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Cardiorespiratory Fitness in Children and Adolescents After Cancer Treatment.

NCT ID: NCT04765020

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-21

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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All Types of Pediatric Cancer

Keywords

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exercise cardiorespiratory fitness pediatric oncology child health physical activity immune function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Intervention group

12 weeks moderate to high-intensity exercise program

Group Type EXPERIMENTAL

Experimental: moderate to high-intensity exercise

Intervention Type 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

Control group

exercise recommendations

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Experimental: moderate to high-intensity exercise

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

Intervention Type BEHAVIORAL

Other Intervention Names

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12-week, partially supervised exercise program general exericse recommendationy

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

23 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helios Hospital Krefeld

UNKNOWN

Sponsor Role collaborator

Oslo Centre for Biostatistics and Epidemiology

UNKNOWN

Sponsor Role collaborator

University Hospital, Essen

OTHER

Sponsor Role collaborator

Universität Duisburg-Essen

OTHER

Sponsor Role lead

Responsible Party

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Miriam Götte

Dr. rer. medic. Miriam Götte

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Miriam Götte, Phd

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Essen

Locations

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Helios Klinik Krefeld

Krefeld, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Sandra Goertz, B.Sc.

Role: CONTACT

Phone: +49 2151 32 45098

Email: [email protected]

Miriam Götte, PhD

Role: CONTACT

Phone: +49 201 723 8083

Email: [email protected]

Facility Contacts

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Lisa Maas, M.Sc

Role: primary

Other Identifiers

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HCRI ID 2020-0250

Identifier Type: -

Identifier Source: org_study_id