Resistance Exercise in Patients With Ocular Melanoma

Официальное название

Impact of an In-hospital Exercise Program on the Health of Patients With Ocular Melanoma Undergoing Plaque Brachytherapy: A Randomized Controlled Trial

Обзор

Choroidal melanoma (CM) is one of the most common intraocular cancers worldwide. During treatment with episcleral brachytherapy, patients require a week of hospitalization in isolation. The primary aim of this study will be to investigate the effects of resistance training during hospitalization on health-related blood biomarkers in CM patients. Our secondary aim will be to assess changes in physical function tests, quality of life and anxiety and depression. Candidates for this study will be patients undergoing CM treatment at the "Hospital Universitari i Politècnic La Fe" of Valencia.

Подробное описание

Candidates of the present study will be adults with CM diagnose and treated with plaque brachytherapy undergoing in "Hospital Universitari i Politècnic La Fe" (Valencia). All the participants will be informed about the objectives and content of the investigation and written informed consent will be obtained. Participants will be excluded if they (1) present a health status that forbids high intensity resistance training, (2) have any unsteady cardiac illness, (3) have serious metabolic disorder or if (4) they have any important orthopaedic disorder impeding exercise. The study will conform to the Declaration of Helsinki and will be approved by the Ethical Committee of "Hospital Universitari i Politècnic de La Fe".

A randomized controlled trial with two parallel groups is planned: a control group following the hospital's standard protocol (usual care) and an intervention group in which patients will complete a daily resistance training session during hospitalization. During the 5-7 days of treatment, where participants are going to be isolated in a room without human contact, are going to perform a daily session of exercise during about 30 minutes. The exercises will be supervised by a trained physician. To carry out the training session, elastic resistance bands will be used. On each day, each exercise will start with 3 sets of two repetitions as a warm-up and to calculate the appropriate intensity. The intensity will be that at which the patient reports a perceived exertion of 5-6 of 10 at the Borg CR10 scale after two repetitions. For each exercise, one set will be completed until task failure is achieved.If in any of the exercises the patient perceives this intensity only with the weight of his own limb or body weight, the exercise will be performed without elastic bands.

To observe the effects of the intervention, various blood tests, functional, quality-of-life and anxiety and depression assessments will be conducted before and after the program, as well as one-month post-hospital discharge.

Вмешательства

• Другое Exercise
  Daily session during hospitalization. To carry out the training session, elastic bands (TheraBand CLX Consecutive Loops; TheraBand, Akron, OH) with resistance graded from very low to very high (i.e, yellow, red, green, blue, black, silver and gold) will be used. On each day, each exercise will start with 3 sets of two repetitions as a warm-up and to calculate the appropriate intensity. The intensity will be that at which the patient reports a perceived exertion of 5-6 of 10 at the Borg CR10 scal

Первичные конечные точки

• Blood biomarkers: glucose [Срок оценки: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.]
• Blood biomarkers: urea [Срок оценки: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.]
• Blood biomarkers: creatinine [Срок оценки: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.]
• Blood biomarkers: glomerular filtration [Срок оценки: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.]
• Blood biomarkers: total bilirubin [Срок оценки: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.]
• Blood biomarkers: aspartate aminotransferase [Срок оценки: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.]
• Blood biomarkers: alanine aminotransferase [Срок оценки: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.]
• Blood biomarkers: alkaline phosphatase [Срок оценки: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.]
• Blood biomarkers: lactate dehydrogenase [Срок оценки: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.]
• Blood biomarkers: creatine kinase [Срок оценки: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.]

Вторичные конечные точки (6)

• EORTC_C30 [Срок оценки: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.]
• EORTC_OPT30 [Срок оценки: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.]
• HADS questionnaire [Срок оценки: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.]
• Physical activity levels [Срок оценки: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.]
• TUG test [Срок оценки: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.]
• 30s StS Test [Срок оценки: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.]

Критерии участия

Критерии включения

• Adults with Choroidal Melanoma diagnose and treated with plaque brachytherapy undergoing in "Hospital Universitari i Politècnic La Fe" (Valencia).

Критерии исключения

• Present a health status that forbids high intensity resistance training.
• Have any unsteady cardiac illness.
• Have serious metabolic disorder.
• Have any important orthopaedic disorder impeding exercise.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Hospital Universitari i Politècnic de La Fe — Valencia

Идентификаторы

NCT: NCT06970236 · IHOPE-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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