Covid 後の線維症患者における肺の遠隔リハビリテーションと身体活動の推奨事項の比較
COVID-19による肺線維症患者における肺遠隔リハビリテーションと身体活動の推奨の有効性の比較
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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Istanbul、トルコ(Türkiye)
- Istanbul University-Cerrahpasa
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的: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 |
|
アクティブコンパレータ: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 |
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Submaximal exercise capacity
時間枠:1 week-8 week
|
Six minute walk test and |
1 week-8 week
|
|
maximal exercise capacity
時間枠:1 week-8 week
|
Incremental shuttle walk test |
1 week-8 week
|
|
endurance exercise capacity
時間枠:1 week-8 week
|
endurance shuttle walk test |
1 week-8 week
|
|
Peripheral muscle strength
時間枠:1 week-8 week
|
Hand-held dynamometer |
1 week-8 week
|
|
Functional exercise capacity
時間枠:1 week-8 week
|
1 min sit to stand test |
1 week-8 week
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Physical activity
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠:1 week-8 week
|
Bioelectrical impedence analysis |
1 week-8 week
|
|
Activities of daily living
時間枠: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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pulmonary Telerehabilitation Feasibility
時間枠: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
時間枠:8 week
|
Adherence and drop-out rate |
8 week
|
|
Pulmonary Telerehabilitation Feasibility
時間枠:8 week
|
System usability: The usability of the telerehabilitation system was assessed using the "System Usability Scale (SUS)". |
8 week
|
|
Pulmonary Telerehabilitation Feasibility
時間枠:8 week
|
Safety |
8 week
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 2022/25
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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