COVID-19 Respiratory InfectionNCT05075018
Musculoskeletal Problems and Endurance in Healthcare Professionals With and Without COVID-19
An observational study of COVID-19 Respiratory Infection, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
The effects of frequency and severity of physical complaints and symptoms on general well-being, sleep and quality of life are known. However, in the COVID-19 process, the disease has very different effects, both physical and psychological, and some symptoms persist even if the disease is overcome; In addition to… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Respiratory Infection
- What is being tested?
- Observational
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2021to 20 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants are health workers working in a health institution; It will consist of two groups, those who have been diagnosed with COVID-19 in the past and those who have not been diagnosed with COVID-19 in the past.
Who may be able to join
- Volunteering,
- Being a healthcare worker
Who cannot join
- Using psychiatric medication
- No surgery in the last 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Düzce Atatürk Devlet Hastanesi
Düzce, 81060
Reşat HAMURCU, +90 552 664 46 68, fztresathmrc@gmail.com
Eylem TÜTÜN YÜMİN, Assoc. Prof., +90 505 676 31 91, eylemtutun78@hotmail.com
About this study
Official title: Evaluation of Musculoskeletal Problems, Endurance, Quality of Life and Physical Activity Level in Healthcare Professionals With COVID-19 Infection and Without COVID-19 Infection
The effects of frequency and severity of physical complaints and symptoms on general well-being, sleep and quality of life are known. However, in the COVID-19 process, the disease has very different effects, both physical and psychological, and some symptoms persist even if the disease is overcome; In addition to these, the fact that the measures taken throughout the country prompt individuals to take measures to protect themselves from the disease and make it compulsory under some conditions intertwine many different dimensions of the disease on human health and significantly affect daily life. In this context, our first aim in this study is to compare factors such as musculoskeletal problems, physical activity level, endurance and quality of life in healthcare workers with and without COVID-19. Seconder aim is to examine the relationships between factors such as musculoskeletal problems, physical activity level, endurance and quality of life, and to examine the effect levels of the parameters by performing regression analyzes depending on the result.
Read the detailed description
COVID-19 (The coronavirus disease 2019), COVID-19 infection with a wide variety of symptoms such as pain, shortness of breath, high fever, loss of taste and smell, diarrhea and can even progress to a very serious condition such as acute respiratory distress syndrome. It is a common disease that has manifested itself worldwide in the last 1 year as a disease and was declared a pandemic by the World Health Organization on March 11, 2020.
80% of the cases have mild or asymptomatic disease, and 20% need treatment in hospital conditions. Although the disease affects different age groups, it generally affects people aged 60 and over more. It can take weeks to get over the disease; however, some symptoms persist even after the infection has cleared. The continuation of physical, cognitive and psychological problems in COVID-19 patients recovering from the acute phase of the disease is called 'Post-COVID-19 Syndrome'. Symptoms of the disease include fever, dry cough and shortness of breath, as well as common musculoskeletal problems such as muscle pain, joint pain and fatigue, anxiety, depression, poor sleep quality and decreased quality of life, and difficulties in daily living activities. Moreover, the course and prevalence of the disease and its severity in our country as well as in the world have developed a new psychological pressure about the disease and revealed the situation of coronavirus phobia, and even this affects the mood and sleep quality of individuals. It has been shown that depression and anxiety are observed, especially in patients with severe respiratory-related symptoms, both during the active period of the disease and during the period when the symptoms continue despite the recovery of the disease, and the quality of life is adversely affected.
The effects of frequency and severity of physical complaints and symptoms on general well-being, sleep and quality of life are known. However, in the COVID-19 process, the disease has very different effects, both physical and psychological, and some symptoms persist even if the disease is overcome; In addition to these, the fact that the measures taken throughout the country prompt individuals to take measures to protect themselves from the disease and make it compulsory under some conditions intertwine many different dimensions of the disease on human health and significantly affect daily life. In this context, our first aim in this study is to compare factors such as musculoskeletal problems, physical activity level, endurance and quality of life in healthcare workers with and without COVID-19. Seconder aim is to examine the relationships between factors such as musculoskeletal problems, physical activity level, endurance and quality of life, and to examine the effect levels of the parameters by performing regression analyzes depending on the result.
- Conditions
- COVID-19 Respiratory Infection
- Being tested
- Observational
- Keywords
- COVID-19, Muscle Endurance, Musculoskeletal Problems, Healthcare Workers
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Individuals' musculoskeletal problems will be evaluated with the Cornell Musculoskeletal Disorder Questionnaire, quality of life, physical activity, Nottingham Health Profile physical activity International Physical Activity Questionnaire, endurance stabilizer device, functional exercise capacity 1 minute sit and stand test, shortness of breath using the Modified Borg Scale. Measurements will be made only once.
| Study group | Role | What they receive |
|---|---|---|
| Healthcare Workers with COVID-19 Infection | Healthcare workers who have been diagnosed with COVID-19 in the past and currently do not have COVID-19 disease constitute this group Receives: Other: Observational | |
| Healthcare Workers without COVID-19 Infection | Healthcare workers who have not been diagnosed with COVID-19 in the past and currently do not have COVID-19 disease constitute this group Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the Endurance
Endurance of deep cervical flexor muscles and core muscles (Transversus abdominous muscle and lumbar multifidus muscle) will be evaluated with The Stabilizer Pressure Biofeedback Unit. The device will be placed on the measured muscles; Individuals will be asked to maintain their position at the desired pressures. It will give the individual the time to maintain the desired value and the pressure score. High scores indicate that endurance is preserved; low scores reflect loss of endurance.
Measured: 15 minutes
Secondary outcomes (5)
Cornell Musculoskeletal Discomfort Questionnaire
The scale divides the body into 20 distinct regions. Each region's score ranges from 0 to 90. It is understood that the higher the score, the greater the pain, the severity of the pain and the limitation of the pain.
Measured: 5 minutes
Nottingham Health Profile
The Nottingham Health Profile will be used to assess health-related quality of life. The questionnaire consists of 38 items and consists of six subsections related to health status: Energy, pain, emotional reactions, sleep, social isolation and physical activity. Each section is scored between 0-100. 0 indicates best health, 100 indicates worst health.
Measured: 10 minutes
International Physical Activity Questionnaire
Physical activity level will be measured with the International Physical Activity Questionnaire. The questionnaire evaluates parameters such as vigorous activities, moderate activities, walking and sitting activities. The higher the score, the higher the physical activity; A low score indicates physical inactivity.
Measured: 5 minutes
1 minute sit to stand test
Sit and stand test can be performed to evaluate functional exercise capacity, lower extremity muscle strength and endurance. Individuals are asked to cross their arms over their shoulders and sit and stand up for 30 seconds as fast and as long as they can, and the number of sit-ups is recorded. High scores indicate good functional capacity, strength and endurance; low scores indicate functional impairment.
Measured: 2 minutes
Modified Borg Scale
Dyspnea assessment will be made with the Modified Borg Scale. Scoring ranges from 0 to 10 points. High scores indicate high dyspnea; low scores indicate low breathlessness.
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start30 Sep 2021
- Primary completion20 Jun 2022 (estimated)
- Study completion20 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Respiratory InfectionStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eylem TÜTÜN YÜMİN, Assoc. Prof., Study director, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05075018
- Sponsor's protocol ID
- AIBU-FTR-ETY-02
- Status last verified
- Apr 2022
- First submitted
- 28 Sep 2021
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Musculoskeletal Problems, Endurance, Quality of Life and Physical Activity Level in Healthcare Professionals With COVID-19 Infection and Without COVID-19 Infection
- ClinicalTrials.gov ID
- NCT05075018
- Acronym / sponsor ID
- AIBU-FTR-ETY-02
- Conditions
- COVID-19 Respiratory Infection
- Keywords
- COVID-19, Muscle Endurance, Musculoskeletal Problems, Healthcare Workers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 20 Jun 2022 (estimated)
- Study completion
- 20 Jul 2022 (estimated)
- First posted
- 12 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effects of frequency and severity of physical complaints and symptoms on general well-being, sleep and quality of life are known. However, in the COVID-19 process, the disease has very different effects, both physical and psychological, and some symptoms persist even if the disease is overcome; In addition to these, the fact that the measures taken throughout the country prompt individuals to take measures to protect themselves from the disease and make it compulsory under some conditions intertwine many different dimensions of the disease on human health and significantly affect daily life. In this context, our first aim in this study is to compare factors such as musculoskeletal problems, physical activity level, endurance and quality of life in healthcare workers with and without COVID-19. Seconder aim is to examine the relationships between factors such as musculoskeletal problems, physical activity level, endurance and quality of life, and to examine the effect levels of the parameters by performing regression analyzes depending on the result.
Detailed description
COVID-19 (The coronavirus disease 2019), COVID-19 infection with a wide variety of symptoms such as pain, shortness of breath, high fever, loss of taste and smell, diarrhea and can even progress to a very serious condition such as acute respiratory distress syndrome. It is a common disease that has manifested itself worldwide in the last 1 year as a disease and was declared a pandemic by the World Health Organization on March 11, 2020.
80% of the cases have mild or asymptomatic disease, and 20% need treatment in hospital conditions. Although the disease affects different age groups, it generally affects people aged 60 and over more. It can take weeks to get over the disease; however, some symptoms persist even after the infection has cleared. The continuation of physical, cognitive and psychological problems in COVID-19 patients recovering from the acute phase of the disease is called 'Post-COVID-19 Syndrome'. Symptoms of the disease include fever, dry cough and shortness of breath, as well as common musculoskeletal problems such as muscle pain, joint pain and fatigue, anxiety, depression, poor sleep quality and decreased quality of life, and difficulties in daily living activities. Moreover, the course and prevalence of the disease and its severity in our country as well as in the world have developed a new psychological pressure about the disease and revealed the situation of coronavirus phobia, and even this affects the mood and sleep quality of individuals. It has been shown that depression and anxiety are observed, especially in patients with severe respiratory-related symptoms, both during the active period of the disease and during the period when the symptoms continue despite the recovery of the disease, and the quality of life is adversely affected.
The effects of frequency and severity of physical complaints and symptoms on general well-being, sleep and quality of life are known. However, in the COVID-19 process, the disease has very different effects, both physical and psychological, and some symptoms persist even if the disease is overcome; In addition to these, the fact that the measures taken throughout the country prompt individuals to take measures to protect themselves from the disease and make it compulsory under some conditions intertwine many different dimensions of the disease on human health and significantly affect daily life. In this context, our first aim in this study is to compare factors such as musculoskeletal problems, physical activity level, endurance and quality of life in healthcare workers with and without COVID-19. Seconder aim is to examine the relationships between factors such as musculoskeletal problems, physical activity level, endurance and quality of life, and to examine the effect levels of the parameters by performing regression analyzes depending on the result.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthcare Workers with COVID-19 Infection | – | Other: ObservationalHealthcare workers who have been diagnosed with COVID-19 in the past and currently do not have COVID-19 disease constitute this group |
| Healthcare Workers without COVID-19 Infection | – | Other: ObservationalHealthcare workers who have not been diagnosed with COVID-19 in the past and currently do not have COVID-19 disease constitute this group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are health workers working in a health institution; It will consist of two groups, those who have been diagnosed with COVID-19 in the past and those who have not been diagnosed with COVID-19 in the past.
Key inclusion criteria (2 listed)
- Volunteering,
- Being a healthcare worker
Key exclusion criteria (2 listed)
- Using psychiatric medication
- No surgery in the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalIndividuals' musculoskeletal problems will be evaluated with the Cornell Musculoskeletal Disorder Questionnaire, quality of life, physical activity, Nottingham Health Profile physical activity International Physical Activity Questionnaire, endurance stabilizer device, functional exercise capacity 1 minute sit and stand test, shortness of breath using the Modified Borg Scale. Measurements will be made only once. | Other | Healthcare Workers with COVID-19 Infection, Healthcare Workers without COVID-19 Infection |
Primary outcome
Measurement of the Endurance
Time frame: 15 minutes
Endurance of deep cervical flexor muscles and core muscles (Transversus abdominous muscle and lumbar multifidus muscle) will be evaluated with The Stabilizer Pressure Biofeedback Unit. The device will be placed on the measured muscles; Individuals will be asked to maintain their position at the desired pressures. It will give the individual the time to maintain the desired value and the pressure score. High scores indicate that endurance is preserved; low scores reflect loss of endurance.
5 secondary outcomes
Cornell Musculoskeletal Discomfort Questionnaire
Time frame: 5 minutes
Nottingham Health Profile
Time frame: 10 minutes
International Physical Activity Questionnaire
Time frame: 5 minutes
1 minute sit to stand test
Time frame: 2 minutes
Modified Borg Scale
Time frame: 2 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eylem TÜTÜN YÜMİN, Assoc. Prof. study director
Abant Izzet Baysal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Respiratory Infection, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eylem TÜTÜN YÜMİN, Assoc. Prof. (+90 505 676 31 91, eylemtutun78@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the Endurance (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.