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临床试验/NCT04365738
NCT04365738已完成不适用

Pulmonary Rehabilitation in Post-Acute Period of COVID-19 Infection: Prospective Randomized Controlled Trial

Istanbul Bilgi University1 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2020年3月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
270
试验地点
1
主要终点
Dyspnea

研究概览

简要总结

The aim of this study is to investigate the efficacy of pulmonary rehabilitation(PR) applied in the isolation processes of post-acute patients with mild and moderate symptoms who had positive COVID-19 test on dyspnea,muscle pain,chest expansion,lower limb muscle strength and dynamic balance,fatigue,anxiety and depression.

详细描述

This study was conducted with 270 patients who were the COVID-19 test was positive and isolated in their homes during post-acute periods.While one of the groups (n=135) was asked to remain isolated at home by providing patient education,a PR program was applied for 4 weeks in addition to the patients in the other group(n=135).PR consists of patient education, breathing, in-house mobilization and range of motion exercises.As the evaluation parameters,pre-treatment and post-treatment dyspnea levels with Borg scale,muscle pain with visual analog scale(VAS),functional capacities with sit-up test,chest expansions with tape measure,respiratory frequency,fatigue level with fatigue severity scale,and emotional status with hospital anxiety and depression(HAD) scale were evaluated.

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
Single (Investigator)

入排标准

年龄范围
28 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Between the ages of 28-45, positive COVID-19 test, being in the post-acute period, having symptoms of mild-moderate severity, respiratory rate ≤40 breaths / min, patients who can make video speech

排除标准

  • •Severe symptom involvement, fever more than 38 degrees, obese patients, patients with multiple comorbidities, patients with one or more organ failure, oxygen saturation in the blood ≤95%, a resting blood pressure of <90/60 mmHg or> 140 / 90 mmHg patients

研究组 & 干预措施

Pulmonary Rehabilitation

Experimental

The patients who applied pulmonary rehabilitation were checked, motivated and followed-up regularly with video calls every day. Pulmonary rehabilitation program consists of patient education, breathing, in-house mobilization and range of motion exercises.

干预措施: Rehabilitation (Other)

Control

Placebo Comparator

As a patient education, information was given about the disease and treatment process, listening to the patient during this process and getting regular sleep, balanced nutrition and taking a break from smokers.

干预措施: Rehabilitation (Other)

结局指标

主要结局

Dyspnea

时间窗: Baseline, up to 4 weeks

The Borg scale is a scale scored between 0-10, indicating the severity of dyspnea. 0 indicates no shortness of breath, 10 indicates severe shortness of breath

次要结局

  • Fatigue severity(Baseline, up to 4 weeks)
  • Hospital anxiety and depression scale(Baseline, up to 4 weeks)
  • Chest expansion(Baseline, up to 4 weeks)
  • Visual Analog Scale for pain(Baseline, up to 4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

TOMRIS DUYMAZ

Assoc.Prof.

Istanbul Bilgi University

研究点 (1)

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