Prehabilitation Prior to Surgery for Kidney Tumors: A Randomized Controlled Research Study (Pre-KiT)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Change in quality of recovery from screening to outpatient follow-up 21 days after surgery
研究概览
简要总结
The goal of this clinical trial is to examine if one month of general health optimization before surgery for kidney tumors can help participants recover more quickly from surgery.
The optimization process is called prehabiliation, and will last one month. It consists of
- A comprehensive health assessment
- Assisted smoking cessation
- A home exercise program.
The investigators will compare an intervention group receiving one month of prehabilitation with a control group receiving the standard of care.
Some of the main questions the investigators want to answer are
- Are participants in the intervention group more satisfied with their quality of recovery after surgery?
- Do participants in the intervention group maintain more of their physical abilites compared to the control group?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •65 years or older
- •cT1 kidney tumor, scheduled for either partial or radical nephrectomy.
- •Clinical Frailty Scale 3-6
排除标准
- •It is determined by an attending physician, or at a multi-disciplinary team-conference, that a 2-4 week postponement of surgery will not be beneficial for the participant.
- •Participant does not understand Danish og English
研究组 & 干预措施
Intervention with Pre-KiT prehabilitation
Participants in the intervention group are scheduled for surgery after four weeks of Pre-KiT prehabilitation. The prehabilitation consists of a geriatric guided assessment with relevant targeted interventions, a home exercise program and assisted smoking cessation.
干预措施: Prehabilitation (Other)
Control group
Participants in the control group are scheduled for surgery in compliance with the Danish cancer patient pathway guarantees (within 14 days).
结局指标
主要结局
Change in quality of recovery from screening to outpatient follow-up 21 days after surgery
时间窗: From enrollment to outpatient follow-up at 21 days after surgery.
Quality of recovery is evaluated with the danish translation of the verified questionnaire Quality of Recovery-15. It is a 15-item patient questionnaire, where the score ranges from 0-150. A higher score indicates better patient-reported quality of recovery. QoR-15 will be assessed at enrollment, preoperatively, and 1, 21 and 90 days after surgery. Change in QoR-15 from enrollment to 21 days after surgery is the primary outcome measure. Change in QoR-15 at other assessment times will be assessed as secondary outcome measures.
次要结局
- Change in Quality of Recovery at other times(Multiple times from enrollment to outpatient follow-up at 90 days after surgery.)
- Change in the 30 second chair stand test(Multiple times from enrollment to outpatient follow-up at 90 days after surgery.)
- Change in hand grip strength(Multiple times from enrollment to outpatient follow-up at 90 days after surgery.)
- Compliance to the prehabilitation program(From enrollment to the preoperative assessment)
- Days alive and out of hospital 90 days(From hospital discharge to follow-up 90 days after surgery.)
- Change in Quality of Life(Multiple times from enrollment to outpatient follow-up at 90 days after surgery.)
- Medical and surgical complications defined according to Clavien-Dindo at 30 and 90 days after surgery(At 30 and 90 days after surgery.)
- Health economic analysis(From enrollment to 1 year follow-up)
- Survival(From surgery to 5 year follow-up.)
- Change in muscle mass(From enrollment to 1 year follow-up)
研究者
Marie Juul-Haslund
M.D., PhD-student
Herlev and Gentofte Hospital