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

NCT ID: NCT01576081

Last Updated: 2012-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-07-31

Brief Summary

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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

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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.

Conditions

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Bone Resorption

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Unilateral orthotic intervention

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

Group Type EXPERIMENTAL

HEPHAISTOS

Intervention Type DEVICE

HEPHAISTOS unloading orthotic

Interventions

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HEPHAISTOS

HEPHAISTOS unloading orthotic

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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DLR German Aerospace Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joern Rittweger, Prof. Dr.

Role: STUDY_DIRECTOR

DLR German Aerospace Center

Tobias Weber

Role: PRINCIPAL_INVESTIGATOR

DLR German Aerospace Center

Michel Ducos

Role: PRINCIPAL_INVESTIGATOR

DLR German Aerospace Center

Locations

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German Aerospace Center

Cologne, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 24119174 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23221961 (View on PubMed)

Related Links

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http://www.dlr.de/me/desktopdefault.aspx/tabid-1935/

Webpage German Aerospace Center (DLR), Division Space Physiology

Other Identifiers

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DLR

Identifier Type: -

Identifier Source: org_study_id