A Methodology Study to Assess Muscle Damage After Eccentric Exercise

NCT ID: NCT02014662

Last Updated: 2017-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-14
• Study Completion Date: 2014-07-02

Brief Summary

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.

Conditions

Tendon Injuries

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Arm 1

Healthy subjects aged 18 to 35 years

Group Type: OTHER

Eccentric exercise

Intervention Type: OTHER

Each subject will perform eccentric exercise against a predefined personal maximal strength of their non-dominant leg on day 1. Changes on strength, biomarker concentrations and muscle protein synthesis during damage and recovery will be measured over 22 days.

Interventions

Eccentric exercise

Each subject will perform eccentric exercise against a predefined personal maximal strength of their non-dominant leg on day 1. Changes on strength, biomarker concentrations and muscle protein synthesis during damage and recovery will be measured over 22 days.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Males aged between 18 and 35 years of age inclusive, at the time of signing the informed consent, not on a regular exercise program.
• Body Mass Index (BMI) 18-27 kilogram per meter square (kg/m^2) with waist circumference <96 centimeter (cm).

Exclusion Criteria

• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
• Based on single or averaged corrected QT interval (QTc) (Bazzett [QTcB] or Fredericia [QTcF]) values of triplicate electrocardiograms (ECGs) obtained over a brief recording period: QTc <450 milliseconds (msec); or QTc < 480 msec in subjects with Bundle Branch Block.
• At least a 1year history of no regular (2-3 times per week) exercise and no heavy exertion within past week.

• History of keloid scarring
• History of dizziness or vertigo
• History of bleeding disorders or elevated partial thromboplastin time/international normalized ratio (PTT/INR) at screening, or currently on anticoagulants
• Taking anti-inflammatory, glucocorticoid or other pain medication more than 2 times per week over the previous month.
• Taking regular statin medication.
• Herbal supplement use
• History of smoking or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
• History of drug or alcohol abuse within 5 years prior to the Screening Period.
• History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >21 units. One unit is equivalent to 8 gram (gm) of alcohol: a half-pint (~240 milliliter [mL]) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits
• History of sensitivity to heparin or heparin-induced thrombocytopenia.
• History of sensitivity to local anesthetics.
• History of sensitivity to any drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation

Criteria Based Upon Diagnostic Assessments:

• A positive pre-study drug/alcohol screen.

Other Criteria:

• Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
• The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
• Exposure to more than four new chemical entities within 12 months prior to the first dosing day.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Nottingham, , United Kingdom

Countries

United Kingdom

Other Identifiers

200794

Identifier Type: -

Identifier Source: org_study_id