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Completed

NCT Number: NCT02612025

Effects of 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.

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Key information

Conditions

Pediatric Oncology

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johannes-Gutenberg-University

Mainz, Rhineland-Palatinate, 55131, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise Training

Behavioral

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Body composition

    Time frame: Six weeks (pre-post intervention)

    Bioelectrical Impedance Analysis

  4. Six-minute-walk performance

    Time frame: Six weeks (pre-post intervention)

  5. Fatigue

    Time frame: six weeks (pre-post intervention)

    Pediatric Quality of Life Inventory (PedsQL) Multidimensional Fatigue Scale

  6. Quality of Life

    Time frame: Six weeks (pre-post intervention)

    KINDL: health related quality of life questionnaire

  7. Cardiorespiratory performance

    Time frame: Six weeks (pre-post intervention)

    Ergospirometry

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Registry information

Official study title

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

Acronym: MUCKI

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Nov 23, 2015
Registry last updated
Mar 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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