Made to Measure Compression Garments for Recovery in Rugby Players

NCT03707470 | Completed

• 1 other identifier: SMU_SHAS_2017_03
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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exerting lower pressures and a sham treatment Rationale for study design The results of a recent meta-analysis (unpublished data) have informed the design of this study.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.

Conditions

Muscle Damage

Keywords

exercise induced muscle damage; recovery; rugby

Outcome Measures

Primary Outcomes (3)

• Change in lower body strength

  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

  Immediately post, 24 hours post, 48 hours post-exercise

• Change in lower body jump performance

  Change in maximal force from counter-movement jump over time, measured on a force platform (Newtons)

  Immediately post, 24 hours post, 48 hours post-exercise

• Change in sprint speed

  Change in 30 m sprint speed over time, measured using electronic timing gates

  Immediately post, 24 hours post, 48 hours post-exercise

Secondary Outcomes (4)

• Change in total haemoglobin concentration (tHb)

  Immediately post-exercise, after having gone from the supine position (5 min), to standing (5 min)

• Change in perceived soreness

  Immediately post, 24 hours post, 48 hours post-exercise

• Change in creatine kinase concentrations (CK)

  Immediately post, 24 hours post, 48 hours post-exercise

• Change in mid-thigh girth (MTG)

  Immediately post, 24 hours post, 48 hours post-exercise

Study Arms (3)

Custom fitted compression garments (CF)

EXPERIMENTAL

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)

Standard-sized compression garments (SSG)

ACTIVE COMPARATOR

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)

Sham ultrasound (CON)

SHAM COMPARATOR

Sham ultrasound using an unplugged machine. Sham treatment for 5 minutes on each of the thighs, calves and hamstrings

Procedure: Sham ultrasound (CON)

Interventions

Custom fitted compression garments (CF) DEVICE

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)

Custom fitted compression garments (CF)

Standard-sized compression garments (SSG) DEVICE

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)

Standard-sized compression garments (SSG)

Sham ultrasound (CON) PROCEDURE

Sham ultrasound using an unplugged machine. Sham treatment for 5 minutes on each of the thighs, calves and hamstrings

Sham ultrasound (CON)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• St Mary's University College: lead

Study Sites (1)

St Marys University

London, TW1 4SX, United Kingdom

Location

Related Publications (3)

• 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.

  BACKGROUND

• Jakeman JR, Byrne C, Eston RG. Lower limb compression garment improves recovery from exercise-induced muscle damage in young, active females. Eur J Appl Physiol. 2010 Aug;109(6):1137-44. doi: 10.1007/s00421-010-1464-0. Epub 2010 Apr 8.

  PMID: 20376479 BACKGROUND

• Leeder J DC, van Someren KA, Gaze D, Jewell A, Deshmukh NI, Shah I, Barker J, Howatson G. Recovery and adaptation from repeated intermittent-sprint exercise. Int J Sports Physiol Perform. 2014 May;9(3):489-96. doi: 10.1123/ijspp.2012-0316. Epub 2013 Mar 8.

  PMID: 23479406 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants to be provided with 2 different types of compression garments and a sham treatment (sham ultrasound) for recovery from muscle damaging exercise
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised, controlled, parallel trial

Study Record Dates

• First Submitted: June 7, 2018
• First Posted: October 16, 2018
• Study Start: November 30, 2016
• Primary Completion: September 1, 2017
• Study Completion: December 31, 2017
• Last Updated: October 16, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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

Locations

GB (1)