Clinical trial NCT04834739: 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
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Functional Capacity
Keywords: Covid-19
healthcare worker
functional capacity
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2021-04-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: 1 minute sit to stand test
timeFrame: Change at 2nd, 4th and 6th months.
measure: 5 times sit to stand test
timeFrame: Change at 2nd, 4th and 6th months.
measure: 6 minute walk test
timeFrame: Change at 2nd, 4th and 6th months.
Secondary outcomes:
measure: Medical Research Council (MRC) dyspnea scale
timeFrame: Change at 2nd, 4th and 6th months
measure: 6 point Likert Scale
timeFrame: Change at 2nd, 4th and 6th months.
measure: Fatigue Severity Scale
timeFrame: Change at 2nd, 4th and 6th months.
measure: Beck Depression Inventory
timeFrame: Change at 2nd, 4th and 6th months.
measure: Beck Anxiety Scale
timeFrame: Change at 2nd, 4th and 6th months.
measure: Short form 12
timeFrame: Change at 2nd, 4th and 6th months.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpasa Training and Research Hospital
Study officials:
affiliation: University of Health Science,Gaziosmanpasa Training and Research Hospital
name: Ebru Yilmaz Yalcinkaya, 3
role: STUDY_CHAIR
affiliation: Koç University
name: Ozden Ozyemisci Taskiran, 4
role: STUDY_DIRECTOR
References: