NCT03707067

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 16, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

November 30, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

November 5, 2018

Status Verified

October 1, 2018

Enrollment Period

1 month

First QC Date

June 7, 2018

Last Update Submit

November 1, 2018

Conditions

Keywords

exercise induced muscle damageelite athleterecovery

Outcome Measures

Primary Outcomes (3)

  • Maximal isometric voluntary contraction strength for knee extension (change in Newtons compared to baseline)

    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).

    36 h. Second leg will be conducted after 1 week "washout" (10 days in total)

  • 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)

    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.

    36 h. Second leg will be conducted after 1 week "washout" (10 days in total)

  • 3200 m run time trial performance (change in seconds compared to baseline)

    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).

    36 h. Second leg will be conducted after 1 week "washout" (10 days in total)

Secondary Outcomes (5)

  • 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.

    36 h. Second leg will be conducted after 1 week "washout" (10 days in total)

  • Circulating creatine kinase concentrations (CK - change in international units compared to baseline)

    36 h. Second leg will be conducted after 1 week "washout" (10 days in total)

  • 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

    36 h. Second leg will be conducted after 1 week "washout" (10 days in total)

  • Free oxygen radicals defense (FORD) status (change in mmol/L Trolox equivalents compared to baseline)

    36 h. Second leg will be conducted after 1 week "washout" (10 days in total)

  • Free oxygen radicals (FORT) status (change in mmol/L H2O2 equivalents compared to baseline)

    36 h. Second leg will be conducted after 1 week "washout" (10 days in total)

Study Arms (2)

Custom fitted compression garments

EXPERIMENTAL

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

Sham recovery drink

SHAM COMPARATOR

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

Interventions

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)

Custom fitted compression garments

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

Sham recovery drink

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Bath

Bath, Somerset, BA2 7AY, United Kingdom

COMPLETED

St Marys University

London, TW1 4SX, United Kingdom

RECRUITING

Related Publications (2)

  • 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.

    PMID: 28434152BACKGROUND
  • 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

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Crossover RCT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2018

First Posted

October 16, 2018

Study Start

November 30, 2018

Primary Completion

December 31, 2018

Study Completion

February 28, 2019

Last Updated

November 5, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will share

Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF) and Clinical Study Report (CSR) will all be available from February 2019

Shared Documents
STUDY PROTOCOL, SAP, ICF, 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

Locations