Меню
Идёт набор NCT07044427

Fall Risk Assessment and an Exercise Intervention for Prevention of Falls in Multiple Myeloma Patients

Без фазы С лечением Multiple Myeloma Fall Risk Factors Strength Training Effects Balance Training Effects

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: Strength and balance training in combination with a treadmill-based pertubation intervention.
Кому может быть актуально
Состояния в реестре: Multiple Myeloma, Fall Risk Factors, Strength Training Effects, Balance Training Effects. 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
Германия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Investigation of Fall Risk Factors and Implementation of an Exercise Intervention for Prevention of Falls in Patients With Multiple Myeloma

Обзор

Approximately one third of the population over the age of 65 falls at least once a year. The risk of falling is in increased in older patients with tumor diseases. In addition to high treatment and care costs for the healthcare system, falls often lead to a decrease of quality of life, a reduction in physical performance and a loss of independence. Despite the high risk, falls in cancer patients have not yet been scientifically investigated in detail. For patients with multiple myeloma in particular, very little data is available on the prevalence, risk factors and effects of falls. In this study, a fall risk assessment is carried out in patients with multiple myeloma. Furthermore, a patient-specific training intervention for fall prevention will be implemented. The aim of the study is to identify possible fall risk factors in multiple myeloma patients and to establish a structured exercise intervention that minimizes the risk of falls and injuries.

Вмешательства

  • Другое Strength and balance training in combination with a treadmill-based pertubation intervention
    Patients receive a personalized home-based training plan with strength and balance exercises to be carried out three times a week for six months. In addition, treadmill-based pertubation training is carried out at 2 timepoints.

Первичные конечные точки

  • Feasibility of at least 48 out of 72 training sessions with the focus on fall prevention within 24 weeks [Срок оценки: From enrollement to the end of the training intervention at 6 months]
  • Effectivity (fear of falling) [Срок оценки: Evaluated at the beginning of the study and at the end of the study after 6 months]

Критерии участия

Критерии включения

  • Patients with multiple myeloma requiring therapy (at least 6 months of systemic therapy)
  • ECOG status ≤ 3
  • Age ≥18 years
  • Patients who state that they want to carry out the training program at least 3 times/week and participate in the planned follow-up visits
  • Ability to give informed consent
  • Written consent to participate in the study
  • Sufficient written and spoken German to complete the questionnaire

Критерии исключения

  • Any physical or mental limitations that would prevent participation in the training program or the planned follow-up checks.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Германия · 1 центр
  • University Hospital Heidelberg — Heidelberg

Публикации

  • Wildes TM, Fiala MA. Falls in older adults with multiple myeloma. Eur J Haematol. 2018 Mar;100(3):273-278. doi: 10.1111/ejh.13009. Epub 2018 Jan 8. PMID 29239009
  • Wildes TM, Dua P, Fowler SA, Miller JP, Carpenter CR, Avidan MS, Stark S. Systematic review of falls in older adults with cancer. J Geriatr Oncol. 2015 Jan;6(1):70-83. doi: 10.1016/j.jgo.2014.10.003. Epub 2014 Oct 30. PMID 25454770
  • Dapunt U, Ehret P, Paratte JL, Kuehl RM, Wiskemann J, Jager D, Muller-Tidow C, Raab MS, Goldschmidt H. A precision-based exercise program for patients with multiple myeloma. Eur J Haematol. 2023 Dec;111(6):930-937. doi: 10.1111/ejh.14106. Epub 2023 Sep 20. PMID 37727991
  • Sattar S, Alibhai SM, Spoelstra SL, Fazelzad R, Puts MT. Falls in older adults with cancer: a systematic review of prevalence, injurious falls, and impact on cancer treatment. Support Care Cancer. 2016 Oct;24(10):4459-69. doi: 10.1007/s00520-016-3342-8. Epub 2016 Jul 22. PMID 27450557
  • Pandya C, Magnuson A, Dale W, Lowenstein L, Fung C, Mohile SG. Association of falls with health-related quality of life (HRQOL) in older cancer survivors: A population based study. J Geriatr Oncol. 2016 May;7(3):201-10. doi: 10.1016/j.jgo.2016.01.007. Epub 2016 Feb 18. PMID 26907564

Идентификаторы

NCT: NCT07044427 · S-045/2024

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗