Strength Training and ADLs in Childhood Leukemia and Lymphoma Patients

Sponsor

Technische Universität München (Other)

Overall Status

Completed

CT.gov ID

NCT03934060

Collaborator

(none)

Enrollment

Location

Arms

41.8

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Childhood Cancer	Other: Exercise	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Effects of a Specific Strength Training Regarding Activities of Daily Living (ADLs) Associated With Movement During Treatment of Leukemia or Non-Hodgkin Lymphoma in Childhood and Adolescence

Actual Study Start Date :

Sep 1, 2017

Actual Primary Completion Date :

Feb 25, 2021

Actual Study Completion Date :

Feb 25, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention 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 specific strength training
No Intervention: Control Supervised exercise training regarding general exercise contents (standard care), 2-3 times per week, 30 min per session

Arm

Intervention/Treatment

Experimental: Intervention

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

specific strength training

No Intervention: Control

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

Outcome Measures

Primary Outcome Measures

Change of score of the Activities Scale for Kids - performance version [Change of the ASK score from baseline to 3 months, change from 3 months to 6 months, change from 6 months to 12 months]
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).

Secondary Outcome Measures

Change of motor performance analyzed with the Motor performance test in Pediatiric Oncology (MOON) [Change of motor performance from baseline to 6 months]
Motor performance is assessed by the MOON-test, a tool to examine motor performance abilities in children and adolescents during and after cancer treatment. There's no summary score; reference values of healthy children enable comparison of the tested children.
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]
Physical activity is assessed using an accelerometer (movisens) for the period of 7 days.
Change in performance in a parkour in activities of daily living [Change of score in the parkour from baseline to 6 months]
A standardized parkour with tasks imitating activities of daily living is used to objectively verify the ASK score. Points from 0-4 are counted for each task depending on quality of movement (0 = task can not be completed, 1 = task can be completed with help, 2 = task can be completed with several attempts, 3 = task can be completed with only little effort, 4 = task can be completed without any problems or effort). There are no reference values for the parkour, but intra-individual changes are analyzed.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Medical contraindications regarding strength training (e.g. risk of bleeding, ...)
Contraindications to one of the inclusion criteria mentioned above
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kinderklinik München Schwabing TUM School of Medicine, Department of Pediatrics and Children's Cancer Research Center, Technical University of Munich	Munich	Bavaria	Germany	80804