Adults 18 to 60, any sex, with Acute Kidney Injury or Exercise. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Concentration of Proenkephalin-A From Baseline to 4 Time-points Surrounding the WorkoutPrimary· Baseline, Immediately pre-exercise, immediately post-exercise, 24 hours post-exercise, 48 hours post-exercise
an endogenous opioid polypeptide hormone which, via proteolytic cleavage, produces the enkephalin peptides \[Met\]enkephalin, and to a lesser extent, \[Leu\]enkephalin.
Marker of skeletal muscle damage measured as a change in concentration between baseline and 4 time-points surrounding exercise
Immediately pre-exercise
Group
Value
95% CI
HIFRT Workout
-48
± 76
Immediately post-exercise
Group
Value
95% CI
HIFRT Workout
98
± 107
24 hours post-exercise
Group
Value
95% CI
HIFRT Workout
781
± 1631
48 hours post-exercise
Group
Value
95% CI
HIFRT Workout
1152
± 2406
Change in 24 Hour Urinary Kidney Injury Molecule 1Primary· Baseline, Day 2, Day 3
Marker of Kidney Injury measured as a change in concentration between baseline to 2 time points surrounding exercise
Day 1 to Day 2 Change
Group
Value
95% CI
HIFRT Workout
71.17
± 132.63
Day 1 to Day 3 Change
Group
Value
95% CI
HIFRT Workout
45.44
± 226.49
Change in 24 Hour Urinary Neutrophil Gelatinase-associated LipocalinPrimary· Baseline, Day 2, Day 3
Marker of kidney damage measured as a change in concentration between baseline and 2 time points surrounding the exercise
Day 1 to Day 2 Change
Group
Value
95% CI
HIFRT Workout
5.52
± 20.94
Day 1 to Day 3 Change
Group
Value
95% CI
HIFRT Workout
2.50
± 15.06
Change in the Short-form McGill Pain QuestionnaireSecondary· Baseline, immediately pre-exercise, immediately post-exercise, 24 hours post-exercise, 48 hours post-exercise
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 sco
Systolic and Diastolic blood pressure measurements
systolic change to immediately pre-exercise
Group
Value
95% CI
HIFRT Workout
3
± 8
systolic change to immediately post-exercise
Group
Value
95% CI
HIFRT Workout
-8
± 11
systolic change to 24 hours post-exercise
Group
Value
95% CI
HIFRT Workout
-3
± 7
systolic change to 48 hours post exercise
Group
Value
95% CI
HIFRT Workout
-3
± 8
diastolic change to immediately pre-exercise
Group
Value
95% CI
HIFRT Workout
2
± 6
diastolic change to immediately post-exercise
Group
Value
95% CI
HIFRT Workout
-3
± 6
diastolic change to 24 hours post-exercise
Group
Value
95% CI
HIFRT Workout
-3
± 6
diastolic change to 48 hours post-exercise
Group
Value
95% CI
HIFRT Workout
-2
± 5
Adverse events — posted to ClinicalTrials.gov
Time frame: During entire protocol enrollment. This was approximately 4 days (96 hours). Participants were able to contact investigators after 96 hours should they have experienced an adverse event following their final visit to the laboratory (i.e., allergy to bandage, increasing muscle soreness, etc.)..
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by University of Wyoming
Last refreshed: 16 July 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03678285.