Bone Diseases, MetabolicSAGNCT01820702
Short Term Bed Rest Study: Evaluation of the Use of Artificial Gravity, Induced by Short-arm Centrifugation
A study testing Defined Training Programme in people with Bone Diseases, Metabolic and Acid-Base Imbalance, run by DLR German Aerospace Center at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bone Diseases, Metabolic, Acid-Base Imbalance, Muscular Atrophy
- What is being tested?
- Defined Training Programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2010to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- • 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
Who cannot join
- • Drug, medication or alcohol abuse (regular consumption of more than 20-30 g alcohol/day)
- Smoking
- Vegetarian, vegan
- Migraine
- Previous psychiatric illness
- Claustrophobia
Show all 36Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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+).
- Conditions
- Bone Diseases, Metabolic, Acid-Base Imbalance, Muscular Atrophy, Sprains and Strains, Protein Metabolism, Body Weight Changes
- Being tested
- Defined Training Programme
- Keywords
- bone metabolism, acid base balance, bed rest
- Medical subject headings
- Bone Diseases, Metabolic, Acid-Base Imbalance, Muscular Atrophy, Sprains and Strains, Body Weight Changes, Cardiovascular Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Defined Training ProgrammeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| defined training programme | Active comparator | Not described Receives: Other: Defined Training Programme |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, after 5 days of bed rest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2013 (estimated)
- Study startNov 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Diseases, MetabolicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- DLR German Aerospace Center
- Sponsor type
- University, hospital or other
- Collaborators
- European Space Agency, University Hospital, Angers, Politecnico di Milano, University Hospital, Bonn, University of Zurich, Leiden University Medical Center, German Sport University, Cologne
- Responsible party
- Sponsor
- Investigators
- Edwin Mulder, Dr., Study director, German Aerospace Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820702
- Sponsor's protocol ID
- Contract 22126/08/NL/VJ (SAG)
- Acronym
- SAG
- Status last verified
- Mar 2013
- First submitted
- 11 Dec 2012
- Last updated
- 29 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01820702
- Acronym / sponsor ID
- SAG / Contract 22126/08/NL/VJ (SAG)
- Conditions
- Bone Diseases, Metabolic, Acid-Base Imbalance, Muscular Atrophy, Sprains and Strains, Protein Metabolism, Body Weight Changes
- Keywords
- bone metabolism, acid base balance, bed rest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- DLR German Aerospace CenterUniversity, hospital or other
- Collaborators
- European Space Agency, University Hospital, Angers, Politecnico di Milano, University Hospital, Bonn, University of Zurich, Leiden University Medical Center, German Sport University, Cologne
- Study start
- Nov 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 29 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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+).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| defined training programme | Active comparator | Other: Defined Training Programme |
| Control | No intervention | – |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- • 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)
Key exclusion criteria (36 listed)
- • Drug, medication or alcohol abuse (regular consumption of more than 20-30 g alcohol/day)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Defined Training ProgrammeA 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. | Other | defined training programme |
Primary outcome
Maximal knee extensor and plantar flexor muscle force
Time frame: Baseline, after 5 days of bed rest
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edwin Mulder, Dr. study director
German Aerospace Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Defined Training Programme in people with Bone Diseases, Metabolic and Acid-Base Imbalance, run by DLR German Aerospace Center at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal knee extensor and plantar flexor muscle force (time frame: Baseline, after 5 days of bed rest). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2013.