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

Primary Purpose

Bone Diseases, Metabolic, Acid-Base Imbalance, Muscular Atrophy

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Defined Training Programme
Sponsored by
DLR German Aerospace Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Bone Diseases, Metabolic focused on measuring bone metabolism, acid base balance, bed rest

Eligibility Criteria

20 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • • 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)

    • 65 - 85 kg
    • 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

Exclusion Criteria:

  • • 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)
    • Thyroid dysfunction (deviation from standard values for plasma TSH, standard value TSH 0.27 - 4.20 U/l)
    • Hyperhomocysteinemia (deviation from standard value for plasma homocysteine, standard value homocysteine >15 µmol/l)
    • Hyper-, Hypouricemia (deviation from plasma uric acid standard values, age dependent standard value 3.0-6.9 mg/dl)
    • Hyper-, Hypocalcemia (deviation from plasma calcium standard values, age dependent standard value 2.15-2.64 mmol/l)
    • Anaemia: (< as standard values for plasma haemoglobin, standard values for men 13.5-17.5 g/dl)
    • Iron deficiency: ferritin < 30 µg/l
    • Vitamin D deficiency: D3-25-OH < 50 ng/ml

    • Blood gas values deviating from the normal values:

      • pH 7.38-7.42
      • pCO2 34-45 mmHg
      • pO2 79-98 mmHg
      • HCO3 20-28 mmol/l
      • Base deviation ± 2 mmol/l
    • Family history of thrombosis or positive response in thrombosis screening procedure: Biochemical analysis of the following parameter: ATIII, protein C and S activities, factor V Leiden, prothrombin mutants, lupus PTT
    • Chronic back complaints
    • Bone fracture in the year preceding the study
    • Bone density of the femur and lower spine (L1-L4) 1.5 SD ≤ t-score
    • Metal implants or other kinds of bone synthesis materials
    • Participation in another clinical study within the last 2 months before start of this study
    • Imprisoned at the time of the study
    • Any other condition which makes the test subject unsuitable for study inclusion in the opinion of the examiner

Sites / Locations

  • German Aerospace Center (DLR)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

defined training programme

Control

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
December 11, 2012
Last Updated
March 26, 2013
Sponsor
DLR German Aerospace Center
Collaborators
European Space Agency, University Hospital, Angers, Politecnico di Milano, University Hospital, Bonn, University of Zurich, Leiden University Medical Center, German Sport University, Cologne
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1. Study Identification

Unique Protocol Identification Number
NCT01820702
Brief Title
Short Term Bed Rest Study: Evaluation of the Use of Artificial Gravity, Induced by Short-arm Centrifugation
Acronym
SAG
Official Title
Short Term Bed Rest Study: Evaluation of the Use of Artificial Gravity, Induced by Short-arm Centrifugation or the Appliance of Definite Combined Training Program to Counteract Effects of Bed Rest (Acronym: SAG Study)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DLR German Aerospace Center
Collaborators
European Space Agency, University Hospital, Angers, Politecnico di Milano, University Hospital, Bonn, University of Zurich, Leiden University Medical Center, German Sport University, Cologne

4. Oversight

5. Study Description

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.
Detailed Description
The SAG study was a single center, open-label crossover trial with healthy men conducted in three campaigns at the Institute of Aerospace Medicine, Cologne, Germany. The subjects were quasi randomized alternatively by enrolment to undertake the different training interventions or to be in the control group during 5 days of immobilisation in 6° head down tilt position. The subjects were quasi randomized either to the one of the training programs or the non-training group depending on the arrival at the Institute of Aerospace Medicine. The study started November 01st, 2010 and was finished May 29th, 2011. The first campaign lasted from November 01st to November 21sh, 2010, the second campaign from January 10th to January 30th, 2011 and the third campaign from May 09th to May 29th, 2011. Each campaign comprised a 5 day adaptation-, a 5 day intervention phase in HDT bed rest, and a 5 day recovery phase (15 days in total) in-house at the Metabolic Ward of the Institute of Aerospace Medicine. Baseline Data were collected during the adaptation phase (BDC Baseline Data Collection) when subjects could move free inside the lab. The intervention was administered during the bed rest phase where the subjects had to lie in bed in 6° head down tilt (HDT Head Down Tilt) position and were not allowed to get up. Recumbency was to be adhered to at all times including all activities (hygienic procedures, leisure activities). The bed rest phase was followed by a recovery phase (R+).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
defined training programme
Arm Type
Active Comparator
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Defined Training Programme
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximal knee extensor and plantar flexor muscle force
Description
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).
Time Frame
Baseline, after 5 days of bed rest

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: • 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) 65 - 85 kg 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 Exclusion Criteria: • 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) Thyroid dysfunction (deviation from standard values for plasma TSH, standard value TSH 0.27 - 4.20 U/l) Hyperhomocysteinemia (deviation from standard value for plasma homocysteine, standard value homocysteine >15 µmol/l) Hyper-, Hypouricemia (deviation from plasma uric acid standard values, age dependent standard value 3.0-6.9 mg/dl) Hyper-, Hypocalcemia (deviation from plasma calcium standard values, age dependent standard value 2.15-2.64 mmol/l) Anaemia: (< as standard values for plasma haemoglobin, standard values for men 13.5-17.5 g/dl) Iron deficiency: ferritin < 30 µg/l Vitamin D deficiency: D3-25-OH < 50 ng/ml Blood gas values deviating from the normal values: pH 7.38-7.42 pCO2 34-45 mmHg pO2 79-98 mmHg HCO3 20-28 mmol/l Base deviation ± 2 mmol/l Family history of thrombosis or positive response in thrombosis screening procedure: Biochemical analysis of the following parameter: ATIII, protein C and S activities, factor V Leiden, prothrombin mutants, lupus PTT Chronic back complaints Bone fracture in the year preceding the study Bone density of the femur and lower spine (L1-L4) 1.5 SD ≤ t-score Metal implants or other kinds of bone synthesis materials Participation in another clinical study within the last 2 months before start of this study Imprisoned at the time of the study Any other condition which makes the test subject unsuitable for study inclusion in the opinion of the examiner
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edwin Mulder, Dr.
Organizational Affiliation
German Aerospace Center
Official's Role
Study Director
Facility Information:
Facility Name
German Aerospace Center (DLR)
City
Cologne
ZIP/Postal Code
51147
Country
Germany

12. IPD Sharing Statement

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

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