Wearable Technology-Supported Exercise Program for Fatigue and Quality of Life in Pediatric Cancer Patients (WE-EX PedsCa)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: standart care, Wearable Technology-Supported Exercise Program.
- Who it may be relevant to
- Registry conditions: Pediatric Cancer, Cancer-related Fatigue, Quality of Life, Exercise. Basic parameters: 13 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of a Wearable Technology-Supported Exercise Program on Fatigue and Health-Related Quality of Life in Pediatric Cancer Patients: A Randomized Controlled Trial
Overview
Children and adolescents receiving cancer treatment often experience fatigue, reduced physical activity, and decreased quality of life. Although exercise has been shown to reduce these problems, maintaining regular and safe physical activity during cancer treatment can be difficult due to treatment side effects, safety concerns, and limited access to supervised programs. This study aims to evaluate the feasibility, safety, and effectiveness of a wearable technology-supported exercise program on fatigue and health-related quality of life in pediatric cancer patients aged 13 to 18 years. Participants will be randomly assigned to either an intervention group or a control group. The intervention group will participate in an 8-week structured exercise program delivered through a mobile application, including video-guided exercise sessions performed three times per week and monitored continuously using a wearable activity tracker. The control group will receive standard care and will wear the activity tracker for passive monitoring only. Fatigue and quality of life will be assessed at baseline, mid-intervention, and after completion of the program. Physical activity, heart rate, sleep patterns, and adherence to the exercise program will be objectively monitored using wearable devices. The findings from this study are expected to provide evidence on whether a digitally delivered, wearable-supported exercise program is a feasible and beneficial approach to improving well-being in children and adolescents undergoing cancer treatment.
Detailed description
Detailed Description
This study is a single-center, parallel-group, randomized controlled trial designed to evaluate the feasibility, safety, and efficacy of a wearable technology-supported structured exercise program on fatigue and health-related quality of life (HRQoL) in pediatric cancer patients aged 13-18 years who are receiving active cancer treatment.
Eligible participants will be randomly assigned in a 1:1 ratio to either an intervention group or a control group using stratified randomization based on age, sex, and cancer diagnosis. Allocation concealment will be ensured through a secure electronic randomization system. Treating pediatric oncologists will remain blinded to group allocation.
Study Intervention
Participants in the intervention group will take part in an 8-week structured exercise program delivered through a mobile application. The program consists of video-guided exercise sessions performed three times per week, with each session lasting approximately 40 minutes. The exercise protocol includes warm-up, aerobic, strengthening, coordination, and cool-down components and is designed to be low to moderate intensity, adaptable to individual clinical conditions, and safely performed either in seated or standing positions. Exercise content was developed by a multidisciplinary team and incorporates engagement strategies such as animated guidance and gamification elements to support adherence.
Participants in the control group will receive standard care without a structured exercise intervention. Both groups will wear a commercially available wearable activity tracker throughout the study period to allow objective monitoring of physical activity and physiological parameters. In the control group, the device will be used for passive monitoring only.
Monitoring and Assessments
Fatigue and health-related quality of life will be assessed at baseline (week 0), mid-intervention (week 4), and post-intervention (week 8) using validated, age-appropriate instruments administered through the mobile platform. Objective physical activity data, including daily step counts, active minutes, heart rate, sleep duration and patterns, and device wear time, will be continuously collected via wearable devices and securely integrated into the study database.
Functional exercise capacity will be assessed using the 6-minute walk test at the same three time points. Engagement and adherence to the intervention will be evaluated using app-based metrics such as exercise session completion, frequency of use, and participation consistency.
Safety and Feasibility
Participants will be monitored throughout the study for adverse events related to exercise participation. A pediatric hematology-oncology physician and specialist nurse will oversee clinical safety. Feasibility outcomes will include recruitment rate, retention rate, adherence to exercise sessions, and completeness of wearable-derived data.
Data Analysis
Analyses will be conducted according to the intention-to-treat principle. Changes in fatigue and HRQoL over time and between groups will be examined using appropriate repeated-measures statistical methods based on data distribution. Secondary analyses will explore changes in physical activity, sleep parameters, and engagement metrics. Effect sizes will be calculated to inform the design of future multicenter trials.
Study Purpose
This trial aims to generate preliminary evidence on the clinical applicability of integrating wearable technology-supported exercise into pediatric oncology care. The findings are intended to inform larger-scale studies and contribute to the development of scalable, evidence-based digital exercise interventions for children and adolescents undergoing cancer treatment.
Interventions
- Other standart care
Usual pediatric oncology care with passive wearable monitoring and no structured exercise guidance. - Other Wearable Technology-Supported Exercise Program
Wearable Technology-Supported Exercise Program
Primary outcome measures
- Cancer-Related Fatigue [Time frame: Baseline (week 0), mid-intervention (week 4), and post-intervention (week 8)]
Secondary outcome measures (1)
- Health-Related Quality of Life [Time frame: Baseline (week 0), mid-intervention (week 4), and post-intervention (week 8)]
Eligibility criteria
Inclusion criteria
- Aged 13 to 18 years.
- Diagnosed with cancer and followed at a pediatric hematology-oncology clinic.
- Currently receiving active cancer treatment and has completed at least one cycle of chemotherapy.
- Clinically stable and medically cleared by the treating physician to participate in low-to-moderate intensity exercise.
- Able to understand instructions and communicate verbally.
- Willing to participate in at least 75% of the prescribed exercise sessions.
- Written informed consent obtained from a parent or legal guardian and assent obtained from the participant.
Exclusion criteria
- Presence of acute infection, uncontrolled cardiac or pulmonary disease, respiratory failure, or uncontrolled hypertension.
- Severe neurological, psychiatric, or musculoskeletal conditions that limit safe participation in exercise.
- Persistent thrombocytopenia (<10,000/µL) or known coagulation disorders.
- Uncontrolled seizure disorders.
- Central nervous system metastases.
- Any medical or psychological condition deemed by the treating physician to contraindicate exercise participation or compromise study procedures.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07337681 · IU-PHO-EX-2026