Impact of an In-hospital Exercise Program on the Health of Patients With Ocular Melanoma Undergoing Plaque Brachytherapy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Blood biomarkers: glucose
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with Choroidal Melanoma diagnose and treated with plaque brachytherapy undergoing in "Hospital Universitari i Politècnic La Fe" (Valencia).
排除标准
- •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.
结局指标
主要结局
Blood biomarkers: glucose
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl).
Blood biomarkers: urea
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl).
Blood biomarkers: creatinine
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl).
Blood biomarkers: alanine aminotransferase
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Metabolic and lipidic response marker measured in units/liter (U/L).
Blood biomarkers: glomerular filtration
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Metabolic and lipidic response marker measured in milliliters/minutes/1,73 (ml/min/1,73).
Blood biomarkers: total bilirubin
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl).
Blood biomarkers: total proteins
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Metabolic and lipidic response marker measured in grams/deciliter (g/dl).
Blood biomarkers: aspartate aminotransferase
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Metabolic and lipidic response marker measured in units/liter (U/L).
Blood biomarkers: alkaline phosphatase
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Metabolic and lipidic response marker measured in units/liter (U/L).
Blood biomarkers: lactate dehydrogenase
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Metabolic and lipidic response marker measured in units/liter (U/L).
Blood biomarkers: creatine kinase
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Metabolic and lipidic response marker measured in units/liter (U/L).
Blood biomarkers: albumin
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Metabolic and lipidic response marker measured in grams/deciliter (g/dl).
Blood biomarkers: C-reactive protein
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Inflammatory response marker measured in milligrams/liter (mg/L).
Blood biomarkers: interleukin 6
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Inflammatory response marker measured in picograms/milliliter (pg/ml).
Blood biomarkers: calcium
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl).
Blood biomarkers: albumine-corrected calcium
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl).
Blood biomarkers: chloride
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Metabolic and lipidic response marker measured in milliequivalents/liter (mEq/L).
Blood biomarkers: sodium
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Metabolic and lipidic response marker measured in milliequivalents/liter (mEq/L).
Blood biomarkers: potassium
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Metabolic and lipidic response marker measured in milliequivalents/liter (mEq/L).
Blood biomarkers: total cholesterol
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl).
Blood biomarkers: HDL cholesterol
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl).
Blood biomarkers: LDL cholesterol
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl).
Blood biomarkers: no HDL cholesterol
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl).
Blood biomarkers: triglycerides
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl).
Blood biomarkers: hematies
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood marker measured in x10\^6/microliter (x10\^6/µL).
Blood biomarkers: hemoglobin
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood marker measured in grams/deciliter (g/dl).
Blood biomarkers: hematocrit
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood marker measured in percentage (%).
Blood biomarkers: mean corpuscular volume
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood marker measured in femtoliters (fL).
Blood biomarkers: mean corpuscular hemoglobine
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood marker measured in picograms (pg).
Blood biomarkers: mean corpuscular hemoglobin concentration
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood marker measured in grams/deciliter (g/dl).
Blood biomarkers: red cell distribution width - standard deviation
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood marker measured in femtoliters (fL).
Blood biomarkers: red cell distribution width - coefficient of variation
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood marker measured in percentage (%).
Blood biomarkers: erythroblasts
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood marker measured in percentage (%).
Blood biomarkers: leukocytes
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood marker measured in x10\^3/microliter (x10\^3/µL).
Blood biomarkers: neutrophils
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood marker measured in x10\^3/microliter (x10\^3/µL).
Blood biomarkers: lymphocytes
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood marker measured in x10\^3/microliter (x10\^3/µL).
Blood biomarkers: monocytes
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood marker measured in x10\^3/microliter (x10\^3/µL).
Blood biomarkers: eosinophils
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood marker measured in x10\^3/microliter (x10\^3/µL).
Blood biomarkers: basophils
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood marker measured in x10\^3/microliter (x10\^3/µL).
Blood biomarkers: neutrophils %
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood marker measured in percentage (%).
Blood biomarkers: lymphocytes %
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood marker measured in percentage (%).
Blood biomarkers: monocytes %
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood marker measured in percentage (%).
Blood biomarkers: eosinophils %
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood marker measured in percentage (%).
Blood biomarkers: basophils %
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood marker measured in percentage (%).
Blood biomarkers: immature granulocytes %
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood marker measured in percentage (%).
Blood biomarkers: platelets
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood marker measured in x10\^3/microliter (x10\^3/µL).
Blood biomarkers: mean platelet volume
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood marker measured in femtoliters (fL).
Blood biomarkers: platelet distribution width
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood marker measured in femtoliters (fL).
Blood biomarkers: platelet large cell ratio
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood marker measured in percentage (%).
Blood biomarkers: prothrombin time
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood marker measured in seconds (sec).
Blood biomarkers: prothrombin time ratio
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood marker.
Blood biomarkers: Quick index
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood marker measured in percentage (%).
Blood biomarkers: activated partial thromboplastin time
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood marker measured in seconds (sec).
Blood biomarkers: activated partial thromboplastin time ratio
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood marker.
Blood biomarkers: derived fibrinogen
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood marker measured in milligrams/deciliter (mg/dl).
Blood biomarkers: procalcitonin
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Inflammatory response markers measured in nanograms/milliliter (ng/ml).
Blood biomarkers: glycated hemoblobin A1c
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Metabolic and lipidic response marker measured in percentage (%).
Blood biomarkers: estimated average glucose
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl).
Blood biomarkers: carcinoembryonic antigen
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Tumor marker measured in nanograms per milliliter (ng/ml).
Blood biomarkers: S-100
时间窗: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Tumor markers measured in micrograms per liter (µg/L).
次要结局
- 30s StS Test(At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.)
- TUG test(At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.)
- EORTC_C30(At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.)
- EORTC_OPT30(At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.)
- HADS questionnaire(At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.)
- Physical activity levels(At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.)
研究者
Joaquín Calatayud Villalba
Professor
University of Valencia