An interventional study of Compression garments and Sham recovery drink in Muscle Damage, sponsored by St Mary's University College. Status unknown at 2 sites in United Kingdom. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-05.
Sponsored by St Mary's University College · Not applicable, Interventional, and Treatment
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:
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:
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.
St Mary's University College is the lead sponsor of 25 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
Device: Compression garments
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
Other: Sham recovery drink
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)
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
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).
Time frame: 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.
Time frame: 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).
Time frame: 36 h. Second leg will be conducted after 1 week "washout" (10 days in total)
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.
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)
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)
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
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).
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)
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).
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)
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).
Time frame: 36 h. Second leg will be conducted after 1 week "washout" (10 days in total)
Plan to share: Yes — Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF) and Clinical Study Report (CSR) will all be available from February 2019
Supporting information: Study protocol, Sap, Icf, Csr
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St Mary's University College