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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bone Resorption
- Sponsor
- DLR German Aerospace Center
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Bone density as measured with pQCT
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •professional athletes
- •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
Outcomes
Primary Outcomes
Bone density as measured with pQCT
Time Frame: 1 year
subjects will be followed for one year, starting from the onset of the study