Comparison of Functional Capacities of Healthcare Workers With and Without Covid-19

NCT ID: NCT04834739

Last Updated: 2021-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-04

Study Completion Date

2021-04-30

Brief Summary

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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

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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.

Conditions

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Covid19 Functional Capacity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors
study and control group

Study Groups

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Study group (30 volunteer healthcare workers who had Covid-19

30 volunteer healthcare workers who had Covid-19 and stayed in hospital or at home were included.

Group Type ACTIVE_COMPARATOR

6 minute walk test

Intervention Type OTHER

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 .

1 minute Sit to Stand Test

Intervention Type OTHER

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.

Fatigue Severity Scale

Intervention Type OTHER

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

Medical Research Council (MRC) dyspnea scale

Intervention Type OTHER

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".

SF-12

Intervention Type OTHER

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.

Beck Depression Inventory

Intervention Type OTHER

The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression

Beck Anxiety Inventory

Intervention Type OTHER

Beck Anxiety Scale is a 21-item, internationally valid, self-report rating inventory that measures the anxiety level.

5 times sit to stand test

Intervention Type OTHER

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.

6 point Likert Scale

Intervention Type OTHER

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).

Control group (30 volunteer healthcare workers who had not have Covid-19)

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.

Group Type ACTIVE_COMPARATOR

6 minute walk test

Intervention Type OTHER

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 .

1 minute Sit to Stand Test

Intervention Type OTHER

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.

Fatigue Severity Scale

Intervention Type OTHER

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

Medical Research Council (MRC) dyspnea scale

Intervention Type OTHER

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".

SF-12

Intervention Type OTHER

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.

Beck Depression Inventory

Intervention Type OTHER

The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression

Beck Anxiety Inventory

Intervention Type OTHER

Beck Anxiety Scale is a 21-item, internationally valid, self-report rating inventory that measures the anxiety level.

5 times sit to stand test

Intervention Type OTHER

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.

6 point Likert Scale

Intervention Type OTHER

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).

Interventions

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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. 30 m long corridor is used for this test .

Intervention Type OTHER

1 minute Sit to Stand Test

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

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

Intervention Type OTHER

Medical Research Council (MRC) dyspnea scale

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

SF-12

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

Beck Depression Inventory

The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression

Intervention Type OTHER

Beck Anxiety Inventory

Beck Anxiety Scale is a 21-item, internationally valid, self-report rating inventory that measures the anxiety level.

Intervention Type OTHER

5 times sit to stand test

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

6 point Likert Scale

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).

Intervention Type OTHER

Eligibility Criteria

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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

* Neurological or musculoskeletal disease that causes gait impairment
* Cognitive impairment
* Having unstable cardiac, respiratory and metabolic disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gaziosmanpasa Research and Education Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ebru Yilmaz Yalcinkaya, 3

Role: STUDY_CHAIR

University of Health Science,Gaziosmanpasa Training and Research Hospital

Ozden Ozyemisci Taskiran, 4

Role: STUDY_DIRECTOR

Koç University

Locations

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Gaziosmanpasa Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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208

Identifier Type: -

Identifier Source: org_study_id

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