Health Effects of Soccer Training in Men With Prostate Cancer Receiving Androgen Deprivation Therapy
2014년 4월 16일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
57
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Copenhagen, 덴마크, 2100
- University of Copenhagen, Centre of Integrated Rehabilitation of Cancer Patients
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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
남성
설명
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)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: 대조군
평소 케어
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활성 비교기: 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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Baseline to post intervention (12 weeks) and follow-up (32 weeks) change in Body Composition.
기간: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Changes in body composition assessed by Dual-energy X-ray absorptiometry(DXA)scan
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Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Bone Mineral Density
기간: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Cardiorespiratory fitness (Vo2 peak)
기간: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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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).
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Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Patient reported outcomes
기간: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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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)
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Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Heart function
기간: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Changes in Heart function measured by Echocardiography from baseline to post-intervention (12 weeks) and follow-up (32 weeks)
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Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Glucose tolerance
기간: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Oral Glucose Tolerance Test
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Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Postural Balance
기간: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Assessed standing on a force platform with feet in bilateral, unilateral and tandem position.
Additionally assessed with a modified Flamingo balance test.
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Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Physical function
기간: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Physical function will be assessed with sit to stand test (30s), stair climbing test and Counter Movement Jump (jump height)
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Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Hip to waist ratio
기간: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Hip and waist circumference will be measured and the hip to waist ratio will be calculated
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Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Muscle Strength
기간: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Muscle strength will be assessed with the 1Repetition Maximum test for knee extensors
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Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Blood markers
기간: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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Markers of inflammation and bone metabolism will be obtained after overnight fasting
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Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Mikael Rørth, Professor, University of Copenhagen
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
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
2012년 3월 1일
기본 완료 (실제)
2013년 12월 1일
연구 완료 (실제)
2013년 12월 1일
연구 등록 날짜
최초 제출
2012년 10월 17일
QC 기준을 충족하는 최초 제출
2012년 10월 18일
처음 게시됨 (추정)
2012년 10월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 4월 21일
QC 기준을 충족하는 마지막 업데이트 제출
2014년 4월 16일
마지막으로 확인됨
2014년 4월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- CIRE-04
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. .
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