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NCT Number: NCT06745609

Prehabilitation Prior to Surgery for Kidney Tumors

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?

Recruiting

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Urology, Herlev and Gentofte Hospital

Herlev, 2730, Denmark

Location status: Recruiting

Location contact

Marie M Haslund, MD

CONTACT

[email protected]

004538682699

Marie M Haslund, MD

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prehabilitation

Other

Pre-KiT prehabilitation consists of

  • 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,
  • Physical activity. A four week home exercise program, adjusted to the participants physical abilities.
  • Assisted smoking cessation

Other names: Geriatric assessment, Physical activity, Smoking cessation

Primary outcomes

  1. Change in quality of recovery from screening to outpatient follow-up 21 days after surgery

    Time frame: 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.

Secondary outcomes

  1. Change in Quality of Recovery at other times

    Time frame: Multiple times from enrollment to outpatient follow-up at 90 days after surgery.

    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.

  2. Change in the 30 second chair stand test

    Time frame: Multiple times from enrollment to outpatient follow-up at 90 days after surgery.

    Physical ability is measured by the 30 second chair stand test. The test is performed at enrollment, preoperatively, 21 and 90 days after surgery.

  3. Change in hand grip strength

    Time frame: Multiple times from enrollment to outpatient follow-up at 90 days after surgery.

    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.

  4. Compliance to the prehabilitation program

    Time frame: From enrollment to the preoperative assessment

    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.

  5. Days alive and out of hospital 90 days

    Time frame: From hospital discharge to follow-up 90 days after surgery.

    Days alive and out of hospital (DAOH) is the number of days not in hospital after surgery. DAOH will be calculated at 90 days after surgery.

  6. Change in Quality of Life

    Time frame: Multiple times from enrollment to outpatient follow-up at 90 days after surgery.

    Quality of life is evaluated with the danish translation of the validated questionnaire EQ-5D-5L. The questionnaire evalutes five health dimensions (mobility, self-care, usual acitivites, pain/discomfort, anxiety/depression) ranging from "no problems" to "unable/ extreme problems". Additionally, it includes a visual analog scale scoring from 0-100, reflecting the participants overall self-reported health state. A higher score indicates a better patient-reported quality of life. Quality of life will be assessed at enrollment, preoperatively, 21 and 90 days after surgery.

  7. Medical and surgical complications defined according to Clavien-Dindo at 30 and 90 days after surgery

    Time frame: At 30 and 90 days after surgery.

    Clavien-Dindo is a system to summarize and classify postoperative complications. Complications will be identified in participants records, and scored according to the Clavien-Dindo grades I-V, where V is the most severe. Registration of complications will be conducted at 30 and 90 days after surgery.

  8. Health economic analysis

    Time frame: From enrollment to 1 year follow-up

    Health-related expenses associated with standard treatment and PreKiT-based treatment will be analyzed and compared across the two study arms.

  9. Survival

    Time frame: From surgery to 5 year follow-up.

    Recurrence-free survival, Cause-specific survival and overall survival measured at 1 and 5 years after surgery.

  10. Change in muscle mass

    Time frame: From enrollment to 1 year follow-up

    Change in muscle mass, comparing measures on preoperative-CT and one year follow-up CT, including assessment of sarcopenia according to current European guidelines.

Study contacts

Contact information is provided by the study sponsor or research team.

Marie M Haslund, MD

CONTACT

[email protected]

004538682699

Professor Fode, MD, PhD, FEBU, FECSM

CONTACT

004538682093

Sponsors and collaborators

Lead sponsor

Herlev and Gentofte Hospital

Other

Registry information

Official study title

Prehabilitation Prior to Surgery for Kidney Tumors: A Randomized Controlled Research Study (Pre-KiT)

Acronym: Pre-KiT

Important dates

Study start
2025
Primary completion
2027
Study completion
2032
First posted
Dec 20, 2024
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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