N/A
N=42
Acute Renal Injury During High Intensity Training
Acute Kidney Injury · Exercise
Bottom Line
View on ClinicalTrials.gov: NCT03678285 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Change in Concentration of Proenkephalin-A From Baseline to 4 Time-points Surrounding the Workout — 1.65; 3.69; 2.50; 2.13 pmol/L
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HIFRT Workout (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wyoming
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Concentration of Proenkephalin-A From Baseline to 4 Time-points Surrounding the Workout |
1.65; 3.69; 2.50; 2.13 | — |
| PRIMARY Change in Serum Creatinine |
0.001; 0.211; 0.008; -0.014 | — |
| PRIMARY Change in Creatinine Kinase |
-48; 98; 781; 1152 | — |
| PRIMARY Change in 24 Hour Urinary Kidney Injury Molecule 1 |
71.17; 45.44 | — |
| PRIMARY Change in 24 Hour Urinary Neutrophil Gelatinase-associated Lipocalin |
5.52; 2.50 | — |
| SECONDARY Change in the Short-form McGill Pain Questionnaire |
-1; 23; 18; 18 | — |
| SECONDARY Post Exercise Hypotension |
3; -8; -3; -3; 2; -3 | — |
Summary
The proposed work is designed to be the first in a series of studies investigating the health benefits and risks related to high intensity training (HIT) exercise. Our specific aims are to determine, 1) if participation in a single bout of HIT induces hematological markers consistent with acute kidney injury (AKI), and 2) if risk is predicted by the pre-exercise concentration of plasma proenkephalin-A.
This investigation is an observational case control study. In year one, data collection procedures will be refined with ~40 participants local to the University of Wyoming and training will occur for collaborators from Wyoming community and tribal colleges. In year two, data collection will expand to some of the 12 CrossFit® gyms in Wyoming with assistance from the community and tribal colleges. Blood and urine samples will be collected before and up to 48 h after a standardized bout of HIT exercise on ~100 participants. Baseline blood samples will be analyzed for proenkephalin-A. All blood samples will be analyzed for markers of muscle damage (e.g., creatine kinase and myoglobin), and markers of kidney function (e.g., serum creatinine and blood urea nitrogen). Urine will be analyzed for markers of filtration function (e.g., albumin, creatinine, neutrophil gelatinase-associated lipocalin [NGAL], and kidney injury molecule 1 [KIM-1]). Lastly, the severity of kidney damage will be compared with the number of risk alleles and proenkephalin-A concentration.
The investigators envision that the bout of HIT exercise will induce markers consistent with skeletal muscle damage in most participants and, based on literature from other styles of intense exercise, that acute kidney injury will be diagnosable in between 50-75% of participants. Secondarily, the investigators predict that the concentration of proenkephalin-A will be inversely related to the change in kidney function from before to after the HIT exercise bout.
Eligibility Criteria
Inclusion Criteria
- Healthy individual who has completed this specific workout on at least one prior occasion
Exclusion Criteria
- Score of "0" on the Functional Movement Screening (FMS) test as evaluated by two investigators * indicating pain during any of the seven functional movements
- Self- reported Kidney (chronic kidney disease, polycystic kidney disease, glomerulonephritis, diabetic nephropathy, interstitial nephritis, Goodpasture syndrome) or other medical condition contraindicating participation in HIFRT (Hypertension, dyslipidemia, type II diabetes mellitus, BMI >30)
- Pregnancy, suspected pregnancy, or breastfeeding
- Blood donations within the last eight weeks leading up to testing day
- Any musculoskeletal injuries which have resulted in > 1 week of absence from HIFRT within the last six months
- Not passing the physical activity readiness questionnaire (PAR-Q)
- Allergy to ibuprofen or non-steroidal anti-inflammatory medication
- Surgical operation on digestive tract or kidneys, except appendectomy
- Inability to participate in the entire study
- Recurrent urinary tract infections or kidney stones
- History of protein or blood in urine
- Moving from a location of low altitude (< 3,000') to Laramie within the past 3 months
- Inability to understand and write English
Data sourced from ClinicalTrials.gov (NCT03678285). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.