Sportivumab - Feasibility of Exercise as a Supportive Measure for Patients Undergoing Checkpoint-inhibitor Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Feasibility of the exercise intervention
研究概览
简要总结
Checkpoint inhibitors like the PD-1 antibodies Pembrolizumab and Nivolumab represent standard of care for patients with metastasized melanoma. Numerous high quality studies demonstrate that endurance and resistance training in cancer patients is safe and elicits beneficial effects. However, there is no systematic experience with regard to exercise interventions in patients undergoing checkpoint inhibitor treatment. Therefore, the Sportivumab Study aimed to investigate safety, feasibility and effectivity of a 12 week combined resistance and endurance exercise intervention program during checkpoint inhibitor treatment. It is planned to enroll 40 patients. Participants will be randomized into an experimental and a wait-list control group (20 per group). The wait-list control group will receive the exercise intervention program after week 13 of enrollment.
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
- •Patients at age ≥ 18 years
- •Diagnosed with melanoma stage (independent of stage)
- •Assigned to receive an immunotherapeutic regimen (PD-1 antibody +/- Ipilimumab)
- •Sufficient German language skills
- •Willing to train at the exercise facilities twice per week and to take part in the scheduled testing at the National Center for Tumor Diseases
- •Signed informed consent
排除标准
- •Any physical or mental conditions that would hamper the performance of the training programs or the completion of the study procedures
- •Engaging in systematic intense exercise training (at least 1h twice per week)
研究组 & 干预措施
Experimental intervention arm (EX)
The supervised progressive endurance and resistance exercise program will be undertaken twice weekly in small groups and will be guided by an exercise physiotherapist over 12 weeks. All sessions will start with a warm-up passing over to the endurance training part and finish with a cool-down and will take approximately 60 minutes. The moderate-to-high-intensity endurance training will be performed at the beginning of each training session on a cycle ergometer for 20 min at 75 to 80 % of peak heart rate obtained from the baseline cardiorespiratory exercise test. This training intensity is within the range of intensities recommended by the American College of Sports Medicine (ACSM) exercise guidelines for cancer survivors. The moderate-to-high-intensity progressive resistance training regime (12 repetition maxima - 3 sets for each exercise) will include 6 exercises that target major upper and lower body muscle groups.
干预措施: Resistance and Endurance Exercise (Behavioral)
Wait list - control group (UC)
Wait list control group will receive usual care. After primary endpoint assessment, UC patients will be offered to participate in the exercise interventions program.
结局指标
主要结局
Feasibility of the exercise intervention
时间窗: During 12 week of the intervention
Participants ability to fulfill the exercise prescription (measured by % of training frequency, intensity and duration as well as type of the exercise) during immune checkpoint inhibitor treatment with a PD-1 antibody +/- ipilimumab
次要结局
- Quality of life(During 12 week of the intervention)
- Depression(During 12 week of the intervention)
- Fatigue(During 12 week of the intervention)
- Muscle strength(During 12 week of the intervention)
- Pain(During 12 week of the intervention)
- Physical Activity Behavior(During 12 week of the intervention)
- Cardiopulmonary Fitness(During 12 week of the intervention)
- Sleep Quality(During 12 week of the intervention)
研究者
Joachim Wiskemann
Dr. Joachim Wiskemann
University Hospital Heidelberg