Sports Nutritional SciencesNCT03083509
A Physiological Profile of Recovery From Resistance, Endurance, and Mixed Exercise Types
A study testing Resistance exercise weight training session, High-Intensity stochastic cycling session and Simulated Team sport protocol in people with Sports Nutritional Sciences, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
The aim of this study to increase understanding of physiological and functional perturbations following a continuum of exercise stressors. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sports Nutritional Sciences
- What is being tested?
- Resistance exercise weight training session, High-Intensity stochastic cycling session and Simulated Team sport protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2016to 29 Jul 2016
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- Individuals that do not fit the training status inclusion criteria.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Physiological Profile of Recovery From Mechanical, Metabolic, and Mixed Exercise Stressors
The aim of this study to increase understanding of physiological and functional perturbations following a continuum of exercise stressors.
Read the detailed description
This study utilised a between groups design, with a within-groups control. This allowed the within-subject profiling of recovery during both a control and exercise week. This design also allowed each group to perform an ecologically valid exercise session as well as having markers of recovery tailored to the areas of interest specific to each cohort. By having each group perform a non-exercise control week, this gives valuable information on the reliability and smallest worthwhile change for a range of both novel and commonly used recovery markers.
- Conditions
- Sports Nutritional Sciences
- Being tested
- Resistance exercise weight training session, High-Intensity stochastic cycling session, Simulated Team sport protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance exercise weight training sessionOther
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.
High-Intensity stochastic cycling sessionOther
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.
Simulated Team sport protocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: Other: Simulated Team sport protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Day 26
Secondary outcomes (18)
Sleep efficiency
Sleep efficiency was measured with a wrist-strap Actigraph worn at all the times by participants from Visits 3-7 and 8-12. Data from the Actigraph was uploaded to a secure cloud-based Web application and selected variable was used for subsequent analysis.
Measured: Up to Day 26
Sleep latency
Sleep latency was measured with a wrist-strap Actigraph worn at all the times by participants from Visits 3-7 and 8-12. Data from the Actigraph was uploaded to a secure cloud-based Web application and selected variable was used for subsequent analysis.
Measured: Up to Day 26
Time in bed
Time in bed was measured with a wrist-strap Actigraph worn at all the times by participants from Visits 3-7 and 8-12. Data from the Actigraph was uploaded to a secure cloud-based Web application and selected variables were used for subsequent analysis.
Measured: Up to Day 26
Time asleep
Time asleep was measured with a wrist-strap Actigraph worn at all the times by participants from Visits 3-7 and 8-12. Data from the Actigraph was uploaded to a secure cloud-based Web application and selected variables were used for subsequent analysis.
Measured: Up to Day 26
Perceived muscle soreness
Active muscle soreness was determined using a 200 millimeter (mm) visual analogue scale with "no pain" indicated at one end and "pain/soreness as bad as it could be" at the other. Participants stand with the hands on hips and feet approximately shoulder width apart. The participant then performed a squat to 90°, before standing and recording the pain felt in the lower limbs.
Measured: Up to Day 26
Perceived recovery measured by the daily analyses of life demands for athletes (DALDA) questionnaire
DALDA questions were scored using following scale: worse than normal, Normal and Better than normal.
Measured: Up to Day 26
Interleukin 10 (IL-10)
Venous blood samples were collected using the venipuncture technique from a vein in the ante-cubital fossa region by a trained phlebotomist. Two samples (2 × 5milileter [mL]) were collected per participant at visits 3 (×3), 4, 5, 6, 7, 8 (×3), 9, 10, 11, and 12. Visits 3-7 and 8-12 were separated by 24hours and will occur on consecutive days. During visits 3 and 8, samples were taken at baseline as well as 2h and 6h post control/exercise. Additionally on visits 3 (×3), 4, 5, 8 (×3), 9, and 10 a 2mL blood draw taken for 600uL of whole blood to be processed and stored at -80 degrees until further analysis for the quantification of GSH:GSSG ratio. Visits 7 and 8 were separated by approximately two weeks, therefore totaling a collection volume of 160mL blood over approximately a four week period. All Blood samples were analysed by enzyme-linked immunosorbent assay (ELISA) technique.
Measured: Up to Day 26
Interleukin 6 (IL-6)
Venous blood samples were collected using the venipuncture technique from a vein in the ante-cubital fossa region by a trained phlebotomist. Two samples (2 × 5milileter [mL]) were collected per participant at visits 3 (×3), 4, 5, 6, 7, 8 (×3), 9, 10, 11, and 12. Visits 3-7 and 8-12 were separated by 24hours and will occur on consecutive days. During visits 3 and 8, samples were taken at baseline as well as 2h and 6h post control/exercise. Additionally on visits 3 (×3), 4, 5, 8 (×3), 9, and 10 a 2mL blood draw taken for 600uL of whole blood to be processed and stored at -80 degrees until further analysis for the quantification of GSH:GSSG ratio. Visits 7 and 8 were separated by approximately two weeks, therefore totaling a collection volume of 160mL blood over approximately a four week period. All Blood samples were analysed by enzyme-linked immunosorbent assay (ELISA) technique.
Measured: Up to Day 26
C-reactive protein
Venous blood samples were collected using the venipuncture technique from a vein in the ante-cubital fossa region by a trained phlebotomist. Two samples (2 × 5milileter [mL]) were collected per participant at visits 3 (×3), 4, 5, 6, 7, 8 (×3), 9, 10, 11, and 12. Visits 3-7 and 8-12 were separated by 24hours and will occur on consecutive days. During visits 3 and 8, samples were taken at baseline as well as 2h and 6h post control/exercise. Additionally on visits 3 (×3), 4, 5, 8 (×3), 9, and 10 a 2mL blood draw taken for 600uL of whole blood to be processed and stored at -80 degrees until further analysis for the quantification of GSH:GSSG ratio. Visits 7 and 8 were separated by approximately two weeks, therefore totaling a collection volume of 160mL blood over approximately a four week period. All Blood samples were analysed by enzyme-linked immunosorbent assay (ELISA) technique.
Measured: Up to Day 26
Neutrophils
Venous blood samples were collected using the venipuncture technique from a vein in the ante-cubital fossa region by a trained phlebotomist. Two samples (2 × 5milileter [mL]) were collected per participant at visits 3 (×3), 4, 5, 6, 7, 8 (×3), 9, 10, 11, and 12. Visits 3-7 and 8-12 were separated by 24hours and will occur on consecutive days. During visits 3 and 8, samples were taken at baseline as well as 2h and 6h post control/exercise. Additionally on visits 3 (×3), 4, 5, 8 (×3), 9, and 10 a 2mL blood draw taken for 600uL of whole blood to be processed and stored at -80 degrees until further analysis for the quantification of GSH:GSSG ratio. Visits 7 and 8 were separated by approximately two weeks, therefore totaling a collection volume of 160mL blood over approximately a four week period. All Blood samples were analysed by enzyme-linked immunosorbent assay (ELISA) technique.
Measured: Up to Day 26
Creatine kinase
Venous blood samples were collected using the venipuncture technique from a vein in the ante-cubital fossa region by a trained phlebotomist. Two samples (2 × 5milileter [mL]) were collected per participant at visits 3 (×3), 4, 5, 6, 7, 8 (×3), 9, 10, 11, and 12. Visits 3-7 and 8-12 were separated by 24hours and will occur on consecutive days. During visits 3 and 8, samples were taken at baseline as well as 2h and 6h post control/exercise. Additionally on visits 3 (×3), 4, 5, 8 (×3), 9, and 10 a 2mL blood draw taken for 600uL of whole blood to be processed and stored at -80 degrees until further analysis for the quantification of GSH:GSSG ratio. Visits 7 and 8 were separated by approximately two weeks, therefore totaling a collection volume of 160mL blood over approximately a four week period. All Blood samples were analysed by enzyme-linked immunosorbent assay (ELISA) technique.
Measured: Up to Day 26
F2-isoprostanes
Venous blood samples were collected using the venipuncture technique from a vein in the ante-cubital fossa region by a trained phlebotomist. Two samples (2 × 5milileter [mL]) were collected per participant at visits 3 (×3), 4, 5, 6, 7, 8 (×3), 9, 10, 11, and 12. Visits 3-7 and 8-12 were separated by 24hours and will occur on consecutive days. During visits 3 and 8, samples were taken at baseline as well as 2h and 6h post control/exercise. Additionally on visits 3 (×3), 4, 5, 8 (×3), 9, and 10 a 2mL blood draw taken for 600uL of whole blood to be processed and stored at -80 degrees until further analysis for the quantification of GSH:GSSG ratio. Visits 7 and 8 were separated by approximately two weeks, therefore totaling a collection volume of 160mL blood over approximately a four week period. All Blood samples were analysed by enzyme-linked immunosorbent assay (ELISA) technique.
Measured: Up to Day 26
Protein carbonyls
Venous blood samples were collected using the venipuncture technique from a vein in the ante-cubital fossa region by a trained phlebotomist. Two samples (2 × 5milileter [mL]) were collected per participant at visits 3 (×3), 4, 5, 6, 7, 8 (×3), 9, 10, 11, and 12. Visits 3-7 and 8-12 were separated by 24hours and will occur on consecutive days. During visits 3 and 8, samples were taken at baseline as well as 2h and 6h post control/exercise. Additionally on visits 3 (×3), 4, 5, 8 (×3), 9, and 10 a 2mL blood draw taken for 600uL of whole blood to be processed and stored at -80 degrees until further analysis for the quantification of GSH:GSSG ratio. Visits 7 and 8 were separated by approximately two weeks, therefore totaling a collection volume of 160mL blood over approximately a four week period. All Blood samples were analysed by enzyme-linked immunosorbent assay (ELISA) technique.
Measured: Up to Day 26
Fast myosin
Venous blood samples were collected using the venipuncture technique from a vein in the ante-cubital fossa region by a trained phlebotomist. Two samples (2 × 5milileter [mL]) were collected per participant at visits 3 (×3), 4, 5, 6, 7, 8 (×3), 9, 10, 11, and 12. Visits 3-7 and 8-12 were separated by 24hours and will occur on consecutive days. During visits 3 and 8, samples were taken at baseline as well as 2h and 6h post control/exercise. Additionally on visits 3 (×3), 4, 5, 8 (×3), 9, and 10 a 2mL blood draw taken for 600uL of whole blood to be processed and stored at -80 degrees until further analysis for the quantification of GSH:GSSG ratio. Visits 7 and 8 were separated by approximately two weeks, therefore totaling a collection volume of 160mL blood over approximately a four week period. All Blood samples were analysed by enzyme-linked immunosorbent assay (ELISA) technique.
Measured: Up to Day 26
Slow myosin
Venous blood samples were collected using the venipuncture technique from a vein in the ante-cubital fossa region by a trained phlebotomist. Two samples (2 × 5milileter [mL]) were collected per participant at visits 3 (×3), 4, 5, 6, 7, 8 (×3), 9, 10, 11, and 12. Visits 3-7 and 8-12 were separated by 24hours and will occur on consecutive days. During visits 3 and 8, samples were taken at baseline as well as 2h and 6h post control/exercise. Additionally on visits 3 (×3), 4, 5, 8 (×3), 9, and 10 a 2mL blood draw taken for 600uL of whole blood to be processed and stored at -80 degrees until further analysis for the quantification of GSH:GSSG ratio. Visits 7 and 8 were separated by approximately two weeks, therefore totaling a collection volume of 160mL blood over approximately a four week period. All Blood samples were analysed by enzyme-linked immunosorbent assay (ELISA) technique.
Measured: Up to Day 26
Matrix metalloproteinase-9
Venous blood samples were collected using the venipuncture technique from a vein in the ante-cubital fossa region by a trained phlebotomist. Two samples (2 × 5milileter [mL]) were collected per participant at visits 3 (×3), 4, 5, 6, 7, 8 (×3), 9, 10, 11, and 12. Visits 3-7 and 8-12 were separated by 24hours and will occur on consecutive days. During visits 3 and 8, samples were taken at baseline as well as 2h and 6h post control/exercise. Additionally on visits 3 (×3), 4, 5, 8 (×3), 9, and 10 a 2mL blood draw taken for 600uL of whole blood to be processed and stored at -80 degrees until further analysis for the quantification of GSH:GSSG ratio. Visits 7 and 8 were separated by approximately two weeks, therefore totaling a collection volume of 160mL blood over approximately a four week period. All Blood samples were analysed by enzyme-linked immunosorbent assay (ELISA) technique.
Measured: Up to Day 26
Limb Girth
Lower limb girth was measured at the mid-thigh on the dominant leg. Mid-thigh was defined as the halfway point between the anterior superior iliac spine and the proximal aspect of the patella. All measurements were taken with the participant standing in anatomical zero with thigh muscles relaxed. A line semi permanently marked around the circumference of the dominant thigh to ensure the reliability of measurements between sessions. The mean of three measurements was used for subsequent analysis. The same investigator will record the measurements between sessions and intra-rater reliability will be reported
Measured: Up to Day 26
Range of motion (ROM) assessment
A goniometer was used to measure the relaxed and flexed knee joint angles of the dominant limb. Measurements was taken when the participants maximally flexes the knee joint to touch the hip with the heel while keeping the knee joint at the side of the body in the anatomical zero position. Maximal extension was taken when the participant extends the knee joint as much as possible and was allowed to hold onto a wall for balance. The mean of three measurements was taken for flexion and extension and ROM was calculated by subtracting flexion from extension. The same investigator will record the measurements between sessions and intra-rater reliability was reported.
Measured: Up to Day 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study start1 Jan 2016
- Primary completion29 Jul 2016
- Study completion29 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sports Nutritional SciencesStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03083509
- Sponsor's protocol ID
- 205085
- Status last verified
- Jul 2017
- First submitted
- 28 Sep 2016
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Physiological Profile of Recovery From Mechanical, Metabolic, and Mixed Exercise Stressors
- ClinicalTrials.gov ID
- NCT03083509
- Acronym / sponsor ID
- 205085
- Conditions
- Sports Nutritional Sciences
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 29 Jul 2016 (actual)
- Study completion
- 29 Jul 2016 (actual)
- First posted
- 20 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study to increase understanding of physiological and functional perturbations following a continuum of exercise stressors.
Detailed description
This study utilised a between groups design, with a within-groups control. This allowed the within-subject profiling of recovery during both a control and exercise week. This design also allowed each group to perform an ecologically valid exercise session as well as having markers of recovery tailored to the areas of interest specific to each cohort. By having each group perform a non-exercise control week, this gives valuable information on the reliability and smallest worthwhile change for a range of both novel and commonly used recovery markers.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group1 (Resistance trained individuals) | Other | Other: Resistance exercise weight training sessionResistance trained individuals (>3 sessions per weeks for ≥2 years with a minimum of 1 session per week including leg-based exercises) |
| Group 2 (Trained cyclists) | Other | Other: High-Intensity stochastic cycling sessionTrained 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) |
| Group 3 (Team sports players) | Other | Other: Simulated Team sport protocolTeam 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) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (7 listed)
- Individuals that do not fit the training status inclusion criteria.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance exercise weight training sessionA 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. | Other | Group1 (Resistance trained individuals) |
| High-Intensity stochastic cycling sessionA 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. | Other | Group 2 (Trained cyclists) |
| Simulated Team sport protocolA 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. | Other | Group 3 (Team sports players) |
Primary outcome
Maximal isometric volume contraction (MIVC)
Time frame: Up to Day 26
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.
Rate of force development (RFD)
Time frame: Up to Day 26
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.
Countermovement jump (CMJ)
Time frame: Up to Day 26
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.
20 meter (m) sprint assessment (Group 1 and 3 only)
Time frame: Up to Day 26
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.
Cycling Time-Trial performance assessment (Group 2 only)
Time frame: Up to Day 26
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.
18 secondary outcomes
Sleep efficiency
Time frame: Up to Day 26
Sleep latency
Time frame: Up to Day 26
Time in bed
Time frame: Up to Day 26
Time asleep
Time frame: Up to Day 26
Perceived muscle soreness
Time frame: Up to Day 26
Perceived recovery measured by the daily analyses of life demands for athletes (DALDA) questionnaire
Time frame: Up to Day 26
Interleukin 10 (IL-10)
Time frame: Up to Day 26
Interleukin 6 (IL-6)
Time frame: Up to Day 26
C-reactive protein
Time frame: Up to Day 26
Neutrophils
Time frame: Up to Day 26
Creatine kinase
Time frame: Up to Day 26
F2-isoprostanes
Time frame: Up to Day 26
Protein carbonyls
Time frame: Up to Day 26
Fast myosin
Time frame: Up to Day 26
Slow myosin
Time frame: Up to Day 26
Matrix metalloproteinase-9
Time frame: Up to Day 26
Limb Girth
Time frame: Up to Day 26
Range of motion (ROM) assessment
Time frame: Up to Day 26
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance exercise weight training session, High-Intensity stochastic cycling session and Simulated Team sport protocol in people with Sports Nutritional Sciences, run by GlaxoSmithKline 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 8 inclusion and 7 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 1 Aug 2017. 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. 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?
Maximal isometric volume contraction (MIVC) (time frame: Up to Day 26). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2017.