Cardiorespiratory Fitness in Children and Adolescents After Cancer Treatment.

NCT04765020 | Recruiting Phase 2

• 1 other identifier: HCRI ID 2020-0250
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

All Types of Pediatric Cancer

Keywords

exercise; cardiorespiratory fitness; pediatric oncology; child health; physical activity; immune function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• 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

  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

  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

  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

  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

Study Arms (2)

Intervention group

EXPERIMENTAL

12 weeks moderate to high-intensity exercise program

Behavioral: Experimental: moderate to high-intensity exercise

Control group

NO INTERVENTION

exercise recommendations

Interventions

Experimental: moderate to high-intensity exercise BEHAVIORAL

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

Also known as: 12-week, partially supervised exercise program, general exericse recommendationy

Intervention group

Eligibility Criteria

• Age: 7 Years - 23 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)
• weeks post cancer-treatment
• Signed informed consent (Parents and Patient)

You may not qualify if:

• \<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

Sponsors & Collaborators

• Universität Duisburg-Essen: lead
• Helios Hospital Krefeld: collaborator
• Oslo Centre for Biostatistics and Epidemiology: collaborator
• University Hospital, Essen: collaborator

Study Sites (1)

Helios Klinik Krefeld

Krefeld, Germany

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Miriam Götte, Phd

  University Hospital, Essen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandra Goertz, B.Sc.

CONTACT

+49 2151 32 45098; sandra.goertz@helios-gesundheit.de

Miriam Götte, PhD

CONTACT

+49 201 723 8083; miriam.goette@uk-essen.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. rer. medic. Miriam Götte

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: February 21, 2021
• Study Start: June 21, 2021
• Primary Completion: June 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

DE (1)