EFFECTS OF A THERAPEUTIC STRENGTH TRAINING PROGRAMME IN PAEDIATRIC CANCER PATIENTS

NCT07638163 | Not Yet Recruiting

• 1 other identifier: PaediatricCancer
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Cancer; Paediatric

Keywords

Cancer; Exercise; Paediatric

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (2)

• Handgrip strength

  12 weeks

• 5-squat test

  12 weeks

Study Arms (2)

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.

Other: Supervised training

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.

Other: Home training

Interventions

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.

Home-based intervention group without supervised exercise

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.

Supervised intervention group using therapeutic strength training

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Salamanca: lead

Related Publications (1)

• 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.

  PMID: 28423225 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Carlos Martin-Sanchez, PhD

CONTACT

+34646774655; carlos_ms@usal.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 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.

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: June 10, 2026
• Study Start: May 30, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: June 10, 2026

Record last verified: 2026-06