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THE EFFECT OF LIFESTYLE ON THE PROGRESS OF COVID 19

Primary Purpose

COVID-19, Lifestyle Factors

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Mini Nutritional Assessment ,Pıtsburg Sleep Qualıty Scale, Short Physical Activity Survey
Sponsored by
Fatih Sultan Mehmet Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for COVID-19 focused on measuring COVİD 19, LİFESTYLE, PANDEMİA

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yıldız

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

COVID 19 positive patients

Arm Description

COVID 19 positive patients receiving inpatient treatment were evaluated.

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

LYMPHOCYTE COUNT
HEMATOLOGICAL BIOMARKER
NEUTROPHIL LYMPHOCYTE RATIO
HEMATOLOGICAL BIOMARKER
PLATELET COUNT
HEMATOLOGICAL BIOMARKER

Full Information

First Posted
January 14, 2022
Last Updated
January 16, 2022
Sponsor
Fatih Sultan Mehmet Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05197478
Brief Title
THE EFFECT OF LIFESTYLE ON THE PROGRESS OF COVID 19
Official Title
LIFE STYLE BEFORE COVID 19 INFECTION IMPACT ON THE PROGRESS OF COVID 19
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
February 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fatih Sultan Mehmet Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Lifestyle Factors
Keywords
COVİD 19, LİFESTYLE, PANDEMİA

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
COVID 19 positive patients
Arm Type
Other
Arm Description
COVID 19 positive patients receiving inpatient treatment were evaluated.
Intervention Type
Other
Intervention Name(s)
Mini Nutritional Assessment ,Pıtsburg Sleep Qualıty Scale, Short Physical Activity Survey
Intervention Description
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
Primary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index (PSQI) .
Description
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
Time Frame
UP TO 24 WEEKS
Title
Mini Nutritional Assessment
Description
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
Time Frame
UP TO 24 WEEKS
Title
International Short Physical Activıiy Questionnaire
Description
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
Time Frame
UP TO 24 WEEKS
Secondary Outcome Measure Information:
Title
LYMPHOCYTE COUNT
Description
HEMATOLOGICAL BIOMARKER
Time Frame
UP TO 24 WEEKS
Title
NEUTROPHIL LYMPHOCYTE RATIO
Description
HEMATOLOGICAL BIOMARKER
Time Frame
UP TO 24 WEEKS
Title
PLATELET COUNT
Description
HEMATOLOGICAL BIOMARKER
Time Frame
UP TO 24 WEEKS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Yıldız
City
Istanbul
ZIP/Postal Code
34734
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Study data can be shared if requested by the editor.

Learn more about this trial

THE EFFECT OF LIFESTYLE ON THE PROGRESS OF COVID 19

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