Clinical trial NCT06745609: Prehabilitation Prior to Surgery for Kidney Tumors
Official title: Prehabilitation Prior to Surgery for Kidney Tumors: A Randomized Controlled Research Study (Pre-KiT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Renal Cancer
Renal Cell Cancer
Kidney Cancers
Stage I Renal Cell Cancer
Prehabilitation
Elderly (People Aged 65 or More)
Keywords: Prehabilitation
Quality of life
Kidney tumor
Renal cell tumor
Renal cell cancer
Kidney cancer
Quality of recovery
Elderly
Lead sponsor: Herlev and Gentofte Hospital
Sponsor class: OTHER
First posted: 2024-12-20
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: Inclusion Criteria:

* 65 years or older
* cT1 kidney tumor, scheduled for either partial or radical nephrectomy.
* Clinical Frailty Scale 3-6

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in quality of recovery from screening to outpatient follow-up 21 days after surgery
timeFrame: From enrollment to outpatient follow-up at 21 days after surgery.
Secondary outcomes:
measure: Change in Quality of Recovery at other times
timeFrame: Multiple times from enrollment to outpatient follow-up at 90 days after surgery.
measure: Change in the 30 second chair stand test
timeFrame: Multiple times from enrollment to outpatient follow-up at 90 days after surgery.
measure: Change in hand grip strength
timeFrame: Multiple times from enrollment to outpatient follow-up at 90 days after surgery.
measure: Compliance to the prehabilitation program
timeFrame: From enrollment to the preoperative assessment
measure: Days alive and out of hospital 90 days
timeFrame: From hospital discharge to follow-up 90 days after surgery.
measure: Change in Quality of Life
timeFrame: Multiple times from enrollment to outpatient follow-up at 90 days after surgery.
measure: Medical and surgical complications defined according to Clavien-Dindo at 30 and 90 days after surgery
timeFrame: At 30 and 90 days after surgery.
measure: Health economic analysis
timeFrame: From enrollment to 1 year follow-up
measure: Survival
timeFrame: From surgery to 5 year follow-up.
measure: Change in muscle mass
timeFrame: From enrollment to 1 year follow-up
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Department of Urology, Herlev and Gentofte Hospital
Study officials:
References: