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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04836767
• Other study ID #: GO21-178
• Status: Completed
• Start date: February 16, 2021
• Est. completion date: February 3, 2022

Study information

• Verified date: August 2022
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 3, 2022
• Est. primary completion date: February 3, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• COVID-19
• Covid19

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Barker-Davies RM, O'Sullivan O, Senaratne KPP, Baker P, Cranley M, Dharm-Datta S, Ellis H, Goodall D, Gough M, Lewis S, Norman J, Papadopoulou T, Roscoe D, Sherwood D, Turner P, Walker T, Mistlin A, Phillip R, Nicol AM, Bennett AN, Bahadur S. The Stanford — View Citation

Belli S, Balbi B, Prince I, Cattaneo D, Masocco F, Zaccaria S, Bertalli L, Cattini F, Lomazzo A, Dal Negro F, Giardini M, Franssen FME, Janssen DJA, Spruit MA. Low physical functioning and impaired performance of activities of daily life in COVID-19 patie — View Citation

Epidemiology Working Group for NCIP Epidemic Response, Chinese Center for Disease Control and Prevention. [The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19) in China]. Zhonghua Liu Xing Bing Xue Za Zhi. 2020 — View Citation

Xu Z, Shi L, Wang Y, Zhang J, Huang L, Zhang C, Liu S, Zhao P, Liu H, Zhu L, Tai Y, Bai C, Gao T, Song J, Xia P, Dong J, Zhao J, Wang FS. Pathological findings of COVID-19 associated with acute respiratory distress syndrome. Lancet Respir Med. 2020 Apr;8( — View Citation

Zhao H, Shen D, Zhou H, Liu J, Chen S. Guillain-Barré syndrome associated with SARS-CoV-2 infection: causality or coincidence? Lancet Neurol. 2020 May;19(5):383-384. doi: 10.1016/S1474-4422(20)30109-5. Epub 2020 Apr 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incremental shuttle walking test	It assesses maximal exercise capacity.	January,2021 - December,2021
Secondary	Time up and Go Test	Functional balance and walking capacity	January,2021 - December,2021
Secondary	Short form McGill-Melzack Pain Questionnaire	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
Secondary	Tampa Kinesophobia Questionnaire	Assessment of fear of movement. Scores range from 17-68. Higher scores indicate higher level of kinesiophobia	January,2021 - December,2021
Secondary	Hospital Anxiety and Depression Scale	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
Secondary	SF-36 Quality of Life Scale	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
Secondary	Fatigue Severity Scale	Assessment of fatigue perception. Scores range from 0-7. Scores higher than 4 indicate severe fatigue perception.	January,2021 - December,2021
Secondary	Cognitive Status Scale	Assessment of cognitive status. Score ranges from 0-100. Higher scores indicate increased tendency to cognitive failure.	January,2021 - December,2021
Secondary	Body Mass Index	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
Secondary	Body composition analysis with bioelectrical impedance analysis system	FM and FFM ratio	January,2021 - December,2021