COVID-19NCT05197478
THE EFFECT OF LIFESTYLE ON THE PROGRESS OF COVID 19
A study testing Mini Nutritional Assessment ,Pıtsburg Sleep Qualıty Scale, Short Physical Activity Survey in people with COVID-19 and Lifestyle Factors, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
THE EFFECT OF LIFESTYLE ON THE PROGRESS OF COVID 19 INFECTION The development of COVID 19 disease depends on the interaction with the immunity of the host. The immune response of the host is related to age, gender, nutrition, sleep and physical activity. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- COVID-19, Lifestyle Factors
- What is being tested?
- Mini Nutritional Assessment ,Pıtsburg Sleep Qualıty Scale, Short Physical Activity Survey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 1 Feb 2022
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COVID 19 pcr test positive over 50 years of age, inpatient treatment patients with pandemic service received ethics committee approval
Who cannot join
- COVID 19 pcr negative Under 50 years of age, Lymphatic system patients with disease or malignant hematological diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: LIFE STYLE BEFORE COVID 19 INFECTION IMPACT ON THE PROGRESS OF COVID 19
THE EFFECT OF LIFESTYLE ON THE PROGRESS OF COVID 19 INFECTION
The development of COVID 19 disease depends on the interaction with the immunity of the host. The immune response of the host is related to age, gender, nutrition, sleep and physical activity. Our study in Fatih Sultan Mehmet Training and Research Hospital; Between 31 January-31 May 2021,positive COVID 19 PCR test was performed with 66 patients over the age of 50, who received inpatient treatment. Demographic data of the patients, length of hospitalization, alcohol/tobacco use, BMI, comorbidities, regular use medication or not, thorax CT findings, place of discharge after treatment, laboratory parameters were recorded at hospitalization and discharge.
Read more
To evaluate the pre-infection lifestyle; physical activity, nutrition and sleep habits were questioned.
According to the PSQS (Pittsburg Sleep Quality Scale) although the increase in discharged lymphocyte measurements compared to the first hospitalization of the patients in the good and bad sleep groups was significant, there was no significant difference between the groups. In the evaluation between the groups, the increase in the NLR value at the first hospitalization was significant in the bad sleep group compared to the good sleep group. There was no difference between the groups in terms of NLR.
According to the MNA(Mini Nutritional Assessment)scale ;the increase in the discharge lymphocyte value of the groups compared to the value at the first hospitalization was significant. The increases in the discharge lymphocyte measurements of the patients compared to the first hospitalization were significant between the groups (p<0.05). The increase in discharge lymphocyte values in patients at risk of malnutrition compared to the first hospitalization was higher than in patients with malnutrition (p<0.05). The decrease in discharge NLR values compared to the first hospitalization was significant in the group under normal nutrition and malnutrition risk. The difference between the first hospitalization PLT (Platelet)measurements of the groups according to the MNA scale was significant.
According to the International Brief Physical Activity Survey; the increase in the discharge lymphocyte value of the inactive, minimally active and very active groups was significant compared to the first hospitalization. A significant difference was found between the PLT measurements between the groups (p<0.05). PLT measurements of very active cases were higher than those of minimally active cases (p<0.05).
In this study, in which we examined the effects of lifestyle before the diagnosis of COVID 19 on the course of COVID 19, we observed that there is no need for intensive care in patients who are well fed, have good sleep quality and are physically active.
Read the detailed description
Our study in Fatih Sultan Mehmet Training and Research Hospital; It was conducted prospectively on 31 January - 31 May 2021:
Inclusion criteria:
Patients over 50 years of age, Who were hospitalized in the pandemic ward Patients with positive COVID 19 pcr test and were taken into ethical examination (E-17073117-050.06)
Exclusion criteria:
Patients under 50 years of age, Patients with negative COVID 19 pcr test, Lymphatic system disease or malignant hematological diseases were excluded from the study.
Patient age, gender, education status,time spent at home before hospitalization ,duration of hospitalization, alcohol/tobacco use, body mass index,presence of thorax CT lesion ,whether the patients were discharged to another service, intensive care unit, or home after the treatment of COVID 19,laboratory findings at admission and discharge (lymphocyte level, neutrophil-lymphocyte ratio and platelet count at first admission) were recorded.
To evaluate the lifestyle before being infected with COVID 19, physical activity, nutrition and sleep habits were questioned.
To evaluate sleep habits; Pittsburg Sleep Quality Scale (PSQS) , Nutritional habits; Mini Nutritional Assessment(MNA) Scale, For the evaluation of physical activity; International Brief Physical Activity Questionnaire Done.
- Conditions
- COVID-19, Lifestyle Factors
- Being tested
- Mini Nutritional Assessment ,Pıtsburg Sleep Qualıty Scale, Short Physical Activity Survey
- Keywords
- COVİD 19, LİFESTYLE, PANDEMİA
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini Nutritional Assessment ,Pıtsburg Sleep Qualıty Scale, Short Physical Activity SurveyOther
To evaluate the lifestyle before being infected with COVID 19, physical activity, nutrition and sleep habits were questioned.
To evaluate sleep habits; Pitsburg Sleep Quality Scale (PSQS) Nutritional habits: Mini Nutritional Assessment(MNA) Scale For the evaluation of physical activity; International Brief Physical Activity Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| COVID 19 positive patients | Other | COVID 19 positive patients receiving inpatient treatment were evaluated. Receives: Other: Mini Nutritional Assessment ,Pıtsburg Sleep Qualıty Scale, Short Physical Activity Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index (PSQI) .
SLEEP QUALİTY SCALE The total PSQI score is obtained by summing the seven sub-scores. The total score ranges from 9 to 21. The PSQI total score clearly distinguishes good sleepers from bad sleepers.
Good sleep:5 points or less Bad Sleep:over 5 points
Measured: UP TO 24 WEEKS
Mini Nutritional Assessment
NUTRITIONAL STATUS
The sum of the MNA score distinguishes between elderly patients with:
- Adequate nutritional status, MNA 24;
- Protein-calorie malnutrition, MNA 17;
- at risk of malnutrition, MNA between 17 and 23.5.
Normal nutritional status:24-30 points
At risk of malnutrition:17-23.5
Malnourished:under 17 points
Measured: UP TO 24 WEEKS
International Short Physical Activıiy Questionnaire
Category 1:INACTIVE
It is the lowest level of physical activity. Conditions that cannot be included in categories 2 and 3 are considered inactive.
Category 2:MINIMUM ACTIVE
2 a:Doing vigorous activity for at least 20 minutes on 3 or more days 2b:5 or more days of moderate-intensity activity or walking for at least 30 minutes a day
2c:A combination of 5 or more days of walking and moderate-intensity activity providing a minimum of 600 MET-min/week
Category 3:VERY ACTIVE
3 a:At least 3 days of vigorous physical activity or more days providing a minimum of 1500 MET-min/week
3b:Moderate to vigorous walking for 7 days providing a minimum of 3000 MET-min/week combination of activity
Measured: UP TO 24 WEEKS
Secondary outcomes (3)
LYMPHOCYTE COUNT
HEMATOLOGICAL BIOMARKER
Measured: UP TO 24 WEEKS
NEUTROPHIL LYMPHOCYTE RATIO
HEMATOLOGICAL BIOMARKER
Measured: UP TO 24 WEEKS
PLATELET COUNT
HEMATOLOGICAL BIOMARKER
Measured: UP TO 24 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start1 Jan 2021
- Primary completion1 Nov 2021
- Study completion1 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- It was conducted prospectively on 31 January - 31 May 2021 patients over 50 years of age, who were hospitalized in the pandemic ward, had the appearance of COVID 19, and were taken into ethical examination (E-17073117-050.06). 50.06,
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197478
- Sponsor's protocol ID
- yildizyigit1
- Status last verified
- Jan 2022
- First submitted
- 14 Jan 2022
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study data can be shared if requested by the editor.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LIFE STYLE BEFORE COVID 19 INFECTION IMPACT ON THE PROGRESS OF COVID 19
- ClinicalTrials.gov ID
- NCT05197478
- Acronym / sponsor ID
- yildizyigit1
- Conditions
- COVID-19, Lifestyle Factors
- Keywords
- COVİD 19, LİFESTYLE, PANDEMİA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 19 Jan 2022 (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 EFFECT OF LIFESTYLE ON THE PROGRESS OF COVID 19 INFECTION
The development of COVID 19 disease depends on the interaction with the immunity of the host. The immune response of the host is related to age, gender, nutrition, sleep and physical activity. Our study in Fatih Sultan Mehmet Training and Research Hospital; Between 31 January-31 May 2021,positive COVID 19 PCR test was performed with 66 patients over the age of 50, who received inpatient treatment. Demographic data of the patients, length of hospitalization, alcohol/tobacco use, BMI, comorbidities, regular use medication or not, thorax CT findings, place of discharge after treatment, laboratory parameters were recorded at hospitalization and discharge.
To evaluate the pre-infection lifestyle; physical activity, nutrition and sleep habits were questioned.
According to the PSQS (Pittsburg Sleep Quality Scale) although the increase in discharged lymphocyte measurements compared to the first hospitalization of the patients in the good and bad sleep groups was significant, there was no significant difference between the groups. In the evaluation between the groups, the increase in the NLR value at the first hospitalization was significant in the bad sleep group compared to the good sleep group. There was no difference between the groups in terms of NLR.
According to the MNA(Mini Nutritional Assessment)scale ;the increase in the discharge lymphocyte value of the groups compared to the value at the first hospitalization was significant. The increases in the discharge lymphocyte measurements of the patients compared to the first hospitalization were significant between the groups (p<0.05). The increase in discharge lymphocyte values in patients at risk of malnutrition compared to the first hospitalization was higher than in patients with malnutrition (p<0.05). The decrease in discharge NLR values compared to the first hospitalization was significant in the group under normal nutrition and malnutrition risk. The difference between the first hospitalization PLT (Platelet)measurements of the groups according to the MNA scale was significant.
According to the International Brief Physical Activity Survey; the increase in the discharge lymphocyte value of the inactive, minimally active and very active groups was significant compared to the first hospitalization. A significant difference was found between the PLT measurements between the groups (p<0.05). PLT measurements of very active cases were higher than those of minimally active cases (p<0.05).
In this study, in which we examined the effects of lifestyle before the diagnosis of COVID 19 on the course of COVID 19, we observed that there is no need for intensive care in patients who are well fed, have good sleep quality and are physically active.
Detailed description
Our study in Fatih Sultan Mehmet Training and Research Hospital; It was conducted prospectively on 31 January - 31 May 2021:
Inclusion criteria:
Patients over 50 years of age, Who were hospitalized in the pandemic ward Patients with positive COVID 19 pcr test and were taken into ethical examination (E-17073117-050.06)
Exclusion criteria:
Patients under 50 years of age, Patients with negative COVID 19 pcr test, Lymphatic system disease or malignant hematological diseases were excluded from the study.
Patient age, gender, education status,time spent at home before hospitalization ,duration of hospitalization, alcohol/tobacco use, body mass index,presence of thorax CT lesion ,whether the patients were discharged to another service, intensive care unit, or home after the treatment of COVID 19,laboratory findings at admission and discharge (lymphocyte level, neutrophil-lymphocyte ratio and platelet count at first admission) were recorded.
To evaluate the lifestyle before being infected with COVID 19, physical activity, nutrition and sleep habits were questioned.
To evaluate sleep habits; Pittsburg Sleep Quality Scale (PSQS) , Nutritional habits; Mini Nutritional Assessment(MNA) Scale, For the evaluation of physical activity; International Brief Physical Activity Questionnaire Done.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- It was conducted prospectively on 31 January - 31 May 2021 patients over 50 years of age, who were hospitalized in the pandemic ward, had the appearance of COVID 19, and were taken into ethical examination (E-17073117-050.06). 50.06,
| Arm | Type | Receives |
|---|---|---|
| COVID 19 positive patients | Other | Other: Mini Nutritional Assessment ,Pıtsburg Sleep Qualıty Scale, Short Physical Activity SurveyCOVID 19 positive patients receiving inpatient treatment were evaluated. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- COVID 19 pcr test positive over 50 years of age, inpatient treatment patients with pandemic service received ethics committee approval
Key exclusion criteria (1 listed)
- COVID 19 pcr negative Under 50 years of age, Lymphatic system patients with disease or malignant hematological diseases
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 |
|---|---|---|
| Mini Nutritional Assessment ,Pıtsburg Sleep Qualıty Scale, Short Physical Activity SurveyTo evaluate the lifestyle before being infected with COVID 19, physical activity, nutrition and sleep habits were questioned. To evaluate sleep habits; Pitsburg Sleep Quality Scale (PSQS) Nutritional habits: Mini Nutritional Assessment(MNA) Scale For the evaluation of physical activity; International Brief Physical Activity Questionnaire | Other | COVID 19 positive patients |
Primary outcome
Pittsburgh Sleep Quality Index (PSQI) .
Time frame: UP TO 24 WEEKS
SLEEP QUALİTY SCALE The total PSQI score is obtained by summing the seven sub-scores. The total score ranges from 9 to 21. The PSQI total score clearly distinguishes good sleepers from bad sleepers. Good sleep:5 points or less Bad Sleep:over 5 points
Mini Nutritional Assessment
Time frame: UP TO 24 WEEKS
NUTRITIONAL STATUS The sum of the MNA score distinguishes between elderly patients with: 1. Adequate nutritional status, MNA 24; 2. Protein-calorie malnutrition, MNA 17; 3. at risk of malnutrition, MNA between 17 and 23.5. Normal nutritional status:24-30 points At risk of malnutrition:17-23.5 Malnourished:under 17 points
International Short Physical Activıiy Questionnaire
Time frame: UP TO 24 WEEKS
Category 1:INACTIVE It is the lowest level of physical activity. Conditions that cannot be included in categories 2 and 3 are considered inactive. Category 2:MINIMUM ACTIVE 2 a:Doing vigorous activity for at least 20 minutes on 3 or more days 2b:5 or more days of moderate-intensity activity or walking for at least 30 minutes a day 2c:A combination of 5 or more days of walking and moderate-intensity activity providing a minimum of 600 MET-min/week Category 3:VERY ACTIVE 3 a:At least 3 days of vigorous physical activity or more days providing a minimum of 1500 MET-min/week 3b:Moderate to vigorous walking for 7 days providing a minimum of 3000 MET-min/week combination of activity
3 secondary outcomes
LYMPHOCYTE COUNT
Time frame: UP TO 24 WEEKS
NEUTROPHIL LYMPHOCYTE RATIO
Time frame: UP TO 24 WEEKS
PLATELET COUNT
Time frame: UP TO 24 WEEKS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- Individual participant dataSharing planned: Yes. Study data can be shared if requested by the editor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mini Nutritional Assessment ,Pıtsburg Sleep Qualıty Scale, Short Physical Activity Survey in people with COVID-19 and Lifestyle Factors, run by Fatih Sultan Mehmet Training and Research Hospital 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 1 inclusion and 1 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 19 Jan 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index (PSQI) . (time frame: UP TO 24 WEEKS). The study lists 3 primary outcomes in all. 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 19 Jan 2022; AzTrials last refreshed its copy on 8 Nov 2026.