Comparison of Functional Capacities of Healthcare Workers With and Without Covid-19
Primary Purpose
Covid19, Functional Capacity
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
6 minute walk test
1 minute Sit to Stand Test
Fatigue Severity Scale
Medical Research Council (MRC) dyspnea scale
SF-12
Beck Depression Inventory
Beck Anxiety Inventory
5 times sit to stand test
6 point Likert Scale
Sponsored by

About this trial
This is an interventional health services research trial for Covid19 focused on measuring Covid-19, healthcare worker, functional capacity
Eligibility Criteria
Inclusion Criteria:
- Being a health worker over the age of 18 (for both control group)
- Having had SARS-CoV-2 (Covid 19) disease in the last 1 month and completed the isolation process
- Volunteer to participate in the study, being discharged from the hospital and completing the isolation process at home (The first assessment will be made within the 1st month after the patient's Covid 19 positivity is detected; control will be made three times in the 2nd, 4th and 6th months)
- Being able to walk or sit and stand without any help
- Speaking and understand the Turkish language.
Exclusion Criteria:*For both study and control group
- Neurological or musculoskeletal disease that causes gait impairment
- Cognitive impairment
- Having unstable cardiac, respiratory and metabolic disease
Sites / Locations
- Gaziosmanpasa Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Study group (30 volunteer healthcare workers who had Covid-19
Control group (30 volunteer healthcare workers who had not have Covid-19)
Arm Description
30 volunteer healthcare workers who had Covid-19 and stayed in hospital or at home were included.
In control group, 30 volunteer healthcare workers who were matched for age ande gender with study group were included and these persons had not have Covid-19.
Outcomes
Primary Outcome Measures
1 minute sit to stand test
1 minute sit to stand test will be used to measure aerobic capacity and endurance.
5 times sit to stand test
The five Times Sit to Stand Test (5x Sit-To-Stand Test) commonly abbreviated as 5XSST is used to assesses functional lower extremity strength, transitional movements, balance, and fall risk in older adults
6 minute walk test
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Secondary Outcome Measures
Medical Research Council (MRC) dyspnea scale
Medical Research Council (MRC) dyspnea scale is a questionnaire that consists of five statements about perceived breathlessness in dailt activities.
6 point Likert Scale
Job performance was assessed by asking "How do you evaluate your job performance?" on 6-point Likert scale.
Fatigue Severity Scale
The Fatigue Severity Scale is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders.
Beck Depression Inventory
The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression
Beck Anxiety Scale
Beck Anxiety Scale is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety in children and adults
Short form 12
Short form 12 will be used to measure quality of life
Full Information
NCT ID
NCT04834739
First Posted
January 10, 2021
Last Updated
August 23, 2021
Sponsor
Gaziosmanpasa Research and Education Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04834739
Brief Title
Comparison of Functional Capacities of Healthcare Workers With and Without Covid-19
Official Title
Comparison of Functional Capacities of Healthcare Workers With and Without Covid-19
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 4, 2021 (Actual)
Primary Completion Date
March 28, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gaziosmanpasa Research and Education Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aimed to investigate if the functional capacity of health workers sustained covid 19 infection effects functional capacity , quality of life and mood of health workers when comparing healthy health workers.
Detailed Description
This study was designed in Physical Medicine and Rehabilitation Service of Gaziosmanpasa Training and Research Hospital between January 4 and June 30, 2021.Data of the health workers from our hospital who suffered from Covid-19 disease and matched control group who had not have Covid-19 disease participants were analyzed. Participants signed a general consent .Inclusion criteria; being a health worker over the age of 18 (for both groups), having had SARS-CoV-2 (Covid 19) disease for last 1 month and completed the isolation process, volunteer to participate in the study, , being able to walk or sit and stand without any help, speaking and understand Turkish language. Exclusion criteria (for both study and control group); Neurological or musculoskeletal disease that causes gait impairment, cognitive impairment, having unstable cardiac, respiratory and metabolic disease.(The first assessment will be made within the 1st month after the patient's Covid 19 positivity is detected; control will be made three times in the 2nd, 4th and 6 months)
30 volunteer healthcare workers who had Covid-19 were included to study group. 30 age and gender matched volunteer healthcare workers were included to control group. Healthcare workers who have had Covid-19 disease will be evaluated for the first time within 1 month after their diagnosis with RT-PCR test for SARS-CoV-2.
Symptom questioning will be reported including the initial symptoms of Covid-19 and ongoing complaints of the patients. During the examination, muscle strength will be evaluated by the Medical Research Council (MRC) total score. Resting heart rate, blood pressure and oxygen saturation (by pulse oxymeter) measurement will be applied to both groups before and after the following tests: 1-min sit-to-stand (1MSTS) test, 5 times sit-to-stand (5TSTS) test, 6 minutes walk test (6MWT).
MRC dyspnea scale will be performed as a measure of patient's complaint of shortness of breath,Job performance was assessed by asking "How do you evaluate your job performance?" on 6-point Likert scale, Short Form-12 (Short Form 12, SF-12) will be used to assess quality of life, mood disorder wil be measured by Beck Anxiety Inventory and Beck Depression Inventory, Fatigue severity scale(FSS) will be performed as level of fatigue. The first evaluation wil be made within 1 month after one positive RT-PCR test for SARS-CoV-2 is detected; control evaluations will be made in the 2nd, 4th and 6th months after positivity of RT-PCR test for SARS-CoV-2. Finally, the patient's sex, age, body mass index (BMI), height, education status, career, status of hospitalization, length of hospitalization, comorbidities , pulmonary involvement that diagnosed radiological methods and examination of symptoms related with Covid-19 will be recorded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Functional Capacity
Keywords
Covid-19, healthcare worker, functional capacity
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
30 volunteer healthcare workers who had Covid-19 and stayed in hospital or at home were included. In control group, 30 volunteer healthcare workers who were matched for age and gender with study group were included and these persons had not have Covid-19. Healthcare workers who have had Covid-19 disease will be evaluated for the first time within 1 month after their diagnosis with RT-PCR test for SARS-CoV-2 (The condition of completing isolation process of the patients will be sought).
Masking
Outcomes Assessor
Masking Description
study and control group
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study group (30 volunteer healthcare workers who had Covid-19
Arm Type
Active Comparator
Arm Description
30 volunteer healthcare workers who had Covid-19 and stayed in hospital or at home were included.
Arm Title
Control group (30 volunteer healthcare workers who had not have Covid-19)
Arm Type
Active Comparator
Arm Description
In control group, 30 volunteer healthcare workers who were matched for age ande gender with study group were included and these persons had not have Covid-19.
Intervention Type
Other
Intervention Name(s)
6 minute walk test
Intervention Description
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. 30 m long corridor is used for this test .
Intervention Type
Other
Intervention Name(s)
1 minute Sit to Stand Test
Intervention Description
The 1-minute STS test is performed with a chair of standard height of 46 cm without arm rests. The patient should be ensured to be seated upright on the chair positioned against a wall. The patient sat with the knees and hips flexed to 90°, feet placed flat on the floor hip-width apart, and the hands placed on the hips.The number of repetitions is measured.
Intervention Type
Other
Intervention Name(s)
Fatigue Severity Scale
Intervention Description
The Fatigue Severity Scale is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders
Intervention Type
Other
Intervention Name(s)
Medical Research Council (MRC) dyspnea scale
Intervention Description
The MRC dyspnea scale is a questionnaire that consists of five statements about perceived breathlessness: grade 1, "I only get breathless with strenuous exercise"; grade 2, "I get short of breath when hurrying on the level or up a slight hill"; grade 3, "I walk slower than people of the same age on the level because of breathlessness or have to stop for breath when walking at my own pace on the level"; grade 4, "I stop for breath after walking 100 yards or after a few minutes on the level"; grade 5, " I am too breathless to leave the house".
Intervention Type
Other
Intervention Name(s)
SF-12
Intervention Description
The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure.
Intervention Type
Other
Intervention Name(s)
Beck Depression Inventory
Intervention Description
The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression
Intervention Type
Other
Intervention Name(s)
Beck Anxiety Inventory
Intervention Description
Beck Anxiety Scale is a 21-item, internationally valid, self-report rating inventory that measures the anxiety level.
Intervention Type
Other
Intervention Name(s)
5 times sit to stand test
Intervention Description
The 5XSST scoring is based on the amount of time (to the nearest decimal in seconds) a patient is able to transfer from a seated to a standing position and back to sitting five times. The equipment need in performing 5XSST test includes: Stopwatch and standard height chair with straight back (43-45 cm, 17-18 inches high). Then the instruction is given by asking the test taker to sit on the chair by resting their back. Also, the test taker is instructed to fold their arms across their chest. Then the test taker should be instructed to do sit-to-stand five times, as quickly as possible, at the count of go and without their back or leg resting on the chair between the interval of repetition.
Intervention Type
Other
Intervention Name(s)
6 point Likert Scale
Intervention Description
Job performance was assessed by asking "How do you evaluate your job performance?" on 6-point Likert scale.A 6 point likert scale forces choice and gives better data.The 6 point Likert scale offers options for ''Excellent, very good, good, fair, poor and very poor''. 6 point scale anges from 1(very poor) to 5 (excellent).
Primary Outcome Measure Information:
Title
1 minute sit to stand test
Description
1 minute sit to stand test will be used to measure aerobic capacity and endurance.
Time Frame
Change at 2nd, 4th and 6th months.
Title
5 times sit to stand test
Description
The five Times Sit to Stand Test (5x Sit-To-Stand Test) commonly abbreviated as 5XSST is used to assesses functional lower extremity strength, transitional movements, balance, and fall risk in older adults
Time Frame
Change at 2nd, 4th and 6th months.
Title
6 minute walk test
Description
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Time Frame
Change at 2nd, 4th and 6th months.
Secondary Outcome Measure Information:
Title
Medical Research Council (MRC) dyspnea scale
Description
Medical Research Council (MRC) dyspnea scale is a questionnaire that consists of five statements about perceived breathlessness in dailt activities.
Time Frame
Change at 2nd, 4th and 6th months
Title
6 point Likert Scale
Description
Job performance was assessed by asking "How do you evaluate your job performance?" on 6-point Likert scale.
Time Frame
Change at 2nd, 4th and 6th months.
Title
Fatigue Severity Scale
Description
The Fatigue Severity Scale is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders.
Time Frame
Change at 2nd, 4th and 6th months.
Title
Beck Depression Inventory
Description
The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression
Time Frame
Change at 2nd, 4th and 6th months.
Title
Beck Anxiety Scale
Description
Beck Anxiety Scale is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety in children and adults
Time Frame
Change at 2nd, 4th and 6th months.
Title
Short form 12
Description
Short form 12 will be used to measure quality of life
Time Frame
Change at 2nd, 4th and 6th months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Being a health worker over the age of 18 (for both control group)
Having had SARS-CoV-2 (Covid 19) disease in the last 1 month and completed the isolation process
Volunteer to participate in the study, being discharged from the hospital and completing the isolation process at home (The first assessment will be made within the 1st month after the patient's Covid 19 positivity is detected; control will be made three times in the 2nd, 4th and 6th months)
Being able to walk or sit and stand without any help
Speaking and understand the Turkish language.
Exclusion Criteria:*For both study and control group
Neurological or musculoskeletal disease that causes gait impairment
Cognitive impairment
Having unstable cardiac, respiratory and metabolic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebru Yilmaz Yalcinkaya, 3
Organizational Affiliation
University of Health Science,Gaziosmanpasa Training and Research Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ozden Ozyemisci Taskiran, 4
Organizational Affiliation
Koç University
Official's Role
Study Director
Facility Information:
Facility Name
Gaziosmanpasa Training and Research Hospital
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Comparison of Functional Capacities of Healthcare Workers With and Without Covid-19
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