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

January 12, 2026 updated by: Yagmur Berktas, Istanbul University

Effect of a Wearable Technology-Supported Exercise Program on Fatigue and Health-Related Quality of Life in Pediatric Cancer Patients: A Randomized Controlled 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Wearable Technology-Supported Exercise Program
Wearable Technology-Supported Exercise Program
Active Comparator: 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.
Other: standart care
Usual pediatric oncology care with passive wearable monitoring and no structured exercise guidance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cancer-Related Fatigue
Time Frame: Baseline (week 0), mid-intervention (week 4), and post-intervention (week 8)
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.
Baseline (week 0), mid-intervention (week 4), and post-intervention (week 8)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-Related Quality of Life
Time Frame: Baseline (week 0), mid-intervention (week 4), and post-intervention (week 8)
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.
Baseline (week 0), mid-intervention (week 4), and post-intervention (week 8)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise Adherence
Time Frame: Throughout the 8-week intervention period
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.
Throughout the 8-week intervention period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

January 4, 2026

First Submitted That Met QC Criteria

January 12, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IU-PHO-EX-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data underlying the results reported in this study will be shared upon reasonable request. Data will be shared only after publication of the main study results and following approval of a data-sharing request.

IPD Sharing Time Frame

Beginning 6 months after publication and ending 5 years following publication.

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal may request access to the data. Requests will be reviewed by the principal investigator. Data will be shared in a de-identified format to protect participant confidentiality.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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