Clinical trial NCT03083509: A Physiological Profile of Recovery From Resistance, Endurance, and Mixed Exercise Types
Official title: A Physiological Profile of Recovery From Mechanical, Metabolic, and Mixed Exercise Stressors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sports Nutritional Sciences
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2017-03-20
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Maximal isometric volume contraction (MIVC)
timeFrame: Up to Day 26
measure: Rate of force development (RFD)
timeFrame: Up to Day 26
measure: Countermovement jump (CMJ)
timeFrame: Up to Day 26
measure: 20 meter (m) sprint assessment (Group 1 and 3 only)
timeFrame: Up to Day 26
measure: Cycling Time-Trial performance assessment (Group 2 only)
timeFrame: Up to Day 26
Secondary outcomes:
measure: Sleep efficiency
timeFrame: Up to Day 26
measure: Sleep latency
timeFrame: Up to Day 26
measure: Time in bed
timeFrame: Up to Day 26
measure: Time asleep
timeFrame: Up to Day 26
measure: Perceived muscle soreness
timeFrame: Up to Day 26
measure: Perceived recovery measured by the daily analyses of life demands for athletes (DALDA) questionnaire
timeFrame: Up to Day 26
measure: Interleukin 10 (IL-10)
timeFrame: Up to Day 26
measure: Interleukin 6 (IL-6)
timeFrame: Up to Day 26
measure: C-reactive protein
timeFrame: Up to Day 26
measure: Neutrophils
timeFrame: Up to Day 26
measure: Creatine kinase
timeFrame: Up to Day 26
measure: F2-isoprostanes
timeFrame: Up to Day 26
measure: Protein carbonyls
timeFrame: Up to Day 26
measure: Fast myosin
timeFrame: Up to Day 26
measure: Slow myosin
timeFrame: Up to Day 26
measure: Matrix metalloproteinase-9
timeFrame: Up to Day 26
measure: Limb Girth
timeFrame: Up to Day 26
measure: Range of motion (ROM) assessment
timeFrame: Up to Day 26
Other outcomes:
Locations:
city: Brentford
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: