Home-based Exercise in COVID-19 Survivors
2022年6月10日 更新者：Bruno Gualano、University of Sao Paulo
Home-based Exercise Training in COVID-19 Survivors: a Randomized Controlled Trial
The physical inactivity promoted by the patient's hospitalization, including those infected with the coronavirus, can lead to an important health impairment, including atrophy and loss of muscle function.
Thus, a prospective study will be conducted to assess the effect of a home-based exercise training program on health outcomes and quality of life in COVID-19 survivors.
調査の概要
研究の種類
介入
入学 (予想される)
50
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Bruno Gualano, PhD
- 電話番号：8021 55112661
- メール：gualano@usp.br
研究場所
-
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Sao Paulo、ブラジル、05508-030
- 募集
- University of Sao Paulo
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
40年～75年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Patients diagnosed with COVID-19
- Positive RT-PCR test and/or serology assay to detect IgG against SARS-CoV-2 in addition to acute symptomatology compatible with the disease
- Admitted in intensive care unit
Exclusion Criteria:
- Cardiovascular disease
- Resting dyspnea
- Acute pulmonary embolism or pulmonary infarction
- Deep venous thromboembolism
- Uncontrolled visual or vestibular disorders
- Pregnancy
- Uncontrolled resting tachycardia
- Uncontrolled hypertension
- Uncontrolled Type II diabetes
- Acute infections
- Neurological disorders
- Patients with chronic kidney disease who are in need of hemodialysis
- Recent malignant neoplasm (<5 years)
- Autoimmune diseases
- Complex ventricular arrhythmias, atrial fibrillation or complete heart block
- Transplant patients
- Any physical disabilities that could hamper physical testing and exercise program
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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 |
|---|---|
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実験的：運動会
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A 16 weeks parallel-group randomised controlled trial will be performed, in which covid-19 survivors patients will complete a telemonitored home-based exercise training program, 3 times per week.
The training program will involve strength, aerobic, balance and flexibility exercises.
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介入なし：Control group
The control group will receive all regular medical care and advice on healthy lifestyle including the promotion of recommended physical activity levels.
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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 |
|---|---|---|
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Change from baseline on quality of life assessed by the SF-36 health survey questionnaire at 16 weeks.
時間枠：Baseline and 16 weeks.
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Higher score means better outcome.
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Baseline and 16 weeks.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from baseline on fatigue evaluated by the fatigue severity scale at 16 weeks.
時間枠：Baseline and 16 weeks.
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Higher score means worse outcome.
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Baseline and 16 weeks.
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Change from baseline on lipid profile at 16 weeks.
時間枠：Baseline and 16 weeks.
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Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides
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Baseline and 16 weeks.
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Change from baseline on insulin sensitivity at 16 weeks.
時間枠：Baseline and 16 weeks.
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Fasting serum concentrations of glucose and insulin.
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Baseline and 16 weeks.
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Change from baseline on inflammatory cytokine IL-1 at 16 weeks.
時間枠：Baseline and 16 weeks.
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Baseline and 16 weeks.
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Change from baseline on inflammatory cytokine IL-1ra at 16 weeks.
時間枠：Baseline and 16 weeks.
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Baseline and 16 weeks.
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Change from baseline on inflammatory cytokine IL-6 at 16 weeks.
時間枠：Baseline and 16 weeks.
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Baseline and 16 weeks.
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Change from baseline on inflammatory cytokine IL-10 at 16 weeks.
時間枠：Baseline and 16 weeks.
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Baseline and 16 weeks.
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Change from baseline on inflammatory cytokine TNF-alpha at 16 weeks.
時間枠：Baseline and 16 weeks.
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Baseline and 16 weeks.
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Change from baseline on C-reactive Protein at 16 weeks.
時間枠：Baseline and 16 weeks.
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Baseline and 16 weeks.
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Change from baseline on Creatine Kinase at 16 weeks.
時間枠：Baseline and 16 weeks.
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Baseline and 16 weeks.
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Change from baseline on cardiopulmonary fitness assessed by a maximal exercise test at 16 weeks.
時間枠：Baseline and 16 weeks.
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Baseline and 16 weeks.
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Change from baseline on lean body mass assessed by Dual-energy absorptiometry at 16 weeks.
時間枠：Baseline and 16 weeks.
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Baseline and 16 weeks.
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Change from baseline body fat assessed by Dual-energy absorptiometry at 16 weeks.
時間枠：Baseline and 16 weeks.
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Baseline and 16 weeks.
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Change from baseline on waist circumference at 16 weeks.
時間枠：Baseline and 16 weeks.
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Baseline and 16 weeks.
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Change from baseline on hip circumference at 16 weeks.
時間枠：Baseline and 16 weeks.
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Baseline and 16 weeks.
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Change from baseline on body weight at 16 weeks.
時間枠：Baseline and 16 weeks.
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Baseline and 16 weeks.
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Change from baseline on muscular strength assessed by handgrip test at 16 weeks.
時間枠：Baseline and 16 weeks.
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Baseline and 16 weeks.
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Change from baseline on muscular function assessed by Timed-Stand Test at 16 weesks.
時間枠：Baseline and 16 weeks.
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Baseline and 16 weeks.
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Change from baseline on muscular function assessed by Timed-Up and Go Test at 16 weeks.
時間枠：Baseline and 16 weeks.
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Baseline and 16 weeks.
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Change from baseline on anxiety symptoms assessed by Back Scale at 16 weeks.
時間枠：Baseline and 16 weeks.
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Higher score means worse outcome.
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Baseline and 16 weeks.
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Change from baseline on depression symptoms assessed by Back Scale at 16 weeks.
時間枠：Baseline and 16 weeks.
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Higher score means worse outcome.
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Baseline and 16 weeks.
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Change from baseline on functional status assessed by Post-COVID-19 Functional Status (PCFS) Scale at 16 weeks.
時間枠：Baseline and 16 weeks.
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Higher score means worse outcome.
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Baseline and 16 weeks.
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Change from baseline on physical activity levels evaluated by the International Physical Activity Questionnaire at 16 weeks.
時間枠：Baseline and 16 weeks.
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Baseline and 16 weeks.
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Change from baseline on resting blood pressure assessed by an automated device at 16 weeks.
時間枠：Baseline and 16 weeks.
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Baseline and 16 weeks.
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Change from baseline on fatigue assessed by Chalder scale at 16 weeks.
時間枠：Baseline and 16 weeks.
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Higher score means worse outcome.
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Baseline and 16 weeks.
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Change from baseline on heart rate variability assessed by heart rate monitor at 16 weeks.
時間枠：Baseline and 16 weeks.
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Baseline and 16 weeks.
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Change from baseline on inspiratory muscular strength assessed by power breathe at 16 weeks.
時間枠：Baseline and 16 weeks.
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Baseline and 16 weeks.
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Change from baseline on quality of life assessed by the SF-36 health survey questionnaire at one year.
時間枠：Baseline and one year.
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Higher score means better outcome.
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Baseline and one year.
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Change from baseline on fatigue evaluated by the fatigue severity scale at one year.
時間枠：Baseline and one year.
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Higher score means worse outcome.
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Baseline and one year.
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Change from baseline on fatigue assessed by Chalder scale at one year.
時間枠：Baseline and one year.
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Higher score means worse outcome.
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Baseline and one year.
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Change from baseline on functional status assessed by Post-COVID-19 Functional Status (PCFS) Scale at one year.
時間枠：Baseline and one year.
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Higher score means worse outcome.
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Baseline and one year.
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Change from baseline on muscular function assessed by Timed-Up and Go Test at one year.
時間枠：Baseline and one year.
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Baseline and one year.
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Change from baseline on muscular function assessed by Timed-Stand Test at one year.
時間枠：Baseline and one year.
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Baseline and one year.
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Change from baseline on muscular strength assessed by handgrip test at one year.
時間枠：Baseline and one year.
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Baseline and one year.
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Change from baseline on cardiopulmonary fitness assessed by a maximal exercise test at one year.
時間枠：Baseline and one year.
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Baseline and one year.
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2020年9月26日
一次修了 (予想される)
2022年9月30日
研究の完了 (予想される)
2022年9月30日
試験登録日
最初に提出
2020年10月29日
QC基準を満たした最初の提出物
2020年11月2日
最初の投稿 (実際)
2020年11月4日
学習記録の更新
投稿された最後の更新 (実際)
2022年6月15日
QC基準を満たした最後の更新が送信されました
2022年6月10日
最終確認日
2022年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 4.342.082
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
いいえ
米国FDA規制機器製品の研究
いいえ
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