Ocular MelanomaIHOPENCT06970236
Resistance Exercise in Patients With Ocular Melanoma
A study testing Exercise in people with Ocular Melanoma, run by University of Valencia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Melanoma
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with Choroidal Melanoma diagnose and treated with plaque brachytherapy undergoing in "Hospital Universitari i Politècnic La Fe" (Valencia).
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari i Politècnic de La Fe
Valencia, Spain, 46026
Joaquín Calatayud, +34 625 577 509, joaquin.calatayud@uv.es
About this study
Official title: Impact of an In-hospital Exercise Program on the Health of Patients With Ocular Melanoma Undergoing Plaque Brachytherapy: A Randomized Controlled 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.
Read the detailed description
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.
- Conditions
- Ocular Melanoma
- Being tested
- Exercise
- Medical subject headings
- Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
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 group | Role | What they receive |
|---|---|---|
| Exercise Intervention Group | Experimental | Participants on this group will follow the exercise intervention mentioned in the protocol. Receives: Other: Exercise |
| Control Group | No intervention | Patients in the control group will follow the hospital's conventional protocol during the hospitalization days, which consists in isolated bed rest. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood biomarkers: glucose
Metabolic and lipidic response marker measured in milligrams/deciliter (mg/dl).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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 (%).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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 (%).
Measured: 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 (%).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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 (%).
Measured: 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 (%).
Measured: 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 (%).
Measured: 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 (%).
Measured: 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 (%).
Measured: 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 (%).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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 (%).
Measured: 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).
Measured: 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.
Measured: 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 (%).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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 (%).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Secondary outcomes (6)
EORTC_C30
The patient self-reported outcomes comprised the EORTC_ C30 questionnaire. This survey assesses various dimensions of quality of life.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start1 Feb 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular MelanomaStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joaquín Calatayud Villalba, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970236
- Sponsor's protocol ID
- IHOPE-2025
- Acronym
- IHOPE
- Status last verified
- May 2025
- First submitted
- 27 Mar 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an In-hospital Exercise Program on the Health of Patients With Ocular Melanoma Undergoing Plaque Brachytherapy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06970236
- Acronym / sponsor ID
- IHOPE / IHOPE-2025
- Conditions
- Ocular Melanoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention Group | Experimental | Other: ExerciseParticipants on this group will follow the exercise intervention mentioned in the protocol. |
| Control Group | No intervention | –Patients in the control group will follow the hospital's conventional protocol during the hospitalization days, which consists in isolated bed rest. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with Choroidal Melanoma diagnose and treated with plaque brachytherapy undergoing in "Hospital Universitari i Politècnic La Fe" (Valencia).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseDaily 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. | Other | Exercise Intervention Group |
Primary outcome
Blood biomarkers: glucose
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 %
Time frame: 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 %
Time frame: 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 %
Time frame: 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 %
Time frame: 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 %
Time frame: 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 %
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood marker.
Blood biomarkers: Quick index
Time frame: 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
Time frame: 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
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Blood marker.
Blood biomarkers: derived fibrinogen
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
6 secondary outcomes
EORTC_C30
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
EORTC_OPT30
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
HADS questionnaire
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Physical activity levels
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
TUG test
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
30s StS Test
Time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Ocular Melanoma, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood biomarkers: glucose (time frame: At baseline, during hospital discharge day (5-7 days after baseline measure) and one month after hospital discharge.). The study lists 60 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.