Compression Garments for Recovery in Modern Pentathletes

NCT ID: NCT03707067

Last Updated: 2018-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-30

Study Completion Date

2019-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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:

* Custom fitted stockings applying over 30 mmHg and 20 mmHg at the calf and mid-thigh respectively (CF)
* A sham treatment (CON) The CON group will receive a sham "recovery" drink immediately after training (Robinsons no added sugar fruit juice), which contains 1 g carbohydrate and 0 g protein per serving. Pressures at the skin-garment interface will be measured for both garments using a pressure monitor at the medial calf and mid-thigh skinfold sites (as defined by the International Society for Anthropometry and Kinanthropometry), as well as 2 cm above the medial malleolus.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Muscle Damage

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Crossover RCT
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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)

Group Type EXPERIMENTAL

Compression garments

Intervention Type DEVICE

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 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

Group Type SHAM_COMPARATOR

Sham recovery drink

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type DEVICE

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Modern Pentathlon GB

UNKNOWN

Sponsor Role collaborator

St Mary's University College

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Bath

Bath, Somerset, United Kingdom

Site Status COMPLETED

St Marys University

London, , United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Freddy Brown, PhD

Role: CONTACT

07746075161

Jessica Hill, PhD

Role: CONTACT

020 8240 4283

References

Explore related publications, articles, or registry entries linked to this study.

Brown F, Gissane C, Howatson G, van Someren K, Pedlar C, Hill J. Compression Garments and Recovery from Exercise: A Meta-Analysis. Sports Med. 2017 Nov;47(11):2245-2267. doi: 10.1007/s40279-017-0728-9.

Reference Type BACKGROUND
PMID: 28434152 (View on PubMed)

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

Reference Type BACKGROUND

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SMU_SHAS_2018_02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.