Progressive Resistance Training Program in Head and Neck Cancer Patients
Feasibility of a 12-week Progressive Resistance Training Program in Head and Neck Cancer Patients During Concurrent Radiochemotherapy - a Pilot Trial
研究概览
详细说明
12 patients with head and neck cancer will be recruited to this trial. Entering a 12-week PRT program which will start one week before radiotherapy. The tested training program is a 12-week, supervised, group based, progressive resistance training program involving the major muscle groups of the body. The program has previously been found to successfully restore the loss of lean body mass (LBM) in head and neck cancer patients post-treatment. A group based approach will be used to facilitate a social and motivating training environment for the patients. This approach has previously been used for exercise interventions for lung cancer patients at our facility, and was highly appreciated by the patients.
In addition to baseline data (height, tumor stage, performance status, etc), the following parameters will be registered on a weekly basis: Weight, patient reported side effects, as well as a questionnaire on amount of physical activity and food intake.
Physical function and strength will be tested at baseline, after the course of chemoradiotherapy and at the end of the 12-week PRT programme, and at 2, 5, 9 and 13 months follow-up. At similar time points dual energy x-ray absorptiometry (DXA) scans for body composition will be performed using a Lunar iDXA (GE Healthcare).
Blood samples will be drawn at baseline, an additional three times during the first 6 weeks and then weekly in relation to training sessions, and at 2, 5, 9 and 13 months follow-up.
Patient reported quality of life (EORTC Quality of Life Questionaire (QLQ)-C30 and QLQ-H&N35) will be registered at baseline, after 12-weeks PRT and during 5 and 13 months follow-up.
Study duration is expected to be 7 months for the pilot-trial, with a follow-up of additional 13 months after the last patient has completed the intervention.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Herlev、丹麦、2730
- Dept. of oncology
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients with head and neck squamous cell carcinoma
- Candidates for concomitant chemoradiotherapy according to Danish Head and Neck Cancer Group (DAHANCA) guidelines.
- Performance status 0-1
- Expected to be able to complete the intervention, i.e. no major comorbidities or social issues that could compromise attendance.
- At least 18 years of age.
学习计划
研究是如何设计的?
设计细节
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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其他:Progressive resistance training
12 weeks, 3 sessions per week, 7 exercises (leg press, leg curl, hamstring curl, chest press, lateral pull down, sit-ups and back extensions).
In general 2-3 sets of 8-15 repetitions will be performed following a progression plan starting with more repetitions at lower intensity progressing to fewer repetitions at higher intensity during the 12-week period (American College of Sports Medicine Position Stand).
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A 12-week, supervised, group based, progressive resistance training program involving the major muscle groups of the body will be tested.
Details of the program: 12 weeks, 3 sessions per week, 7 exercises (leg press, leg curl, hamstring curl, chest press, lateral pull down, sit-ups and back extensions).
In general 2-3 sets of 8-15 repetitions will be performed following a progression plan starting with more repetitions at lower intensity progressing to fewer repetitions at higher intensity during the 12-week period (American College of Sports Medicine Position Stand)
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Feasibility
大体时间:up to 7 months
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The feasibility outcomes will be inclusion rate defined as the number of patients recruited from the number of eligible patients and completion rate defined as the number of participants able to complete the intervention. Adherence to the exercise intervention will be evaluated via patient-reported training logs. |
up to 7 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in LBM
大体时间:up to 20 months
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Whole body LBM will be determined using dual energy x-ray absorptiometry (DXA).
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up to 20 months
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Weight loss
大体时间:up to 20 months
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Patient will be weighed weekly during the 12-week PRT program; afterwards at each follow-up (2, 5, 9, and 13 months)
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up to 20 months
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Number of patients with side-effects to treatment
大体时间:up to 7 months
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Side-effects will be registered using Common Terminology Criteria for Advers Events v4.0 (CTCAE).
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up to 7 months
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Quality of Life
大体时间:Up to 20 months
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Up to 20 months
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Change in physical function and strength
大体时间:Up to 20 months
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Change in muscle strength will be evaluated by 1 repetition maximum test (1RM) measured in kg. Change in muscle power will be evaluated by Nottingham Power Rig and measured in watts and watt/kg. Change in physical function will be evaluated by 30 second sit-to-stand test, arm curl test and stair climbing. |
Up to 20 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Muscle biopsies
大体时间:up to 7 months
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In order to establish energy-reserves in the muscles
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up to 7 months
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Blood samples
大体时间:Up to 20 months
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In order to identify systemic factors released during exercise
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Up to 20 months
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合作者和调查者
调查人员
- 首席研究员:Julie Gehl, ph.d.、Herlev Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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