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Compression Garments for Recovery in Modern Pentathletes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03707067
Recruitment Status : Unknown
Verified October 2018 by St Mary's University College.
Recruitment status was:  Recruiting
First Posted : October 16, 2018
Last Update Posted : November 5, 2018
Sponsor:
Collaborator:
Modern Pentathlon GB
Information provided by (Responsible Party):
St Mary's University College

Brief 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 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.

Condition or disease Intervention/treatment Phase
Muscle Damage Device: Compression garments Other: Sham recovery drink Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Crossover RCT
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Randomization carried out and compression garments allocated by a third party. All testing will be completed once athletes have removed their garments, without the knowledge of outcomes assessors or primary investigator
Primary Purpose: Treatment
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
Estimated Study Start Date : November 30, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : February 28, 2019

Arm Intervention/treatment
Experimental: Custom fitted compression garments
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
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 Comparator: Sham recovery drink
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
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




Primary Outcome Measures :
  1. 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).

  2. 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.


  3. 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).


Secondary Outcome Measures :
  1. 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) ]
    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.

  2. 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) ]
    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)

  3. 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) ]
    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).

  4. 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) ]
    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).

  5. 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) ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03707067


Contacts
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Contact: Freddy Brown, PhD 07746075161 freddybrown1984@gmail.com
Contact: Jessica Hill, PhD 020 8240 4283 jessica.hill@stmarys.ac.uk

Locations
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United Kingdom
University of Bath Completed
Bath, Somerset, United Kingdom, BA2 7AY
St Marys University Recruiting
London, United Kingdom, TW1 4SX
Principal Investigator: Freddy Brown, MSc         
Sub-Investigator: Jessica Hill, PhD         
Sponsors and Collaborators
St Mary's University College
Modern Pentathlon GB
Publications:
Brophy-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

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Responsible Party: St Mary's University College
ClinicalTrials.gov Identifier: NCT03707067    
Other Study ID Numbers: SMU_SHAS_2018_02
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF) and Clinical Study Report (CSR) will all be available from February 2019
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF) and Clinical Study Report (CSR) will all be available from February 2019. Data will be stored for 10 years
Access Criteria: Must demonstrate planned research protocol and ethics application

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St Mary's University College:
exercise induced muscle damage
elite athlete
recovery