Effect of a Wearable Technology-Supported Exercise Program on Fatigue and Health-Related Quality of Life in Pediatric Cancer Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Cancer-Related Fatigue
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: standart care (Other)
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.
干预措施: Wearable Technology-Supported Exercise Program (Other)
结局指标
主要结局
Cancer-Related Fatigue
时间窗: 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.
次要结局
- Health-Related Quality of Life(Baseline (week 0), mid-intervention (week 4), and post-intervention (week 8))
研究者
Yagmur Berktas
Principal Investigator
Istanbul University