- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04396353
EXercise TRAining and Sedentary Lifestyle on Clinical Outcomes in Patients With COVID-19 (WHO)
The Impact of EXercise TRAining, Physical Activity and Sedentary Lifestyle on Clinical Outcomes in Surviving Patients Infected With the Severe Acute Respiratory Syndrome Coronavirus 2: Cross-sectional Study
연구 개요
상세 설명
The new severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is responsible for the 2019 novel coronavirus (COVID-19) disease, initially discovered in the city of Wuhan, China, at the end of December 2019. In March 2020, the World Health Organization (WHO) declared SARS-CoV-2 as a worldwide pandemic. The disease quickly spread to several continents, also reaching Brazil strongly. This pandemic claimed (and still does) several victims, affecting more than 3 million confirmed cases worldwide with more than 200,000 deaths (official data: coronavirus.jhu.edu/map.html). In Brazil alone, by the time of writing this research project, 60,311 cases have been confirmed with 4,117 deaths. Epidemiological studies show that these numbers can be even higher, reaching up to eight times the number of cases.
As a new virus with such lethality and without the knowledge of its pathophysiology, WHO and the governments of each country have adopted isolation and social distance as a preventive measure to contain the spread of the virus, especially among the most vulnerable people such as the elderly, obese, diabetics and patients with cardiovascular diseases. So far, there is no effective and scientifically proven treatment for the disease, nor a vaccine for its effective control. In this sense, preventive measures such as personal hygiene, good nutrition and physical exercise seem to be the best forms of prevention. However, it is not known whether these measures can prevent contagion or whether they help the recovery of patients infected with SARS-CoV-2. It is well known that exercise training improves the response of the immune system providing protection against infections caused by intracellular microorganisms, thus being an important prevention strategy against SARS-CoV-2.
The present study aims to assess the impact of exercise training, physical activity, and sedentary lifestyle on clinical outcomes in surviving patients infected with the SARS-CoV-2 virus. Therefore, this study will evaluate cross-sectionally and through a questionnaire in Portuguese and English on the internet, whether physically active patients have better outcomes for the disease such as shorter hospital stay, lesser symptoms, lesser need for mechanical ventilation and medications.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
Sao Paulo
-
São Paulo, Sao Paulo, 브라질, 05403-900
- Marcelo Rodrigues dos Santos
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Men and women recovered and survivors of the disease
- With or without symptoms
- Patients with disease confirmation by reverse transcription-polymerase chain reaction (RT-PCR) test, blood test (serology), and a rapid antibody test
- With or without the need for hospitalization (nursery, semi-intensive and intensive unit)
- With or without the need for drug treatment
- Presence of any chronic disease such as diabetes, hypertension, coronary artery disease, obesity, metabolic syndrome, cancer, among others
- Literate patients in Portuguese and/or English.
Exclusion Criteria:
- Illiterate patients with difficulties in filling out the electronic form
- Patients still hospitalized and/or with symptoms of COVID-19
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
Physically active
Those who receive regular amounts of physical activity.
Those who participate in a minimum of 150 minutes of moderate exercise, or 75 minutes of a more vigorous regimen as recommended by the health organizations.
Additionally, a person who spend less time sitting (i.e.
watching television, surfing the web, playing video games).
|
Clinical, anthropometric, and sociodemographic variables to characterize the sample will be collected using the Google Form.
The same tool will be used to collect clinical variables (outcomes), as well as to obtain data on the level of physical activity and sedentary behavior time (predictor variables) prior to SARS-CoV-2 contamination.
For this, we will use the International Physical Activity Questionnaire (IPAQ).
|
Sedentary
Those who do not receive regular amounts of physical activity.
Where physical inactivity is considered the failure to meet the recommendations of the health organizations, stating that an individual should participate in a minimum of 150 minutes of moderate exercise, or 75 minutes of a more vigorous regimen.
Sitting about 70-85% of the time (i.e.
watching television, surfing the web, playing video games) is also considered a person living a sedentary lifestyle.
|
Clinical, anthropometric, and sociodemographic variables to characterize the sample will be collected using the Google Form.
The same tool will be used to collect clinical variables (outcomes), as well as to obtain data on the level of physical activity and sedentary behavior time (predictor variables) prior to SARS-CoV-2 contamination.
For this, we will use the International Physical Activity Questionnaire (IPAQ).
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Number of hospitalizations
기간: Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)
|
Number of hospitalizations required due to COVID-19
|
Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Percentage of symptoms of the disease
기간: Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)
|
Symptoms such as fever, cough, shortness of breathe, and muscle pain due to COVID-19
|
Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)
|
Length of hospital stay
기간: Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)
|
Length of hospital stay required due to COVID-19
|
Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)
|
Percentage of mechanical ventilation
기간: Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)
|
Need for mechanical ventilation during hospitalization due to COVID-19
|
Up to 6 months after hospital discharge and/or full recovery from the disease (asymptomatic)
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Marcelo R Santos, PhD, University of Sao Paulo Medical School
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- COVID-19
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
코로나바이러스감염증-19 : 코로나19에 대한 임상 시험
-
Yang I. Pachankis모집하지 않고 적극적으로COVID-19 호흡기 감염 | COVID-19 스트레스 증후군 | COVID-19 백신 부작용 | COVID-19 관련 혈전색전증 | COVID-19 집중 치료 후 증후군 | COVID-19 관련 뇌졸중중국
-
Endourage, LLC모병긴 COVID | 긴 Covid19 | 포스트 급성 COVID-19 | 장거리 COVID | 장거리 COVID-19 | COVID-19 후 증후군미국
-
Massachusetts General Hospital모병
-
University Hospital, Ioannina1st Division of Internal Medicine, University Hospital of Ioannina모병COVID-19 폐렴 | COVID-19 호흡기 감염 | 코로나19 감염병 세계적 유행 | COVID-19 급성호흡곤란증후군 | COVID-19 관련 폐렴 | COVID 19 관련 응고병증 | COVID-19(코로나바이러스 질병 2019) | COVID-19 관련 혈전색전증그리스
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention...완전한
-
Jonathann Kuo, MD모집하지 않고 적극적으로SARS-CoV2 감염 | 코로나19 이후 증후군 | 자율신경실조증 | 급성 COVID-19 후 증후군 | 긴 COVID | 긴 Covid19 | COVID-19 재발 | 포스트 급성 COVID-19 | 급성 COVID-19 감염 후 | COVID-19의 급성 후유증 | 자율신경실조증 유사 장애 | 자율신경실조증 기립성 저혈압 증후군 | COVID-19 이후 상태 | 포스트 코로나 증후군 | COVID-19 이후 상태, 지정되지 않음미국
-
Patrick Robinson모병코로나19 | COVID-19 폐렴 | COVID-19 호흡기 감염 | COVID-19 급성 기관지염미국
-
Janssen Vaccines & Prevention B.V.완전한
-
Daewoong Pharmaceutical Co. LTD.Novotech (Australia) Pty Limited알려지지 않은COVID-19 환자
Electronic questionnaire에 대한 임상 시험
-
University Hospital, Toulouse모병
-
AHS Cancer Control AlbertaTom Baker Cancer Centre모병
-
Cambridge University Hospitals NHS Foundation TrustUniversity of Cambridge알려지지 않은근골격계 질환 | 근골격계 부상
-
Assistance Publique - Hôpitaux de Paris완전한
-
NYU Langone HealthNational Heart, Lung, and Blood Institute (NHLBI)모집하지 않고 적극적으로
-
Medical University of Lublin완전한