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Muscle DamageNCT03707470

Made to Measure Compression Garments for Recovery in Rugby Players

A study testing Custom fitted compression garments (CF) and Standard-sized compression garments (SSG) in people with Muscle Damage, run by St Mary's University College at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for
Muscle Damage
What is being tested?
Custom fitted compression garments (CF) and Standard-sized compression garments (SSG)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 siteUnited Kingdom
Study dates
30 Nov 2016to 31 Dec 2017
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
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • St Marys University

    London, TW1 4SX

Other trials in United Kingdom

About this study

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

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
Read more

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.
Read the detailed description

Study 1) A comparison of the pressures exerted by different compression garments Participants were assessed for anthropometry; including height and body-mass, as well as waist, hip thigh, calf, ankle and gluteal circumferences. All limb measurements were taken from the right side, in accordance with guidelines set by the International Society of Anthropometry and Kinanthropometry (ISAK). Skinfold measurements were taken according to the ISAK 8 site protocol by a level 1 anthropometrist.

Thirty-two of the initially recruited 48 participants (see Study 2, below) were randomly selected and fitted for custom fitted compression garments (CG - stockings), after taking real-time 3D images using the manufacturer's proprietary, digitised method (Isobar, Manchester, UK). The custom fitted stockings (CF) were manufactured to apply pressures of 35 mmHg and 20 mmHg for the calf and mid-thigh respectively. Using a crossover design, applied pressures were compared to those from standard sized CG (SSG) which provided lower pressures (5-15 mmHg) for each athlete. Garments were provided in small, medium or large, dependent on athletes' size and fitted according to the manufacturer's guidelines based upon height and body-mass (2XU, Campbelltown, Australia). Pressures at the skin-garment interface were measured for both garments, worn in a randomised order, using a pressure monitor. Pressures applied at three sites were recorded: font-thigh and medial calf landmarks as defined by The International Society for the Advancement of Kinanthropometry (ISAK), and 2 cm above the centre of the median malleolus of the ankle. This visit to the laboratory took approximately 30 minutes per participant. Means and standard deviations were calculated from the pressure data to ascertain the average pressure exerted by the garments, as well as the variation in pressure across this population. Differences in measured pressures between garments were assessed using a paired-samples t-test (SPSS Statistics 22, IBM, New York, USA).

Study 2) An investigation into the effects of the pressures applied by different compression garments in facilitating the short term recovery of strength and power performance The full cohort of 48 athletes originally recruited participated in a randomised clinical trial (parallel design) to assess the effects of CG on recovery from a standardised eccentric exercise protocol. Athletes were required to avoid strenuous exercise for 48 hours before the start of the study, and then throughout 48 hours recovery. The first session included assessment of performance followed by a bout of damaging exercise and re-assessment, lasting approximately 90 minutes. Recovery was assessed in 2 further sessions, at 24 hours and at 48 hours after exercise (each lasting approximately 30 minutes).

Initial assessment Following a standardised warm up (400 m jogging, 20 leg swings in both the horizontal and sagittal planes on either leg, and any individual stretches usually performance by an athlete), maximal force production (using a strain-gauge - MIE Medical Research Ltd., Leeds, UK) was assessed by measuring the best of three attempts of maximal knee extension. Participants will be seated on a plyometric box, starting from a flexed position of 90o, as measured with a goniometer. In addition, 30 m sprint time (timing gates by Brower, Utah, USA) and vertical jump performance, using a jump mat (FSL electronics, Cookstown, UK), were assessed (best of 3 attempts). Soreness (200 mm visual analogue scale) and swelling (spring loaded tape measure - Lafayette Instrument Co, Lafayette, Indiana, USA) were also assessed. Muscle damage was also be quantified by creatine kinase analysis (RX Monza, Kearneysville, West Virginia, USA) from venous blood samples taken from the arm at baseline and at each time-point throughout recovery.

Eccentric muscle-damage protocol Following initial assessment, participants completed 20 sets of 20 m sprints with a 5 m deceleration phase, followed by 100 drop jumps. Sprints were separated by 60 s intervals. This combined protocol represents a novel and ecologically valid stimulus which combines the mechanical and metabolic stressors faced by Rugby Union players from competition and training. Sprints were timed to provide real-time feedback and encourage maximal effort, and sprints repeated if deceleration continued past the 5 m zone permitted. Subsequent drop jumps were performed from a 0.6 m platform, while athletes were encouraged to achieve the maximum height possible following a down-phase that resulted in the hips dropping below the level of the knee.

In a randomised, parallel-group design, athletes undertook either a sham treatment (CON), or wore CG immediately from the cessation of exercise for 48 hours recovery, removing them only to wash. Garments were manufactured to apply the pressures below, with no differences in physical appearance between garments. Athletes were allocated to one of the following three conditions:

  • Custom fitted stockings (Isobar, Manchester, UK) applying over 35 mmHg and 20 mmHg at the calf and mid-thigh respectively (CF)
  • Standard sized garments (2XU, Campbelltown, Australia) applying lower pressures (SSG - applying 5-15 mmHg, at both the calf and thigh)
  • A sham ultrasound treatment (CON) The CON group received 15 minutes (5 minutes of quadriceps, 5 minutes of hamstrings, and 5 minutes of gastrocnemius) of sham ultrasound therapy (Combined therapy ultrasound/inferential; Shrewsbury Medical, Shropshire, United Kingdom) within 1 hour of the completion of performance testing. Pressures at the skin-garment interface were measured for both garments using a pressure monitor.

Performance measures - dependent variables Recovery was quantified by repeating the initial assessment and comparing to baseline values. Recovery of performance and recovery of markers of muscle damage were measured at the following time-points: pre-exercise, post-exercise, 24 hours post-exercise, 48 hours post-exercise. Between-group differences in the recovery of performance and physiological factors were assessed over time using a 2 way (time by condition) mixed-measures analysis of variance (SPSS Statistics 22, IBM, New York, USA).

All equipment used and methods employed made use of validated measures of strength, power, muscle damage and compression pressures.

Conditions
Muscle Damage
Being tested
Custom fitted compression garments (CF), Standard-sized compression garments (SSG), Sham ultrasound (CON)
Keywords
exercise induced muscle damage, recovery, rugby

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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)

  • 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)

  • Sham ultrasound (CON)Procedure or surgery

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

Study groups in NCT03707470
Study groupRoleWhat they receive
Custom fitted compression garments (CF)ExperimentalCustom 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)
Receives: Device: Custom fitted compression garments (CF)
Standard-sized compression garments (SSG)Active comparatorOff-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)
Receives: Device: Standard-sized compression garments (SSG)
Sham ultrasound (CON)Sham comparatorSham ultrasound using an unplugged machine. Sham treatment for 5 minutes on each of the thighs, calves and hamstrings
Receives: Procedure: Sham ultrasound (CON)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. Change in lower body jump performance

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

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

  3. Change in sprint speed

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

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

Secondary outcomes (4)
  1. Change in total haemoglobin concentration (tHb)

    Accumulation of total haemoglobin, as measured with NIRS

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

  2. Change in perceived soreness

    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")

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

  3. Change in creatine kinase concentrations (CK)

    Change in creatine kinase concentrations (IU) over time

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

  4. Change in mid-thigh girth (MTG)

    Change in mid-thigh girth (cm) over time

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2018
  2. Study start30 Nov 2016
  3. Primary completion1 Sep 2017
  4. Study completion31 Dec 2017

Resources

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
Parallel groups
Model description
Randomised, controlled, parallel trial
Masking
Single blind
Who is masked
Participant
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03707470
Sponsor's protocol ID
SMU_SHAS_2017_03
Status last verified
Oct 2018
First submitted
7 Jun 2018
Last updated
16 Oct 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), Clinical, Study Report (CSR) all available on request.

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.

  • 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.

    PubMed 20376479
  • 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.

    PubMed 23479406

Questions about this trial

What is this clinical trial studying?

A study testing Custom fitted compression garments (CF) and Standard-sized compression garments (SSG) in people with Muscle Damage, run by St Mary's University College at 1 site 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 3 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: finished, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in lower body strength (time frame: Immediately post, 24 hours post, 48 hours post-exercise). 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 NCT03707470, which also lists 3 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 16 Oct 2018.

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