NCT03934060

Brief Summary

Reduced activity levels and reduced muscular strength could severely impair the activities of daily living (ADLs) in pediatric leukemia and Non-Hodgkin lymphoma patients. Increased muscle strength is associated with improved accomplishment of ADLs and consequently greatest possible normality, autonomy and mobility. Primary outcome of this RCT (n=20/20) is the analysis of effects of a treatment-associated and close to every day life strength training (2-3 times/week) compared to a general exercise program (standard care).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 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

September 1, 2017

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 1, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2021

Completed
Last Updated

May 27, 2021

Status Verified

May 1, 2021

Enrollment Period

3.5 years

First QC Date

April 14, 2019

Last Update Submit

May 26, 2021

Conditions

Childhood Cancer

Keywords

exercisestrength trainingactivities of daily livingchildhood cancerleukemiaNon-Hodgkin lymphoma

Outcome Measures

Primary Outcomes (1)

  • Change of score of the Activities Scale for Kids - performance version

    The ASK - Activities Scale for Kids performance version by NL Young assesses an overall summary score (0-100) of self-reported activities of daily living in children and adolescents. The scale monitors changes associated with therapeutic interventions. Higher values represent a better outcome. The ASK contains 30 items in 7 sub-domains (personal care, dressing, other skills, locomotion, play, standing skills and transfer).

    Change of the ASK score from baseline to 3 months, change from 3 months to 6 months, change from 6 months to 12 months

Secondary Outcomes (3)

  • Change of motor performance analyzed with the Motor performance test in Pediatiric Oncology (MOON)

    Change of motor performance from baseline to 6 months

  • Change of level of physical activity

    Change of physical activity level from baseline to 3 months, from 3 to 6 months, from 6 to 12 months

  • Change in performance in a parkour in activities of daily living

    Change of score in the parkour from baseline to 6 months

Study Arms (2)

Intervention

EXPERIMENTAL

Supervised exercise training including specific strength training tools and general exercise contents (standard care), 2-3 times per week, 30 minutes per session

Other: Exercise

Control

NO INTERVENTION

Supervised exercise training regarding general exercise contents (standard care), 2-3 times per week, 30 min per session

Interventions

ExerciseOTHER

specific strength training

Intervention

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with Acute Leukemia or Non-Hodgkin Lymphoma
  • Diagnosed and/or treated at the Kinderklinik München Schwabing, Technische Universität München
  • Informed consent as documented by signature

You may not qualify if:

  • Medical contraindications regarding strength training (e.g. risk of bleeding, ...)
  • Inability to follow the procedures and understand the intervention and assessments of this study, e.g. due to cognitive impairment, language problems, psychological disorders etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kinderklinik München Schwabing TUM School of Medicine, Department of Pediatrics and Children's Cancer Research Center, Technical University of Munich

Munich, Bavaria, 80804, Germany

Location

MeSH Terms

Conditions

NeoplasmsMotor ActivityLeukemiaLymphoma, Non-Hodgkin

Interventions

Exercise

Condition Hierarchy (Ancestors)

BehaviorNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesLymphomaLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

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
Prinzipal Investigator

Study Record Dates

First Submitted

April 14, 2019

First Posted

May 1, 2019

Study Start

September 1, 2017

Primary Completion

February 25, 2021

Study Completion

February 25, 2021

Last Updated

May 27, 2021

Record last verified: 2021-05

Locations

DE(1)