Cardiorespiratory Fitness in Children and Adolescents After Cancer Treatment.

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age7-23
SponsorUniversität Duisburg-Essen

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

<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

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

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).

Time frame
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

1

Adverse events

Time frame
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
2

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

Time frame
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
3

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.

Time frame
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
4

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

Time frame
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

Sponsors and contacts

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Universität Duisburg-Essen

Lead sponsor

Helios Hospital Krefeld

Collaborator

Oslo Centre for Biostatistics and Epidemiology

Collaborator

University Hospital, Essen

Collaborator