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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03559452
Other study ID # 171206/B/08
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2018
Est. completion date October 31, 2019

Study information

Verified date September 2021
Source University of Exeter
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date October 31, 2019
Est. primary completion date October 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - Aged 18 - 40 - BMI between 18 and 27 - Healthy, recreationally active, non smoker Exclusion Criteria: - 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.

Study Design


Intervention

Procedure:
Eccentric exercise
300 eccentric contractions of the knee extensors

Locations

Country Name City State
United Kingdom University of Exeter 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 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
Primary 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 Change in unilateral knee extensor 1 repetition maximum Unilateral knee extensor 1 repetition maximum will be measured before and after 7 days of single leg immobilisation using a weight stack leg extension machine After 7 days of immobilisation
Secondary Change in unilateral knee extensor maximal voluntary torque production Unilateral knee extensor maximal voluntary torque production will be measured before and after 7 days of single leg immobilisation using an isokinetic dynamometer. After 7 days of immobilisation
Secondary Change in unilateral knee extensor isokinetic total work Unilateral knee extensor total isokinetic work after 30 consecutive contractions will be measured before and after 7 days of single leg immobilisation using an isokinetic dynamometer. After 7 days of immobilisation
Secondary Muscle protein synthesis assessed using the stable isotope Deuterium Oxide The enrichment of deuterated alanine (from the deuterium oxide heavy water stable isotope tracer) in vastus lateralis biopsy samples will be measured relative to the non-deuterated alanine. The change between pre-immobilisation and 2 days of immobilisation will be used to calculated a fractional synthetic rate (% day). After 2 days of immobilisation
Secondary Muscle protein synthesis assessed using the stable isotope Deuterium Oxide The enrichment of deuterated alanine (from the deuterium oxide heavy water stable isotope tracer) in vastus lateralis biopsy samples will be measured relative to the non-deuterated alanine. The change between pre-immobilisation and 7 days of immobilisation will be used to calculated a fractional synthetic rate (% day). After 7 days of immobilisation
Secondary Change in skeletal muscle gene expression Skeletal muscle gene expression will be measured before and after 2 days of single leg immobilisation. After 2 days of immobilisation
Secondary Change in skeletal muscle gene expression Skeletal muscle gene expression will be measured before and after 7 days of single leg immobilisation. After 7 days of immobilisation
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