NCT03559452

Brief Summary

Limb injury generally requires a period of recovery during which time the limb is often immobilised (e.g. with a cast or brace) resulting in a rapid loss of skeletal muscle. Despite the importance of muscle loss during injury, our understanding of how it occurs is incomplete. Several factors are likely to contribute, including a lack of muscle contraction and injury induced inflammation. In this study, the investigators will recruit healthy volunteers who will spend 7 days in a knee brace to replicate leg immobilisation. Prior to immobilisation, half of the participants will perform a single session of strenuous resistance exercise which is known to cause muscle damage and initiate an inflammatory response. This is designed to replicate the muscle damage and inflammation that occurs with injury. The remaining half of participants will not perform this exercise, allowing us to look at the additive effect of muscle damage and inflammation on muscle loss with immobilisation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 31, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 18, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

September 27, 2021

Status Verified

September 1, 2021

Enrollment Period

1.5 years

First QC Date

May 31, 2018

Last Update Submit

September 20, 2021

Conditions

Muscle Disuse Atrophy

Keywords

Muscle damageInflammationImmobilisation

Outcome Measures

Primary Outcomes (2)

  • Change in thigh muscle volume from pre-immobilisation

    The volume of the muscles comprising the thigh after 2 days of immobilisation will be compared to pre-immobilisation values. This will be measured using MRI.

    After 2 days of immobilisation

  • Change in thigh muscle volume from pre-immobilisation

    The volume of the muscles comprising the thigh after 7 days of immobilisation will be compared to pre-immobilisation values, and values obtained after 2 days of immobilisation. This will be measured using MRI.

    After 7 days of immobilisation

Secondary Outcomes (7)

  • Change in unilateral knee extensor 1 repetition maximum

    After 7 days of immobilisation

  • Change in unilateral knee extensor maximal voluntary torque production

    After 7 days of immobilisation

  • Change in unilateral knee extensor isokinetic total work

    After 7 days of immobilisation

  • Muscle protein synthesis assessed using the stable isotope Deuterium Oxide

    After 2 days of immobilisation

  • Muscle protein synthesis assessed using the stable isotope Deuterium Oxide

    After 7 days of immobilisation

  • +2 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

Immobilisation without prior exercise

Muscle damage

EXPERIMENTAL

300 bilateral knee extensor eccentric contraction performed immediately prior to immobilisation

Procedure: Eccentric exercise

Interventions

Eccentric exercisePROCEDURE

300 eccentric contractions of the knee extensors

Muscle damage

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18 - 40
  • BMI between 18 and 27
  • Healthy, recreationally active, non smoker

You may not qualify if:

  • Non-removable metallic implants (including heart pacemaker, cochlear implants, medication pumps, surgical clips, plates or screws) or claustrophobia
  • Use of nutritional supplements
  • Chronic use of over the counter medication
  • Any diagnosed metabolic disease (e.g. type 1 or 2 Diabetes).
  • Any diagnosed cardiovascular disease or hypertension.
  • Anyone with previous motor disorders. Anyone with a current musculoskeletal injury that may impair their use of crutches.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Exeter

Exeter, Devon, EX1 2LU, United Kingdom

Location

MeSH Terms

Conditions

Muscular Disorders, AtrophicInflammation

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2018

First Posted

June 18, 2018

Study Start

May 1, 2018

Primary Completion

October 31, 2019

Study Completion

October 31, 2019

Last Updated

September 27, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)