Clinical trial NCT04765020: Cardiorespiratory Fitness in Children and Adolescents After Cancer Treatment.
Official title: Effects of a Physical Activity Program on Cardiorespiratory Fitness in Children and Adolescents FolloWing Acute CancER Treatment: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: All Types of Pediatric Cancer
Keywords: exercise
cardiorespiratory fitness
pediatric oncology
child health
physical activity
immune function
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
Collaborators: name: Helios Hospital Krefeld
name: Oslo Centre for Biostatistics and Epidemiology
name: University Hospital, Essen
First posted: 2021-02-21
Enrollment: 56
Sex: ALL
Minimum age (years): 7
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in maximal oxygen uptake (VO2peak, ml/kg/min) from Baseline to T1 (end of intervention/12-weeks post randomization) between the two study groups, assessed in a maximal incremental exercise test (CPET) on a bicycle ergometer.
timeFrame: At Baseline T0: 6 weeks following acute cancer treatment, T1: after 12 weeks of intervention, T2 (Follow up): after 12 weeks after end of intervention = 24 weeks after study inclusion
Secondary outcomes:
measure: Adverse events
timeFrame: At Baseline T0: 6 weeks following acute cancer treatment, T1: after 12 weeks of intervention, T2 (Follow up): after 12 weeks after end of intervention = 24 weeks after study inclusion
measure: Muscle strength
timeFrame: At Baseline T0: 6 weeks following acute cancer treatment, T1: after 12 weeks of intervention, T2 (Follow up): after 12 weeks after end of intervention = 24 weeks after study inclusion
measure: Functional mobility
timeFrame: At Baseline T0: 6 weeks following acute cancer treatment, T1: after 12 weeks of intervention, T2 (Follow up): after 12 weeks after end of intervention = 24 weeks after study inclusion
measure: Static Balance
timeFrame: At Baseline T0: 6 weeks following acute cancer treatment, T1: after 12 weeks of intervention, T2 (Follow up): after 12 weeks after end of intervention = 24 weeks after study inclusion
measure: Body Composition
timeFrame: At Baseline T0: 6 weeks following acute cancer treatment, T1: after 12 weeks of intervention, T2 (Follow up): after 12 weeks after end of intervention = 24 weeks after study inclusion
measure: Change in level of physical activity
timeFrame: At Baseline T0: 6 weeks following acute cancer treatment, T1: after 12 weeks of intervention, T2 (Follow up): after 12 weeks after end of intervention = 24 weeks after study inclusion
measure: Change in Quality of Life
timeFrame: At Baseline T0: 6 weeks following acute cancer treatment, T1: after 12 weeks of intervention, T2 (Follow up): after 12 weeks after end of intervention = 24 weeks after study inclusion
measure: Changes in serum markers
timeFrame: At Baseline T0: 6 weeks following acute cancer treatment, T1: after 12 weeks of intervention, T2 (Follow up): after 12 weeks after end of intervention = 24 weeks after study inclusion
measure: Changes in Echocardiography markers
timeFrame: At Baseline T0: 6 weeks following acute cancer treatment, T1: after 12 weeks of intervention, T2 (Follow up): after 12 weeks after end of intervention = 24 weeks after study inclusion
measure: Changes in Echocardiography markers
timeFrame: At Baseline T0: 6 weeks following acute cancer treatment, T1: after 12 weeks of intervention, T2 (Follow up): after 12 weeks after end of intervention = 24 weeks after study inclusion
measure: Changes in Echocardiography markers
timeFrame: At Baseline T0: 6 weeks following acute cancer treatment, T1: after 12 weeks of intervention, T2 (Follow up): after 12 weeks after end of intervention = 24 weeks after study inclusion
measure: Changes in Echocardiography markers
timeFrame: At Baseline T0: 6 weeks following acute cancer treatment, T1: after 12 weeks of intervention, T2 (Follow up): after 12 weeks after end of intervention = 24 weeks after study inclusion
Other outcomes:
Locations:
city: Krefeld
country: Germany
facility: Helios Klinik Krefeld
Study officials:
affiliation: University Hospital, Essen
name: Miriam Götte, Phd
role: PRINCIPAL_INVESTIGATOR
References: