NCT04765020

Cardiorespiratory Fitness in Children and Adolescents After Cancer Treatment.

Effects of a Physical Activity Program on Cardiorespiratory Fitness in Children and Adolescents FolloWing Acute CancER Treatment: a Randomized Controlled Trial

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Universität Duisburg-Essen · Academic / Other
• Sex: All
• Age: 7 Years – 23 Years
• Healthy volunteers: Not accepted

Summary

The POWER-study is a two-arm exercise intervention study for pediatric patients following acute cancer treatment. This clinical trial will investigate the effects of a 12-week moderate to high-intensity exercise program on cardiorespiratory fitness in children and adolescents beginning 6 weeks after completion of acute cancer treatment.

Detailed description

The main objective of the POWER study is to investigate the effects of a 12-week moderate to high-intensity, partially supervised exercise program on cardiorespiratory fitness (VO2peak) in children and adolescents who have completed acute cancer treatment. This randomized controlled trial will include n=56 patients. Patients will be randomly assigned to the intervention or the control group. Patients in the intervention group will perform two supervised exercise sessions per week, one personal training session and one group-based training session. During an initial consultation, both groups receive recommendations for individual physical activity goals and a brochure with exercise recommendations as well as a fitness tracker to monitor their daily physical activity. Only the intervention group will receive daily activity targets, which will be adjusted on a regular basis. The study starts 6 weeks after completion of the patient's acute cancer treatment. Secondary aims of this interventional study are to evaluate additional performance markers, including muscle strength, functional mobility, balance, body composition and patient-reported outcomes including QoL, fatigue, and cognitive function as well as blood markers to evaluate changes in metabolic, immune, and heart health.

Conditions

• All Types of Pediatric Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Experimental: moderate to high-intensity exercise	Four parts: 1. Initial consultation with recommendations for general physical activity, brochure with exercise recommendations 2. Once per week multi-modal group-based exercise (endurance, strength, mobility, coordination) 3. Once per week supervised multi-modal individual training session (endurance, strength, mobility, coordination). Intensity: 60-80% of max. HR 4. Activity trackers with individual movement goals that will be adjusted every two weeks

Timeline

• Start date: 2021-06-21
• Primary completion: 2025-06-01
• Completion: 2026-12-01
• First posted: 2021-02-21
• Last updated: 2024-12-06

Locations

1 site across 1 country: Germany