NCT02612025

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 23, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

March 4, 2019

Status Verified

March 1, 2019

Enrollment Period

2.8 years

First QC Date

November 17, 2015

Last Update Submit

March 1, 2019

Conditions

Pediatric Oncology

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Muscle strength: upper limb

    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

  • Body composition

    Six weeks (pre-post intervention)

  • Six-minute-walk performance

    Six weeks (pre-post intervention)

  • Fatigue

    six weeks (pre-post intervention)

  • +2 more secondary outcomes

Study Arms (2)

Exercise group

EXPERIMENTAL

Exercise training during intensive medical treatment

Behavioral: Exercise Training

Control group

NO INTERVENTION

Usual Care

Interventions

Exercise TrainingBEHAVIORAL

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

Exercise group

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Malignant Tumor
  • Medical Treatment in the Center for Pediatrics, Hematology, Oncology and Hemostaseology Mainz (Germany)
  • \> 3 years
  • Signed Informed Consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johannes-Gutenberg-University

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Related Publications (2)

  • 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.

    PMID: 34860287DERIVED

  • 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.

    PMID: 32582585DERIVED

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ.-Prof. Dr. med.

Study Record Dates

First Submitted

November 17, 2015

First Posted

November 23, 2015

Study Start

November 1, 2015

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

March 4, 2019

Record last verified: 2019-03

Locations

DE(1)