Effects of Resistance and Endurance Training in Pediatric Cancer Patients During Intensive Treatment Phase

NCT ID: NCT02612025

Last Updated: 2019-03-04

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

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2018-09-30

Brief Summary

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The purpose of this study is to determine whether combined endurance and resistance training can improve muscle strength in children and adolescents with cancer during the intensive treatment phase.

Detailed Description

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Conditions

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Pediatric Oncology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Exercise group

Exercise training during intensive medical treatment

Group Type EXPERIMENTAL

Exercise Training

Intervention Type BEHAVIORAL

Exercise training during intensive medical treatment. Training mainly composed of endurance and resistance exercises. 3 to 5 times per week for six weeks.

Control group

Usual Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise Training

Exercise training during intensive medical treatment. Training mainly composed of endurance and resistance exercises. 3 to 5 times per week for six weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Malignant Tumor
* Medical Treatment in the Center for Pediatrics, Hematology, Oncology and Hemostaseology Mainz (Germany)
* \> 3 years
* Signed Informed Consent

Exclusion Criteria

* Functional and/or cognitive limitations which limit performance during training
* Orthopedic condition which hinders to adequately participate in exercise training
* Heart failure (NYHA III-IV)
* Partial or global respiratory failure
* Symptomatic coronary disease
* Serious therapy-refractory hypertonia
* Sustainable thrombocytopenia \<10.000/µl, f. ex. therapy-refractory autoimmune thrombocytopenia
* Hereditary or acquired thrombocytopenia or coagulation disturbance
* Uncontrolled cerebral spasm
* CNS metastases
* Medical or psychological condition which does in the doctors opinion not allow participation in sport activity
Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johannes Gutenberg University Mainz

OTHER

Sponsor Role lead

Responsible Party

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Univ.Prof.Dr.med. Joerg Faber

Univ.-Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Johannes-Gutenberg-University

Mainz, Rhineland-Palatinate, Germany

Site Status

Countries

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Germany

References

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Winker M, Stossel S, Neu MA, Lehmann N, El Malki K, Paret C, Joisten N, Bloch W, Zimmer P, Faber J. Exercise reduces systemic immune inflammation index (SII) in childhood cancer patients. Support Care Cancer. 2022 Apr;30(4):2905-2908. doi: 10.1007/s00520-021-06719-3. Epub 2021 Dec 3.

Reference Type DERIVED
PMID: 34860287 (View on PubMed)

Stossel S, Neu MA, Wingerter A, Bloch W, Zimmer P, Paret C, Malki KE, Baumann FT, Russo A, Henninger N, Lehmann N, Otto H, Faber J. Benefits of Exercise Training for Children and Adolescents Undergoing Cancer Treatment: Results From the Randomized Controlled MUCKI Trial. Front Pediatr. 2020 Jun 5;8:243. doi: 10.3389/fped.2020.00243. eCollection 2020.

Reference Type DERIVED
PMID: 32582585 (View on PubMed)

Other Identifiers

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Mucki01

Identifier Type: -

Identifier Source: org_study_id

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