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

March 1, 2019 updated by: Univ.Prof.Dr.med. Joerg Faber, Johannes Gutenberg University Mainz

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany, 55131
        • Johannes-Gutenberg-University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise group
Exercise training during intensive medical treatment
Behavioral: 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.
No Intervention: Control group
Usual Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle strength: lower limb
Time Frame: Six weeks (pre-post intervention)
Lower limb muscle strength measured by the load (kg) sustained in one repetition maximum test
Six weeks (pre-post intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle strength: upper limb
Time Frame: Six weeks (pre-post intervention)
Upper limb muscle strength measured by the load (kg) sustained in one repetition maximum test
Six weeks (pre-post intervention)
Biomarker in Blood
Time Frame: At the beginning of the intervention and three and six weeks after the beginning. Comparing the two time points inbetween study groups
Immune status and metabolic status
At the beginning of the intervention and three and six weeks after the beginning. Comparing the two time points inbetween study groups
Body composition
Time Frame: Six weeks (pre-post intervention)
Bioelectrical Impedance Analysis
Six weeks (pre-post intervention)
Six-minute-walk performance
Time Frame: Six weeks (pre-post intervention)
Six weeks (pre-post intervention)
Fatigue
Time Frame: six weeks (pre-post intervention)
Pediatric Quality of Life Inventory (PedsQL) Multidimensional Fatigue Scale
six weeks (pre-post intervention)
Quality of Life
Time Frame: Six weeks (pre-post intervention)
KINDL: health related quality of life questionnaire
Six weeks (pre-post intervention)
Cardiorespiratory performance
Time Frame: Six weeks (pre-post intervention)
Ergospirometry
Six weeks (pre-post intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johannes Gutenberg University Mainz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

November 17, 2015

First Submitted That Met QC Criteria

November 20, 2015

First Posted (Estimate)

November 23, 2015

Study Record Updates

Last Update Posted (Actual)

March 4, 2019

Last Update Submitted That Met QC Criteria

March 1, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mucki01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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