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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DLR German Aerospace Center
ClinicalTrials.gov Identifier:
NCT01576081
First received: April 3, 2012
Last updated: August 15, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Bone Resorption
Device: HEPHAISTOS

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
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.

Resource links provided by NLM:


Further study details as provided by DLR German Aerospace Center:

Primary Outcome Measures:
  • Bone density as measured with pQCT [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    subjects will be followed for one year, starting from the onset of the study


Enrollment: 11
Study Start Date: April 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Unilateral orthotic intervention
The HEPHAISTOS orthotic was worn unilaterally for 56days by 11 healthy male subjects.
Device: HEPHAISTOS
HEPHAISTOS unloading orthotic

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.
  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01576081

Locations
Germany
German Aerospace Center
Cologne, Germany, 51147
Sponsors and Collaborators
DLR German Aerospace Center
Investigators
Study Director: Joern Rittweger, Prof. Dr. DLR German Aerospace Center
Principal Investigator: Tobias Weber DLR German Aerospace Center
Principal Investigator: Michel Ducos DLR German Aerospace Center
  More Information

Additional Information:
No publications provided by DLR German Aerospace Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: DLR German Aerospace Center
ClinicalTrials.gov Identifier: NCT01576081     History of Changes
Other Study ID Numbers: DLR
Study First Received: April 3, 2012
Last Updated: August 15, 2012
Health Authority: Germany: Ethics Commission
Germany: Federal Office for Radiation Protection

Keywords provided by DLR German Aerospace Center:
bone density
weight bearing
muscle atrophy
vascular degeneration
gravitational loading
muscular unloading

Additional relevant MeSH terms:
Bone Resorption
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 15, 2014