About this trial
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
1. A comprehensive health assessment 2. Assisted smoking cessation 3. 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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
65 years or older
cT1 kidney tumor, scheduled for either partial or radical nephrectomy.
Clinical Frailty Scale 3-6
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Prehabilitation
Other interventionPre-KiT prehabilitation consists of 1. A geriatric guided assessment with relevant interventions. The assessment will include cognitive evaluation, screening for depression, functional assessment, as well as evaluation of nutritional risk, assessment of past and current diseases, and a thorough review of the patient's medication list focusing on drug interactions. It will also include social history and standard laboratory results, 2. Physical activity. A four week home exercise program, adjusted to the participants physical abilities. 3. Assisted smoking cessation
Treatment groups
Trial outcomes
Primary outcomes
Change in quality of recovery from screening to outpatient follow-up 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.
Secondary outcomes
Change in Quality of Recovery at other times
Quality of recovery is measured by 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 the 30 second chair stand test
Physical ability is measured by the 30 second chair stand test. The test is performed at enrollment, preoperatively, 21 and 90 days after surgery.
Change in hand grip strength
Physical ability is measured by hand grip strength. The test is performed with a hand-dynamometer at enrollment, preoperatively, 21 and 90 days after surgery.
Compliance to the prehabilitation program
Compliance to the prehabilitation program is measured by brief phone interviews with the study participants in the intervention group two times a week during the intervention.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.