ImmobilizationNCT00936039
Effects of Unloading on Muscle Mass
A study testing unloading in people with Immobilization and Physical Inactivity, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
In the present study, the effects of 3 weeks of unloading on muscle mass and muscle fiber characteristics will be determined. In addition, the effects of 6 weeks of recovery will be assessed. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Immobilization, Physical Inactivity
- What is being tested?
- unloading
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2009to Jun 2013
- 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 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- BMI < 30 kg/m2
Who cannot join
- Use of medication that may affect haemostasis
- Subjects with (recent) musculoskeletal/orthopaedic disorders known to affect the outcome of the study or that compromise their ability to walk with crutches
- Subjects with metal implants in their lower limbs
- Subjects with known cardiovascular and/or haemostasis disorders
- Subjects with known severe hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Immobilization on Myocellular Characteristics in Healthy, Young Males
In the present study, the effects of 3 weeks of unloading on muscle mass and muscle fiber characteristics will be determined. In addition, the effects of 6 weeks of recovery will be assessed.
- Conditions
- Immobilization, Physical Inactivity
- Being tested
- unloading
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
unloadingBehavioural
2 weeks of unloading of a single leg
| Study group | Role | What they receive |
|---|---|---|
| unloading | Experimental | 2 weeks of unloading Receives: Behavioral: unloading |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle mass, muscle fiber size
Measured: 1 week before unloading; immediately (1 day) after unloading and 6 weeks after unloading
Secondary outcomes (1)
muscle strength
Measured: 1 week before unloading; immediately (1 day) after unloading and 6 weeks after unloading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2009 (estimated)
- Study startOct 2009
- Primary completionFeb 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ImmobilizationStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luc JC van Loon, PhD, Principal investigator, Maastricht UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00936039
- Sponsor's protocol ID
- MEC-09-3-011
- Status last verified
- Jul 2013
- First submitted
- 6 Jul 2009
- Last updated
- 2 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Gorissen SHM, Trommelen J, Kouw IWK, Holwerda AM, Pennings B, Groen BBL, Wall BT, Churchward-Venne TA, Horstman AMH, Koopman R, Burd NA, Fuchs CJ, Dirks ML, Res PT, Senden JMG, Steijns JMJM, de Groot LCPGM, Verdijk LB, van Loon LJC. Protein Type, Protein Dose, and Age Modulate Dietary Protein Digestion and Phenylalanine Absorption Kinetics and Plasma Phenylalanine Availability in Humans. J Nutr. 2020 Aug 1;150(8):2041-2050. doi: 10.1093/jn/nxaa024.
PubMed 32069356
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Immobilization on Myocellular Characteristics in Healthy, Young Males
- ClinicalTrials.gov ID
- NCT00936039
- Acronym / sponsor ID
- MEC-09-3-011
- Conditions
- Immobilization, Physical Inactivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Feb 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 9 Jul 2009 (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.
In the present study, the effects of 3 weeks of unloading on muscle mass and muscle fiber characteristics will be determined. In addition, the effects of 6 weeks of recovery will be assessed.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| unloading | Experimental | Behavioral: unloading2 weeks of unloading |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy
- BMI < 30 kg/m2
Key exclusion criteria (5 listed)
- Use of medication that may affect haemostasis
- Subjects with (recent) musculoskeletal/orthopaedic disorders known to affect the outcome of the study or that compromise their ability to walk with crutches
- Subjects with metal implants in their lower limbs
- Subjects with known cardiovascular and/or haemostasis disorders
- Subjects with known severe hypertension
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 |
|---|---|---|
| unloading2 weeks of unloading of a single leg | Behavioural | unloading |
Primary outcome
muscle mass, muscle fiber size
Time frame: 1 week before unloading; immediately (1 day) after unloading and 6 weeks after unloading
1 secondary outcome
muscle strength
Time frame: 1 week before unloading; immediately (1 day) after unloading and 6 weeks after unloading
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 2 Jul 2013.
- Derived from this study: PubMed 32069356Gorissen SHM, Trommelen J, Kouw IWK, Holwerda AM, Pennings B, Groen BBL, Wall BT, Churchward-Venne TA, Horstman AMH, Koopman R, Burd NA, Fuchs CJ, Dirks ML, Res PT, Senden JMG, Steijns JMJM, de Groot LCPGM, Verdijk LB, van Loon LJC. Protein Type, Protein Dose, and Age Modulate Dietary Protein Digestion and Phenylalanine Absorption Kinetics and Plasma Phenylalanine Availability in Humans. J Nutr. 2020 Aug 1;150(8):2041-2050. doi: 10.1093/jn/nxaa024.
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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.
Luc JC van Loon, PhD principal investigator
Maastricht UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing unloading in people with Immobilization and Physical Inactivity, run by Maastricht University Medical Center at 1 site in Netherlands.
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 2 inclusion and 5 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 2 Jul 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 Netherlands. 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?
muscle mass, muscle fiber size (time frame: 1 week before unloading; immediately (1 day) after unloading and 6 weeks after unloading). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00936039, which also lists 1 linked publication.
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 2 Jul 2013.