Resistance Exercise in Patients With Ocular Melanoma

NCT ID: NCT06970236

Last Updated: 2025-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Ocular Melanoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Exercise Intervention Group

Participants on this group will follow the exercise intervention mentioned in the protocol.

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

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.

Control Group

Patients in the control group will follow the hospital's conventional protocol during the hospitalization days, which consists in isolated bed rest.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adults with Choroidal Melanoma diagnose and treated with plaque brachytherapy undergoing in "Hospital Universitari i Politècnic La Fe" (Valencia).

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Valencia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Joaquín Calatayud Villalba

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Universitari i Politècnic de La Fe

Valencia, Spain, Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Joaquín Calatayud

Role: primary

+34 625 577 509

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IHOPE-2025

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Melphalan Chemoreduction for Ocular Melanoma
NCT05893654 ENROLLING_BY_INVITATION PHASE1/PHASE2
A Phase II Study of BVD-523 in Metastatic Uveal Melanoma
NCT03417739 ACTIVE_NOT_RECRUITING PHASE2