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

Effects of a Physical Activity Program On Cardiorespiratory Fitness in Children and Adolescents folloWing Acute cancER Treatment: a Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: All Types of Pediatric Cancer
• Intervention / Treatment: Behavioral: Experimental: moderate to high-intensity exercise

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.

• Study Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Sandra Goertz, B.Sc.; Phone Number: +49 2151 32 45098; Email: sandra.goertz@helios-gesundheit.de
• Study Contact Backup: Name: Miriam Götte, PhD; Phone Number: +49 201 723 8083; Email: miriam.goette@uk-essen.de

Study Locations

• Germany
  • Krefeld, Germany
    • Recruiting
    • Helios Klinik Krefeld
    • Contact: Lisa Maas, M.Sc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 23 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 12 weeks moderate to high-intensity exercise program	Behavioral: Experimental: moderate to high-intensity exercise; Four parts: Initial consultation with recommendations for general physical activity, brochure with exercise recommendations; Once per week multi-modal group-based exercise (endurance, strength, mobility, coordination); Once per week supervised multi-modal individual training session (endurance, strength, mobility, coordination). Intensity: 60-80% of max. HR; Activity trackers with individual movement goals that will be adjusted every two weeks; Other Names: 12-week, partially supervised exercise program; general exericse recommendationy
No Intervention: Control group; exercise recommendations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	CPET is performed on an electronically braked cycle ergometer (Ergoline ergoselect 150 P) following the GDPK-Ergometry-Protocol). Ventilation and gas exchange data are determined breath-by-breath (Geratherm Respiratory Ergostik). VO2 peak is defined as the highest mean over 60 s and expressed on milliliters/kilogram/minute (ml/kg/min).	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events		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
Muscle strength	Change in maximal muscle strength (CITEC handheld dynamometer; expressed in Newton), balance (single leg stance; expressed in seconds), functional mobility (TUG 3m; expressed in seconds), and body composition (Data Input Nutribox) between both study arms from T0 to T1, T0 to T2 and T1 to T2	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
Functional mobility	Time (in sec) to complete the Timed Up and Go Test (TUG). The participants perform one test trial. The time of standing up, walking at a safe and comfortable pace to a mark 3 meters away from them, returning to the chair and sitting back down is recorded.	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
Static Balance	Single leg stance on a wooden bar, adapted by the MOON test, number of times the ground is touched during a one-minute test procedure	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
Body Composition	Body composition is assessed by bioimpedance analysis. Whole body resistance and reactance are measured using the BIA device Data Input Nutribox.	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
Change in level of physical activity	3. Change in level of physical activity (questionnaire and activity monitor) between both study arms at T1 and T2 and intra-individually	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
Change in Quality of Life	(PedsQL - Pediatric Quality of Life Inventory), change in Fatigue (Multidimensional Fatigue Inventory) and cognitive function (Ravens Progressive; WISC V - subtest memory; TAP ) between both study arms at T1 and T2 and intra-individually	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
Changes in serum markers	CRP, BDNF, Insulin, Glukose, Adiponectin, Leptin, IL-1 beta, IL-2, IL-4, IL-6, IL-7, IL-8, IL-10, IL-15, IL 17a, TNF alpha, CRP, BDNF, IGF 1, MIF (macrophage migration inhibiting factor), IFN gamma, Troponin, NT-pro-BNP, between both study arms at T1 and T2 and intra-individually	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
Changes in Echocardiography markers	M-Mode-Parameter	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
Changes in Echocardiography markers	Left ventricle end diastolic volume (LVEDV) in ml/m²	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
Changes in Echocardiography markers	Ejection Fraction (EF) in %	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
Changes in Echocardiography markers	Tricuspid Annular Plane Systolic Excursion (TAPSE) in Millimeter	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

Collaborators and Investigators

• Sponsor: Universität Duisburg-Essen
• Collaborators: University Hospital, Essen; Helios Hospital Krefeld; Oslo Centre for Biostatistics and Epidemiology
• Investigators: Principal Investigator: Miriam Götte, Phd, University Hospital, Essen

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2021
• Primary Completion (Anticipated): June 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: January 26, 2021
• First Submitted That Met QC Criteria: February 18, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): November 3, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: physical activity; exercise; immune function; child health; cardiorespiratory fitness; pediatric oncology
• Other Study ID Numbers: HCRI ID 2020-0250

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No