Muscular AtrophyTIMENCT02984332
Timecourse of Immobilization Experiment
A study testing Lower limb immobilisation (leg brace) in people with Muscular Atrophy, run by University of Exeter at 1 site in United Kingdom.
Trial summary
The effect of unilateral lower limb immobilisation over one week on muscle atrophy 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
- Muscular Atrophy
- What is being tested?
- Lower limb immobilisation (leg brace)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2016to Oct 2019
- 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
- BMI >18 and <28 no prescription medications or current illness -
Who cannot join
- BMI <18 and >28 current prescription medication no history of leg injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-term Muscle Disuse Induces a Rapid and Sustained Decline in Daily Myofibrillar Protein Synthesis Rates
The effect of unilateral lower limb immobilisation over one week on muscle atrophy
Read the detailed description
This study aims to assess the effect of one week of unilateral leg immobilization on quadriceps muscle volume and muscle protein synthesis rates. Participants wore a leg brace on one leg and ambulated on crutches during the immobilization period. Thirteen healthy young males were recruited to undertake this study.
It is currently understood that unilateral leg immobilization will result in a reduction in muscle size (Berg et al., 1996, Wall et al., 2015) and muscle protein synthesis rates after a period of disuse (de Boer et al., 2015, Glover et al., 2008). Recent research in this area has shown that even short term periods of leg immobilization (i.e. <1 week) will result in reductions in muscle size and muscle protein synthesis rates after the period of disuse (Wall et al., 2015). However we currently do not have detailed information on how muscle disuse affects muscle size and muscle protein synthesis over time during short term disuse (e.g. the first week).
The stable isotope tracer deuterium oxide (D2O) will be applied to assess cumulative muscle protein synthesis between days 0-2, 2-7 and 0-7 of the immobilization period in both the immobilized and non immobilized legs. This will be in-conjunction with bilateral vastus lateralis muscle biopsies before and after 2 and 7 days of immobilization. Furthremore, quadriceps muscle volume was assessed via MRI scans that again occured before and after 2 and 7 days of immobilization. To gain a mechanistic insight on the molecular changes during disuse a custom designed 48 well Taqman low density microarray genecard was applied to assess the transcriptional response on genes involved in muscle protein synthesis and breakdown.
- Conditions
- Muscular Atrophy
- Being tested
- Lower limb immobilisation (leg brace)
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower limb immobilisation (leg brace)Other
| Study group | Role | What they receive |
|---|---|---|
| Lower limb immobilisation | Experimental | All participants will undergo 7 days of unilateral leg immobilization. Participants will wear a leg brace (Donjoy X-ACT, DJO Global, USA) on one of their legs which will fix the leg at 40 degrees of flexion for the 7 days. Participants will not be allowed to remove the brace at any stage and are prohibited from bearing weight on the immobilized leg, and will ambulate on crutches throughout the week of immobilization. Receives: Other: Lower limb immobilisation (leg brace) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle size
Quadriceps muscle volume measured via MRI
Measured: Days 0, 2 and 7
Secondary outcomes (2)
Muscle protein synthesis
The stable isotope tracer deuterium oxide will be used to assess muscle protein synthesis. In conjunction with bilateral vastus lateralis muscle biopsies before and after 2 and 7 days which allow for the calculation of muscle protein synthesis (fractional synthesis rate) between days 0-2, 2-7 and 0-7.
Measured: days 0-2, 2-7 and 0-7
Muscle strength
Skeletal muscle one repetition maximum strength was assessed using standard gym equipment
Measured: Pre and post immobilization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2017
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscular AtrophyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02984332
- Sponsor's protocol ID
- 650061958
- Acronym
- TIME
- Status last verified
- Nov 2019
- First submitted
- 2 Dec 2016
- Last updated
- 8 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Muscle Disuse Induces a Rapid and Sustained Decline in Daily Myofibrillar Protein Synthesis Rates
- ClinicalTrials.gov ID
- NCT02984332
- Acronym / sponsor ID
- TIME / 650061958
- Conditions
- Muscular Atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 6 Dec 2016 (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.
The effect of unilateral lower limb immobilisation over one week on muscle atrophy
Detailed description
This study aims to assess the effect of one week of unilateral leg immobilization on quadriceps muscle volume and muscle protein synthesis rates. Participants wore a leg brace on one leg and ambulated on crutches during the immobilization period. Thirteen healthy young males were recruited to undertake this study.
It is currently understood that unilateral leg immobilization will result in a reduction in muscle size (Berg et al., 1996, Wall et al., 2015) and muscle protein synthesis rates after a period of disuse (de Boer et al., 2015, Glover et al., 2008). Recent research in this area has shown that even short term periods of leg immobilization (i.e. <1 week) will result in reductions in muscle size and muscle protein synthesis rates after the period of disuse (Wall et al., 2015). However we currently do not have detailed information on how muscle disuse affects muscle size and muscle protein synthesis over time during short term disuse (e.g. the first week).
The stable isotope tracer deuterium oxide (D2O) will be applied to assess cumulative muscle protein synthesis between days 0-2, 2-7 and 0-7 of the immobilization period in both the immobilized and non immobilized legs. This will be in-conjunction with bilateral vastus lateralis muscle biopsies before and after 2 and 7 days of immobilization. Furthremore, quadriceps muscle volume was assessed via MRI scans that again occured before and after 2 and 7 days of immobilization. To gain a mechanistic insight on the molecular changes during disuse a custom designed 48 well Taqman low density microarray genecard was applied to assess the transcriptional response on genes involved in muscle protein synthesis and breakdown.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lower limb immobilisation | Experimental | Other: Lower limb immobilisation (leg brace)All participants will undergo 7 days of unilateral leg immobilization. Participants will wear a leg brace (Donjoy X-ACT, DJO Global, USA) on one of their legs which will fix the leg at 40 degrees of flexion for the 7 days. Participants will not be allowed to remove the brace at any stage and are prohibited from bearing weight on the immobilized leg, and will ambulate on crutches throughout the week of immobilization. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI >18 and <28 no prescription medications or current illness -
Key exclusion criteria (1 listed)
- BMI <18 and >28 current prescription medication no history of leg injury
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 |
|---|---|---|
| Lower limb immobilisation (leg brace) | Other | Lower limb immobilisation |
Primary outcome
Muscle size
Time frame: Days 0, 2 and 7
Quadriceps muscle volume measured via MRI
2 secondary outcomes
Muscle protein synthesis
Time frame: days 0-2, 2-7 and 0-7
Muscle strength
Time frame: Pre and post immobilization
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 8 Nov 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lower limb immobilisation (leg brace) in people with Muscular Atrophy, run by University of Exeter at 1 site in United Kingdom.
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 1 inclusion and 1 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 8 Nov 2019. 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 United Kingdom. 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 size (time frame: Days 0, 2 and 7). 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 8 Nov 2019.