Acute Renal Injury During High Intensity Training

NCT03678285 | Completed Results

• 1 other identifier: 20180607EJ02013
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Kidney Injury; Exercise

Keywords

High intensity exercise; Proenkephalin-A

Outcome Measures

Primary Outcomes (5)

• Change in Concentration of Proenkephalin-A From Baseline to 4 Time-points Surrounding the Workout

  an endogenous opioid polypeptide hormone which, via proteolytic cleavage, produces the enkephalin peptides \[Met\]enkephalin, and to a lesser extent, \[Leu\]enkephalin.

  Baseline, Immediately pre-exercise, immediately post-exercise, 24 hours post-exercise, 48 hours post-exercise

• Change in Serum Creatinine

  Marker of kidney function measured as a change in concentration between baseline to 4 time-points surrounding the workout

  Baseline, Immediately pre-exercise, immediately post-exercise, 24 hours post-exercise, 48 hours post-exercise.

• Change in Creatinine Kinase

  Marker of skeletal muscle damage measured as a change in concentration between baseline and 4 time-points surrounding exercise

  Baseline, Immediately pre-exercise, immediately post-exercise, 24 hours post-exercise, 48 hours post-exercise

• Change in 24 Hour Urinary Kidney Injury Molecule 1

  Marker of Kidney Injury measured as a change in concentration between baseline to 2 time points surrounding exercise

  Baseline, Day 2, Day 3

• Change in 24 Hour Urinary Neutrophil Gelatinase-associated Lipocalin

  Marker of kidney damage measured as a change in concentration between baseline and 2 time points surrounding the exercise

  Baseline, Day 2, Day 3

Secondary Outcomes (2)

• Change in the Short-form McGill Pain Questionnaire

  Baseline, immediately pre-exercise, immediately post-exercise, 24 hours post-exercise, 48 hours post-exercise

• Post Exercise Hypotension

  Baseline, immediately pre-exercise, immediately post-exercise, 24 hours post-exercise, 48 hours post-exercise

Study Arms (1)

HIFRT Workout

EXPERIMENTAL

Consecutive completion of; 1 mile run, 100 pull ups, 200 push-ups, 300 bodyweight squats, 1 mile run.

Other: HIFRT Workout

Interventions

HIFRT Workout OTHER

A single high intensity functional resistance training (HIFRT) exercise bout.

HIFRT Workout

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Healthy individual who has completed this specific workout on at least one prior occasion

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wyoming: lead
• Lund University: collaborator

Study Sites (1)

University of Wyoming

Laramie, Wyoming, 82071, United States

Location

Related Publications (4)

• Poston WS, Haddock CK, Heinrich KM, Jahnke SA, Jitnarin N, Batchelor DB. Is High-Intensity Functional Training (HIFT)/CrossFit Safe for Military Fitness Training? Mil Med. 2016 Jul;181(7):627-37. doi: 10.7205/MILMED-D-15-00273.

  PMID: 27391615 BACKGROUND

• Bergeron MF, Nindl BC, Deuster PA, Baumgartner N, Kane SF, Kraemer WJ, Sexauer LR, Thompson WR, O'Connor FG. Consortium for Health and Military Performance and American College of Sports Medicine consensus paper on extreme conditioning programs in military personnel. Curr Sports Med Rep. 2011 Nov-Dec;10(6):383-9. doi: 10.1249/JSR.0b013e318237bf8a.

  PMID: 22071400 BACKGROUND

• Mansour SG, Verma G, Pata RW, Martin TG, Perazella MA, Parikh CR. Kidney Injury and Repair Biomarkers in Marathon Runners. Am J Kidney Dis. 2017 Aug;70(2):252-261. doi: 10.1053/j.ajkd.2017.01.045. Epub 2017 Mar 28.

  PMID: 28363731 BACKGROUND

• Schulz CA, Christensson A, Ericson U, Almgren P, Hindy G, Nilsson PM, Struck J, Bergmann A, Melander O, Orho-Melander M. High Level of Fasting Plasma Proenkephalin-A Predicts Deterioration of Kidney Function and Incidence of CKD. J Am Soc Nephrol. 2017 Jan;28(1):291-303. doi: 10.1681/ASN.2015101177. Epub 2016 Jul 8.

  PMID: 27401687 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury; Motor Activity

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavior

Results Point of Contact

• Title: Dr. Evan Johnson
• Organization: University of Wyoming

ejohns54@uwyo.edu

307-766-5282

Study Officials

• Evan C Johnson, PhD

  University of Wyoming

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No other parties besides the participants will be masked.
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will take part in the same, single bout, exercise intervention

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: September 19, 2018
• Study Start: October 1, 2018
• Primary Completion: May 30, 2019
• Study Completion: June 30, 2019
• Last Updated: July 16, 2021
• Results First Posted: April 19, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)