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Clinical Trials/NCT02612025
NCT02612025CompletedNot Applicable

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

Johannes Gutenberg University Mainz2 sites in 1 country35 target enrollmentStarted: November 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
35
Locations
2
Primary Endpoint
Muscle strength: lower limb

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
4 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Exercise group

Experimental

Exercise training during intensive medical treatment

Intervention: Exercise Training (Behavioral)

Control group

No Intervention

Usual Care

Outcomes

Primary Outcomes

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

  • Six-minute-walk performance(Six weeks (pre-post intervention))
  • Muscle strength: upper limb(Six weeks (pre-post intervention))
  • Body composition(Six weeks (pre-post intervention))
  • Fatigue(six weeks (pre-post intervention))
  • Biomarker in Blood(At the beginning of the intervention and three and six weeks after the beginning. Comparing the two time points inbetween study groups)
  • Quality of Life(Six weeks (pre-post intervention))
  • Cardiorespiratory performance(Six weeks (pre-post intervention))

Investigators

Sponsor
Johannes Gutenberg University Mainz
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Univ.Prof.Dr.med. Joerg Faber

Univ.-Prof. Dr. med.

Johannes Gutenberg University Mainz

Study Sites (2)

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