Exercise Intervention for Adolescents With Cancer (EXERCADOL): A Randomized Controlled Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The investigators will study the effects of an supevised exercise intervention along the duration of intensive treatment (neoadjuvant \[solid tumours\]/intense chemotherapy \[leukemias\], expected median duration 5-6 months) on several health-related variables. Participants will be recruited from 4 hospitals in Madrid (Spain). Inclusion criteria: male/female aged 12-19 years, newly diagnosed--or relapse of-- a malignant extracranial tumour; not having received any type of therapy--except surgery--at the time of diagnosis; adequate health status (Karnofsky/Eastern Cooperative Oncology Group scale score ≥50/≤2); to understand Spanish language and to provide written informed consent. The investigators will recruit ≥136 participants and conduct a randomised controlled trial. The intervention group will follow a supervised concurrent exercise program from the start to the end of intensive treatment. The exercise intervention will be performed in the hospital gymnasium or in the patients' ward (during neutropenic phases), and will also include supervised online sessions. Additionally, the intervention group will perform include inspiratory muscle training. The following outcomes will be assessed at baseline (diagnosis), end of treatment, and at 3-month follow-up in all participants: echocardiography-determined left ventricular function (primary outcome); and other echocardiography-determined variables, cardiac biomarkers, blood pressure, blood lipids, body composition, physical activity levels, energy intake, cardiorespiratory fitness, muscle strength, functional mobility, health-related quality of life, cancer-related fatigue, clinical variables, and potential biological underpinnings of exercise multisystemic benefits (metabolic and inflammatory markers, plasma proteome, gut microbiome, and immune function).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 19
Healthy Volunteers: f
View:

• Newly diagnosed with a malignant extracranial tumour

• Not having received any therapy--except surgery--at diagnosis

• Adequate health status (Karnofsky/Eastern Cooperative Oncology Group scale score ≥50/2)

• To understand Spanish language and provide written informed consent.

Locations
Other Locations
Spain
UEM
RECRUITING
Madrid
Universidad Europea de Madrid
RECRUITING
Villaviciosa De Odón
Contact Information
Primary
Alejandro Lucia
alejandro.lucia@universidadeuropea.es
+34661393101
Time Frame
Start Date: 2022-04-15
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 136
Treatments
Experimental: Intervention
The intervention group will follow a supervised physical exercise program.
No_intervention: Control
Standard care
Related Therapeutic Areas
Sponsors
Leads: Universidad Europea de Madrid

This content was sourced from clinicaltrials.gov