Clinical trial NCT02612025: Effects of Resistance and Endurance Training in Pediatric Cancer Patients During Intensive Treatment Phase
Official title: Effects of Combined Resistance and Endurance Training in Pediatric Cancer Patients During Intensive Treatment Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Oncology
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2015-11-23
Enrollment: 35
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Muscle strength: lower limb
timeFrame: Six weeks (pre-post intervention)
Secondary outcomes:
measure: Muscle strength: upper limb
timeFrame: Six weeks (pre-post intervention)
measure: Biomarker in Blood
timeFrame: At the beginning of the intervention and three and six weeks after the beginning. Comparing the two time points inbetween study groups
measure: Body composition
timeFrame: Six weeks (pre-post intervention)
measure: Six-minute-walk performance
timeFrame: Six weeks (pre-post intervention)
measure: Fatigue
timeFrame: six weeks (pre-post intervention)
measure: Quality of Life
timeFrame: Six weeks (pre-post intervention)
measure: Cardiorespiratory performance
timeFrame: Six weeks (pre-post intervention)
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Johannes-Gutenberg-University
state: Rhineland-Palatinate
Study officials:
References:
citation: 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.
citation: 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.