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EFFECTS OF A THERAPEUTIC STRENGTH TRAINING PROGRAMME IN PAEDIATRIC CANCER PATIENTS

4. Juni 2026 aktualisiert von: CARLOS MARTIN SANCHEZ, University of Salamanca

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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

20

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Carlos Martin-Sanchez, PhD
  • Telefonnummer: +34646774655
  • E-Mail: carlos_ms@usal.es

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Supervised intervention group using therapeutic strength training
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.
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.
Experimental: Home-based intervention group without supervised exercise
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.
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Short Physical Performance Battery
Zeitfenster: From enrollment to the end of treatment at 12 weeks
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
Zeitfenster: 12 weeks
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
Zeitfenster: 12 weeks
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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Handgrip strength
Zeitfenster: 12 weeks
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
Zeitfenster: 12 weeks
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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

30. Mai 2026

Primärer Abschluss (Geschätzt)

30. September 2026

Studienabschluss (Geschätzt)

30. Dezember 2026

Studienanmeldedaten

Zuerst eingereicht

20. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. Juni 2026

Zuerst gepostet (Tatsächlich)

10. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • PaediatricCancer

Plan für individuelle Teilnehmerdaten (IPD)

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Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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