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Acute Renal Injury During High Intensity Training (HIFRT-KH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03678285
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : September 19, 2018
Lund University
Information provided by (Responsible Party):
University of Wyoming

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.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Exercise Other: HIFRT Workout Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All participants will take part in the same, single bout, exercise intervention
Masking: None (Open Label)
Masking Description: No other parties besides the participants will be masked.
Primary Purpose: Screening
Official Title: Hematological Risk Factors Related to Acute Renal Injury During High Intensity Training
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: HIFRT Workout
Consecutive completion of; 1 mile run, 100 pull ups, 200 push-ups, 300 bodyweight squats, 1 mile run.
Other: HIFRT Workout
A single high intensity functional resistance training (HIFRT) exercise bout.

Primary Outcome Measures :
  1. Baseline concentration of proenkephalin-A [ Time Frame: Baseline, immediately pre, immediately post, 24h post, 48h post. ]
    an endogenous opioid polypeptide hormone which, via proteolytic cleavage, produces the enkephalin peptides [Met]enkephalin, and to a lesser extent, [Leu]enkephalin.

  2. Change in serum creatinine concentration between pre- and post-workout time points [ Time Frame: Baseline, immediately pre, immediately post, 24h post, 48h post. ]
    Marker of kidney function

  3. Change in creatinine kinase concentration between pre- and post-workout time points [ Time Frame: Baseline, immediately pre, immediately post, 24h post, 48h post. ]
    Marker of skeletal muscle damage

  4. Change in kidney injury molecule 1 concentration between pre- and post-workout time points [ Time Frame: Baseline, immediately pre, immediately post, 24h post, 48h post. ]
    Marker of Kidney Injury

  5. Change in neutrophil gelatinase-associated lipocalin between pre- and post-workout time points [ Time Frame: Baseline, immediately pre, immediately post, 24h post, 48h post. ]
    Marker of kidney damage

Secondary Outcome Measures :
  1. Change in the short-form McGill Pain Questionnaire [ Time Frame: Baseline, immediately pre, immediately post, 24h post, 48h post. ]
    Subjective perception of muscle pain. The participant responds to 15 word prompts designed to describe types of pain (e.g., "shooting"), with "none", "mild", "moderate", or "severe". These are scored as 0, 1, 2, and 3 respectively. A participant's Pain Score is the cumulative score for all prompt responses added together. As a participant's total score increases this denotes greater subjective feeling of pain which may be associated with the above markers of skeletal muscle and/or kidney damage. The minimum score for this questionnaire is 0 and the maximum score is 45. Typically, the total score is only reported. However, if there are prompts (i.e., subscales) that are consistently rated high or low, we will report these as a way to further describe the type of pain that is being reported (e.g., "throbbing" versus "sharp"). This will only be done after the total score is reported.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  1. Score of "0" on the Functional Movement Screening (FMS) test as evaluated by two investigators * indicating pain during any of the seven functional movements
  2. 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)
  3. Pregnancy, suspected pregnancy, or breastfeeding
  4. Blood donations within the last eight weeks leading up to testing day
  5. Any musculoskeletal injuries which have resulted in > 1 week of absence from HIFRT within the last six months
  6. Not passing the physical activity readiness questionnaire (PAR-Q)
  7. Allergy to ibuprofen or non-steroidal anti-inflammatory medication
  8. Surgical operation on digestive tract or kidneys, except appendectomy
  9. Inability to participate in the entire study
  10. Recurrent urinary tract infections or kidney stones
  11. History of protein or blood in urine
  12. Moving from a location of low altitude (< 3,000') to Laramie within the past 3 months
  13. Inability to understand and write English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03678285

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Contact: Evan C Johnson, PhD 307-766-5282

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United States, Wyoming
University of Wyoming Recruiting
Laramie, Wyoming, United States, 82071
Contact: Evan C Johnson, PhD    307-766-5282   
Sponsors and Collaborators
University of Wyoming
Lund University
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Principal Investigator: Evan C Johnson, PhD University of Wyoming

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Responsible Party: University of Wyoming Identifier: NCT03678285     History of Changes
Other Study ID Numbers: 20180607EJ02013
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Wyoming:
High intensity exercise

Additional relevant MeSH terms:
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Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases