An interventional study of Supervised training and Home training in Cancer and Paediatric, sponsored by University of Salamanca. Not yet recruiting. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by University of Salamanca · Not applicable, Interventional, and Treatment
This project is made possible through the Pediatrics Department of the University Hospital of Salamanca, in collaboration with researchers specialized in therapeutic exercise from other clinical trials and research projects, alongside physical therapists experienced in designing, programming, and supervising therapeutic exercise programs.
Furthermore, the project addresses current healthcare needs, as a significant portion of the patient population exhibits symptoms that impair functional capacity and overall quality of life-driven both by age and the oncological disease and its treatment. Consequently, this initiative aims to implement a strength training program to foster beneficial outcomes across various aspects of these patients' health, while sharing the findings with the scientific community.
Background and Current State of the Art Childhood cancer, although relatively rare compared to adult cancer, is one of the leading causes of morbidity and mortality due to disease in the pediatric population worldwide. It is estimated that more than 400,000 cases of cancer are diagnosed each year in children and adolescents under the age of 19, with leukemias, central nervous system tumors, and lymphomas being the most common types. Despite significant advances in diagnosis and treatment that have substantially increased survival rates in recent decades, many pediatric patients experience physical and psychological side effects derived from both the disease and oncological treatments, including chemotherapy, radiotherapy, or surgery.
Among the most frequent complications are cancer-related fatigue, muscle mass loss, decreased cardiorespiratory capacity, functional impairment, and psychological alterations such as anxiety, depression, or social adaptation difficulties. These effects can significantly impact the physical, cognitive, and emotional development of children, as well as their quality of life during and after treatment.
In this context, physical exercise has emerged as a promising non-pharmacological intervention to improve the health and well-being of pediatric patients with chronic diseases, including cancer. Various studies in the adult population have shown that exercise can help reduce fatigue, preserve muscle mass, improve cardiorespiratory function, and promote psychological well-being during oncological treatment. In recent years, research in the pediatric population has begun to explore these benefits, showing positive preliminary results.
Physical exercise, when prescribed safely and adapted to the patient's clinical and functional characteristics, can contribute to enhancing functional capacity, promoting physical recovery, and fostering participation in daily and school activities. Furthermore, it has been observed that physical activity can play an important role in regulating relevant physiological processes in cancer patients, such as systemic inflammation, energy metabolism, and immune function.
Despite these promising findings, scientific evidence regarding the effects of physical exercise in the pediatric cancer population remains limited compared to that available for adults. In particular, there are significant gaps regarding optimal exercise prescription, including the most appropriate type of activity, intensity, frequency, and duration for different ages, tumor types, and treatment phases. Therefore, further research into the impact of physical exercise on children with cancer is necessary to develop evidence-based intervention programs that contribute to improving their recovery and quality of life.
Background and Current State of the Problem In recent years, interest in the role of physical exercise in pediatric cancer care has increased considerably. Several studies have shown that supervised physical activity is safe and feasible during different phases of cancer treatment in children and adolescents, and that it can contribute to improving cardiorespiratory capacity, muscle strength, and quality of life.
One of the main problems associated with cancer and its treatments in the pediatric population is the decline in physical fitness. Prolonged chemotherapy, frequent hospitalization, and the reduction of habitual physical activity promote the development of muscle weakness, loss of muscle mass, and decreased functional capacity. These alterations can have long-term consequences, including an increased risk of cardiovascular disease, obesity, and metabolic syndrome in survivors of childhood cancer.
In this regard, physical exercise-and particularly combined training that includes aerobic and strength components-has proven effective in improving muscle strength, cardiorespiratory endurance, and functionality in children with chronic diseases. In pediatric cancer patients, some studies have reported improvements in mobility, exercise tolerance, and the ability to perform daily activities following the implementation of supervised exercise programs.
In addition to physical benefits, exercise can have a positive impact on the psychological well-being of children with cancer. Participation in adapted physical activities can boost self-esteem, reduce anxiety levels, and improve mood, as well as promote social interaction and the maintenance of routines similar to those of other children their age.
Another relevant aspect is the potential effect of exercise on physiological processes involved in disease progression and patient recovery, such as systemic inflammation and immune function. Some studies have suggested that physical activity can modulate the release of inflammatory cytokines and improve the immune response, which could contribute to a better adaptation of the organism to oncological treatment [17].
However, despite advances in this field, research on physical exercise in pediatric cancer patients remains limited and heterogeneous. There are major methodological differences between studies regarding the design of exercise programs, the duration of interventions, and the variables evaluated, which makes it difficult to establish clear recommendations for clinical practice.
Therefore, it is fundamental to continue developing research that allows for a better understanding of the effects of physical exercise in this population and to establish safe, effective intervention protocols tailored to the specific needs of pediatric patients. Generating evidence in this area will contribute to integrating physical exercise as part of a multidisciplinary approach to childhood cancer care, aimed not only at survival but also at improving the quality of life and holistic development of affected children.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 7,703 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →University of Salamanca is the lead sponsor of 112 studies on the registry; 47 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Supervised Intervention Group (Therapeutic Strength Exercise Program): The therapeutic strength exercise program will focus on strength exercises, although daily aerobic exercises will also be included.The intervention group will perform a supervised therapeutic strength exercise program two days a week, combined with a physical activity promotion program to be completed at home four days a week. All supervised strength exercise sessions will be led by a physical therapist in a physical therapy clinic with appropriate space for the intervention.
Other: Supervised training
Patients in the home-based intervention group will only follow the physical activity promotion programme five days a week. This will be combined with a 60-minute walk every day of the week.
Other: Home training
Supervised Strength Exercise Sessions: There will be two weekly sessions, each lasting 50 minutes. Each session consists of three well-defined parts:Warm-up: 10 minutes of global strength and aerobic exercises at an estimated 60% of VO2max, focusing on the primary areas to be worked on during that session.Strength Training: 6 strength exercises targeting the main muscle groups, with a duration of 30 minutes. The initial load will be set between 40-70% of the estimated 1-RM (to be assessed in the first session and based on the patient's individual characteristics). When the participant is able to complete 3 sets of 12 repetitions with the established weight in two consecutive sessions, the weight will be increased by 10%. Cool-down/Stretching: 10 minutes of a combination of breathing exercises and stretching of the main muscle groups.
Participants will complete four weekly home-based exercise sessions, which will not coincide with the supervised training days. Each session will last approximately 20 minutes, and they will complete two sets of five exercises-primarily light strength work-with one minute of work and one minute of rest. Additionally, all participants will be required to walk for 60 minutes every day of the week.
Short Physical Performance Battery
Functional status: the Short Physical Performance Battery (SPPB) will be used. It consists of three tests that assess balance, lower limb strength (using the 5-squat test) and walking speed over 4 metres. The maximum score is 12 points, and a score of ≤ 8 points indicates poor physical performance, although each of the three tests is also assessed independently. Minimum value 0, maximum value 12. Higher scores mean a better outcome.
Time frame: From enrollment to the end of treatment at 12 weeks
Patient Health Questionnaire-9
The PHQ-9 (Patient Health Questionnaire-9) is a standard 9-question self-report tool used by clinicians to screen for depression and measure its severity. It asks you to rate how often you have been bothered by specific symptoms over the past two weeks. Each of the 9 items is scored from 0 to 3 based on frequency: 0: Not at all 1: Several days 2: More than half the days 3: Nearly every day. Total scores range from 0 to 27, with higher numbers indicating more severe depressive symptoms.0-4: Minimal or no depression5-9: Mild depression (monitor and use clinical judgment)10-14: Moderate depression15-19: Moderately severe depression (warrants active treatment)20-27: Severe depression.
Time frame: 12 weeks
Generalized Anxiety Disorder 7
The GAD-7 (Generalized Anxiety Disorder 7) is a brief, 7-question clinical screening tool used to measure the severity of generalized anxiety and identify probable anxiety disorders based on symptoms experienced over the past two weeks. Each of the 7 items is rated on a 4-point scale, resulting in a total score ranging from 0 to 21: Not at all: 0 points Several days: 1 point More than half the days: 2 points Nearly every day: 3 points Interpreting Your Results: Add the scores for all 7 questions together to find your severity level: 0-4: Minimal Anxiety 5-9: Mild Anxiety 10-14: Moderate Anxiety 15-21: Severe Anxiety
Time frame: 12 weeks
Handgrip strength
Handgrip strength: This will be assessed using a dynamometer to measure grip strength. Grip strength values below 16 kg are considered indicative of possible sarcopenia. Higher scores mean a better outcome.
Time frame: 12 weeks
5-squat test
5-squat test: The time taken to stand up and sit down 5 times on a chair without support is assessed. Times exceeding 15 seconds are considered positive, indicating probable sarcopenia. Higher values mean worse outcome
Time frame: 12 weeks
No study locations are listed for this record.
Plan to share: Undecided
Start is estimated for May 2026; primary completion for Sep 2026, 4 months later.
Of 1,981 non-industry interventional studies with no phase under Neoplasms, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 52. This study's planned 4 months is below that.
Counting every sponsor, half of 2,056 studies reached it within 29 months; a quarter within 13 and three quarters within 52.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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