NCT02984332

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 6, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

November 8, 2019

Status Verified

November 1, 2019

Enrollment Period

1.9 years

First QC Date

December 2, 2016

Last Update Submit

November 6, 2019

Conditions

Muscular Atrophy

Outcome Measures

Primary Outcomes (1)

  • Muscle size

    Quadriceps muscle volume measured via MRI

    Days 0, 2 and 7

Secondary Outcomes (2)

  • Muscle protein synthesis

    days 0-2, 2-7 and 0-7

  • Muscle strength

    Pre and post immobilization

Study Arms (1)

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.

Other: Lower limb immobilisation (leg brace)

Interventions

Lower limb immobilisation (leg brace)OTHER
Lower limb immobilisation

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI \>18 and \<28 no prescription medications or current illness -

You may not qualify if:

  • BMI \<18 and \>28 current prescription medication no history of leg injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sport & Health Sciences

Exeter, Devon, EX1 2LU, United Kingdom

Location

MeSH Terms

Conditions

Muscular Atrophy

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2016

First Posted

December 6, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2017

Study Completion

October 1, 2019

Last Updated

November 8, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)