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포스트 Covid 섬유증 환자의 폐 원격 재활 및 신체 활동 권장 사항 비교

2026년 9월 29일 업데이트: Ozge Ertan, Istanbul University - Cerrahpasa

COVID-19로 인한 폐 섬유증 환자에서 폐 원격 재활 및 신체 활동 권장의 효과 비교

Rehabilitation plays a very important role in the management of patients with COVID-19, focusing on respiratory and motor functions, and therefore the importance of establishing treatment strategies to ensure optimal recovery of these patients has been emphasized. It has been stated that physical activity recommendations should be clarified for the management of symptoms associated with prolonged COVID-19 Syndrome and for the continuation of activities of daily living. It has been stated that after COVID-19 pneumonia, it is necessary to evaluate the physical functions of patients with long-term follow-up and to establish rehabilitation programs. The importance of being included in the rehabilitation program was emphasized, especially for patients with lung fibrosis.

The primary aim of this study was to compare the effects of pulmonary telerehabilitation and physical activity recommendations on exercise capacity and peripheral muscle strength in patients with pulmonary fibrosis due to COVID-19.

The secondary aim of this study is to compare the effects of pulmonary telerehabilitation and physical activity recommendations on symptoms, activity and participation in patients with pulmonary fibrosis due to COVID-19.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

30

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • >18 years old
  • Patients who have been infected with the COVID-19 virus at least 12 months ago and have been diagnosed with a positive PCR
  • Patients with post-COVID-19 pulmonary fibrosis followed by a pulmonologist
  • Patients who have sufficient technological infrastructure to participate in the telerehabilitation program and can adapt to online systems
  • Patients who are clinically stable

Exclusion Criteria:

  • Patients with orthopedic/neurological problems that prevent walking and exercise
  • Patients with uncontrolled cardiovascular disease
  • Patients with uncontrolled medical conditions

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Pulmonary Rehabilitation Group

A total of 24 sessions of breathing exercises and high-repetitive muscle endurance and strengthening exercises will be applied to the pulmonary telerehabilitation group for 8 weeks, two days a week and one day a week unsupervised, via online systems. High-repetition muscle endurance and strengthening exercises will be applied to large muscle groups of the lower and upper extremities by creating resistance with body weight and theraband.

High repetition muscle endurance and strengthening exercises Walking

활성 비교기: Physical Activity Group

Respiratory exercises and physical activity recommendations will be given to the physical activity group. Physical activity recommendations are; It will include information about the importance of physical activity and walking 3-5 days a week for at least 30 minutes of moderate intensity (4-6 on the Modified Borg scale of perceived exertion level).

High repetition muscle endurance and strengthening exercises Walking

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Submaximal exercise capacity
기간: 1 week-8 week

Six minute walk test and

1 week-8 week
maximal exercise capacity
기간: 1 week-8 week

Incremental shuttle walk test

1 week-8 week
endurance exercise capacity
기간: 1 week-8 week

endurance shuttle walk test

1 week-8 week
Peripheral muscle strength
기간: 1 week-8 week

Hand-held dynamometer

1 week-8 week
Functional exercise capacity
기간: 1 week-8 week

1 min sit to stand test

1 week-8 week

2차 결과 측정

결과 측정
측정값 설명
기간
Physical activity
기간: 1 week-8 week also Participants will monitor their weekly step counts during the study

Pedometer

1 week-8 week also Participants will monitor their weekly step counts during the study
Physical activity
기간: 1 week-8 week

Physical activity will be assessed using a SenseWear Armband (BodyMedia Inc., Pittsburgh, PA, USA), worn for at least 72 hours.

1 week-8 week
Dyspnea
기간: 1 week-8 week

Modified Medical Research Council Dyspnea Scale stratifies severity of dyspnea in respiratory diseases. The mMRC scale is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4: 0, no breathlessness except on strenuous exercise; 1, shortness of breath when hurrying on the level or walking up a slight hill; 2, walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level; 3, stops for breath after walking ∼100 m or after few minutes on the level; and 4, too breathless to leave the house, or breathless when dressing or undressing

1 week-8 week
Fatigue
기간: 1 week-8 week

The Fatigue Severity Scale (FSS) is a method of evaluating the impact of fatigue on patients. The FSS is a short questionnaire that requires to rate your level of fatigue. The FSS questionnaire contains nine statements that rate the severity of fatigue symptoms. Patients read each statement and circle a number from 1 to 7, based on how accurately it reflects their condition during the past week and how much they agree or disagree that the statement applies to patients. A low value (e.g., 1) indicates strong disagreement with the statement, whereas a high value (e.g., 7) indicates strong agreement. Total score between 9-63. A total score of less than 36 suggests that you may not be suffering from fatigue.

1 week-8 week
Functionality
기간: 1 week-8 week

Post covid-19 functionality scale (PCFS): The PCFS scale stratifies functional status limitation as follows: grade 0 (No functional limitations), grade 1 (Negligible functional limitations), grade 2 (Slight functional limitations), grade 3 (Moderate functional limitations), grade 4 (Severe functional limitations), and grade 5 (death)

1 week-8 week
Emotional status
기간: 1 week-8 week

Hospital anxiety and depression scale is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21).

1 week-8 week
Body composition
기간: 1 week-8 week

Bioelectrical impedence analysis

1 week-8 week
Activities of daily living
기간: 1 week-8 week

London chest activity of daily living scale: Perceived dyspnea while performing daily living activities is scored between 0-5. A high score indicates greater disability in performing ADLs. The minimum score 0 and maximum total score is 75.

1 week-8 week

기타 결과 측정

결과 측정
측정값 설명
기간
Pulmonary Telerehabilitation Feasibility
기간: 8 week

Changes in clinical status will be assessed using the 'Global Change Scale' in order to determine the programme's effect on clinical status.

8 week
Pulmonary Telerehabilitation Feasibility
기간: 8 week

Adherence and drop-out rate

8 week
Pulmonary Telerehabilitation Feasibility
기간: 8 week

System usability: The usability of the telerehabilitation system was assessed using the "System Usability Scale (SUS)".

8 week
Pulmonary Telerehabilitation Feasibility
기간: 8 week

Safety

8 week

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

협력자

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2022년 9월 4일

기본 완료 (실제)

2025년 3월 7일

연구 완료 (실제)

2025년 3월 7일

연구 등록 날짜

최초 제출

2022년 3월 25일

QC 기준을 충족하는 최초 제출

2022년 3월 28일

처음 게시됨 (실제)

2022년 3월 29일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 29일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 2022/25

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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. .