Health Effects of Soccer Training in Men With Prostate Cancer Receiving Androgen Deprivation Therapy
2014年4月16日 更新者：Jacob Uth、University of Copenhagen
A Randomized Controlled Clinical Trial on the Effects of Recreational Soccer Training in Men With Prostate Cancer Receiving Androgen Deprivation Therapy: The FC Prostate Study
Androgen Deprivation Therapy (ADT) is standard treatment for locally advanced or advanced Prostate Cancer (PC).
The musculoskeletal toxicity associated with ADT is well established, leading to a decrease in muscle mass, increased fat percentage, weight gain, sexual dysfunction and increased risk of depression, fatigue, diabetes, cardiovascular disease and reduced quality of life.
Numerous studies have shown an association between physical activity, physical capacity and quality of life in cancer patients and recent epidemiological research suggest that regular, moderate-intensity physical activity may have a positive effect on survival in men with prostate cancer.
Within exercise physiology there is new evidence pointing to recreational soccer as a unique form of intermittent exercise that effectively stimulates aerobic and anaerobic energy delivery systems, leading to beneficial musculoskeletal, metabolic and cardiovascular adaptations of importance for health.
It is our overall hypothesis that 12 weeks of recreational soccer training 2-3 times per week will improve the health profile of PC patients receiving ADT treatment.
調査の概要
研究の種類
介入
入学 (実際)
57
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
-
-
-
Copenhagen、デンマーク、2100
- University of Copenhagen, Centre of Integrated Rehabilitation of Cancer Patients
-
-
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～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
男
説明
Inclusion Criteria:
- Patients with locally advanced or advanced prostate cancer being treated with androgen deprivation therapy (S-testosterone < 1.7) for at least 6 months at the time of inclusion
Exclusion Criteria:
- WHO performance level above 1,symptomatic cardiovascular disorders, osteoporosis (T-score below -2.5)
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：支持療法
- 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 |
|---|---|
|
介入なし：対照群
普段のお手入れ
|
|
|
アクティブコンパレータ：Soccer Training
12 weeks of soccer training.
(2 times per week for the first 8 weeks and 3 times per week in the last 4 weeks.
Training will consist of 15 minutes warm-up and 2 x 15 minutes matches for the first 4 weeks and of 15 minutes warm-up and 3 x 15 minutes matches for the last 8 weeks).
After 12 weeks assessments participants in the intervention group will continue bi-weekly supervised training for additional 20 weeks at the end of which tests will be repeated.
|
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 |
|---|---|---|
|
Baseline to post intervention (12 weeks) and follow-up (32 weeks) change in Body Composition.
時間枠：Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
|
Changes in body composition assessed by Dual-energy X-ray absorptiometry(DXA)scan
|
Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Bone Mineral Density
時間枠：Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
|
Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
|
|
|
Cardiorespiratory fitness (Vo2 peak)
時間枠：Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
|
Change in maximal oxygen consumption (Vo2 peak) assessed directly during an incremental test on a cycle ergometer from baseline to post-intervention (12 weeks) and follow-up (32 weeks).
|
Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
|
|
Patient reported outcomes
時間枠：Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
|
Changes in Psychological distress (Hospital Anxiety and Depression Scale, HADS), Quality of Life (EORTC QLQ C-30), general well-being (SF-36), disease specific symptoms and side-effects (EORTC PR-25)from baseline to post-intervention (12 weeks) and follow-up (32 weeks)
|
Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
|
|
Heart function
時間枠：Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
|
Changes in Heart function measured by Echocardiography from baseline to post-intervention (12 weeks) and follow-up (32 weeks)
|
Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
|
|
Glucose tolerance
時間枠：Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
|
Oral Glucose Tolerance Test
|
Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
|
|
Postural Balance
時間枠：Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
|
Assessed standing on a force platform with feet in bilateral, unilateral and tandem position.
Additionally assessed with a modified Flamingo balance test.
|
Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
|
|
Physical function
時間枠：Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
|
Physical function will be assessed with sit to stand test (30s), stair climbing test and Counter Movement Jump (jump height)
|
Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
|
|
Hip to waist ratio
時間枠：Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
|
Hip and waist circumference will be measured and the hip to waist ratio will be calculated
|
Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
|
|
Muscle Strength
時間枠：Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
|
Muscle strength will be assessed with the 1Repetition Maximum test for knee extensors
|
Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
|
|
Blood markers
時間枠：Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
|
Markers of inflammation and bone metabolism will be obtained after overnight fasting
|
Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
|
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：Mikael Rørth, Professor、University of Copenhagen
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Uth J, Hornstrup T, Christensen JF, Christensen KB, Jorgensen NR, Helge EW, Schmidt JF, Brasso K, Helge JW, Jakobsen MD, Andersen LL, Rorth M, Midtgaard J, Krustrup P. Football training in men with prostate cancer undergoing androgen deprivation therapy: activity profile and short-term skeletal and postural balance adaptations. Eur J Appl Physiol. 2016 Mar;116(3):471-80. doi: 10.1007/s00421-015-3301-y. Epub 2015 Nov 30.
- Uth J, Hornstrup T, Christensen JF, Christensen KB, Jorgensen NR, Schmidt JF, Brasso K, Jakobsen MD, Sundstrup E, Andersen LL, Rorth M, Midtgaard J, Krustrup P, Helge EW. Efficacy of recreational football on bone health, body composition, and physical functioning in men with prostate cancer undergoing androgen deprivation therapy: 32-week follow-up of the FC prostate randomised controlled trial. Osteoporos Int. 2016 Apr;27(4):1507-1518. doi: 10.1007/s00198-015-3399-0. Epub 2015 Nov 16.
- Bruun DM, Krustrup P, Hornstrup T, Uth J, Brasso K, Rorth M, Christensen JF, Midtgaard J. "All boys and men can play football": a qualitative investigation of recreational football in prostate cancer patients. Scand J Med Sci Sports. 2014 Aug;24 Suppl 1:113-21. doi: 10.1111/sms.12193.
- Uth J, Hornstrup T, Schmidt JF, Christensen JF, Frandsen C, Christensen KB, Helge EW, Brasso K, Rorth M, Midtgaard J, Krustrup P. Football training improves lean body mass in men with prostate cancer undergoing androgen deprivation therapy. Scand J Med Sci Sports. 2014 Aug;24 Suppl 1:105-12. doi: 10.1111/sms.12260.
- Krustrup P, Hansen PR, Nielsen CM, Larsen MN, Randers MB, Manniche V, Hansen L, Dvorak J, Bangsbo J. Structural and functional cardiac adaptations to a 10-week school-based football intervention for 9-10-year-old children. Scand J Med Sci Sports. 2014 Aug;24 Suppl 1:4-9. doi: 10.1111/sms.12277.
- Uth J, Schmidt JF, Christensen JF, Hornstrup T, Andersen LJ, Hansen PR, Christensen KB, Andersen LL, Helge EW, Brasso K, Rorth M, Krustrup P, Midtgaard J. Effects of recreational soccer in men with prostate cancer undergoing androgen deprivation therapy: study protocol for the 'FC Prostate' randomized controlled trial. BMC Cancer. 2013 Dec 13;13:595. doi: 10.1186/1471-2407-13-595.
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
2012年3月1日
一次修了 (実際)
2013年12月1日
研究の完了 (実際)
2013年12月1日
試験登録日
最初に提出
2012年10月17日
QC基準を満たした最初の提出物
2012年10月18日
最初の投稿 (見積もり)
2012年10月22日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年4月21日
QC基準を満たした最後の更新が送信されました
2014年4月16日
最終確認日
2014年4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。
Soccer trainingの臨床試験
-
University of MinnesotaNational Institute of Mental Health (NIMH)完了精神病性障害 | 統合失調症 | 統合失調症スペクトラムおよびその他の精神病性障害 | 統合失調感情障害 | 精神病 | 統合失調感情障害 | 統合失調症性障害 | 精神病、感情的 | 精神性気分障害 | 精神病患者番号/その他アメリカ
-
VA Office of Research and Development募集
-
University of WashingtonNational Institute on Aging (NIA); Kaiser Permanente完了