Last updated: 11/03/2018 23:08:04
A physiological profile of recovery from resistance, endurance, and mixed exercise types
GSK study ID
205085
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A physiological profile of recovery from mechanical, metabolic, and mixed exercise stressors
Trial description: The aim of this study to increase understanding of physiological and functional perturbations following a continuum of exercise stressors.
Primary purpose:
Basic Science
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Maximal isometric volume contraction (MIVC)
Timeframe: Up to Day 26
Rate of force development (RFD)
Timeframe: Up to Day 26
Countermovement jump (CMJ)
Timeframe: Up to Day 26
20 meter (m) sprint assessment (Group 1 and 3 only)
Timeframe: Up to Day 26
Cycling Time-Trial performance assessment (Group 2 only)
Timeframe: Up to Day 26
Secondary outcomes:
Sleep efficiency
Timeframe: Up to Day 26
Sleep latency
Timeframe: Up to Day 26
Time in bed
Timeframe: Up to Day 26
Time asleep
Timeframe: Up to Day 26
Perceived muscle soreness
Timeframe: Up to Day 26
Perceived recovery measured by the daily analyses of life demands for athletes (DALDA) questionnaire
Timeframe: Up to Day 26
Interleukin 10 (IL-10)
Timeframe: Up to Day 26
Interleukin 6 (IL-6)
Timeframe: Up to Day 26
C-reactive protein
Timeframe: Up to Day 26
Neutrophils
Timeframe: Up to Day 26
Creatine kinase
Timeframe: Up to Day 26
F2-isoprostanes
Timeframe: Up to Day 26
Protein carbonyls
Timeframe: Up to Day 26
Fast myosin
Timeframe: Up to Day 26
Slow myosin
Timeframe: Up to Day 26
Matrix metalloproteinase-9
Timeframe: Up to Day 26
Limb Girth
Timeframe: Up to Day 26
Range of motion (ROM) assessment
Timeframe: Up to Day 26
Interventions:
Enrollment:
24
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Sports Nutritional Sciences
Product
Not applicable
Collaborators
Not applicable
Study date(s)
January 2016 to July 2016
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Male
Age
18 - 35 years
Accepts healthy volunteers
Yes
- 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
- 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.
Inclusion and exclusion 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.
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2016-29-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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