Tendon InjuriesPhase 1NCT02014662
A Methodology Study to Assess Muscle Damage After Eccentric Exercise
A Phase 1 study testing Eccentric exercise in people with Tendon Injuries, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Tendon Injuries
- What is being tested?
- Eccentric exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Jan 2014to 2 Jul 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the Investigator in consultation with the GSK Medical Monitor agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Measure Force Recovery and Protein Synthetic Rates After Unilateral Eccentric Exercise in Healthy Males Volunteers Unaccustomed to Eccentric Exercise
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
- Being tested
- Eccentric exercise
- Keywords
- Muscle function, Muscle damage and recovery, Eccentric exercise, Muscle soreness, Protein synthesis
- Medical subject headings
- Tendon Injuries, Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Healthy subjects aged 18 to 35 years Receives: Other: Eccentric exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change and percent change in maximal leg isometric strength from the baseline up to three weeks after eccentric exercise
Muscle strength is a measure the amount of force produced during a maximal voluntary contraction. Strength will be assessed by a maximal isometric (fixed length) contraction.
Measured: Day 1, 2, 3, 4, 6, 8, 11, 17 and Day 22
Secondary outcomes (5)
Change in peak torque and total work performed over the course of 10 consecutive, maximal isokinetic knee extension and flexion contractions
Each subject will be asked to produce 10 consecutive, maximal isokinetic knee extension and flexion contractions through the full range of motion with the exercised leg on an ergometer
Measured: Day 1, 2, 3, 4, 6, 8, 11, 17 and Day 22
Patient pain assessment using a visual analog scale
Leg pain will be assessed for the exercised leg with a visual analog scale (0-100 mm) before and up to three weeks after eccentric exercise
Measured: Day 1, 2, 3, 4, 6, 8, 11, 17 and Day 22
Change in degree of motion
Each subject will be asked to attempt to move the exercised leg through a full range of motion with zero resistance from baseline up to three weeks after eccentric exercise
Measured: Day 1, 2, 3, 4, 6, 8, 11, 17 and Day 22
Change in plasma CPK and aldolase
Blood sample will be collected to assess CPK and aldolase from baseline and up to three weeks after eccentric exercise
Measured: Day 1, 2, 3, 4, 6, 8, 11, 17 and Day 22
Change in plasma markers
Blood sample will be collected to assess blood inflammatory markers including, but are not limited to, tissue necrosis factor alpha (TNFalpha), interleukin (IL) 1 beta, IL6, IL8, IL10, chemokine ligand (CCL)7, complement 3a (C3a), granulocyte macrophage colony stimulating factor (GM-CSF), and c-reactive protein (CRP) from baseline and up to three weeks after eccentric exercise
Measured: Day 1, 2, 3, 4, 6, 8, 11, 17 and Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2013 (estimated)
- Study start14 Jan 2014
- Primary completion2 Jul 2014
- Study completion2 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tendon InjuriesStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02014662
- Sponsor's protocol ID
- 200794
- Status last verified
- May 2017
- First submitted
- 12 Dec 2013
- Last updated
- 15 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Measure Force Recovery and Protein Synthetic Rates After Unilateral Eccentric Exercise in Healthy Males Volunteers Unaccustomed to Eccentric Exercise
- ClinicalTrials.gov ID
- NCT02014662
- Acronym / sponsor ID
- 200794
- Conditions
- Tendon Injuries
- Keywords
- Muscle function, Muscle damage and recovery, Eccentric exercise, Muscle soreness, Protein synthesis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 14 Jan 2014 (actual)
- Primary completion
- 2 Jul 2014 (actual)
- Study completion
- 2 Jul 2014 (actual)
- First posted
- 18 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Other: Eccentric exerciseHealthy subjects aged 18 to 35 years |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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).
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the Investigator in consultation with the GSK Medical Monitor agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eccentric exerciseEach 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. | Other | Arm 1 |
Primary outcome
Change and percent change in maximal leg isometric strength from the baseline up to three weeks after eccentric exercise
Time frame: Day 1, 2, 3, 4, 6, 8, 11, 17 and Day 22
Muscle strength is a measure the amount of force produced during a maximal voluntary contraction. Strength will be assessed by a maximal isometric (fixed length) contraction.
5 secondary outcomes
Change in peak torque and total work performed over the course of 10 consecutive, maximal isokinetic knee extension and flexion contractions
Time frame: Day 1, 2, 3, 4, 6, 8, 11, 17 and Day 22
Patient pain assessment using a visual analog scale
Time frame: Day 1, 2, 3, 4, 6, 8, 11, 17 and Day 22
Change in degree of motion
Time frame: Day 1, 2, 3, 4, 6, 8, 11, 17 and Day 22
Change in plasma CPK and aldolase
Time frame: Day 1, 2, 3, 4, 6, 8, 11, 17 and Day 22
Change in plasma markers
Time frame: Day 1, 2, 3, 4, 6, 8, 11, 17 and Day 22
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Results for study 200794 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
Related trials for Tendon Injuries
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Active, not recruiting
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
Rotator Cuff Tears
Recruiting
Effect of Ultrasound-Guided Posterior Cutaneous Nerve of the Forearm Epicondylar Branch Block on Pain and Function in Lateral Epicondylitis (PCNF-BrEpi)
Lateral Epicondylitis
Active, not recruiting
Lyophilized Platelet-Rich Plasma Lysate vs Dextrose Prolotherapy for Partial Rotator Cuff Tears
Rotator Cuff Tear, Rotator Cuff Syndrome
Not yet recruiting
Correlation Between Soft Tissue Displacement and Functional Performance in Orthopedic Patients
Hamstring Muscle Strain, Adult Acquired Flatfoot Deformity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Eccentric exercise in people with Tendon Injuries, run by GlaxoSmithKline at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change and percent change in maximal leg isometric strength from the baseline up to three weeks after eccentric exercise (time frame: Day 1, 2, 3, 4, 6, 8, 11, 17 and Day 22). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2017.