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CancerNCT07638163

EFFECTS OF A THERAPEUTIC STRENGTH TRAINING PROGRAMME IN PAEDIATRIC CANCER PATIENTS

A study testing Supervised training and Home training in people with Cancer and Paediatric, run by University of Salamanca.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages Up to 18 years
Conditions the study is for
Cancer, Paediatric
What is being tested?
Supervised training and Home training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
30 May 2026to 30 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 Up to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • People under the age of 18 who have been diagnosed with cancer and are currently undergoing treatment or living with the after-effects of the disease.
  • People who have not engaged in regular physical activity in the last 8 weeks.
  • Performance Status (ECOG) 0-1.
  • Signing of the informed consent form.

Who cannot join

  • Have any contraindications to physical exercise: severe musculoskeletal disorders, severe cardiovascular diseases, uncontrolled bone metastases, and other conditions as determined by a healthcare professional.
  • Patients who are unable to undergo the initial assessment tests or who have difficulty performing basic exercises.
  • Patients who must discontinue treatment due to intolerance to it.
  • Other circumstances, at the discretion of the investigators, that may interfere with the purpose or conduct of the study.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Carlos Martin-Sanchez, PhD contact

+34646774655

carlos_ms@usal.es

About this study

Official title: EFFECTS OF A THERAPEUTIC STRENGTH TRAINING PROGRAMME ON QUALITY OF LIFE, FUNCTIONAL ABILITY AND MENTAL HEALTH IN PAEDIATRIC CANCER PATIENTS

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.

Read the detailed description

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.

Conditions
Cancer, Paediatric
Being tested
Supervised training, Home training
Keywords
Cancer, Exercise, Paediatric
Medical subject headings
Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Supervised trainingOther

    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.

  • Home trainingOther

    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.

Study groups in NCT07638163
Study groupRoleWhat they receive
Supervised intervention group using therapeutic strength trainingExperimentalSupervised 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.
Receives: Other: Supervised training
Home-based intervention group without supervised exerciseExperimentalPatients 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.
Receives: Other: Home training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From enrollment to the end of treatment at 12 weeks

  2. 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.

    Measured: 12 weeks

  3. 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

    Measured: 12 weeks

Secondary outcomes (2)
  1. 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.

    Measured: 12 weeks

  2. 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

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2026
  2. Study start30 May 2026 (estimated)
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

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
Model description
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.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07638163
Sponsor's protocol ID
PaediatricCancer
Status last verified
Jun 2026
First submitted
20 May 2026
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 28423225

Questions about this trial

What is this clinical trial studying?

A study testing Supervised training and Home training in people with Cancer and Paediatric, run by University of Salamanca.

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 4 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: opening soon, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

Contact Carlos Martin-Sanchez, PhD (+34646774655, carlos_ms@usal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Short Physical Performance Battery (time frame: From enrollment to the end of treatment at 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07638163, which also lists 1 linked publication.

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 10 Jun 2026.

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