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The Novel Unloading Device "HEPHAISTOS" and Its Effects Upon Bone, Muscle and Vasculature (HEP)

Primary Purpose

Bone Resorption

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
HEPHAISTOS
Sponsored by
DLR German Aerospace Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Bone Resorption focused on measuring bone density, weight bearing, muscle atrophy, vascular degeneration, gravitational loading, muscular unloading

Eligibility Criteria

20 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • male
  • age: 20-40 years
  • BMI: 20-30
  • passing the psychological and medical check up.
  • signed consent to participate in the study
  • faultless certificate of good conduct

Exclusion Criteria:

  • smoking
  • professional athletes
  • diabetes
  • muscle or joint disease
  • trabecular bone density in the distal tibia epiphysis < 160mg/cm3
  • increase risk of thrombosis
  • bone fractures 12 months prior to the study
  • metal implants, any material of osteosynthesis
  • participation in another clinical intervention study 2 months prior to the study
  • bleeding disorder
  • anesthetic intolerance
  • vascular disease
  • epilepsy
  • claustrophobia
  • herniated disk
  • pacemaker
  • alcohol or drug abuse
  • anti-inflammatory drug intake during the study
  • hyperlipidemia
  • kidney disease
  • hyperhomocysteinaemia
  • vitamin d deficit
  • chronical back pain
  • detained

Sites / Locations

  • German Aerospace Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Unilateral orthotic intervention

Arm Description

The HEPHAISTOS orthotic was worn unilaterally for 56days by 11 healthy male subjects.

Outcomes

Primary Outcome Measures

Bone density as measured with pQCT
subjects will be followed for one year, starting from the onset of the study

Secondary Outcome Measures

Full Information

First Posted
April 3, 2012
Last Updated
August 15, 2012
Sponsor
DLR German Aerospace Center
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1. Study Identification

Unique Protocol Identification Number
NCT01576081
Brief Title
The Novel Unloading Device "HEPHAISTOS" and Its Effects Upon Bone, Muscle and Vasculature
Acronym
HEP
Official Title
The Effects of a 56day Unilateral Muscular Unloading Intervention With a Novel Device That Allows Normal Ambulation While Reducing Muscle Activation Drastically, on Muscles, Bones and Vessels.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DLR German Aerospace Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The present study aimed to investigate the importance of gravitational induced forces that appear during normal ambulation for the health of muscles, bones and blood vessels. The main hypothesis of the present study is that gravitational loading alone, without muscle contractions, is insufficient to maintain bone strength.
Detailed Description
The 56day unloading intervention with HEPHAISTOS had the following key objectives: Primary objective: Assessment and evaluation of bone adaptation. Secondary objective: Assessment and evaluation of functional and structural muscular adaptations. Third objective: Assessment and evaluation of functional and structural vascular adaptations. Fourth objective: Assessment and evaluation if the present findings deviate from findings observed in established unloading models.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Resorption
Keywords
bone density, weight bearing, muscle atrophy, vascular degeneration, gravitational loading, muscular unloading

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Unilateral orthotic intervention
Arm Type
Experimental
Arm Description
The HEPHAISTOS orthotic was worn unilaterally for 56days by 11 healthy male subjects.
Intervention Type
Device
Intervention Name(s)
HEPHAISTOS
Intervention Description
HEPHAISTOS unloading orthotic
Primary Outcome Measure Information:
Title
Bone density as measured with pQCT
Description
subjects will be followed for one year, starting from the onset of the study
Time Frame
1 year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: male age: 20-40 years BMI: 20-30 passing the psychological and medical check up. signed consent to participate in the study faultless certificate of good conduct Exclusion Criteria: smoking professional athletes diabetes muscle or joint disease trabecular bone density in the distal tibia epiphysis < 160mg/cm3 increase risk of thrombosis bone fractures 12 months prior to the study metal implants, any material of osteosynthesis participation in another clinical intervention study 2 months prior to the study bleeding disorder anesthetic intolerance vascular disease epilepsy claustrophobia herniated disk pacemaker alcohol or drug abuse anti-inflammatory drug intake during the study hyperlipidemia kidney disease hyperhomocysteinaemia vitamin d deficit chronical back pain detained
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joern Rittweger, Prof. Dr.
Organizational Affiliation
DLR German Aerospace Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tobias Weber
Organizational Affiliation
DLR German Aerospace Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michel Ducos
Organizational Affiliation
DLR German Aerospace Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
German Aerospace Center
City
Cologne
ZIP/Postal Code
51147
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
24119174
Citation
Weber T, Ducos M, Mulder E, Beijer A, Herrera F, Zange J, Degens H, Bloch W, Rittweger J. The relationship between exercise-induced muscle fatigue, arterial blood flow and muscle perfusion after 56 days local muscle unloading. Clin Physiol Funct Imaging. 2014 May;34(3):218-29. doi: 10.1111/cpf.12087. Epub 2013 Oct 7.
Results Reference
derived
PubMed Identifier
23221961
Citation
Weber T, Ducos M, Mulder E, Herrera F, Bruggemann GP, Bloch W, Rittweger J. The specific role of gravitational accelerations for arterial adaptations. J Appl Physiol (1985). 2013 Feb;114(3):387-93. doi: 10.1152/japplphysiol.01117.2012. Epub 2012 Dec 6.
Results Reference
derived
Links:
URL
http://www.dlr.de/me/desktopdefault.aspx/tabid-1935/
Description
Webpage German Aerospace Center (DLR), Division Space Physiology

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The Novel Unloading Device "HEPHAISTOS" and Its Effects Upon Bone, Muscle and Vasculature

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