NCT04834739

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable covid19

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2021

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

August 24, 2021

Status Verified

January 1, 2021

Enrollment Period

3 months

First QC Date

January 10, 2021

Last Update Submit

August 23, 2021

Conditions

Keywords

Covid-19healthcare workerfunctional capacity

Outcome Measures

Primary Outcomes (3)

  • 1 minute sit to stand test

    1 minute sit to stand test will be used to measure aerobic capacity and endurance.

    Change at 2nd, 4th and 6th months.

  • 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

    Change at 2nd, 4th and 6th months.

  • 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.

    Change at 2nd, 4th and 6th months.

Secondary Outcomes (6)

  • Medical Research Council (MRC) dyspnea scale

    Change at 2nd, 4th and 6th months

  • 6 point Likert Scale

    Change at 2nd, 4th and 6th months.

  • Fatigue Severity Scale

    Change at 2nd, 4th and 6th months.

  • Beck Depression Inventory

    Change at 2nd, 4th and 6th months.

  • Beck Anxiety Scale

    Change at 2nd, 4th and 6th months.

  • +1 more secondary outcomes

Study Arms (2)

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

ACTIVE COMPARATOR

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

Other: 6 minute walk testOther: 1 minute Sit to Stand TestOther: Fatigue Severity ScaleOther: Medical Research Council (MRC) dyspnea scaleOther: SF-12Other: Beck Depression InventoryOther: Beck Anxiety InventoryOther: 5 times sit to stand testOther: 6 point Likert Scale

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

ACTIVE COMPARATOR

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.

Other: 6 minute walk testOther: 1 minute Sit to Stand TestOther: Fatigue Severity ScaleOther: Medical Research Council (MRC) dyspnea scaleOther: SF-12Other: Beck Depression InventoryOther: Beck Anxiety InventoryOther: 5 times sit to stand testOther: 6 point Likert Scale

Interventions

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 .

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

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.

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

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

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

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".

Control group (30 volunteer healthcare workers who had not have Covid-19)Study group (30 volunteer healthcare workers who had Covid-19
SF-12OTHER

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.

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

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

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

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

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

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.

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

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Neurological or musculoskeletal disease that causes gait impairment
  • Cognitive impairment
  • Having unstable cardiac, respiratory and metabolic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19

Interventions

antigens, CD200

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Ebru Yilmaz Yalcinkaya, 3

    University of Health Science,Gaziosmanpasa Training and Research Hospital

    STUDY CHAIR
  • Ozden Ozyemisci Taskiran, 4

    Koç University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
study and control group
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2021

First Posted

April 8, 2021

Study Start

January 4, 2021

Primary Completion

March 28, 2021

Study Completion

April 30, 2021

Last Updated

August 24, 2021

Record last verified: 2021-01

Locations