Trial document




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  DRKS00010407

Trial Description

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Title

Whole-body vibration for childhood cancer patients after acute medical treatment – a pilot trial to assess feasibility and benefits

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Trial Acronym

Whole-body vibration after pediatric cancer treatment

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URL of the Trial

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Brief Summary in Lay Language

Many survivors of childhood cancer suffer serious late effects such as limitations in functional performance of lower extremities. These limitations may affect gait, mobility and physical activity and thus restrict participation in active daily living.
A novel approach for treating functional deficits is vibration therapy as it could already be applied as a safe and effective therapy method for chronically sick children as well as for adult cancer patients. Nevertheless, vibration therapy is only rarely used in childhood cancer patients and survivors and is not scientifically evaluated, yet.
To assess the feasibility of vibration therapy in pediatric oncology and to provide first hints of possible benefits, 11
childhood cancer patients after cessation of inpatient medical treatment (age 6-20 years) take part in the present study and participate in a supervised vibration therapy program. For 12 weeks, vibration therapy is applied once a week for 9 to 13 minutes (5 vibration blocks, frequency 18-27 Hz, amplitude 2mm peak-to-peak) on a side-altering vibration platform (Galileo® home) in the children’s hospital Amsterdamer Straße Cologne. For participating, a medical clearance and a written consent from the legal guardian are necessary. Feasibility is assessed by training acceptance and adverse events. Moreover, to evaluate the program, functional measurements are performed before and after the intervention. Assessed parameters are functional performance of lower extremities (isometric strength of ankle dorsiflexion and knee extension, ankle dorsiflexion range of motion, functional strength of lower extremity) functional mobility, gait performance, walk-to-run-transition-time and physical activity behavior.

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Brief Summary in Scientific Language

Many survivors of childhood cancer suffer serious late effects such as limitations in functional performance of lower extremities. These limitations may affect gait, mobility and physical activity and thus restrict participation in active daily living.
A novel approach for treating functional deficits is whole-body vibration (WBV) therapy as it could already be applied as a safe and effective therapy method for chronically sick children as well as for adult cancer patients. Nevertheless, WBV therapy is only rarely used in childhood cancer patients and survivors and is not scientifically evaluated, yet.
To assess the feasibility of WBV therapy in pediatric oncology and to provide first hints of possible benefits, 11 childhood cancer patients after cessation of inpatient medical treatment (age 6-20 years) take part in the present study and participate in a supervised WBV therapy program. For 12 weeks, WBV is applied once a week for 9 to 13 minutes (5 vibration blocks, frequency 18-27 Hz, amplitude 2mm peak-to-peak) on a side-altering vibration platform (Galileo® home) in the children’s hospital Amsterdamer Straße Cologne. For participating, a medical clearance and a written consent from the legal guardian are necessary. Feasibility is assessed by training acceptance and adverse events. Moreover, to evaluate the program, functional measurements are performed before and after the intervention. Assessed parameters are functional performance of lower extremities (isometric strength of ankle dorsiflexion and knee extension, ankle dorsiflexion range of motion, functional strength of lower extremity) functional mobility, gait performance, walk-to-run-transition-time and physical activity behavior.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00010407
  •   2016/04/26
  •   [---]*
  •   yes
  •   Approved
  •   031/2016, Ethikkommission der Deutschen Sporthochschule Köln
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C00-D48 -  Neoplasms
  •   childhood cancer patients
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Interventions/Observational Groups

  •   Intervention group includes childhood cancer patients (4-20 years) after inpatient medical treatment who participate in a vibration therapy program (Galileo® home) for 12 weeks. Vibration therapy is applied once a week for 9-13 minutes (side-altering, frequency 18-27Hz, peak-to-peak amplitude 2 mm).
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Supportive care
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

As primary endpoint, the program’s feasibility is assessed. Therefore, training acceptance (questionnaire) and exercise-related adverse events are considered. The questionnaire will be completed after the end of the intervention. In addition, the number of completed training sessions, detailed training setup and reasons for non-participating/ drop out/ training interruption are documented.

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Secondary Outcome

First hints of possible benefits on functional performance of lower extremities, functional mobility, gait performance and physical activity behavior are analyzed. Secondary endpoints ae assessed before and after the intervention:
- isometric strength of ankle dorsiflexion and knee extension (dynamometer)
- active and passive ankle dorsiflexion range of motion (goinometer)
- functional strength of lower extremity (standing long jump)
- functional mobility (timed-up-and-go test)
- time-walking-tests: [10m-walking test (free and fastest walking pace), 2min-walking test (walking efficiency)]
-walk-to-run-transition time (treadmill test)
- physical activiy behavior (activity questionnaire)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2016/04/04
  •   10
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   4   Years
  •   20   Years
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Additional Inclusion Criteria

• Age: ≥ 4 und ≤ 20 years
• pediatric cancer disease
• completion off all inpatient medical treatment
• cessation of inpatient medical treatment within the last 5 years
• medical clearance (approval of the treating physician)
• written informed consent from the legal guardian

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Exclusion Criteria

• Exclusion criteria according to the manufacturer's recommendations
• specific stress conditions (according to the physician’s advice)
• specific physiological impairments that would make participation in functional motor testing or in the intervention not possible (according to the physician’s advice)
• specific psychological impairments that would make participation in functional motor testing or in the intervention not possible (according to the physician’s advice)

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Addresses

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    • Deutsche Sporthochschule Köln, Insstitut für Kreislaufforschung und Sportmedizin
    • Mr.  PD Dr.  Freerk  Baumann 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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    • Deutsche Sporthochschule Köln, Insstitut für Kreislaufforschung und Sportmedizin
    • Mr.  PD Dr.  Freerk  Baumann 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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    • Deutsche Sporthochschule Köln, Institut für Kreislaufforschung und 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, Insstitut für Kreislaufforschung und Sportmedizin
    • Mr.  PD Dr.  Freerk  Baumann 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/07/29
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Trial Publications, Results and other Documents

  •   Rustler V, Prokop A, Baumann FT, Streckmann F, Bloch W, Daeggelmann J. Whole-Body Vibration Training Designed to Improve Functional Impairments After Pediatric Inpatient Anticancer Therapy: A Pilot Study. Pediatr Phys Ther. 2018;30(4):341-349
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* This entry means the parameter is not applicable or has not been set.