Muscle DamageNCT03707067
Compression Garments for Recovery in Modern Pentathletes
A study testing Compression garments in people with Muscle Damage, run by St Mary's University College at 2 sites in United Kingdom.
Trial summary
Aims To assess the efficacy of made to measure, high pressure compression garments (CG) for facilitating the recovery of strength, muscular power, and physiological markers of muscle damage following fencing, when compared a sham treatment Rationale for study design The results of a recent meta-analysis have informed… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Damage
- What is being tested?
- Compression garments
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 30 Nov 2018to 28 Feb 2019
- Phase
- Interventional
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Athletes must be full-time athletes over the age of 18
- Training regularly for at least 3 months without extended disruption to training (> 2 weeks)
Who cannot join
- Presentation of injuries or chronic illnesses
- Inactivity or disruptions to training > 2 weeks (e.g. due to injury)
- The use of anti-inflammatory medications
- Over 40 years old (classification as a "Masters" athlete)
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 1 recruiting
- Completed
University of Bath
Bath, Somerset, BA2 7AY
- Recruiting
St Marys University
London, TW1 4SX
Freddy Brown, MSc
Jessica Hill, PhD
About this study
Official title: The Effects of Made-To-Measure Compression Garments on the Recovery of Performance and Markers of Muscle Damage and Inflammation in Elite Modern Pentathletes
Aims To assess the efficacy of made to measure, high pressure compression garments (CG) for facilitating the recovery of strength, muscular power, and physiological markers of muscle damage following fencing, when compared a sham treatment
Rationale for study design
Read more
The results of a recent meta-analysis have informed the design of this study. The conclusions of the meta-analysis were that CG are most effective for the recovery of:
- Force and power performance following eccentric/plyometric exercise
- Maximal force production, at least 24 hours post-exercise (for example in strength and power athletes undertaking resistance training programmes)
- Additionally, the recovery of high-intensity cardiovascular performance may also be enhanced by the used of CG, when tested 24 hours following exercise which incurs metabolic stress Accordingly, the current study was designed to investigate the effects of CG of intense, competitive sparring following fencing sessions, held at the British Modern Pentathlon training base at the University of Bath.
Read the detailed description
The efficacy of compression garments (CG) for recovery will be assessed in 10 elite modern pentathletes, using a crossover design. Athletes will complete each of two different recovery interventions immediately after each of 2 identical 3 hour fencing sessions, in a random order. Sessions will be separated by at least 2 weeks, standardising training in the lead-up to control for training-load and fatigue. A two-way (4 time-points x 2 conditions) crossover trial will be conducted to assess differences in performance tests following fencing ("sparring"), conducted before and after sparring, then 12 hours and 36 hours afterwards. In addition, 3200 m running performance will be assessed the afternoon before and at 12 hours and 36 hours after the fencing session.
All testing will be carried out at the British Modern Pentathlon base at the University of Bath. One month before testing, athletes will familiarised with strength testing using a strain-gauge (MIE Medical Research Ltd., Leeds, UK). Participants will be seated on a plyometric box, starting from a flexed position of 90 degrees, as measured with a goniometer, before taking the best of three attempts of maximal knee flexion. All other measures to be taken form part of the athletes' regular performance monitoring tests. Body composition will be assessed, including height and body-mass, as well as waist, hip thigh, calf, ankle and gluteal circumferences. All limb measurements will be taken from the right side, in accordance with guidelines set by the International Society of Anthropometry and Kinanthropometry (ISAK). Skinfold measurements will be taken according to the ISAK 8 site protocol by a level 1 anthropometrist. Athletes will be fitted for custom fitted (CF) CG (stockings), after taking real-time 3D images using the manufacturer's proprietary, digitised method (Isobar Compression Ltd., Manchester, UK).
In the afternoon before fencing begins (12 midday), 3200 m running performance will be timed using a stopwatch on a 400 m running track (8 laps). Fencing sparring will commence at 5 p.m. the same day, preceded immediately by the other performance measures and physiological tests. Following athletes' individual warm-ups, maximal leg strength will be assessed, as well as vertical jump performance (maximal force and maximum height from the best of 3 attempts) using a force plate (Kistler 3-Component Force-Link, New York, USA). Maximal grip strength will also be assessed (Takei Digital Hand-Grip Dynanometer 4001, Takei Scientific Instruments Co., Niigata-City, Japan). Soreness (200 mm visual analogue scale) and swelling at the mid-thigh skinfold site will also be recorded (spring loaded tape measure - Lafayette Instrument Co, Lafayette, Ind, USA). Muscle damage will be quantified with creatine kinase analysis (CK), and inflammation quantified with C-reactive protein (RX Daytona, Kearneysville, West Virginia, USA) from venous blood samples taken from the arm at baseline and at each time-point throughout recovery. Biomarkers of oxidative damage (the free oxygen radicals - FORT - test) and anti-oxidant defense (free oxygen radicals defense - FORD) will also be assessed. Testing will be conducted after warm-up before sparring, and then immediately after the cessation of the fencing session, after 12 hours and 36 hours recovery. However, 3200 m running performance will be assessed only in the afternoon before, then at 12 hours and 36 hours.
Athletes will complete each of two recovery conditions immediately after training and testing, being randomly assigned to a different condition over each session. Athletes will be allocated to one of the following 3 conditions:
- Custom fitted stockings applying over 30 mmHg and 20 mmHg at the calf and mid-thigh respectively (CF)
- A sham treatment (CON) The CON group will receive a sham "recovery" drink immediately after training (Robinsons no added sugar fruit juice), which contains 1 g carbohydrate and 0 g protein per serving. Pressures at the skin-garment interface will be measured for both garments using a pressure monitor at the medial calf and mid-thigh skinfold sites (as defined by the International Society for Anthropometry and Kinanthropometry), as well as 2 cm above the medial malleolus.
Between-treatment differences in the recovery of performance and physiological factors will be assessed over time using a 2 way (time by condition) mixed-measures analysis of variance (SPSS Statistics 22, IBM, New York, USA).
Equipment used and methods employed make use of validated measures of strength, power, muscle damage and compression pressures, cited in the protocol above.
- Conditions
- Muscle Damage
- Being tested
- Compression garments, Sham recovery drink
- Keywords
- exercise induced muscle damage, elite athlete, recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression garmentsDevice
Made-to-measure compression garments providing high pressures (> 30 mmHg at the ankle and >20 mmHg at the thigh - equivalent to European class-2 stockings)
Sham recovery drinkOther
Non-caloric beverage, labelled as a "recovery" drink proposed to enhance athletic recovery. Aspartame/acesulfame-k based sweetener, providing 0.5 g carbohydrate and 2 Kcal per serving
| Study group | Role | What they receive |
|---|---|---|
| Custom fitted compression garments | Experimental | Made-to-measure compression garments providing high pressures (> 30 mmHg at the ankle and >20 mmHg at the thigh - equivalent to European class-2 stockings) Receives: Device: Compression garments |
| Sham recovery drink | Sham comparator | Non-caloric beverage, labelled as a "recovery" drink to enhance athletic recovery. Aspartame/acesulfame-k based sweetener, providing 0.5 g carbohydrate and 2 Kcal per serving Receives: Other: Sham recovery drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal isometric voluntary contraction strength for knee extension (change in Newtons compared to baseline)
Participants will be assessed for strength performance with maximal isometric voluntary contraction of the knee extensors (using a strain gauge) at the following time-points after fencing and compared to baseline: Immediately post, 12 hours post, 36 hours post-fencing (x 2 - crossover).
Measured: 36 h. Second leg will be conducted after 1 week "washout" (10 days in total)
Lower body reactive strength (jump height/contact time in m/s) following a drop from a 0.6 m box onto a force plate (change in m/s compared to baseline)
Participants will be compared to baseline for reactive strength performance at the following time-points after fencing:Immediately post, 12 hours post, 36 hours post-fencing (x 2 - crossover).
Jump height (m) and contact time (s) will be recorded following a drop from a 0.6 m box onto a force-plate.
Measured: 36 h. Second leg will be conducted after 1 week "washout" (10 days in total)
3200 m run time trial performance (change in seconds compared to baseline)
Participants will be timed for 3200 m running performance at the following time-points after fencing and compared to baseline: Immediately post, 12 hours post, 36 hours post-fencing (x 2 - crossover).
Measured: 36 h. Second leg will be conducted after 1 week "washout" (10 days in total)
Secondary outcomes (5)
Perceived soreness, scored by drawing a vertical line on a 200 mm visual analogue scale from 0 mm (no soreness) to 200 mm (worst soreness imaginable). Change in mm will be compared to baseline.
Participants will be measured for muscular soreness at the following time-points after fencing and compared to baseline: Immediately post, 12 hours post, 36 hours post-fencing (x 2 - crossover). Perceived soreness will be scored by drawing a vertical line on a 200 mm visual analogue scale from 0 mm (no soreness) to 200 mm (worst soreness imaginable) and compared to baseline.
Measured: 36 h. Second leg will be conducted after 1 week "washout" (10 days in total)
Circulating creatine kinase concentrations (CK - change in international units compared to baseline)
Participants will be measured for circulating creatine kinase concentrations (CK) at the following time-points after fencing and compared to baseline: Immediately post, 12 hours post, 36 hours post-fencing (x 2 - crossover). Change from baseline will be measured in international units (IU)
Measured: 36 h. Second leg will be conducted after 1 week "washout" (10 days in total)
Mid-thigh girth (MTG) at the mid-thigh skinfold site as defined by International Society of Anthropometry and Kinanthropometry. Change will be measured in mm by comparing to baseline
Thigh circumference (mm) at the mid-thigh skinfold site (as defined by International Society of Anthropoemtry and Kinanthropometry) will be measured at the following time-points after fencing and compared to baseline: Immediately post, 12 hours post, 36 hours post-fencing (x 2 - crossover).
Measured: 36 h. Second leg will be conducted after 1 week "washout" (10 days in total)
Free oxygen radicals defense (FORD) status (change in mmol/L Trolox equivalents compared to baseline)
Blood free oxygen radicals defense (FORD) will be measured from capillary samples taken from the earlobe at the following time-points after fencing and compared to baseline: Immediately post, 12 hours post, 36 hours post-fencing (x 2 - crossover).
Measured: 36 h. Second leg will be conducted after 1 week "washout" (10 days in total)
Free oxygen radicals (FORT) status (change in mmol/L H2O2 equivalents compared to baseline)
Blood free oxygen radicals (FORT) will be measured from capillary samples taken from the earlobe at the following time-points after fencing and compared to baseline: Immediately post, 12 hours post, 36 hours post-fencing (x 2 - crossover).
Measured: 36 h. Second leg will be conducted after 1 week "washout" (10 days in total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start30 Nov 2018 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion28 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Muscle DamageStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover RCT
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St Mary's University College
- Sponsor type
- University, hospital or other
- Collaborators
- Modern Pentathlon GB
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03707067
- Sponsor's protocol ID
- SMU_SHAS_2018_02
- Status last verified
- Oct 2018
- First submitted
- 7 Jun 2018
- Last updated
- 5 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF) and Clinical Study Report (CSR) will all be available from February 2019
Publications
Brown F, Gissane C, Howatson G, van Someren K, Pedlar C, Hill J. Compression Garments and Recovery from Exercise: A Meta-Analysis. Sports Med. 2017 Nov;47(11):2245-2267. doi: 10.1007/s40279-017-0728-9.
PubMed 28434152Brophy-Williams N, Driller M, Halson S, Fell J, Shing C. Evaluating the Kikuhime pressure monitor for use with sports compression clothing. Sports Engineering. 2014;17(1):55-60
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Made-To-Measure Compression Garments on the Recovery of Performance and Markers of Muscle Damage and Inflammation in Elite Modern Pentathletes
- ClinicalTrials.gov ID
- NCT03707067
- Acronym / sponsor ID
- SMU_SHAS_2018_02
- Conditions
- Muscle Damage
- Keywords
- exercise induced muscle damage, elite athlete, recovery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- St Mary's University CollegeUniversity, hospital or other
- Collaborators
- Modern Pentathlon GB
- Study start
- 30 Nov 2018 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 28 Feb 2019 (estimated)
- First posted
- 16 Oct 2018 (actual)
- 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.
Aims To assess the efficacy of made to measure, high pressure compression garments (CG) for facilitating the recovery of strength, muscular power, and physiological markers of muscle damage following fencing, when compared a sham treatment
Rationale for study design
The results of a recent meta-analysis have informed the design of this study. The conclusions of the meta-analysis were that CG are most effective for the recovery of:
- Force and power performance following eccentric/plyometric exercise
- Maximal force production, at least 24 hours post-exercise (for example in strength and power athletes undertaking resistance training programmes)
- Additionally, the recovery of high-intensity cardiovascular performance may also be enhanced by the used of CG, when tested 24 hours following exercise which incurs metabolic stress Accordingly, the current study was designed to investigate the effects of CG of intense, competitive sparring following fencing sessions, held at the British Modern Pentathlon training base at the University of Bath.
Detailed description
The efficacy of compression garments (CG) for recovery will be assessed in 10 elite modern pentathletes, using a crossover design. Athletes will complete each of two different recovery interventions immediately after each of 2 identical 3 hour fencing sessions, in a random order. Sessions will be separated by at least 2 weeks, standardising training in the lead-up to control for training-load and fatigue. A two-way (4 time-points x 2 conditions) crossover trial will be conducted to assess differences in performance tests following fencing ("sparring"), conducted before and after sparring, then 12 hours and 36 hours afterwards. In addition, 3200 m running performance will be assessed the afternoon before and at 12 hours and 36 hours after the fencing session.
All testing will be carried out at the British Modern Pentathlon base at the University of Bath. One month before testing, athletes will familiarised with strength testing using a strain-gauge (MIE Medical Research Ltd., Leeds, UK). Participants will be seated on a plyometric box, starting from a flexed position of 90 degrees, as measured with a goniometer, before taking the best of three attempts of maximal knee flexion. All other measures to be taken form part of the athletes' regular performance monitoring tests. Body composition will be assessed, including height and body-mass, as well as waist, hip thigh, calf, ankle and gluteal circumferences. All limb measurements will be taken from the right side, in accordance with guidelines set by the International Society of Anthropometry and Kinanthropometry (ISAK). Skinfold measurements will be taken according to the ISAK 8 site protocol by a level 1 anthropometrist. Athletes will be fitted for custom fitted (CF) CG (stockings), after taking real-time 3D images using the manufacturer's proprietary, digitised method (Isobar Compression Ltd., Manchester, UK).
In the afternoon before fencing begins (12 midday), 3200 m running performance will be timed using a stopwatch on a 400 m running track (8 laps). Fencing sparring will commence at 5 p.m. the same day, preceded immediately by the other performance measures and physiological tests. Following athletes' individual warm-ups, maximal leg strength will be assessed, as well as vertical jump performance (maximal force and maximum height from the best of 3 attempts) using a force plate (Kistler 3-Component Force-Link, New York, USA). Maximal grip strength will also be assessed (Takei Digital Hand-Grip Dynanometer 4001, Takei Scientific Instruments Co., Niigata-City, Japan). Soreness (200 mm visual analogue scale) and swelling at the mid-thigh skinfold site will also be recorded (spring loaded tape measure - Lafayette Instrument Co, Lafayette, Ind, USA). Muscle damage will be quantified with creatine kinase analysis (CK), and inflammation quantified with C-reactive protein (RX Daytona, Kearneysville, West Virginia, USA) from venous blood samples taken from the arm at baseline and at each time-point throughout recovery. Biomarkers of oxidative damage (the free oxygen radicals - FORT - test) and anti-oxidant defense (free oxygen radicals defense - FORD) will also be assessed. Testing will be conducted after warm-up before sparring, and then immediately after the cessation of the fencing session, after 12 hours and 36 hours recovery. However, 3200 m running performance will be assessed only in the afternoon before, then at 12 hours and 36 hours.
Athletes will complete each of two recovery conditions immediately after training and testing, being randomly assigned to a different condition over each session. Athletes will be allocated to one of the following 3 conditions:
- Custom fitted stockings applying over 30 mmHg and 20 mmHg at the calf and mid-thigh respectively (CF)
- A sham treatment (CON) The CON group will receive a sham "recovery" drink immediately after training (Robinsons no added sugar fruit juice), which contains 1 g carbohydrate and 0 g protein per serving. Pressures at the skin-garment interface will be measured for both garments using a pressure monitor at the medial calf and mid-thigh skinfold sites (as defined by the International Society for Anthropometry and Kinanthropometry), as well as 2 cm above the medial malleolus.
Between-treatment differences in the recovery of performance and physiological factors will be assessed over time using a 2 way (time by condition) mixed-measures analysis of variance (SPSS Statistics 22, IBM, New York, USA).
Equipment used and methods employed make use of validated measures of strength, power, muscle damage and compression pressures, cited in the protocol above.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Crossover RCT
| Arm | Type | Receives |
|---|---|---|
| Custom fitted compression garments | Experimental | Device: Compression garmentsMade-to-measure compression garments providing high pressures (> 30 mmHg at the ankle and >20 mmHg at the thigh - equivalent to European class-2 stockings) |
| Sham recovery drink | Sham comparator | Other: Sham recovery drinkNon-caloric beverage, labelled as a "recovery" drink to enhance athletic recovery. Aspartame/acesulfame-k based sweetener, providing 0.5 g carbohydrate and 2 Kcal per serving |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Athletes must be full-time athletes over the age of 18
- Training regularly for at least 3 months without extended disruption to training (> 2 weeks)
Key exclusion criteria (4 listed)
- Presentation of injuries or chronic illnesses
- Inactivity or disruptions to training > 2 weeks (e.g. due to injury)
- The use of anti-inflammatory medications
- Over 40 years old (classification as a "Masters" athlete)
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 |
|---|---|---|
| Compression garmentsMade-to-measure compression garments providing high pressures (> 30 mmHg at the ankle and >20 mmHg at the thigh - equivalent to European class-2 stockings) | Device | Custom fitted compression garments |
| Sham recovery drinkNon-caloric beverage, labelled as a "recovery" drink proposed to enhance athletic recovery. Aspartame/acesulfame-k based sweetener, providing 0.5 g carbohydrate and 2 Kcal per serving | Other | Sham recovery drink |
Primary outcome
Maximal isometric voluntary contraction strength for knee extension (change in Newtons compared to baseline)
Time frame: 36 h. Second leg will be conducted after 1 week "washout" (10 days in total)
Participants will be assessed for strength performance with maximal isometric voluntary contraction of the knee extensors (using a strain gauge) at the following time-points after fencing and compared to baseline: Immediately post, 12 hours post, 36 hours post-fencing (x 2 - crossover).
Lower body reactive strength (jump height/contact time in m/s) following a drop from a 0.6 m box onto a force plate (change in m/s compared to baseline)
Time frame: 36 h. Second leg will be conducted after 1 week "washout" (10 days in total)
Participants will be compared to baseline for reactive strength performance at the following time-points after fencing:Immediately post, 12 hours post, 36 hours post-fencing (x 2 - crossover). Jump height (m) and contact time (s) will be recorded following a drop from a 0.6 m box onto a force-plate.
3200 m run time trial performance (change in seconds compared to baseline)
Time frame: 36 h. Second leg will be conducted after 1 week "washout" (10 days in total)
Participants will be timed for 3200 m running performance at the following time-points after fencing and compared to baseline: Immediately post, 12 hours post, 36 hours post-fencing (x 2 - crossover).
5 secondary outcomes
Perceived soreness, scored by drawing a vertical line on a 200 mm visual analogue scale from 0 mm (no soreness) to 200 mm (worst soreness imaginable). Change in mm will be compared to baseline.
Time frame: 36 h. Second leg will be conducted after 1 week "washout" (10 days in total)
Circulating creatine kinase concentrations (CK - change in international units compared to baseline)
Time frame: 36 h. Second leg will be conducted after 1 week "washout" (10 days in total)
Mid-thigh girth (MTG) at the mid-thigh skinfold site as defined by International Society of Anthropometry and Kinanthropometry. Change will be measured in mm by comparing to baseline
Time frame: 36 h. Second leg will be conducted after 1 week "washout" (10 days in total)
Free oxygen radicals defense (FORD) status (change in mmol/L Trolox equivalents compared to baseline)
Time frame: 36 h. Second leg will be conducted after 1 week "washout" (10 days in total)
Free oxygen radicals (FORT) status (change in mmol/L H2O2 equivalents compared to baseline)
Time frame: 36 h. Second leg will be conducted after 1 week "washout" (10 days in total)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2018.
- Background: PubMed 28434152Brown F, Gissane C, Howatson G, van Someren K, Pedlar C, Hill J. Compression Garments and Recovery from Exercise: A Meta-Analysis. Sports Med. 2017 Nov;47(11):2245-2267. doi: 10.1007/s40279-017-0728-9.
- BackgroundBrophy-Williams N, Driller M, Halson S, Fell J, Shing C. Evaluating the Kikuhime pressure monitor for use with sports compression clothing. Sports Engineering. 2014;17(1):55-60
- Individual participant dataSharing planned: Yes. Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF) and Clinical Study Report (CSR) will all be available from February 2019
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compression garments in people with Muscle Damage, run by St Mary's University College at 2 sites 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 5 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Freddy Brown, PhD (07746075161, freddybrown1984@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal isometric voluntary contraction strength for knee extension (change in Newtons compared to baseline) (time frame: 36 h. Second leg will be conducted after 1 week "washout" (10 days in total)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03707067, which also lists 2 linked publications.
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 5 Nov 2018.