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

Pediatric Oncology Clinical Trial

— MUCKI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02612025
• Other study ID #: Mucki01
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: September 2018

Study information

• Verified date: March 2019
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Pediatric Oncology

Intervention

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.

Locations

Country	Name	City	State
Germany	Johannes-Gutenberg-University	Mainz	Rhineland-Palatinate

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle strength: lower limb	Lower limb muscle strength measured by the load (kg) sustained in one repetition maximum test	Six weeks (pre-post intervention)
Secondary	Muscle strength: upper limb	Upper limb muscle strength measured by the load (kg) sustained in one repetition maximum test	Six weeks (pre-post intervention)
Secondary	Biomarker in Blood	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
Secondary	Body composition	Bioelectrical Impedance Analysis	Six weeks (pre-post intervention)
Secondary	Six-minute-walk performance		Six weeks (pre-post intervention)
Secondary	Fatigue	Pediatric Quality of Life Inventory (PedsQL) Multidimensional Fatigue Scale	six weeks (pre-post intervention)
Secondary	Quality of Life	KINDL: health related quality of life questionnaire	Six weeks (pre-post intervention)
Secondary	Cardiorespiratory performance	Ergospirometry	Six weeks (pre-post intervention)