CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 42 enrolled
Drug / intervention
HIFRT Workoutother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03678285
NCT03678285N/ACompleted

Hematological Risk Factors Related to Acute Renal Injury During High Intensity Training

University of Wyoming·interventional·Posted Sep 19, 2018·Updated Jul 16, 2021

In Brief

A clinical study evaluating HIFRT Workout for Acute Kidney Injury and Exercise. Completed, enrolled 42 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsLund University

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedSep 19, 2018
Enrollment StartOct 1, 2018
Primary CompletionMay 30, 2019
Study CompletionJun 30, 2019
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 7.8 years ago

Interventions

HIFRT Workoutother

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