Wearable Technology-Supported Exercise Program for Fatigue and Quality of Life in Pediatric Cancer Patients (WE-EX PedsCa)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-18
SponsorIstanbul University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • standart care

    Other intervention

    Usual pediatric oncology care with passive wearable monitoring and no structured exercise guidance.

  • Wearable Technology-Supported Exercise Program

    Other intervention

    Wearable Technology-Supported Exercise Program

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Wearable Technology-Supported Exercise ProgramExperimental treatment 1 intervention
Group B: Standard Care with Passive MonitoringActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cancer-Related Fatigue

Cancer-related fatigue will be assessed using a validated multidimensional fatigue scale including physical, cognitive, and general fatigue subscales. Higher scores indicate greater fatigue severity.

Time frame
Baseline (week 0), mid-intervention (week 4), and post-intervention (week 8)

Secondary outcomes

1

Health-Related Quality of Life

Health-related quality of life will be measured using the Pediatric Quality of Life Inventory (PedsQL 4.0) Cancer Module, which assesses physical, emotional, social, and school functioning.

Time frame
Baseline (week 0), mid-intervention (week 4), and post-intervention (week 8)

Other outcomes

1

Exercise Adherence

Exercise adherence will be evaluated based on the proportion of prescribed exercise sessions completed by participants in the intervention group, as recorded through the mobile application and wearable activity tracker.

Time frame
Throughout the 8-week intervention period

Locations

This trial has no locations.

Sponsors and contacts

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