zoom)

结局指标

主要结局

Respiratory rate

时间窗: 5 minutes after each session

breathing rate in one minute. The patient sitting upright takes the number of breaths per minute.

Euroqol-5d european quality of life-5 dimensions

时间窗: 4 week

The EQ-5D is a generic Quality of Life measurement instrument. The individual himself evaluates his state of health, first in levels of severity by dimensions. The descriptive system contains five health dimensions (mobility, self-care, activities of daily living, pain/discomfort and anxiety/depression) and each one has three levels of severity (no problems, some moderate problems or problems and serious problems). In this part of the questionnaire, the individual must mark the level of severity corresponding to his or her state of health in each one of the dimensions, referring to the same day that he or she completes the questionnaire. In each dimension of the EQ-5D, the levels of severity are coded with a 1 if the answer option is "no (I have) problems"; with a 2 if the answer option is "some or moderate problems"; and with a 3 if the answer option is "many problems".

Dysnea scale Borg

时间窗: 5 minutes after each session

The modified Borg scale is a visual analog scale standardized in Spanish that allows to evaluate the subjective perception of the breathing difficulty or the physical effort exercised. This variable is taken in sedation

Anxiety

时间窗: 4 week

STAI, questionary of anxiety, we will take before the first session and at the end of the last session

Level oxigen %

时间窗: 4 week

pulxe-oximetry, the patient is sitting at rest

Effort dysnea Scale

时间窗: 4 week

Effort dyspnea scale, Malher Scale A multidimensional scale that measures 3 magnitudes of dyspnea at a given time: the difficulty of the task, the intensity of the effort and the functional impairment.

次要结局

未报告次要终点

研究者

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

Marta de la Plaza

Physiotherapy teacher, PH student

European University of Madrid

研究点 (2)

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