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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
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 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.
Hospital Universitari i Politècnic de La Fe
Valencia, Spain, Spain
RECRUITINGBlood biomarkers: glucose
Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: urea
Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: creatinine
Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: glomerular filtration
Metabolic and lipidic response marker measured in milliliters/minutes/1,73 (ml/min/1,73).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: total bilirubin
Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: aspartate aminotransferase
Metabolic and lipidic response marker measured in units/liter (U/L).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: alanine aminotransferase
Metabolic and lipidic response marker measured in units/liter (U/L).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: alkaline phosphatase
Metabolic and lipidic response marker measured in units/liter (U/L).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: lactate dehydrogenase
Metabolic and lipidic response marker measured in units/liter (U/L).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: creatine kinase
Metabolic and lipidic response marker measured in units/liter (U/L).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: total proteins
Metabolic and lipidic response marker measured in grams/deciliter (g/dl).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: albumin
Metabolic and lipidic response marker measured in grams/deciliter (g/dl).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: C-reactive protein
Inflammatory response marker measured in milligrams/liter (mg/L).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: interleukin 6
Inflammatory response marker measured in picograms/milliliter (pg/ml).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: calcium
Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: albumine-corrected calcium
Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: chloride
Metabolic and lipidic response marker measured in milliequivalents/liter (mEq/L).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: sodium
Metabolic and lipidic response marker measured in milliequivalents/liter (mEq/L).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: potassium
Metabolic and lipidic response marker measured in milliequivalents/liter (mEq/L).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: total cholesterol
Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: HDL cholesterol
Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: LDL cholesterol
Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: no HDL cholesterol
Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: triglycerides
Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: hematies
Blood marker measured in x10\^6/microliter (x10\^6/µL).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: hemoglobin
Blood marker measured in grams/deciliter (g/dl).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: hematocrit
Blood marker measured in percentage (%).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: mean corpuscular volume
Blood marker measured in femtoliters (fL).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: mean corpuscular hemoglobine
Blood marker measured in picograms (pg).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: mean corpuscular hemoglobin concentration
Blood marker measured in grams/deciliter (g/dl).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: red cell distribution width - standard deviation
Blood marker measured in femtoliters (fL).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: red cell distribution width - coefficient of variation
Blood marker measured in percentage (%).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: erythroblasts
Blood marker measured in percentage (%).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: leukocytes
Blood marker measured in x10\^3/microliter (x10\^3/µL).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: neutrophils
Blood marker measured in x10\^3/microliter (x10\^3/µL).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: lymphocytes
Blood marker measured in x10\^3/microliter (x10\^3/µL).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: monocytes
Blood marker measured in x10\^3/microliter (x10\^3/µL).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: eosinophils
Blood marker measured in x10\^3/microliter (x10\^3/µL).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: basophils
Blood marker measured in x10\^3/microliter (x10\^3/µL).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: neutrophils %
Blood marker measured in percentage (%).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: lymphocytes %
Blood marker measured in percentage (%).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: monocytes %
Blood marker measured in percentage (%).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: eosinophils %
Blood marker measured in percentage (%).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: basophils %
Blood marker measured in percentage (%).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: immature granulocytes %
Blood marker measured in percentage (%).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: platelets
Blood marker measured in x10\^3/microliter (x10\^3/µL).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: mean platelet volume
Blood marker measured in femtoliters (fL).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: platelet distribution width
Blood marker measured in femtoliters (fL).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: platelet large cell ratio
Blood marker measured in percentage (%).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: prothrombin time
Blood marker measured in seconds (sec).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: prothrombin time ratio
Blood marker.
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: Quick index
Blood marker measured in percentage (%).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: activated partial thromboplastin time
Blood marker measured in seconds (sec).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: activated partial thromboplastin time ratio
Blood marker.
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: derived fibrinogen
Blood marker measured in milligrams/deciliter (mg/dl).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: procalcitonin
Inflammatory response markers measured in nanograms/milliliter (ng/ml).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: glycated hemoblobin A1c
Metabolic and lipidic response marker measured in percentage (%).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: estimated average glucose
Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: carcinoembryonic antigen
Tumor marker measured in nanograms per milliliter (ng/ml).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood biomarkers: S-100
Tumor markers measured in micrograms per liter (µg/L).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
EORTC_C30
The patient self-reported outcomes comprised the EORTC\_ C30 questionnaire. This survey assesses various dimensions of quality of life.
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
EORTC_OPT30
The patient self-reported outcomes comprised also the complementary EORTC\_ OPT30 module specifically designed for patients with eye cancer. This survey assesses various dimensions of quality of life, and the OPT30 module has a particular focus on evaluating visual functioning limitations.
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
HADS questionnaire
The Hospital Anxiety and Depression Scale (HADS) will be used to measure symptoms of anxiety (HADS Anxiety) and depression (HADS Depression).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Physical activity levels
The patients will be also asked about their levels of physical activity prior to hospitalization (minutes/week during the last month).
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
TUG test
To evaluate agility/coordination, the timed-up-and-go-test (TUG) will be used to, which consists of rising from a chair on command, walking a distance of 3 m, turning around, and walking back to the chair as fast as possible.
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
30s StS Test
To assess muscle strength of lower limbs (endurance strength), the patient will be performed the 30-s sit-to-stand test (30 s StS), which is to stand up and sit down as many times as possible in 30 s.
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Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.