THE EFFECT OF LIFESTYLE ON THE PROGRESS OF COVID 19

COVID-19 Clinical Trial

Official title:

LIFE STYLE BEFORE COVID 19 INFECTION IMPACT ON THE PROGRESS OF COVID 19

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05197478
• Other study ID #: yildizyigit1
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: February 1, 2022

Study information

• Verified date: January 2022
• Source: Fatih Sultan Mehmet Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 66
• Est. completion date: February 1, 2022
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

COVID 19 pcr test positive over 50 years of age, inpatient treatment patients with pandemic service received ethics committee approval

Exclusion Criteria:

COVID 19 pcr negative Under 50 years of age, Lymphatic system patients with disease or malignant hematological diseases

Related Conditions & MeSH terms

• COVID-19
• Lifestyle Factors

Intervention

Other:
• Mini Nutritional Assessment ,Pitsburg Sleep Quality Scale, Short Physical Activity Survey
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

Locations

Country	Name	City	State
Turkey	Yildiz	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Fatih Sultan Mehmet Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pittsburgh Sleep Quality Index (PSQI) .	SLEEP QUALITY 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	UP TO 24 WEEKS
Primary	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	UP TO 24 WEEKS
Primary	International Short Physical Activiiy 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	UP TO 24 WEEKS
Secondary	LYMPHOCYTE COUNT	HEMATOLOGICAL BIOMARKER	UP TO 24 WEEKS
Secondary	NEUTROPHIL LYMPHOCYTE RATIO	HEMATOLOGICAL BIOMARKER	UP TO 24 WEEKS
Secondary	PLATELET COUNT	HEMATOLOGICAL BIOMARKER	UP TO 24 WEEKS