NCT03083509

Brief Summary

The aim of this study to increase understanding of physiological and functional perturbations following a continuum of exercise stressors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2016

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 20, 2017

Completed
Last Updated

August 1, 2017

Status Verified

July 1, 2017

Enrollment Period

7 months

First QC Date

September 28, 2016

Last Update Submit

July 31, 2017

Conditions

Outcome Measures

Primary Outcomes (5)

  • Maximal isometric volume contraction (MIVC)

    Following a five minute warm-up cycling at 100W (Power output of the cycle in watts), participants seated on a dynamometer. For each participant the chair height, length and dynamometer position were recorded and maintained in subsequent trials. Participants completed a standardised warm-up consisting of contractions at 50, 75, and 90% of perceived maximal force. Participants then performed three MIVC of the dominant limb each lasting approximately 3 seconds (sec). Sixty seconds rest was given in between repetitions with peak force (N) recorded and the best attempt used for subsequent analysis.

    Up to Day 26

  • Rate of force development (RFD)

    Participants were instructed to stand with their feet approximately shoulder width apart on a force plate, with hands placed on hips. Participants completed a standardised warm-up consisting of jumps at 50, 75, and 90% of perceived maximum jump height. Participants were instructed to perform a maximal vertical jump by using their own choice of depth and pace (whilst maintaining hands on hips throughout) and to land with straight legs. If flight time is exaggerated by participants removing hands from the hips or bending their legs whilst in the air, the test was performed again. Three maximal efforts were performed with sixty seconds rest in between repetitions, RFD (N·s-1) recorded, and the best attempt used for subsequent analysis.

    Up to Day 26

  • Countermovement jump (CMJ)

    Participants were instructed to stand with their feet approximately shoulder width apart on a force plate, with hands placed on hips. Participants completed a standardised warm-up consisting of jumps at 50, 75, and 90% of perceived maximum jump height. Participants were instructed to perform a maximal vertical jump by using their own choice of depth and pace (whilst maintaining hands on hips throughout) and to land with straight legs. If flight time is exaggerated by participants removing hands from the hips or bending their legs whilst in the air, the test was performed again. Three maximal efforts were performed with sixty seconds rest in between repetitions with jump height (cm) recorded, and the best attempt was used for subsequent analysis.

    Up to Day 26

  • 20 meter (m) sprint assessment (Group 1 and 3 only)

    A 20 m runway in an indoor track was marked using cones and two sets of infrared timing gates, one set at each end of the start and finish line. Participants completed a standardised warm-up consisting of performing 20 m runs at 50, 75, and 90% of perceived maximal effort. Participants stand 0.3 m behind the start line to avoid premature triggering of the timing system, and were instructed to lead with the same starting leg for all attempts before performing three sprints interspersed with 60sec rest. Sprint time (sec) was recorded and the best attempt was used for subsequent analysis.

    Up to Day 26

  • Cycling Time-Trial performance assessment (Group 2 only)

    Following a standardised five minute warm-up at 100 W, with a 10sec sprint at 2 minutes 30 sec, participants completed a 5 minute all-out time trial, covering as much distance as possible. Participants were initially instructed that they were to cover as much distance as possible in 5 minutes, before being blinded to time and test performance and informed of the half-way stage by the investigator. Distance covered (m), mean power (W) and work done (J) were calculated and used for subsequent analysis.

    Up to Day 26

Secondary Outcomes (18)

  • Sleep efficiency

    Up to Day 26

  • Sleep latency

    Up to Day 26

  • Time in bed

    Up to Day 26

  • Time asleep

    Up to Day 26

  • Perceived muscle soreness

    Up to Day 26

  • +13 more secondary outcomes

Study Arms (3)

Group1 (Resistance trained individuals)

OTHER

Resistance trained individuals (\>3 sessions per weeks for ≥2 years with a minimum of 1 session per week including leg-based exercises)

Other: Resistance exercise weight training session

Group 2 (Trained cyclists)

OTHER

Trained cyclists (competing at a minimum of Category 3 road racing/estimated 10 mile TT of \<25 minutes and a training history of ≥5 hours per week for ≥2 years)

Other: High-Intensity stochastic cycling session

Group 3 (Team sports players)

OTHER

Team sports players (minimum of University 1st team level e.g. soccer, rugby union, rugby league, hockey and basketball, playing competitively ≥1x per week for ≥2 years)

Other: Simulated Team sport protocol

Interventions

A resistance exercise session was performed. Following a warm-up that consisted of five-minutes cycling at a self-selected intensity, as well as three progressive lifts at 50, 75, and 90% 6 rep max (RM), participants performed four sets of six repetitions at 100% of 6RM (as determined by the maximal weight lifted during the maximal strength assessment) of the following lifts; back squat, front squat, good mornings, and Bulgarian split-squat. Two minutes rest was afforded between sets and exercises.

Group1 (Resistance trained individuals)

A high-intensity stochastic cycling session was performed. The cycling protocol was performed using a magnetically-braked cycle ergometer (Velotron, RacerMate). Following a 10 minute standardised warm-up including 3 × 3s sprints, participants completed a simulated road-race, consisting of sprints of varied length, differing work to rest ratios and short time-trials.

Group 2 (Trained cyclists)

A simulated team sport protocol was performed. Participants performed a standardised warm-up consisting of performing three laps of the circuit jogging, and three laps at 50, 75, and 90% of perceived maximal speed. Participants were then afforded five minutes to perform self-selected stretching prior to commencing the session. Participants performed two sets of 45 minutes of the simulated team sport protocol, separated by 15 minutes rest. Each 45 minute period consisted of a one minute circuit repeated 45 times that replicates typical movement patterns observed during team sports and includes walking, jogging, jumping, sprinting, agility, and decelerations. Each circuit was initiated on the minute, therefore enabling participants to rest following the completion of each circuit. Pilot testing showed participants completes each circuit in approximately 48-55 seconds (sec) therefore enabling 5-12sec rest after each circuit.

Group 3 (Team sports players)

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent (see Appendices 2-4) and has received a signed and dated copy of the informed consent form.
  • Participant is male
  • Good general and mental health as assessed by a health questionnaire and with, in the opinion of the investigator or medically qualified designee ,no clinically significant and relevant abnormalities in medical history or upon oral examination. As well as absence of any condition that would impact on the participant's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.
  • Participants will be fully briefed prior to agreeing to participate in the study and the research team will confirm that they are willing, able, and likely to comply with all procedures and complete the study.
  • Only the following individuals will be recruited as participants for the study:
  • Group 1: Resistance trained individuals (≥3 sessions per week for ≥2 years with a minimum of 1 session per week including leg-based exercises).
  • Group 2: Trained cyclists (competing at a minimum of Category 3 roadracing/ estimated 10 mile TT of \<25 minutes and a training history of ≥5 hours per week for ≥2 years).
  • Group 3: Team sports players (minimum of University 1st team level e.g. soccer, rugby union, rugby league, hockey, and basketball, playing competitively ≥1x per week for ≥2 years).

You may not qualify if:

  • Current use of any non-steroidal anti-inflammatory drugs (NSAID's) or other analgesics for pain relief.
  • Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
  • Previous participation in this study.
  • Recent history (within the last 1 year) of alcohol or other substance abuse.
  • An employee of the sponsor or the study site or members of their immediate family.
  • Have a heart or any other medical condition that may contra-indicate participants from taking part in high intensity or exhaustive physical activity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Brentford, TW8 9 DA, United Kingdom

Location

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2016

First Posted

March 20, 2017

Study Start

January 1, 2016

Primary Completion

July 29, 2016

Study Completion

July 29, 2016

Last Updated

August 1, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations