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临床试验/NCT01977066
NCT01977066已完成不适用

SUPPORT - Study Supervised Progressive Resistance Training for Pancreatic Cancer Patients: a Randomized Controlled Intervention Trial

German Cancer Research Center1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2013年11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
已完成
入组人数
65
试验地点
1
主要终点
Physical functioning score, as assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) EORTC QLQ-C30

研究概览

简要总结

The purpose of this study is to compare the effects of two specific exercise interventions and one standard care control arm on physical functioning.The investigators expect that supervised training is most beneficial to the patients. However, they also expect some benefit for patients in the home-based training.

详细描述

The randomized-controlled balanced-parallel-group trial included 65 adult pancreatic cancer patients (stage I-IV) from the University Surgery Clinic in Heidelberg. The study compared two specific exercise interventions and one standard care control arm. The intervention programs were (1) a 6-month supervised moderate-to-high-intensity, progressive resistance training, and (2) a 6-month home-based exercise training. Thus, the two interventions differed primarily by the intensity and mode-of-administration of the intervention. Both interventions started at the earliest 8 weeks after surgery to allow for wound healing until Maximum 12 months after the surgery. The supervised progressive training started with only moderate-intensity training during the first 4 weeks. Only patients without comorbidities that preclude participation in the intervention arms (e.g. severe pain, heart insufficiency, reduced standing or walking ability) were eligible.

The primary objective is to compare the effects of the different interventions on physical functioning, measured as change from baseline to 6 months. Additional endpoints are overall quality of life, fatigue, endurance, and strength performance, adherence to the interventions, discontinuation of adjuvant therapy, body weight and composition, disease progression, overall and progression-free survival. All outcomes has been assessed every 3 months for a minimum follow-up period of 12 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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
否

入选标准

  • •Pancreatic cancer patients (stage I-IV)
  • •Patients ≥ 18 years of age
  • •Resection performed at the University Clinic of Heidelberg
  • •Sufficient German language skills
  • •Signed informed consent

排除标准

  • •Presence of comorbidities that preclude participation in the intervention arms (e.g. severe pain, heart insufficiency, reduced standing or walking ability)

研究组 & 干预措施

Six months supervised exercise training

Experimental

干预措施: Six months supervised resistance training (Behavioral)

Six months home-based exercise training

Experimental

干预措施: Six months home-based exercise training (Behavioral)

Control group

No Intervention

结局指标

主要结局

Physical functioning score, as assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) EORTC QLQ-C30

时间窗: Change from baseline to end of intervention (after 6 months)

次要结局

  • Overall quality of life from EORTC QLQ-C30 and the specific module for pancreatic cancer(QLQ-PAN26)(change from Baseline to end of intervention (6 months))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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