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Evaluation of Physical and Functional Status in Patients With COVID-19 in Long Term

2022年8月6日 更新者:Ebru Calik Kutukcu、Hacettepe University

Evaluation of Exercise Capacity, Peripheral Muscle Strength, Balance, Cognitive Status and Quality of Life in Patients With COVID-19 in Long Term

The reason the investigators want to do this research; Especially after Covid-19 infection, no research has been found on functional status in the long term. Therefore, in our study, the investigators aimed to evaluate exercise capacity, functional status, peripheral muscle strength, balance, anxiety and depression level, consciousness, work productivity, pain, fear of movement, and quality of life in patients with Covid-19 and to compare them with healthy individuals who have not had COVID-19.

研究概览

地位

完全的

详细说明

In our study, the investigators aimed to evaluate long-term exercise capacity, functional status, peripheral muscle strength, balance, anxiety and depression level, cognitive status, pain, kinesophobia and quality of life in patients with COVID-19, and to compare them with healthy individuals who have not had COVID-19. Our second goal; It is the evaluation of the relationship between long-term exercise capacity, pain, kinesiophobia, peripheral muscle strength, balance, anxiety and depression level, cognitive status and quality of life in individuals with COVID-19. It will also be examined whether these parameters change according to the post-COVID functional restriction level.

3. Materials and Methods of the Research: 3.1. The place of the study: Cardiopulmonary Rehabilitation Unit of Hacettepe University Faculty of Physical Therapy and Rehabilitation and Hacettepe University Faculty of Medicine Department of General Internal Medicine

3.2. Time of the study: It is planned to collect data and write the study between February 2021 and February 2022.

3.3. Research population, sample, research group:

The population of the study is individuals who have passed the diagnosis of COVID-19 for at least 12 weeks and healthy individuals who have not had COVID-19.

The sample of the study is individuals in the long-term after the diagnosis of COVID-19 at least 12 weeks after the diagnosis of COVID-19 in Hacettepe University Adult Hospital who meet the inclusion criteria and volunteer to participate in the study, and healthy individuals who have not had COVID-19.

Study Design:

Individuals meeting the inclusion criteria will be included in the study. The study will be conducted with people between the ages of 18-65, whose education level is at least primary school, and whose local language is Turkish. A total of 40 participants, 20 healthy without COVID-19, and 20 with at least 12 weeks past the diagnosis of COVID-19, will be included in the study. The guidance of the participants will be provided by the relevant physicians of the General Internal Medicine Unit of Hacettepe University Internal Diseases Department.

In accordance with the COVID-19 pandemic precautions, social distance rules will be followed in the tests to be carried out with individuals, care will be taken to use masks, and the materials to be used in tests and measurements will be disinfected before and after use.

COVID-19 Group Inclusion Criteria

  • Having been diagnosed with COVID-19 at least 12 weeks ago,
  • Being literate,
  • Being in the age range of 18-65,
  • Volunteering to participate in research,
  • To be clinically stable, to be under control if any accompanying comorbid conditions (such as hypertension, diabetes),
  • Not having any orthopedic and neurological problems that might interfere with evaluating peripheral muscle strength, balance and exercise capacity.

COVID-19 Group Exclusion Criteria

  • Those with an ICU hospitalization history due to the diagnosis of COVID-19,
  • Recent myocardial infarction and pulmonary embolism.
  • Having accompanying chronic diseases,
  • Those who have any orthopedic or neurological disorders that will prevent walking,
  • Another COVID-19 PCR Test positivity in the last 12 weeks,
  • Not being able to cooperate and adapt to exercise test due to neurological influences such as cerebrovascular disease or psychiatric disorders,

Healthy Group Inclusion Criteria

  • Not having COVID-19,
  • Being literate,
  • Being in the age range of 18-65,
  • Volunteering to participate in research.

The Criteria for Not Including the Healthy Group in the Study

  • Those who have any orthopedic or neuromuscular disorders that will prevent walking,
  • Having any chronic illness or psychiatric conditions or mental afflictions that may interfere with cooperation or compliance with exercise tests.

Individuals participating in the study will be informed verbally and in writing about the study protocol and informed consent form will be obtained.

研究类型

观察性的

注册 (实际的)

40

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Ankara、火鸡
        • Hacettepe University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 70年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

概率样本

研究人群

The population of the study is individuals who live in Ankara and have passed the diagnosis of COVID-19 for at least 12 weeks and healthy individuals who have not had COVID-19.

The sample of the study is healthy individuals in the long term after the diagnosis of COVID-19 at least 12 weeks after the diagnosis of COVID-19 and healthy individuals who have not had COVID-19 in Hacettepe University Adult Hospital who meet the inclusion criteria and volunteer to participate in the study.

描述

COVID-19 Group Inclusion Criteria

  • Having been diagnosed with COVID-19 at least 12 weeks ago,
  • Being literate,
  • Being in the age range of 18-65,
  • Volunteering to participate in research,
  • To be clinically stable, to be under control if any accompanying comorbid conditions (such as hypertension, diabetes),
  • Not having any orthopedic and neurological problems that might interfere with evaluating peripheral muscle strength, balance and exercise capacity.

COVID-19 Group Exclusion Criteria Those with an ICU hospitalization history due to the diagnosis of COVID-19,

  • Recent myocardial infarction and pulmonary embolism.
  • Having accompanying chronic diseases,
  • Those who have any orthopedic or neurological disorders that will prevent walking,
  • Another COVID-19 PCR Test positivity in the last 12 weeks,
  • Not being able to cooperate and adapt to exercise test due to neurological influences such as cerebrovascular disease or psychiatric disorders, Healthy Group Inclusion Criteria
  • Not having COVID-19,
  • Being literate,
  • Being in the age range of 18-65,
  • Volunteering to participate in research. The Criteria for Not Including the Healthy Group in the Study
  • Those who have any orthopedic or neuromuscular disorders that will prevent walking,
  • Having any chronic illness or psychiatric conditions or mental afflictions that may interfere with cooperation or compliance with exercise tests.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
people with a history of COVID-19

COVID-19 Group Inclusion Criteria

  • Having been diagnosed with COVID-19 at least 12 weeks ago,
  • Being literate,
  • Being in the age range of 18-65,
  • Volunteering to participate in research,
  • To be clinically stable, to be under control if any accompanying comorbid conditions (such as hypertension, diabetes),
  • Not having any orthopedic and neurological problems that might interfere with evaluating peripheral muscle strength, balance and exercise capacity.

COVID-19 Group Exclusion Criteria

  • Those with an ICU hospitalization history due to the diagnosis of COVID-19,
  • Recent myocardial infarction and pulmonary embolism.
  • Having accompanying chronic diseases,
  • Those who have any orthopedic or neurological disorders that will prevent walking,
  • Another COVID-19 PCR Test positivity in the last 12 weeks,
  • Not being able to cooperate and adapt to exercise test due to neurological influences such as cerebrovascular disease or psychiatric disorders,
healthy people

Healthy Group Inclusion Criteria

  • Not having COVID-19,
  • Being literate,
  • Being in the age range of 18-65,
  • Volunteering to participate in research. The Criteria for Not Including the Healthy Group in the Study
  • Those who have any orthopedic or neuromuscular disorders that will prevent walking,
  • Having any chronic illness or psychiatric conditions or mental afflictions that may interfere with cooperation or compliance with exercise tests.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Incremental shuttle walking test
大体时间:January,2021 - December,2021
It assesses maximal exercise capacity.
January,2021 - December,2021

次要结果测量

结果测量
措施说明
大体时间
Time up and Go Test
大体时间:January,2021 - December,2021
Functional balance and walking capacity
January,2021 - December,2021
Short form McGill-Melzack Pain Questionnaire
大体时间:January,2021 - December,2021

The pain rating index has 2 subscales:

Sensory subscale with 11 words, and Affective subscale with 4 words. These words or items are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate and 3 = severe. There's also one item for present pain intensity and one item for a 10 cm visual analogue scale (VAS) for average pain.

The higher the total score on the MPQ, the more the pain experience for the patient increases

January,2021 - December,2021
Tampa Kinesophobia Questionnaire
大体时间:January,2021 - December,2021
Assessment of fear of movement. Scores range from 17-68. Higher scores indicate higher level of kinesiophobia
January,2021 - December,2021
Hospital Anxiety and Depression Scale
大体时间:January,2021 - December,2021
Assessment of anxiety and depression. Scores range from 0 to 21 for each of the two subscales. Higher scores indicate higher level of anxiety and depression
January,2021 - December,2021
SF-36 Quality of Life Scale
大体时间:January,2021 - December,2021
Assessment of life quality. The scores of each domain ranges from zero to 100 which higher scores indicating higher levels of functioning or well-being
January,2021 - December,2021
Fatigue Severity Scale
大体时间:January,2021 - December,2021
Assessment of fatigue perception. Scores range from 0-7. Scores higher than 4 indicate severe fatigue perception.
January,2021 - December,2021
Cognitive Status Scale
大体时间:January,2021 - December,2021
Assessment of cognitive status. Score ranges from 0-100. Higher scores indicate increased tendency to cognitive failure.
January,2021 - December,2021
Body Mass Index
大体时间:January,2021 - December,2021
Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women.
January,2021 - December,2021
Body composition analysis with bioelectrical impedance analysis system
大体时间:January,2021 - December,2021
FM and FFM ratio
January,2021 - December,2021

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Gülay Sain-Guven, Professor、Hacettepe University, Faculty of Medicine

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年2月16日

初级完成 (实际的)

2022年2月3日

研究完成 (实际的)

2022年2月3日

研究注册日期

首次提交

2021年4月7日

首先提交符合 QC 标准的

2021年4月7日

首次发布 (实际的)

2021年4月8日

研究记录更新

最后更新发布 (实际的)

2022年8月9日

上次提交的符合 QC 标准的更新

2022年8月6日

最后验证

2022年8月1日

更多信息

与本研究相关的术语

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研究美国 FDA 监管的设备产品

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