- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04982042
Post COVID-19 Pulmonary Rehabilitation Program (COVID19REHAB)
Outpatient and Home Pulmonary Rehabilitation Program for Post COVID-19 Patients
Coronavirus-2019 disease (COVID-19) is a highly infectious respiratory disease that causes respiratory, physical and psychological dysfunction in patients.
With the increased understanding of the severity of COVID-19 and clinical evidence in accordance with the opinions of first-line clinical experts involved in the treatment of this epidemic, the investigators believe that the participation of patients with sequelae of COVID-19 in a Pulmonary Rehabilitation Program would be of utmost importance.
According to recent scientific recommendations for patients with sequelae of COVID-19, respiratory rehabilitation would alleviate symptoms of dyspnea, anxiety and depression and, eventually, improve physical functions and quality of life.
Therefore, it is essential to anticipate early rehabilitation after the acute phase of ARDS, in order to limit the severity of the effects of the ICU and promote rapid functional recovery. Physiotherapy will play a role in providing exercise, mobilization and rehabilitation interventions for survivors of critical illnesses associated with COVID-19, in order to enable a functional social return.
연구 개요
상태
개입 / 치료
상세 설명
The investigatores propose a clinical, prospective and consecutive study composed of participants with pulmonary sequelae of COVID-19 and pulmonary diseases such as COPD, Asthma, Bronchitis, Emphysema, Bronchiectasis and pulmonary fibrosis. Initially, all patients will undergo a physical assessment, pulmonary function tests and nutritional assessment, in addition to applying the modified dyspnea scale of the MMRC (Modified Medical Research Council) and the 6-minute walk test (6MWT), according to the standards recommended by the American Thoracic Society (ATS).
The proposed Outpatient and Home Pulmonary Rehabilitation Program is based on the Guidelines recommended by the Brazilian Society of Pulmonology (SBPT) and by the Global Initiative for Chronic Obstructive Lung Disease (GOLD), with a minimum duration of 12 weeks, frequency of 3 weekly sessions, accompanied by health professionals in this field.
Patients who seek care at municipal and state health services in the city of Anápolis, (Goiás) will be recruited. Patients with clinically stabilized COVID - 19 sequelae will be considered eligible, and who agree to participate in the study, signing the Informed Consent .
The outpatient PRP consisted of a combination of aerobic and strengthening exercises, lasting 12 weeks, frequency 3 times a week. Each session will consist of active warm-up exercises, upper and lower limb strengthening, aerobic conditioning and stretching exercises. The warm-up phase consists of intercalated calisthenic exercises for different muscle groups, according to each patient's tolerance.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Luis LV Oliveira, PhD
- 전화번호: 0055 62 999052309
- 이메일: oliveira.lvf@gmail.com
연구 연락처 백업
- 이름: Luis VF Oliveira, PhD
- 전화번호: 0055 62 999052309
- 이메일: luis.oliveira@unievangelica.edu.br
연구 장소
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GO
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Anápolis, GO, 브라질, 75083-515
- 모병
- Centro Universitário de Anápolis - UniEVANGÉLICA
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연락하다:
- Luis VF Oliveira, PhD
- 전화번호: 6717 +55 62 33106600
- 이메일: oliveira.lvf@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients with a diagnosis of pulmonary sequelae post COVID-19
- Patients clinically stabilized
- Who agreed to participate in the clinical study, signing the informed consent form, will be considered eligible.
Exclusion Criteria:
- Hospitalized patients
- Patients who present clinical instability
- Patients who do not commit to adhering to the Pulmonary Rehabilitation Program
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Post COVID-19 Outpatient Pulmonary Rehabilitation Program
The outpatient Pulmonary Rehabilitation Program will be carried out at the Pulmonary Rehabilitation Laboratory, consisting of a combination of aerobic and strengthening exercises, lasting 12 weeks, with a frequency of 3 times a week, always in the morning.
Each session consists of active warm-up exercises, upper and lower limb strengthening, aerobic conditioning and stretching exercises.
The warm-up phase consists of intercalated calisthenic exercises for different muscle groups, according to each patient's tolerance.
|
The Pulmonary Rehabilitation Program consists of a combination of aerobic and strengthening exercises, lasting 12 weeks, with a frequency of 3 times a week, always in the morning.
Each session consists of active warm-up exercises, upper and lower limb strengthening, aerobic conditioning and stretching exercises.
The warm-up phase consists of intercalated calisthenic exercises for different muscle groups, according to each patient's tolerance.
|
|
활성 비교기: Post COVID-19 Home Pulmonary Rehabilitation Program
The Home Pulmonary Rehabilitation Program will be carried out at the patients' homes, consisting of the same combination of aerobic and strengthening exercises, lasting 12 weeks, 3 times a week, always in the morning.
Each session consists of active warm-up exercises, upper and lower limb strengthening, aerobic conditioning and stretching exercises.
The warm-up phase consists of intercalated calisthenic exercises for different muscle groups, according to each patient's tolerance.
Patients will be monitored weekly via whatsapp.
|
The Pulmonary Rehabilitation Program consists of a combination of aerobic and strengthening exercises, lasting 12 weeks, with a frequency of 3 times a week, always in the morning.
Each session consists of active warm-up exercises, upper and lower limb strengthening, aerobic conditioning and stretching exercises.
The warm-up phase consists of intercalated calisthenic exercises for different muscle groups, according to each patient's tolerance.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Functional status after Pulmonary Rehabilitation Program (COVID-19REHAB)
기간: 12 weeks
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Effects of an Ambulatory and Home Pulmonary Rehabilitation Program on levels of functional status assessed with the Medical Research Council (MRC) Scale in patients with pulmonary sequelae resulting from COVID-19.
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12 weeks
|
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Exercise capacity after Pulmonary Rehabilitation Program (COVID-19REHAB)
기간: 12 weeks
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Effects of an Ambulatory and Home Pulmonary Rehabilitation Program on exercise capacity assessed with the six minutes Walk Test ( 6MWT) in patients with pulmonary sequelae resulting from COVID-19.
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12 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Forced Vital Capacity after Pulmonary Rehabilitation Program (COVID-19REHAB)
기간: 12 weeks
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Effects of an Ambulatory and Home Pulmonary Rehabilitation Program on the forced vital capacity (FVC) measured by spirometry in patients with pulmonary sequelae resulting from COVID-19.
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12 weeks
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Forced Expiratory Volume in first second after Pulmonary Rehabilitation Program (COVID-19REHAB)
기간: 12 weeks
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Effects of an Ambulatory and Home Pulmonary Rehabilitation Program on the forced expiratory volume in first second (FEV1) measured by spirometry in patients with pulmonary sequelae resulting from COVID-19.
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12 weeks
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Inspiratory muscle strength after Pulmonary Rehabilitation Program (COVID-19REHAB)
기간: 12 weeks
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Effects of an Ambulatory and Home Pulmonary Rehabilitation Program on the inspiratory muscles strength measured by vacuometry in patients with pulmonary sequelae resulting from COVID-19.
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12 weeks
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Peripheral muscle strength after Pulmonary Rehabilitation Program (COVID-19REHAB)
기간: 12 weeks
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Effects of an Ambulatory and Home Pulmonary Rehabilitation Program on the peripheral muscle strength measured by Hand Grip Dynamometer in patients with pulmonary sequelae resulting from COVID-19.
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12 weeks
|
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Levels of anxiety and depression after Pulmonary Rehabilitation Program (COVID-19REHAB)
기간: 12 weeks
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Effects of an Ambulatory and Home Pulmonary Rehabilitation Program on the Anxiety and depression levels measured by the Hospital Anxiety and Depression scale in patients with pulmonary sequelae resulting from COVID-19.
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12 weeks
|
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Quality of Life after Pulmonary Rehabilitation Program (COVID-19REHAB)
기간: 12 weeks
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Effects of an Ambulatory and Home Pulmonary Rehabilitation Program on the Quality of Life levels measured by Medical Outcomes Study/SF-36 Questionnaire in patients with pulmonary sequelae resulting from COVID-19.
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12 weeks
|
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Health costs after COVID - 19.
기간: 36 weeks
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Effects of an Ambulatory and Home Pulmonary Rehabilitation Program on healthcare costs verified through the financial expenses of patients with pulmonary sequelae resulting from COVID-19.
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36 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Luis VF OLiveira, PhD, Evangelical University of Goiás - UNIEVANGELICA
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
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 PULMONARY REHAB
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
- ICF
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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