Cardiorespiratory Fitness in Children and Adolescents After Cancer Treatment. (POWER)

Universität Duisburg-Essen

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: All Types of Pediatric Cancer

Treatments: Behavioral: Experimental: moderate to high-intensity exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04765020

HCRI ID 2020-0250

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 estimated patients

Sex: All

Ages: 7 to 23 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children and adolescents between 7 and 23 years of age
• Completion of acute cancer treatment and receiving follow-up care in Krefeld (Helios Hospital Krefeld)
• 6 weeks post cancer-treatment
• Signed informed consent (Parents and Patient)

Exclusion criteria

• <7 years of age, >23 years of age
• Medical condition that limits participation in one of the study arms
• Inability to follow the training-protocol
• Inability to carry out the spiroergometry on a cycle ergometer

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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56 participants in 2 patient groups

Intervention group

Experimental group

Description:

12 weeks moderate to high-intensity exercise program

Treatment:

Behavioral: Experimental: moderate to high-intensity exercise

Control group

No Intervention group

Description:

exercise recommendations