Clinical trial NCT01576081: The Novel Unloading Device "HEPHAISTOS" and Its Effects Upon Bone, Muscle and Vasculature
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
Overall status: COMPLETED
Phase: NA
Conditions: Bone Resorption
Keywords: bone density
weight bearing
muscle atrophy
vascular degeneration
gravitational loading
muscular unloading
Lead sponsor: DLR German Aerospace Center
Sponsor class: OTHER
First posted: 2012-04-12
Enrollment: 11
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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:

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 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

Primary outcomes:
measure: Bone density as measured with pQCT
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: German Aerospace Center
Study officials:
affiliation: DLR German Aerospace Center
name: Joern Rittweger, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: DLR German Aerospace Center
name: Tobias Weber
role: PRINCIPAL_INVESTIGATOR
affiliation: DLR German Aerospace Center
name: Michel Ducos
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.