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Идёт набор NCT06745609

Prehabilitation Prior to Surgery for Kidney Tumors

Без фазы С лечением Renal Cancer Renal Cell Cancer Kidney Cancers Stage I Renal Cell Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Prehabilitation.
Кому может быть актуально
Состояния в реестре: Renal Cancer, Renal Cell Cancer, Kidney Cancers, Stage I Renal Cell Cancer. Базовые параметры: от 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Дания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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?

Вмешательства

  • Другое Prehabilitation
    Pre-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, adjust

Первичные конечные точки

  • Change in quality of recovery from screening to outpatient follow-up 21 days after surgery [Срок оценки: From enrollment to outpatient follow-up at 21 days after surgery.]
Вторичные конечные точки (10)
  • Change in Quality of Recovery at other times [Срок оценки: Multiple times from enrollment to outpatient follow-up at 90 days after surgery.]
  • Change in the 30 second chair stand test [Срок оценки: Multiple times from enrollment to outpatient follow-up at 90 days after surgery.]
  • Change in hand grip strength [Срок оценки: Multiple times from enrollment to outpatient follow-up at 90 days after surgery.]
  • Compliance to the prehabilitation program [Срок оценки: From enrollment to the preoperative assessment]
  • Days alive and out of hospital 90 days [Срок оценки: From hospital discharge to follow-up 90 days after surgery.]
  • Change in Quality of Life [Срок оценки: 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 [Срок оценки: At 30 and 90 days after surgery.]
  • Health economic analysis [Срок оценки: From enrollment to 1 year follow-up]
  • Survival [Срок оценки: From surgery to 5 year follow-up.]
  • Change in muscle mass [Срок оценки: From enrollment to 1 year follow-up]

Критерии участия

Критерии включения

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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Дания · 1 центр
  • Department of Urology, Herlev and Gentofte Hospital — Herlev

Публикации

  • Juul-Haslund M, Lund CM, Dolin TG, Schou-Jensen K, Ostergren PB, Vinther A, Thomsen FF, Fode M. Geriatric prehabilitation prior to surgery for kidney tumors: Study protocol for Pre-KiT - A randomized controlled trial. J Geriatr Oncol. 2026 Mar;17(2):102893. doi: 10.1016/j.jgo.2026.102893. Epub 2026 Jan 26. PMID 41592385

Идентификаторы

NCT: NCT06745609 · H-24066449

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗