Physical Activity Intervention Trial to Mitigate Muscle Loss and Increase Muscle Strength
2020年12月10日 更新者：Karolinska Institutet
Physical Activity Intervention Trial to Mitigate Muscle Loss and Increase Muscle Strength in Esophageal Cancer Survivors
This intervention study will be conducted on patients included in a nationwide and prospective cohort, The Oesophageal Surgery in Cancer patients: Adaptation and Recovery study (OSCAR). The OSCAR includes patients operated on for oesophageal cancer in Sweden between 2013-2018, identified through pathology departments and included in the cohort 1 year after surgery. A comprehensive interview is conducted by a research nurse during a home visit using patient reported outcomes on several HRQOL, psychosocial, emotional and nutritional aspects. Regular follow-ups are carried out at 1½, 2, 2½, 3, 4 and 5 years postoperatively.
All patients within OSCAR are invited to the intervention trial. Half of the eligible patients will be randomised to intervention and half to standard care (control group) by means of block randomisation method. The intervention group will be encouraged to adhere to a physical activity regimen of 150 minutes of weekly minimum intensity activities and 5 simple strength training exercises twice a week as instructed by the research nurse. The control group will follow their routine daily physical activity. HRQOL measures, height and weight, body composition, muscle strength, functional mobility and strength, and dietary intake are assessed before and after the intervention. Compliance will be ensured by means of a daily physical activity dairy and a weekly follow up on telephone with all patients.
調査の概要
研究の種類
介入
入学 (実際)
162
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。
研究場所
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Stockholm、スウェーデン
- Surgical cares sciences, Karolinksa Institutet
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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
18年歳以上 (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:
- All patients from the nationwide prospective cohort the Oesophageal Surgery in Cancer patients: Adaptation and Recovery study (OSCAR) with willingness to participate
Exclusion Criteria:
- Current malignancies or co-morbidities, psychological or social conditions that prevent participation
- Patients with pacemakers; cochlear or other electrical implants cannot be screened using the bio-impedance scale for safety reasons
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：なし（オープンラベル）
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：Physical activity intervention group
The physical activity program includes 150 minutes of minimum intensity activity during a week (e.g.
walking, swimming) and five strength training exercises (10 repetitions and 2 sets of: squats, wall push ups, rowing with resistance band, shoulder press with resistance band, hip abduction) targeting the major muscle groups to do twice a week are demonstrated by the research nurse.
The resistance training is progressive by increasing resistance in the band based on patient's adaptability during the intervention.
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150 minutes of minimum intensity activity during a week (e.g.
walking, swimming) and five strength training exercises (10 repetitions and 2 sets of: squats, wall push ups, rowing with resistance band, shoulder press with resistance band, hip abduction) targeting the major muscle groups to do twice a week.
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介入なし：Standard care control group
Patients follow their routine daily physical activity.
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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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Number of participants with treatment related increase in muscle mass as assessed by a bio-impedance body composition scale.
時間枠：At baseline and after the 12 weeks intervention/control programme.
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The main outcome measure will be increase in skeletal muscle mass using a bio-impedance analysis portable monitor.
Changes occurring during the period just before and just after the 12-weeks intervention programme, or standard of care in the comparison group, will be compared between the intervention group.
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At baseline and after the 12 weeks intervention/control programme.
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Number of participants with treatment related increase in muscle strength as assessed by a hand grip dynamometer and chair stand test.
時間枠：At baseline and after the 12 weeks intervention/control programme.
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The main outcome measure will be increase in skeletal muscle strength using a handgrip dynamometer and 30 second sit stand test.
Changes occurring during the period just before and just after the 12-weeks intervention programme, or standard of care in the comparison group, will be compared between the intervention group.
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At baseline and after the 12 weeks intervention/control programme.
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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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Number of participants with improvement in physical function scale of health related quality of life as assessed from the questionnaire - European Organization for Research and Treatment of Cancer (EORTC); Quality of Life Questionnaire (QLQ) - C30.
時間枠：At baseline and after the12 weeks intervention/control programme.
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This secondary outcome will assess the physical function scale of HRQOL using EORTC QLQ-C30 questionnaires before and after the intervention.
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At baseline and after the12 weeks intervention/control programme.
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Number of participants with improvement in fatigue scale of health related quality of life as assessed from the questionnaire - EORTC QLQ-FA13.
時間枠：At baseline and after the12 weeks intervention/control programme.
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This secondary outcome will assess the fatigue scale of HRQOL using EORTC fatigue questionnaire QLQ-FA13 before and after the intervention.
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At baseline and after the12 weeks intervention/control programme.
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Number of participants with improvement in appetite loss function of health related quality of life as assessed from the oesophageal disease specific module - EORTC QLQ-OG25.
時間枠：At baseline and after the12 weeks intervention/control programme.
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This secondary outcome will assess the appetite loss function of HRQOL using EORTC QLQ-OG25 questionnaire before and after the intervention.
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At baseline and after the12 weeks intervention/control programme.
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Number of participants with improvement in eating difficulties scale of health related quality of life as assessed from the cachexia module of EORTC - QLQ-CAX24.
時間枠：At baseline and after the12 weeks intervention/control programme.
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This secondary outcome will assess the eating difficulties scale of HRQOL using EORTC QLQ-CAX24 questionnaire before and after the intervention.
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At baseline and after the12 weeks intervention/control programme.
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Number of participants with improvement in psycho social issues as assessed from the questionnaire - Hospital Anxiety and Depression Scale (HADS).
時間枠：At baseline and after the12 weeks intervention/control programme.
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This secondary outcome will assess the psychosocial issues using HADS questionnaire before and after the intervention.
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At baseline and after the12 weeks intervention/control programme.
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Number of participants with improvement in physical activity level measured using the international physical activity questionnaire (IPAQ).
時間枠：At baseline and after the 12 weeks intervention/control programme.
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This secondary outcome shall include changes in the total physical activity level measured using the international physical activity questionnaire (IPAQ) before and after the intervention.
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At baseline and after the 12 weeks intervention/control programme.
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Number of participants with improvement in dietary intake measured using 3 day food diary.
時間枠：Just before (baseline) and just after (final follow up) the 12 weeks intervention programme.
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This secondary outcome shall include changes in dietary intake measured using food dairy measured thrice a week: two weekdays and 1 weekend day before and after the intervention.
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Just before (baseline) and just after (final follow up) the 12 weeks intervention programme.
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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
捜査官
- 主任研究者：Pernilla Lagergren, Professor、Karolinska Institutet
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)
2016年1月1日
一次修了 (実際)
2020年6月1日
研究の完了 (実際)
2020年6月1日
試験登録日
最初に提出
2016年4月28日
QC基準を満たした最初の提出物
2016年5月16日
最初の投稿 (見積もり)
2016年5月17日
学習記録の更新
投稿された最後の更新 (実際)
2020年12月14日
QC基準を満たした最後の更新が送信されました
2020年12月10日
最終確認日
2020年12月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
食道がんの臨床試験
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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); Highlight Therapeutics積極的、募集していない平滑筋肉腫 | 悪性末梢神経鞘腫瘍 | 滑膜肉腫 | 未分化多形肉腫 | 骨の未分化高悪性度多形肉腫 | 粘液線維肉腫 | II期の体幹および四肢の軟部肉腫 AJCC v8 | III期の体幹および四肢の軟部肉腫 AJCC v8 | IIIA 期の体幹および四肢の軟部肉腫 AJCC v8 | IIIB 期の体幹および四肢の軟部肉腫 AJCC v8 | 切除可能な軟部肉腫 | 多形性横紋筋肉腫 | 切除可能な脱分化型脂肪肉腫 | 切除可能な未分化多形肉腫 | 軟部組織線維肉腫 | 紡錘細胞肉腫 | ステージ I 後腹膜肉腫 AJCC (American Joint Committee on Cancer) v8 | 体幹および四肢の I 期軟部肉腫 AJCC v8 | ステージ... およびその他の条件アメリカ
Physical activity intervention groupの臨床試験
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University of OttawaThe Ottawa Hospital; Queen's University; Consortium of Multiple Sclerosis Centers完了
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Centre Hospitalier Universitaire de Besancon募集