Clinical Trials Directory

Trials / Completed

CompletedNCT07003607

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
72 (actual)
Sponsor
Ke Liu · Academic / Other
Sex
All
Age
6 Years – 18 Years
Healthy volunteers
Not accepted

Summary

This is a clinical trial that tested whether a 12-week exercise program using smart wristbands and personalized goal-setting could help children with cancer become more active, feel more confident about exercising, and improve their quality of life. The study included 72 children and teenagers (ages 6-18) receiving cancer treatment at two hospitals in China. They were divided into two groups: Intervention group (33 children): Used a smart wristband to track daily steps, followed a personalized exercise plan, and received weekly guidance. Control group (39 children): Continued with usual care (no special exercise program). The main questions it aims to answer are: 1. Does the exercise program help children with cancer move more and sit less; 2. Can it boost their confidence to stay active and improve their physical and emotional well-being?

Detailed description

What did the study find? * Children in the exercise group: * Increased active time: They did more moderate-to-vigorous exercise (like brisk walking or playing) by the end of the program. * Walked more steps daily: From about 2,200 steps/day at the start to over 6,300 steps/day after 12 weeks. * Felt more confident: They believed they could keep exercising even during treatment. * Improved well-being: Parents and children reported better physical energy, mood, and social interactions. * Comparison with the control group: * The exercise group showed much greater improvements than the group without the program. What does this mean for families? This study suggests that combining wearable devices (like step trackers) with simple goal-setting and family support may help children with cancer stay active during treatment. Staying active could reduce fatigue, improve mood, and support recovery. What's next? While these results are promising, larger studies are needed to confirm the long-term benefits and safety of such programs.

Conditions

Interventions

TypeNameDescription
BEHAVIORALControl group (placebo)Children in the control group received routine health education, which included cancer-related treatment, care, and general health education (e.g., treatment-related, diet, and exercise) without systematic PA health education. Every four weeks, knowledge related to sports activities, the harms of insufficient physical activity, and the benefits of increasing physical activity were pushed through the WeChat platform. During the hospitalization of the child patient, they can voluntarily participate in the activities organized by social workers.
BEHAVIORALIn-Hospital ProgramResearchers will conduct a comprehensive evaluation for each pediatric patient, including: * Disease status and clinical characteristics * Patient and family knowledge regarding physical activity (PA) * Availability of social support systems
BEHAVIORALIn-Hospital ProgramBased on assessment findings, two structured educational sessions (20-30 minutes each) will be delivered, covering: * Disease-specific knowledge and PA guidelines * Practical strategies for safe exercise (e.g., intensity adjustment, injury prevention) * Interactive demonstrations of age-appropriate movement techniques
BEHAVIORALIn-Hospital ProgramPatients will co-develop personalized PA plans using the six-step self-regulation framework from the ITHBC (Integrative Theory of Health Behavior Change), including: * Short/long-term goal formulation * Progress monitoring tools * Barrier problem-solving protocols
BEHAVIORALPost-Discharge ProgramPatients will perform PA 3-5 times weekly (20-30 minutes/session) aligned with individualized goals, adhering to oncology-specific safety guidelines
BEHAVIORALPost-Discharge ProgramMondays: Curated PA educational content (e.g., home-based exercise videos, fatigue management tips) will be disseminated via the WeChat platform. Sundays: Scheduled telehealth check-ins with patients and caregivers to: * Review PA adherence and experiential feedback * Address knowledge gaps through tailored coaching * Reinforce behavior change techniques (e.g., self-monitoring logs)
BEHAVIORALPost-Discharge ProgramRegular monitoring and evaluation will be conducted to assess PA outcomes: comprehensive evaluations will identify barriers (e.g., treatment-related fatigue) and guide real-time adjustments to the exercise plan based on the patient's physical condition and performance. To enhance adherence, families will collaboratively set alarm reminders for PA sessions, and caregivers will be invited to supervise daily activities.

Timeline

Start date
2023-07-10
Primary completion
2024-07-30
Completion
2024-12-25
First posted
2025-06-04
Last updated
2025-06-04

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT07003607. Inclusion in this directory is not an endorsement.