- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02984332
Timecourse of Immobilization Experiment (TIME)
Short-term Muscle Disuse Induces a Rapid and Sustained Decline in Daily Myofibrillar Protein Synthesis Rates
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Devon
-
Exeter, Devon, United Kingdom, EX1 2LU
- Sport & Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
BMI >18 and <28 no prescription medications or current illness -
Exclusion Criteria:
BMI <18 and >28 current prescription medication no history of leg injury
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Lower limb immobilisation
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle size
Time Frame: Days 0, 2 and 7
|
Quadriceps muscle volume measured via MRI
|
Days 0, 2 and 7
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle protein synthesis
Time Frame: days 0-2, 2-7 and 0-7
|
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.
|
days 0-2, 2-7 and 0-7
|
Muscle strength
Time Frame: Pre and post immobilization
|
Skeletal muscle one repetition maximum strength was assessed using standard gym equipment
|
Pre and post immobilization
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 650061958
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Muscular Atrophy
-
St Mary's University CollegeNot yet recruitingAtrophy, Muscular | Atrophy, Disuse
-
United States Army Research Institute of Environmental...Not yet recruitingMuscular Disorders, Atrophic | Muscle Atrophy | Disuse Atrophy | Atrophy, Disuse | Disuse Atrophy Muscle of Thigh
-
Marco CapogrossoRoche-GenentechRecruitingSpinal Muscular Atrophy Type 3 | Spinal Muscular Atrophy Type 4United States
-
Institut de Myologie, FranceInstitut RocheCompletedType 2 Spinal Muscular Atrophy | Type 3 Spinal Muscular AtrophyBelgium, France, Germany
-
McMaster UniversityUnknownSarcopenia | Muscle Atrophy | Muscle Disuse AtrophyCanada
-
South Dakota State UniversitySanford ResearchCompletedDisuse AtrophyUnited States
-
McGill UniversityRecruitingMuscle Atrophy | Muscle Disuse AtrophyCanada
-
Marco CapogrossoRoche-GenentechNot yet recruitingSpinal Muscular Atrophy | Spinal Muscular Atrophy Type 3 | SMA | Spinal Muscular Atrophy Type II | Spinal Muscular Atrophy 4United States
-
University of Sao Paulo General HospitalRecruitingAtrophy, MuscularBrazil
-
GlaxoSmithKlineCompleted
Clinical Trials on Lower limb immobilisation (leg brace)
-
University of ExeterCompleted
-
University of NottinghamBiotechnology and Biological Sciences Research CouncilUnknownMuscular Atrophy | Immobility SyndromeUnited Kingdom
-
University Hospital, BrestCompleted
-
Salisbury UniversityUnknownPeripheral Arterial DiseaseUnited States
-
McMaster UniversityAxcella Health, IncCompleted
-
University of OttawaCompletedHyperthermia | Aging | Heat Stress | Weather; Heat | Heat SyncopeCanada
-
Riphah International UniversityCompleted
-
Singapore General HospitalRecruitingPeripheral Arterial Disease | Critical Limb IschemiaSingapore
-
Seoul National University HospitalCompletedMyocardial Infarction | Stable Angina | Unstable Angina | Triple Vessel DiseaseKorea, Republic of
-
Université de MontréalCanadian Institutes of Health Research (CIHR)Completed