Resistance Exercise in Patients With Ocular Melanoma
ConditionOcular Melanoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Valencia
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Adults with Choroidal Melanoma diagnose and treated with plaque brachytherapy undergoing in "Hospital Universitari i Politècnic La Fe" (Valencia).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise
Other interventionDaily 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Exercise Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Blood 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.2
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.3
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.4
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.Secondary outcomes
1
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.2
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.3
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.4
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.Sponsors and contacts
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Source ClinicalTrials.gov