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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supervised intervention group using therapeutic strength training | Experimental | 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. |
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| Home-based intervention group without supervised exercise | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supervised training | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| 5-squat test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carlos Martin-Sanchez, PhD | Contact | +34646774655 | carlos_ms@usal.es |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28423225 | Background | Rustler V, Hagerty M, Daeggelmann J, Marjerrison S, Bloch W, Baumann FT. Exercise interventions for patients with pediatric cancer during inpatient acute care: A systematic review of literature. Pediatr Blood Cancer. 2017 Nov;64(11). doi: 10.1002/pbc.26567. Epub 2017 Apr 19. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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This is a double-blind, randomised, controlled clinical trial with two parallel groups, in which paediatric patients with cancer will be recruited. Study participants will be assigned to one of the two study arms: 1) Supervised intervention group with therapeutic strength training; 2) Home-based intervention group without supervised exercise.
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In this research project, the evaluators will be blinded, as none of them will know which group the participants belong to. Due to the nature of the study, the participants cannot be blinded. Furthermore, the statistical analysis will be carried out by an independent statistician who will not know which intervention group the participants are in; therefore, they will also be blinded.
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| Home training | Other | 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. |
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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
| 12 weeks |