NCT02014662

A Methodology Study to Assess Muscle Damage After Eccentric Exercise

Completed Phase 1 Last updated 15 May 2017

What this trial tests

Phase 1 trial testing Eccentric exercise in Tendon Injuries in 12 participants. Completed in 2 July 2014.

Timeline

14 January 2014

Primary endpoint
2 July 2014

2 July 2014

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	12
Start date	14 January 2014
Primary completion	2 July 2014
Estimated completion	2 July 2014
Sites	1 location across United Kingdom

Drugs / interventions tested

• Eccentric exercise

Conditions studied

• Tendon Injuries — all drugs for Tendon Injuries →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 35, male only, with Tendon Injuries. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

An isolated bout of unaccustomed maximal eccentric exercise is associated with muscle force loss for 2-4 days, mild reversible muscle tenderness, and ultra-structural damage to the muscle fibers, elevation of muscle proteins in serum, and a detriment in range of motion. This single center, pilot study is designed to optimize conditions for the robust measurement of functional deficits after muscle damage and to identify markers of repair over 22 days to inform future intervention studies. The primary measure will be limb force (assessed electronically from the ergometer), previous studies have demonstrated that functional measures return fairly rapidly, usually between 2-4 days. Additionally, several biomarkers of muscle function will be measured over 22 days, as well as changes in protein synthesis in biopsy samples Deuterium-labelled water (D2O) will be consumed by all study participants from Day-3 through Day 22 to aid in quantifying newly synthesized proteins.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.