muscle-atrophy
Conditions
Interventions
Group 1: Intervention group: 12 subjects are immobilized for 60 days in a 6 ° head-down-tilt bed rest. In the first two weeks of the bed rest, 5 training units are completed weekly with the sledge sys
Sponsors
DLR - Institut für Luft- und Raumfahrtmedizin
Eligibility
Sex/Gender
Male
Age
20 Years to 45 Years
Inclusion criteria
Inclusion criteria: • Physically and mentally healthy male test subjects that are able and declare their willingness to participate in the entire study and successfully passed the psychological and medical screening • Willingness to be assigned randomly either to the treatment or the control group • Aged between 20 and 45 years old with a Body Mass Index (BMI) of 20-26 kg/m2, weight between 65-85 kg, and a height between 158-190 cm • No competitive sportsman • Non-smoker, for at least six months before the start of the study • Capable of completing the study • Demonstrable medical insurance and official certificate of absence of criminal record
Exclusion criteria
Exclusion criteria: • Drug, medication or alcohol abuse (regular consumption of more than 20-30 g alcohol/day)* • Smoking • Vegetarian, vegan • Migraine • Previous psychiatric illness • Increased intraocular pressure • Claustrophobia • Hiatus hernia • Gastro-oesophageal reflux • Diabetes mellitus • Rheumatic illness • Muscle or joint disorder • History of prolapsed intervertebral disc • Pronounced orthostatic intolerance ( than normal values), Normal values: TG 35 mg/dl, LDL 15 µmol/l • Hyperuricaemia or hypouricaemia: deviations from normal values for uric acid in plasma. (Normal values for uric acid in the appropriate age group in the range 3.0-6.9 mg/dl)** • Hypercalcaemia or hypocalcaemia: deviations from normal values for calcium in plasma. (Normal values for calcium in appropriate age group in the range 2.15-2.64 mmol/l)** • Anaemia: Hb under normal values. (Normal values of Hb for men: 13.5-17.5 g/l)** • Iron deficiency: ferritin 3.7 mSv) for research or treatment purposes during the last 10 years • Participation in another clinical study within the last 3 months before start of this study • Imprisoned at the time of the study • History of adverse events to local anaesthesia • Any other condition which makes the test subject unsuitable for study inclusion in the opinion of the examiner
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Loss of bone mass and density: DXA measurements BMC lower limb (measured on BDC-13, BDC-3, HDT13, HDT30, HDT45, HDT60, R + 7, R + 14; for the endpoint the comparison between BDC-3 and R+14 is relevant) and pQCT measurements (Peripheral quantitative computed tomography ) at four sites of the Tibia (4%, 38%, 66%, and 98% of the tibial length) for the endpoint the comparison between BDC-3 and R+14 is relevant. Muscle mass, strength and function: muscle mass see DXA (Dual Energy X-ray Absorptiometry); Muscle strength measured with Isomed2000 (knee stretching and flexion as well as plantarflexion and dorsal elongation), at the times BDC-7 and BDC-1 as well as R + 0, relevant comparison BDC-1 and R + 0 (BDC = Baseline data collection, HDT = Head Down Tilt bed rest, R = Recovery period) | — |
Secondary
| Measure | Time frame |
|---|---|
| Cardivascular: maximum exercise capacity during spiroergometry (step test with breath gas analysis) at BDC-8 and R + 1 Neuromuscular: postural stability and gait, measured with posturography (Leonardo force measuring plate, one-shot with open and closed eyes) and gait analysis (video recording) at BDC-9, R + 0, R + 3 and R + 10 Questionnaires: are standardized, namely POMS (profile of mood state), measured at BDC-10 BDC-4 HDT14 HDT28 HDT42 HDT56 R + 2 R + 10 PANAS (positive and negative affect schedule) measured at BDC-10 BDC-4 HDT7 HDT14 HDT21 HDT28 HDT35 HDT42 HDT49 HDT56 R + 2 R + 10 Pittburgh (Sleep Assessment), measured on BDC-10 BDC-6 HDT7 HDT14 HDT21 HDT28 HDT35 HDT42 HDT49 HDT56 R + 2 R + 10 GHQ (general health questionnaire) as measured on BDC-10 BDC-4 HDT7 HDT14 HDT21 HDT28 HDT35 HDT42 HDT49 HDT56 R + 2 R + 10 Bodymass: daily (balance); body composition: using DXA, time points see bone DXA | — |
Countries
Germany
Contacts
Public ContactAlexandra Noppe
DLR - Institut für Luft- und Raumfahrtmedizin
Outcome results
None listed