Strength Training and ADLs in Childhood Leukemia and Lymphoma Patients

May 26, 2021 updated by: Sabine Kesting, Technical University of Munich

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 80804
        • Kinderklinik München Schwabing TUM School of Medicine, Department of Pediatrics and Children's Cancer Research Center, Technical University of Munich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

4 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of score of the Activities Scale for Kids - performance version
Time Frame: 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).
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of motor performance analyzed with the Motor performance test in Pediatiric Oncology (MOON)
Time Frame: 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 motor performance from baseline to 6 months
Change of level of physical activity
Time Frame: 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 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
Time Frame: 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.
Change of score in the parkour from baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Technical University of Munich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 25, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 25, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 14, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 27, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DJCLS 15 R/2016

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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