Resistance Exercise in Patients With Ocular Melanoma

Condition(s) studied

Investigational drug(s) / intervention(s)

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 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Blood biomarkers: glucose — 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 — 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 — 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: glomerular filtration — 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 — 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: aspartate aminotransferase — 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: alanine aminotransferase — 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 — 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 — 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 — 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: total proteins — 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: albumin — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 % — 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 % — 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 % — 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 % — 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 % — 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 % — 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 — 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 — 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 — 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 — 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 — 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 — At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
  Blood marker.
• Blood biomarkers: Quick index — 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 — 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 — At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
  Blood marker.
• Blood biomarkers: derived fibrinogen — 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 — 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 — 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 — 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 — 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 — 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).

Trial sites (1)

More University of Valencia trials in Spain

Other trials for the same condition