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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02984332
Other study ID # 650061958
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2016
Est. completion date October 2019

Study information

Verified date November 2019
Source University of Exeter
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The effect of unilateral lower limb immobilisation over one week on muscle atrophy


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.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date October 2019
Est. primary completion date December 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Lower limb immobilisation (leg brace)


Locations

Country Name City State
United Kingdom Sport & Health Sciences Exeter Devon

Sponsors (1)

Lead Sponsor Collaborator
University of Exeter

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle size Quadriceps muscle volume measured via MRI Days 0, 2 and 7
Secondary 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. days 0-2, 2-7 and 0-7
Secondary Muscle strength Skeletal muscle one repetition maximum strength was assessed using standard gym equipment Pre and post immobilization
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