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EFFECTS OF A THERAPEUTIC STRENGTH TRAINING PROGRAMME IN PAEDIATRIC CANCER PATIENTS

ConditionsCancerPaediatric
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorUniversity of Salamanca

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Supervised training

    Other 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.

  • Home training

    Other intervention

    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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Supervised intervention group using therapeutic strength trainingExperimental treatment 1 intervention
Group B: Home-based intervention group without supervised exerciseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
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

Time frame
12 weeks

Secondary outcomes

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.

Time frame
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

Time frame
12 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Salamanca

Lead sponsor

Source ClinicalTrials.gov

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