Trial document




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  DRKS00014713

Trial Description

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Title

WBV-training in pediatric cancer survivors after cessation of inpatient medical treatment: A randomized-controlled cross-over study assessing potential benefits on functional mobility and further mobility-related factors

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Trial Acronym

benefits of WBV following pediatric cancer care

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URL of the Trial

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Brief Summary in Lay Language

In pediatric oncology, improvements in survival rates have led to a growing interest in prevention and rehabilitation of adverse effects in this population. In this context, childhood cancer survivors often suffer physical impairments including restricted functional mobility, limited strength and range of motion or balance disorders, which might negatively impact children’s physical activity behavior. An exercise-based concept to counteract these specific impairments is lacking as yet. However, a promising approach might be whole-body vibration (WBV) training.

The aim of this study is to investigate potential benefits of WBV on selected lower extremity physical impairments in childhood cancer survivors after the cessation of inpatient anticancer therapy. Therefore, ten survivors (6-21 years of age) participate in a 24-week trial, whereof five participants receive WBV-training during the first (week 1 to12 weeks) and five participants during the second study period (week 13 to week 24). WBV-training will be conducted 3x/week; 1x/week supervised by exercise physiologists, 2x/week supervised by parents at home. Each training session lasts 30 minutes at the most. Allocation to either training or waiting first group is randomly conducted.

Each participant performs three testings (t0: baseline, t1: after 12 weeks, t2: after 24 weeks). Potential benefits of WBV on functional mobility, balance, walking capacity, strength of feet and legs, symptoms of peripheral neuropathy, muscle fatigue and physical activity are assessed by age-appropriate assessments. Program acceptance is assessed through a questionnaire survey.

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Brief Summary in Scientific Language

In pediatric oncology, improvements in survival rates have led to a growing interest in prevention and rehabilitation of adverse effects in this population. In this context, childhood cancer survivors often suffer physical impairments including limited functional mobility, restricted strength and range of motion or balance disorders, which might negatively impact children’s physical activity behavior. An exercise-based concept to counteract these specific impairments is lacking as yet. However, a promising approach might be whole-body vibration (WBV) training.

The aim of this study is to investigate potential benefits of side-alternating WBV on selected lower extremity physical impairments in childhood cancer survivors after the cessation of inpatient anticancer therapy. Therefore, ten survivors (6-21 years of age) participate in a 24-week, two-armed, randomized-controlled Cross-over trial (each group: n=5). In the course of the study, each survivor participates in a 12 week WBV-training, either during the first (week 1-12) or the second (week 13-24) study period.

Three testings are performed by each participant (t0: baseline, t1: after 12 weeks, t2: after 24 weeks). Potential benefits of WBV on functional mobility, balance, walking capacity, isometric strength of knee extensors and ankle dorsiflexors, symptoms of peripheral neuropathy, muscle fatigue and physical activity are assessed by age-appropriate assessments (Timed-Up-And-Go Test, One-leg stand, 2-minute Walk Test, 10-meter Walk test, hand-held dynamometer, goniometer, ped mTNS, NIRS, accelerometer). Program acceptance is assessed through a questionnaire survey.

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Organizational Data

  •   DRKS00014713
  •   2018/05/15
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  •   yes
  •   Approved
  •   021/2018, Ethikkommission der Deutschen Sporthochschule Köln, Köln
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Secondary IDs

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Health Condition or Problem studied

  •   C00-D48 -  Neoplasms
  •   Cancer in childhood and adolescence
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Interventions/Observational Groups

  •   Pediatric cancer survivors after cessation of inpatient medical treatment receiving WBV-training in addition to standard care during the first (week 1-12) and standard care during the second (week 13-24) study period

    Whole body vibration training (week 1-12):
    WBV-training will be conducted 3x/week; 1x/week supervised by exercise physiologists, 2x/week supervised by parents at home. Each training session lasts 30 minutes at the most (18-27 Hz, 2mm Amplitude peak-to-peak, 5-10 repetitions per 60-90 seconds).
  •   Pediatric cancer survivors after cessation of inpatient medical treatment receiving standard care during the first (week 1-12) and WBV-training in addition to standard care during the second (week 13-24) study period

    Whole body vibration training (week 13-24):
    WBV-training will be conducted 3x/week; 1x/week supervised by exercise physiologists, 2x/week supervised by parents at home. Each training session lasts 30 minutes at the most (18-27 Hz, 2mm Amplitude peak-to-peak, 5-10 repetitions per 60-90 seconds).
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Supportive care
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

Functional mobility (Timed-up-and-Go-Test): t0 (baseline), t1 (after 12 weeks), t2 (after 24 weeks)

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Secondary Outcome

• Balance (one-leg stand)
• walking capacity (2-minute walk test)
• walking speed (10-meter walk test)
• functional mobility (Timed-Up-And-Go-Test)
• symptoms of peripheral neuropathy (ped mTNS)
• ankle dorsiflexion range of motion (goniometer)
• strength of knee extensors and ankle dorsiflexors (hand-held dynamometer)
• physical activity (accelerometer)
• muscle fatigue (NIRS)
• Satisfaction with the training program

t0 (baseline), t1 (after 12 weeks), t2 (after 24 weeks)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2018/05/02
  •   10
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   6   Years
  •   21   Years
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Additional Inclusion Criteria

• Completion of inpatient care for pediatric cancer within the last five years
• Medical treatment for pediatric cancer included chemotherapy
• Age between 6 and 21 years
• Medical clearance of the treating physician prior to study participation
• Written informed consent from the legal guardian and a child-specific informed assent from the participant prior to study participant

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Exclusion Criteria

• Other diseases that go along with peripheral neuropaty/neuromuscular disorders
• Amputations or other strong functional impairments of the lower limb
• Palliative care
• Specific conditions that would prevent participation in WBV-training or testing (following the physician’s advice)
• exclusion criteria according to the suggestions of the device manufacturer

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Addresses

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    • Deutsche Sporthochschule Köln, Institut für Kreislaufforschugn und Sportmedizin, Abteilung Molekulare und Zelluläre Sportmedizin
    • Mr.  Prof.  Wilhelm  Bloch 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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    • Deutsche Sporthochschule Köln, Institut für Kreislaufforschung und Sportmedizin, Abteilung Molekulare und Zelluläre Sportmedizin
    • Ms.  Dr.  Julia  Däggelmann 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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    • Deutsche Sporthochschule Köln, Institut für Kreislaufforschung und Sportmedizin, Abteilung Molekulare und Zelluläre Sportmedizin
    • Ms.  Vanessa  Oschwald 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Sporthochschule Köln, Institut für Kreislaufforschung und Sportmedizin, Abteilung Molekulare und Zelluläre Sportmedizin
    • Ms.  Dr.  Julia  Däggelmann 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.