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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04836767
Recruitment Status : Active, not recruiting
First Posted : April 8, 2021
Last Update Posted : May 6, 2021
Sponsor:
Information provided by (Responsible Party):
Ebru Calik Kutukcu, Hacettepe University

Tracking Information
First Submitted Date April 7, 2021
First Posted Date April 8, 2021
Last Update Posted Date May 6, 2021
Actual Study Start Date February 16, 2021
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 7, 2021)
Incremental shuttle walking test [ Time Frame: January,2021 - December,2021 ]
It assesses maximal exercise capacity.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 8, 2021)
  • Time up and Go Test [ Time Frame: January,2021 - December,2021 ]
    Functional balance and walking capacity
  • Short form McGill-Melzack Pain Questionnaire [ Time Frame: 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
  • Tampa Kinesophobia Questionnaire [ Time Frame: January,2021 - December,2021 ]
    Assessment of fear of movement. Scores range from 17-68. Higher scores indicate higher level of kinesiophobia
  • Hospital Anxiety and Depression Scale [ Time Frame: 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
  • SF-36 Quality of Life Scale [ Time Frame: 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
  • Fatigue Severity Scale [ Time Frame: January,2021 - December,2021 ]
    Assessment of fatigue perception. Scores range from 0-7. Scores higher than 4 indicate severe fatigue perception.
  • Cognitive Status Scale [ Time Frame: January,2021 - December,2021 ]
    Assessment of cognitive status. Score ranges from 0-100. Higher scores indicate increased tendency to cognitive failure.
  • Body Mass Index [ Time Frame: 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.
  • Body composition analysis with bioelectrical impedance analysis system [ Time Frame: January,2021 - December,2021 ]
    FM and FFM ratio
Original Secondary Outcome Measures
 (submitted: April 7, 2021)
  • Time up and Go Test [ Time Frame: January,2021 - December,2021 ]
    Functional balance and walking capacity
  • McGill-Melzack Pain Questionnaire [ Time Frame: January,2021 - December,2021 ]
    Assessment of Pain
  • Tampa Kinesophobia Questionnaire [ Time Frame: January,2021 - December,2021 ]
    Assessment of fear of movement
  • Hospital Anxiety and Depression Scale [ Time Frame: January,2021 - December,2021 ]
    Assessment of anxiety and depression
  • SF-36 Quality of Life Scale [ Time Frame: January,2021 - December,2021 ]
    Assessment of life quality
  • Fatigue Severity Scale [ Time Frame: January,2021 - December,2021 ]
    Assessment of fatigue perception
  • Cognitive Status Scale [ Time Frame: January,2021 - December,2021 ]
    Assessment of cognitive status
  • Body Mass Index [ Time Frame: 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.
  • Body composition analysis with bioelectrical impedance analysis system [ Time Frame: January,2021 - December,2021 ]
    FM and FFM ratio
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Physical and Functional Status in Patients With COVID-19 in Long Term
Official Title Evaluation of Exercise Capacity, Peripheral Muscle Strength, Balance, Cognitive Status and Quality of Life in Patients With COVID-19 in Long Term
Brief 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.
Detailed 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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 12 Weeks
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population

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.

Condition
  • Corona Virus Infection
  • Covid19
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: April 7, 2021)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 1, 2022
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT04836767
Other Study ID Numbers GO21-178
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Ebru Calik Kutukcu, Hacettepe University
Study Sponsor Hacettepe University
Collaborators Not Provided
Investigators
Study Director: Gülay Sain-Guven, Professor Hacettepe University, Faculty of Medicine
PRS Account Hacettepe University
Verification Date May 2021