Acute Renal Injury During High Intensity Training (HIFRT-KH)
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|ClinicalTrials.gov Identifier: NCT03678285|
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : September 19, 2018
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
|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.|
|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|
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.
- 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.
- 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
- 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
- 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
- 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
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT03678285
|Contact: Evan C Johnson, PhDemail@example.com|
|United States, Wyoming|
|University of Wyoming||Recruiting|
|Laramie, Wyoming, United States, 82071|
|Contact: Evan C Johnson, PhD 307-766-5282 firstname.lastname@example.org|
|Principal Investigator:||Evan C Johnson, PhD||University of Wyoming|