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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-31

Study Completion Date

2026-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

POZIKIDS: Exercise and Comprehensive Care to Improve the Quality of Life of Children and Adolescents With Cancer

NCT06321016

Exercise Childhood Cancer

NOT_YET_RECRUITING NA

Web-Based Physical Activity Intervention in Improving Long Term Health in Children and Adolescents With Cancer

NCT03223753

Carcinoma In Situ Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

ACTIVE_NOT_RECRUITING PHASE3

Physical Activity in Pediatric Cancer (PAPEC)

NCT01645436

Pediatric Cancer

COMPLETED NA

Wearable Device and Self-Regulation Strategies to Promote Physical Activity Among Children With Cancer: A Pilot Study

NCT07003607

Cancer

COMPLETED NA

Impact of a Physical Activity Program on the Health-Related Quality of Life in Pediatric Cancer Patients

NCT06813950

Cancer Pediatric Cancer

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pediatric Cancer Cancer-related Fatigue Quality of Life Exercise

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a single-center, parallel-group randomized controlled trial in which participants are assigned in a 1:1 ratio to either an intervention group receiving a wearable technology-supported structured exercise program or a control group receiving standard care with passive monitoring. Outcomes are assessed concurrently in both groups over an 8-week study period.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

This is an open-label study. Due to the nature of the exercise intervention, participants and study personnel are aware of group assignment. Treating pediatric oncologists are not informed of allocation and are not involved in outcome assessments.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Wearable Technology-Supported Exercise Program

A structured, video-guided exercise program delivered via a mobile application and supported by continuous monitoring using a wearable activity tracker.

Group Type EXPERIMENTAL

Wearable Technology-Supported Exercise Program

Intervention Type OTHER

Wearable Technology-Supported Exercise Program

Standard Care with Passive Monitoring

Participants assigned to this arm will receive standard pediatric oncology care without a structured exercise program. Participants will wear a wearable activity tracker for passive monitoring of physical activity, heart rate, and sleep patterns only.

Group Type ACTIVE_COMPARATOR

standart care

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

standart care

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

Intervention Type OTHER

Wearable Technology-Supported Exercise Program

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No