Geriatric prehabilitation prior to surgery for kidney tumors: Study protocol for Pre-KiT - A randomized controlled trial.
Marie Juul-Haslund, Cecilia M Lund, Troels G Dolin...
https://pubmed.ncbi.nlm.nih.gov/41592385Actively Recruiting
Phase Not Applicable
Age: 65Years +
All Genders
ID06745609
Prehabilitation Prior to Surgery for Kidney Tumors: A Randomized Controlled Research Study (Pre-KiT)
Led by Herlev and Gentofte Hospital · Updated on 2025-01-24
60
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether one month of general health optimization before surgery for kidney tumors can help participants recover faster. This process, called prehabilitation, is being compared to the standard care approach. The study aims to see if those who receive prehabilitation have better satisfaction with their recovery and maintain more physical abilities after surgery. The prehabilitation program lasts four weeks and includes a detailed health assessment guided by a geriatric specialist. This assessment covers cognitive checks, depression screening, functional and nutritional evaluations, disease history, medication review, social history, and lab tests. The program also involves a home exercise plan tailored to each participant's physical condition and assisted smoking cessation. Participants in the intervention group undergo surgery after completing this program, while the control group has surgery following standard timing guidelines. Participants will be monitored from enrollment through outpatient follow-ups at 21 and 90 days after surgery, and longer-term assessments up to five years. Researchers will measure changes in quality of recovery, physical tests like the chair stand and hand grip strength, adherence to the prehabilitation program, hospital stay duration, quality of life, surgical complications, economic impact, survival, and muscle mass changes. These evaluations help determine if prehabilitation improves recovery and outcomes for older adults undergoing kidney tumor surgery.
CONDITIONS
Brief Title
Prehabilitation Prior to Surgery for Kidney Tumors
Who Can Participate
Age: 65Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 65 years or older
- Diagnosed with cT1 kidney tumor and scheduled for partial or radical nephrectomy
- Clinical Frailty Scale score between 3 and 6
You will not qualify if you...
- Surgery postponement of 2-4 weeks is not expected to benefit the participant, as determined by a physician or team
- Participant does not understand Danish or English
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Prehabilitation
Duration - 4 weeks
Participants in the intervention group complete a four week home exercise program with a geriatric guided assessment including cognitive, depression, functional and nutritional evaluations, along with assisted smoking cessation.
1 to 2 visits depending on assessment and intervention needs
Surgery
Duration - 1 day
Participants undergo partial or radical nephrectomy for kidney tumor removal following their assigned schedule.
1 in-person visit for surgery
Post-operative Follow-up
Duration - Up to 90 days
Participants are followed up after surgery to assess recovery, complications, quality of life, and functional outcomes.
1 outpatient follow-up visit at 21 days and 1 additional follow-up visit at 90 days after surgery
Long-term Monitoring
Duration - Up to 5 years
Participants are monitored for survival, muscle mass changes, and health economic outcomes up to 5 years after surgery.
Trial Site Locations
Total: 1 location
1
Department of Urology, Herlev and Gentofte Hospital
Herlev, Denmark, 2730
Actively Recruiting
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Research Team
M
Marie M Haslund, MD
P
Professor Fode, MD, PhD, FEBU, FECSM
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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