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Made to Measure Compression Garments for Recovery in Rugby Players

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: NCT03707470
Recruitment Status : Completed
First Posted : October 16, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
St Mary's University College

Brief Summary:

Aims

  • To compare the compression pressures exerted by made-to-measure compression garments (CG) with those from standard sized garments
  • To assess the efficacy of custom fitted, high pressure CG for facilitating the recovery of strength, muscular power and sprint performance, and to compare the effects with those of garments exerting lower pressures and a sham treatment

Rationale for study design

The results of a recent meta-analysis (unpublished data) have informed the design of this study.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 on the recovery of force, muscular power and sprint performance in rugby players over a 48 hour period following damaging exercise. The exercise protocol chosen (detailed below) provided both mechanical and metabolic recovery demands.

Condition or disease Intervention/treatment Phase
Muscle Damage Device: Custom fitted compression garments (CF) Device: Standard-sized compression garments (SSG) Procedure: Sham ultrasound (CON) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised, controlled, parallel trial
Masking: Single (Participant)
Masking Description: Participants to be provided with 2 different types of compression garments and a sham treatment (sham ultrasound) for recovery from muscle damaging exercise
Primary Purpose: Treatment
Official Title: The Effects of Made-To-Measure Compression Garments on Pressures Exerted on the Lower Limbs and Recovery From Muscle Damage in Rugby Players
Actual Study Start Date : November 30, 2016
Actual Primary Completion Date : September 1, 2017
Actual Study Completion Date : December 31, 2017

Arm Intervention/treatment
Experimental: Custom fitted compression garments (CF)
Custom fitted compression garments (Isobar, Manchester, UK) designed to provide 35 mmHg at the ankle and >20 mmHg at the mid-thigh (equivalent to European class 2 compression garments)
Device: Custom fitted compression garments (CF)
Custom fitted compression garments (Isobar, Manchester, UK) designed to provide 35 mmHg at the ankle and >20 mmHg at the mid-thigh (equivalent to European class 2 compression garments)

Active Comparator: Standard-sized compression garments (SSG)
Off-the-shelf, standard-sized garments (2XU, Campbelltown, Australia), typically providing pressures equivalent to European grade 1 compression or below (5 - 15 mmHg at both the ankle and thigh)
Device: Standard-sized compression garments (SSG)
Off-the-shelf, standard-sized garments (2XU, Campbelltown, Australia), typically providing pressures equivalent to European grade 1 compression or below (5 - 10 mmHg at both the ankle and thigh)

Sham Comparator: Sham ultrasound (CON)
Sham ultrasound using an unplugged machine. Sham treatment for 5 minutes on each of the thighs, calves and hamstrings
Procedure: Sham ultrasound (CON)
Sham ultrasound using an unplugged machine. Sham treatment for 5 minutes on each of the thighs, calves and hamstrings




Primary Outcome Measures :
  1. Change in lower body strength [ Time Frame: Immediately post, 24 hours post, 48 hours post-exercise ]
    Change in maximal voluntary isometric contraction force of the knee extensors over time, measured in Newtons, using a force-meter to measure knee flexion force at 90 degrees

  2. Change in lower body jump performance [ Time Frame: Immediately post, 24 hours post, 48 hours post-exercise ]
    Change in maximal force from counter-movement jump over time, measured on a force platform (Newtons)

  3. Change in sprint speed [ Time Frame: Immediately post, 24 hours post, 48 hours post-exercise ]
    Change in 30 m sprint speed over time, measured using electronic timing gates


Secondary Outcome Measures :
  1. Change in total haemoglobin concentration (tHb) [ Time Frame: Immediately post-exercise, after having gone from the supine position (5 min), to standing (5 min) ]
    Accumulation of total haemoglobin, as measured with NIRS

  2. Change in perceived soreness [ Time Frame: Immediately post, 24 hours post, 48 hours post-exercise ]
    Change in perceived muscle soreness over time, measured by participants marking a line on a 200 mm visual analogue scale (from 0 mm - "no soreness"; to 200 mm - "worst soreness imaginable")

  3. Change in creatine kinase concentrations (CK) [ Time Frame: Immediately post, 24 hours post, 48 hours post-exercise ]
    Change in creatine kinase concentrations (IU) over time

  4. Change in mid-thigh girth (MTG) [ Time Frame: Immediately post, 24 hours post, 48 hours post-exercise ]
    Change in mid-thigh girth (cm) over time



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:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Actively playing
  • A minimum of 2 years training experience.

Exclusion Criteria:

  • Current injuries or illnesses
  • Not actively playing at the time of testing
  • Disruptions to training > 2 weeks within 8 weeks prior to testing

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): NCT03707470


Locations
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United Kingdom
St Marys University
London, United Kingdom, TW1 4SX
Sponsors and Collaborators
St Mary's University College
Publications:
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Responsible Party: St Mary's University College
ClinicalTrials.gov Identifier: NCT03707470    
Other Study ID Numbers: SMU_SHAS_2017_03
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: October 16, 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), Clinical, Study Report (CSR) all available on request.
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), Clinical, Study Report (CSR) all available on request from now until records are destroyed (after 10 years)
Access Criteria: Those requesting data should be planning a trial and provide their protocol, or be the participants whom the data belongs to

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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
recovery
rugby