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
Univ.Prof.Dr.med. Joerg Faber
Univ.-Prof. Dr. med.
Johannes Gutenberg University Mainz
Study Sites (2)
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