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临床试验/NCT03524755
NCT03524755已完成不适用

Effects of a Progressive Resistance Training in Cachectic Cancer Patients During Radiotherapy - a Randomized Controlled Pilot Trial

Ludwig-Maximilians - University of Munich0 个研究点目标入组 20 人开始时间: 2013年7月10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
20
主要终点
Change from Baseline Cancer-related fatigue at post-radiotherapy and follow-up

研究概览

简要总结

Cancer cachexia is a prevalent symptom of head and neck neoplasms. The reduction in skeletal muscle mass is one of the main characteristics which can lead to poor physical functioning. The purpose of this study was to determine the feasibility of progressive resistance training in cachectic head and neck cancer patients during radiotherapy in a pilot randomized controlled design.

Baseline data for all participants were ascertained via medical records and patient interview. This included demographic information, Union internationale contre le cancer-status (UICC-status), comorbidities and the results of blood samples. Outcomes were measured at admission. One study coordinator completed all assessments to enhance patient compliance. Body weight loss percentage was calculated via the individuals' body weight 6 months before (in retrospect) and the current body weight. Participants completed two questionnaires: The Multidimensional Fatigue Inventory and the Functional Assessment of Anorexia/Cachexia Therapy questionnaire. Six-Minute Walk Test was applied. To document changes in muscle force, strength of the functional muscle group for elbow flexion in supine position as well as of knee extension in sitting position (in each case right and left) was tested via hand-held dynamometry for isometric maximal muscle strength. Bioelectrical impedance analysis was executed to assess the adaption in body composition.

The exercise intervention was undertaken in the hospitals department of physical and rehabilitation medicine and based on standardized but individualized training protocols. It consisted of a warm up period for 5 minutes on a bicycle ergometer or an upper body cycle with individual selectable wattage. A leg press, a latissimus pull-down and a chest press formed the three equipment supported core exercises. All exercises were performed with 8-12 repetitions and 3 sets.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

  • planned inpatient or outpatient radiotherapy
  • ≥ 18 years of age
  • diagnosed state of cachexia (weight loss greater than 5 % over the past 6 months) or pre-cachexia (unintentional weight loss of 5 % or less of usual body weight during the last 6 months)

排除标准

  • metastatic disease
  • severe neurological problems or other contraindications for resistance training

研究组 & 干预措施

Training Group

Experimental

Warm up period for 5 minutes on a bicycle ergometer or an upper body cycle with individual selectable wattage. A leg press, a latissimus pull-down and a chest press formed the three equipment supported core exercises. All exercises were performed with 8-12 repetitions and 3 sets. 3 training sessions (30min for each session) per week for during the course of radiotherapy (~6 weeks).

干预措施: Exercise (Other)

Control Group

No Intervention

The control group received usual care.

结局指标

主要结局

Change from Baseline Cancer-related fatigue at post-radiotherapy and follow-up

时间窗: Baseline, post-radiotherapy (~6weeks), follow-up (~8 weeks)

The Multidimensional Fatigue Inventory (MFI) which consists of 20 items that measure subgroups (general, physical and mental fatigue as well as reduced motivation and reduced activity) of fatigue with a 5-point Likert scale.

次要结局

  • Change from Baseline Anorexia/Cachexia at post-radiotherapy and follow-up(Baseline, post-radiotherapy (~6weeks), follow-up (~8 weeks))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. med. Dipl.-Phys. Maximilian Niyazi

PD Dr. med. Dipl. Phys. Karim- Maximilian Niyazi

Ludwig-Maximilians - University of Munich

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