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

NCT01576081 | Completed DMC

• 1 other identifier: DLR
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Resorption

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Bone density as measured with pQCT

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

  1 year

Study Arms (1)

Unilateral orthotic intervention

EXPERIMENTAL

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

Device: HEPHAISTOS

Interventions

HEPHAISTOS DEVICE

HEPHAISTOS unloading orthotic

Unilateral orthotic intervention

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• DLR German Aerospace Center: lead

Study Sites (1)

German Aerospace Center

Cologne, 51147, Germany

Location

Related Publications (2)

• 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.

  PMID: 24119174 DERIVED

• 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.

  PMID: 23221961 DERIVED

Related Links

• Webpage German Aerospace Center (DLR), Division Space Physiology

MeSH Terms

Conditions

Bone Resorption; Muscular Atrophy

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Joern Rittweger, Prof. Dr.

  DLR German Aerospace Center

  STUDY DIRECTOR

• Tobias Weber

  DLR German Aerospace Center

  PRINCIPAL INVESTIGATOR

• Michel Ducos

  DLR German Aerospace Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2012
• First Posted: April 12, 2012
• Study Start: April 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: August 16, 2012

Record last verified: 2012-08

Locations

DE (1)