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

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.

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.

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.

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