Идёт набор NCT07341698

Prehabilitation for Patients Diagnosed With Blood Cancer and Treated With Al-logeneic Hematopoietic Stem Cell Transplantation

Без фазы С лечением Allogeneic Hematopoietic Stem Cell Transplantation Recipient

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: Resistance training, Nutritional Support, Usual care.
Кому может быть актуально: Состояния в реестре: Allogeneic Hematopoietic Stem Cell Transplantation Recipient. Базовые параметры: от 18 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 for Patients Diagnosed With Blood Cancer and Treated With Alloge-neic Hematopoietic Stem Cell Transplantation - a National Randomized Controlled Trial

Обзор

Seventy-five percent of patients treated with hematopoietic stem cell transplants survive one-year post-transplantation. However, this intensive treatment is associated with prolonged hospitalizations and significant deconditioning. Pathophysiological changes in skeletal muscle mass and function have notable implications for disease progression and long-term prognosis. Patients frequently report substantial rehabilitation needs, though these needs are highly individualized and fluctuate over time, with musculoskeletal dysfunction and fa-tigue being the most common barriers to prehabilitation. Furthermore, at least 35% of cancer patients are found to have inadequate daily protein intake, which may hinder improve-ments in physical performance through prehabilitation. Several recent studies have demonstrated the safety and feasibility of exercise-based prehabilitation interventions during the pre-transplant period. However, no full-scale randomized controlled trial (RCT) has been conducted to date.

Подробное описание

Evaluate the effectiveness of an individualized prehabilitation intervention in addition to usual care, compared to usual care alone on HRQoL, and secondary outcomes hospitalization, muscle mass and muscle function.

Вмешательства

Другое Resistance training
Structured and supervised, group-based, resistance training 3x per week (individually tailored to the individual's capabilities)
Пищевая добавка Nutritional Support
Optimized dietary counseling and supplementation to optimize nutritional intake
Процедура Usual care
Usual care is the standard care before allogeneic hematopoietic stem cell transplantation

Первичные конечные точки

Health-Related Quality of Life using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core questionnaires with 30 questions (EORTC QLQ C-30) [Срок оценки: From enrollment to 90 days post-transplantation]

Вторичные конечные точки (7)

Hospitalization [Срок оценки: From enrollment to 90 days post-transplantation]
Appendicular lean mass [Срок оценки: From enrollment to 90 days post-transplantation]
Appendicular Lean Mass Index [Срок оценки: From enrollment to 90 days post-transplantation]
Hand grip strength [Срок оценки: From enrollment to 90 days post-transplantation.]
Lower limb strength [Срок оценки: From enrollment to 90 days post-transplantation.]
Lower limb strength and endurance [Срок оценки: From enrollment to 90 days post-transplantation.]
Leg Extensor Power [Срок оценки: From enrollment to 90 days post-transplantation]

Критерии участия

Критерии включения

Adult patients >18 years will be eligible for inclusion if they are scheduled for a allo-HSCT with at least four weeks before their scheduled transplantation date.