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CompletedNCT01576081HEPUpdated Aug 16, 2012

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

An interventional study of HEPHAISTOS in Bone Resorption, sponsored by DLR German Aerospace Center. Completed at 1 site in Germany. Open to male participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-08-16.

Sponsored by DLR German Aerospace Center · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
11
Allocation
Not applicable
Ages
20 Years to 40 Years
Sex
Male
01

Study 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.

Read the detailed description

The 56day unloading intervention with HEPHAISTOS had the following key objectives:

  1. Primary objective: Assessment and evaluation of bone adaptation.
  2. Secondary objective: Assessment and evaluation of functional and structural muscular adaptations.
  3. Third objective: Assessment and evaluation of functional and structural vascular adaptations.
  4. Fourth objective: Assessment and evaluation if the present findings deviate from findings observed in established unloading models.
02

Conditions studied

  • Bone Resorption

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Keywords

  • bone density
  • weight bearing
  • muscle atrophy
  • vascular degeneration
  • gravitational loading
  • muscular unloading
03

In context

Bone Resorption

153 studies on the registry are indexed under Bone Resorption; 25 are open to participants now.

This study's enrollment of 11 is below the median of 22 across 133 interventional studies indexed under Bone Resorption.

Browse Bone Resorption studies →

Lead sponsor

DLR German Aerospace Center is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Experimental
    Unilateral orthotic intervention

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

    Device: HEPHAISTOS

Interventions

  • DeviceHEPHAISTOS

    HEPHAISTOS unloading orthotic

06

What researchers measure

Primary outcomes

  1. Bone density as measured with pQCT

    subjects will be followed for one year, starting from the onset of the study

    Time frame: 1 year

07

Study locations

1 site
  • German Aerospace Center
    Cologne, 51147, Germany
08

References and documents

Publications

  • 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. PubMed 24119174 ↗
  • 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. PubMed 23221961 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 16, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01576081
Lead sponsor
DLR German Aerospace Center
Responsible party
Sponsor
First posted
Apr 12, 2012
Start date
Apr 2011
Primary completion
Jul 2012
Completion
Jul 2012
Last update
Aug 16, 2012

Study contacts

Joern Rittweger, Prof. Dr.
study director · DLR German Aerospace Center
Tobias Weber
principal investigator · DLR German Aerospace Center
Michel Ducos
principal investigator · DLR German Aerospace Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.

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