Short Term Bed Rest Study: Evaluation of the Use of Artificial Gravity, Induced by Short-arm Centrifugation

NCT01820702 | Completed

• 1 other identifier: Contract 22126/08/NL/VJ (SAG)
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized cross-over design with 10 male subjects and 3 campaigns to test whether the negative effects of bed rest (6º head-down tilt) on the various systems of the body and the consequences to health of simulated weightlessness can be counteracted by the use of a defined training programme.

Conditions

Bone Diseases, Metabolic; Acid-Base Imbalance; Muscular Atrophy; Sprains and Strains; Protein Metabolism; Body Weight Changes; Cardiovascular Abnormalities

Keywords

bone metabolism; acid base balance; bed rest

Outcome Measures

Primary Outcomes (1)

• Maximal knee extensor and plantar flexor muscle force

  The maximal voluntary isometric force (MVC) was assessed before and following bed rest. MVC measurements were obtained from the left leg using the Biodex 3 system (Biodex Medical Systems, Shirley, New York, USA).

  Baseline, after 5 days of bed rest

Study Arms (2)

defined training programme

ACTIVE COMPARATOR

Other: Defined Training Programme

Control

NO INTERVENTION

Interventions

Defined Training Programme OTHER

A Smith Machine with fixed rails was used to guide the heel raise and squat exercises in the vertical axis. A metronome was used to direct the subjects during the performance of the exercises. Squats and heel raises were performed against body weight plus the additional weight of the barbell (15 kg). The heel raises were performed with straight knees and without ankle dorsiflexion. The shallow squats were performed continuously for 3 minutes. The hopping and the cross-hopping exercises were performed without Smith Machine. The bilateral hops were performed at \~ 3 repetitions per second with 15-s rest insertions between each set. Cross-hopping was performed continuously for 3 minutes against \~ 1.3 repetitions per second. Except for the duration of the static squat, with progressed from 45 s at HDT1 to 70 s at HDT5, none of the exercises were progressed during the study. Including the scheduled rest pauses, the LRT sessions were completed in 24 minutes.

defined training programme

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male test subjects, aged between 20 and 45 years old with a Body Mass Index (BMI) of 20 - 26 kg/m2 and a height of 158 - 190 cm (62 - 75 inches)
• Not a competitive athlete
• Non-smoker, for at least six months before the start of the study
• In the position to participate in the complete study
• Demonstrable social insurance and official certificate of absence of criminal record
• Successful completion of screening examination
• Provision of Declaration on Consent at the start of the study

You may not qualify if:

• Drug, medication or alcohol abuse (regular consumption of more than 20-30 g alcohol/day)
• Smoking
• Vegetarian, vegan
• Migraine
• Previous psychiatric illness
• Claustrophobia
• Hiatus hernia
• Gastro-oesophageal reflux
• Diabetes mellitus
• Rheumatic illness
• Muscle or joint disorder
• Prolapse of intervertebral disk
• Pronounced orthostatic intolerance
• Hyperlipidaemia (deviations from standard values, standard values: TG \< 180 mg/dl, cumulative CH \< 200 mg/dl, HDL \> 35 mg/dl, LDL \< 160 mg/dl)
• Renal dysfunction (deviation from plasma creatinin standard values, standard value \< 1.20 mg/dl)

Sponsors & Collaborators

• DLR German Aerospace Center: lead
• European Space Agency: collaborator
• University Hospital, Angers: collaborator
• Politecnico di Milano: collaborator
• University Hospital, Bonn: collaborator
• University of Zurich: collaborator
• Leiden University Medical Center: collaborator
• German Sport University, Cologne: collaborator

Study Sites (1)

German Aerospace Center (DLR)

Cologne, 51147, Germany

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic; Acid-Base Imbalance; Muscular Atrophy; Sprains and Strains; Body Weight Changes; Cardiovascular Abnormalities

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Wounds and Injuries; Body Weight; Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Edwin Mulder, Dr.

  German Aerospace Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2012
• First Posted: March 29, 2013
• Study Start: November 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: March 29, 2013

Record last verified: 2013-03

Locations

DE (1)