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临床试验/NCT02192216
NCT02192216终止不适用

The Effect of Resistance Training and Aerobic Training on Body Composition During Chemotherapy

Department of Public Health, Denmark2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2014年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
16
试验地点
2
主要终点
Changes in body composition

研究概览

简要总结

Chemotherapy can induce muscle loss in colorectal, breast and advanced renal cell carcinoma patients. The Danish nation-wide training and rehabilitation offer 'Body & Cancer' offers intensive resistance and endurance training to all Danish cancer patients receiving chemotherapy with the aim of reducing treatment-related fatigue and physical impairments, but the potential of the training to preserve or improve muscle mass is uninvestigated.

Furthermore, the underlying biological mechanisms of treatment and/or exercise induced changes in muscle mass in cancer patients remains uninvestigated.

Thus, the primary purpose of the present study is to investigate changes in body composition during chemotherapy and after resistance and aerobic training combined with protein supplementation during ongoing chemotherapy in cancer patients. Secondly, we aim to investigate the underlying biological mechanisms of muscle mass regulation in biopsies obtained before and after a control period as well as after 10 weeks of exercise, both during chemotherapy.

We hypothesize that 10 weeks exercise will improve muscle mass and body composition in cancer patients during chemotherapy as compared to a control period during chemotherapy alone.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Currently receiving curative, adjuvant, neo-adjuvant or palliative chemotherapy
  • No documented bone metastases or myelomatosis
  • No documented CNS affection
  • WHO performance status 0-1
  • No chronical thrombocytopenia or leukopenia
  • No physical conditions preventing exercise participation
  • No serious symptoms of heart disease
  • No dementia or mental illness preventing participation
  • Signed written concent
  • Age above 18 years

排除标准

  • Participation in systematic resistance training three months prior to inclusion

研究组 & 干预措施

Exercise & Chemotherapy

Experimental

Following a control period during active chemotherapy the patients undergo ten weeks of supervised exercise comprised of resistance and aerobic training in combination with protein supplementation during ongoing chemotherapy.

干预措施: Exercise (Behavioral)

结局指标

主要结局

Changes in body composition

时间窗: Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).

Changes in lean body mass and fat mass wil be assessed using Dual Energy X-Ray Absorptiometry

次要结局

  • Changes in underlying biological mechanisms associated with changes in muscle mass(Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).)
  • Changes in aerobic performance(Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).)
  • Changes in cancer related fatigue and quality of life(Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).)
  • Changes in dynamic muscle strength(Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).)
  • Changes in functional performance(Assessment before (baseline) and after (pre-training) the control period of 7 weeks (average), where patients recieve chemotherapy, and again after completion of 10 weeks of exericse (post-training).)

研究者

发起方
Department of Public Health, Denmark
申办方类型
Other
责任方
Principal Investigator
主要研究者

Simon Lønbro

M.Sc., PhD.

Department of Public Health, Denmark

研究点 (2)

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