Trial Outcomes & Findings for Acute Renal Injury During High Intensity Training (NCT NCT03678285)
NCT ID: NCT03678285
Last Updated: 2021-07-16
Results Overview
an endogenous opioid polypeptide hormone which, via proteolytic cleavage, produces the enkephalin peptides \[Met\]enkephalin, and to a lesser extent, \[Leu\]enkephalin.
COMPLETED
NA
42 participants
Baseline, Immediately pre-exercise, immediately post-exercise, 24 hours post-exercise, 48 hours post-exercise
2021-07-16
Participant Flow
Subjects recruited between October 2018 and May 2019
Participant milestones
| Measure |
HIFRT Workout
Consecutive completion of; 1 mile run, 100 pull ups, 200 push-ups, 300 bodyweight squats, 1 mile run.
HIFRT Workout: A single high intensity functional resistance training (HIFRT) exercise bout.
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|---|---|
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Overall Study
STARTED
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42
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Overall Study
Started Workout
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40
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Overall Study
COMPLETED
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38
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Overall Study
NOT COMPLETED
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4
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Reasons for withdrawal
| Measure |
HIFRT Workout
Consecutive completion of; 1 mile run, 100 pull ups, 200 push-ups, 300 bodyweight squats, 1 mile run.
HIFRT Workout: A single high intensity functional resistance training (HIFRT) exercise bout.
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|---|---|
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Overall Study
Adverse Event
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2
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Overall Study
Withdrawal by subject prior to start of workout
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1
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Overall Study
Dehydrated prior to start of workout
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1
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Baseline Characteristics
4 participants discontinued participation after enrolling but prior to baseline measurements
Baseline characteristics by cohort
| Measure |
HIFRT Workout
n=42 Participants
Consecutive completion of; 1 mile run, 100 pull ups, 200 push-ups, 300 bodyweight squats, 1 mile run.
HIFRT Workout: A single high intensity functional resistance training (HIFRT) exercise bout.
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|---|---|
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Age, Continuous
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28.1 years
STANDARD_DEVIATION 8.8 • n=42 Participants
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Sex: Female, Male
Female
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12 Participants
n=42 Participants
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Sex: Female, Male
Male
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30 Participants
n=42 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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2 Participants
n=42 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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35 Participants
n=42 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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5 Participants
n=42 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=42 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=42 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=42 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=42 Participants
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Race (NIH/OMB)
White
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35 Participants
n=42 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=42 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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7 Participants
n=42 Participants
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Region of Enrollment
United States
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42 participants
n=42 Participants
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Systolic Blood Pressure
|
119 mmHg
STANDARD_DEVIATION 11 • n=38 Participants • 4 participants discontinued participation after enrolling but prior to baseline measurements
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Diastolic Blood Pressure
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74 mmHg
STANDARD_DEVIATION 7 • n=38 Participants • 4 subjects ended participation after enrollment but prior to baseline measurements.
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Visual Analog Pain Perception
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3 units on a scale
STANDARD_DEVIATION 6 • n=38 Participants • 4 subjects stopped participation after enrollment but prior to baseline measurements.
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urinary neutrophil gelatinase-associated Lipocalin
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9.2 (ng/ml)/(ml/min)
STANDARD_DEVIATION 25.7 • n=36 Participants • 4 subjects stopped participation prior to baseline measurements. 2 subjects did not provide adequate baseline urine sample for analysis.
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Serum Creatinine
|
1.05 mg/dL
STANDARD_DEVIATION 0.16 • n=38 Participants • 4 subjects stopped participation prior to baseline measurements
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Proenkephalin
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61.1 pmol/L
STANDARD_DEVIATION 16.9 • n=38 Participants • 4 subjects stopped participation prior to baseline measurements
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urinary kidney injury molecule 1
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170.5 pg/mL
STANDARD_DEVIATION 180.8 • n=36 Participants • 4 subjects stopped participation prior to baseline measurements. 2 subjects did not provide adequate baseline urine samples for analysis.
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Creatine Kinase
|
267.8 U/L
STANDARD_DEVIATION 185.3 • n=37 Participants • 4 subjects stopped participation prior to baseline measurements. 1 participant sample was not available.
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PRIMARY outcome
Timeframe: Baseline, Immediately pre-exercise, immediately post-exercise, 24 hours post-exercise, 48 hours post-exercisePopulation: Number analyzed for 48 hour post-exercise change is 1 less than total sample due to a blood sample that was not able to be analyzed at the final time point
an endogenous opioid polypeptide hormone which, via proteolytic cleavage, produces the enkephalin peptides \[Met\]enkephalin, and to a lesser extent, \[Leu\]enkephalin.
Outcome measures
| Measure |
HIFRT Workout
n=38 Participants
Consecutive completion of; 1 mile run, 100 pull ups, 200 push-ups, 300 bodyweight squats, 1 mile run.
HIFRT Workout: A single high intensity functional resistance training (HIFRT) exercise bout.
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|---|---|
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Change in Concentration of Proenkephalin-A From Baseline to 4 Time-points Surrounding the Workout
Immediately pre-exercise
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1.65 pmol/L
Standard Deviation 13.18
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Change in Concentration of Proenkephalin-A From Baseline to 4 Time-points Surrounding the Workout
Immediately post-exercise
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3.69 pmol/L
Standard Deviation 15.49
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Change in Concentration of Proenkephalin-A From Baseline to 4 Time-points Surrounding the Workout
24 hours post-exercise
|
2.50 pmol/L
Standard Deviation 12.58
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Change in Concentration of Proenkephalin-A From Baseline to 4 Time-points Surrounding the Workout
48 hours post-exercise
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2.13 pmol/L
Standard Deviation 12.68
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PRIMARY outcome
Timeframe: Baseline, Immediately pre-exercise, immediately post-exercise, 24 hours post-exercise, 48 hours post-exercise.Population: One sample at the final time point was not able to be analyzed.
Marker of kidney function measured as a change in concentration between baseline to 4 time-points surrounding the workout
Outcome measures
| Measure |
HIFRT Workout
n=38 Participants
Consecutive completion of; 1 mile run, 100 pull ups, 200 push-ups, 300 bodyweight squats, 1 mile run.
HIFRT Workout: A single high intensity functional resistance training (HIFRT) exercise bout.
|
|---|---|
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Change in Serum Creatinine
Immediately pre-exercise
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0.001 mg/dL
Standard Deviation 0.066
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Change in Serum Creatinine
Immediately post-exercise
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0.211 mg/dL
Standard Deviation 0.119
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Change in Serum Creatinine
24 hours post-exercise
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0.008 mg/dL
Standard Deviation 0.062
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Change in Serum Creatinine
48 hours post-exercise
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-0.014 mg/dL
Standard Deviation 0.086
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PRIMARY outcome
Timeframe: Baseline, Immediately pre-exercise, immediately post-exercise, 24 hours post-exercise, 48 hours post-exercisePopulation: There is a discrepancy in the number of participants analyzed because one participant's samples were unable to be analyzed at all time points. One additional participant had a sample that was missing at the final time point.
Marker of skeletal muscle damage measured as a change in concentration between baseline and 4 time-points surrounding exercise
Outcome measures
| Measure |
HIFRT Workout
n=38 Participants
Consecutive completion of; 1 mile run, 100 pull ups, 200 push-ups, 300 bodyweight squats, 1 mile run.
HIFRT Workout: A single high intensity functional resistance training (HIFRT) exercise bout.
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|---|---|
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Change in Creatinine Kinase
Immediately pre-exercise
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-48 U/L
Standard Deviation 76
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Change in Creatinine Kinase
Immediately post-exercise
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98 U/L
Standard Deviation 107
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Change in Creatinine Kinase
24 hours post-exercise
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781 U/L
Standard Deviation 1631
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Change in Creatinine Kinase
48 hours post-exercise
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1152 U/L
Standard Deviation 2406
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PRIMARY outcome
Timeframe: Baseline, Day 2, Day 3Population: One subject declined to collect 24hr urine at any time during the study. One subject did not provide an adequate sample for the baseline measurement (therefore no change scores could be calculated from baseline at either of the follow up points). Two additional subjects did not return complete collections on the final day of measurement
Marker of Kidney Injury measured as a change in concentration between baseline to 2 time points surrounding exercise
Outcome measures
| Measure |
HIFRT Workout
n=36 Participants
Consecutive completion of; 1 mile run, 100 pull ups, 200 push-ups, 300 bodyweight squats, 1 mile run.
HIFRT Workout: A single high intensity functional resistance training (HIFRT) exercise bout.
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|---|---|
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Change in 24 Hour Urinary Kidney Injury Molecule 1
Day 1 to Day 2 Change
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71.17 pg/mL
Standard Deviation 132.63
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Change in 24 Hour Urinary Kidney Injury Molecule 1
Day 1 to Day 3 Change
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45.44 pg/mL
Standard Deviation 226.49
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PRIMARY outcome
Timeframe: Baseline, Day 2, Day 3Population: One subject declined to collect 24hr urine at any time during the study. One subject did not provide an adequate sample for the baseline measurement (therefore no change scores could be calculated from baseline at either of the follow up points). Two additional subjects did not return complete collections on the final day of measurement
Marker of kidney damage measured as a change in concentration between baseline and 2 time points surrounding the exercise
Outcome measures
| Measure |
HIFRT Workout
n=36 Participants
Consecutive completion of; 1 mile run, 100 pull ups, 200 push-ups, 300 bodyweight squats, 1 mile run.
HIFRT Workout: A single high intensity functional resistance training (HIFRT) exercise bout.
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|---|---|
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Change in 24 Hour Urinary Neutrophil Gelatinase-associated Lipocalin
Day 1 to Day 2 Change
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5.52 (ng/ml)/(ml/min)
Standard Deviation 20.94
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Change in 24 Hour Urinary Neutrophil Gelatinase-associated Lipocalin
Day 1 to Day 3 Change
|
2.50 (ng/ml)/(ml/min)
Standard Deviation 15.06
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SECONDARY outcome
Timeframe: Baseline, immediately pre-exercise, immediately post-exercise, 24 hours post-exercise, 48 hours post-exerciseSubjective 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.
Outcome measures
| Measure |
HIFRT Workout
n=38 Participants
Consecutive completion of; 1 mile run, 100 pull ups, 200 push-ups, 300 bodyweight squats, 1 mile run.
HIFRT Workout: A single high intensity functional resistance training (HIFRT) exercise bout.
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|---|---|
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Change in the Short-form McGill Pain Questionnaire
Change to Immediately pre-exercise
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-1 score on a scale in millimeters
Standard Deviation 5
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Change in the Short-form McGill Pain Questionnaire
Change to immediately post-exercise
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23 score on a scale in millimeters
Standard Deviation 23
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Change in the Short-form McGill Pain Questionnaire
Change to 24 hours post-exercise
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18 score on a scale in millimeters
Standard Deviation 16
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Change in the Short-form McGill Pain Questionnaire
Change to 48 hours post-exercise
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18 score on a scale in millimeters
Standard Deviation 17
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SECONDARY outcome
Timeframe: Baseline, immediately pre-exercise, immediately post-exercise, 24 hours post-exercise, 48 hours post-exercisePopulation: No blood pressure measurement was recorded for a single subject at the immediately pre-exercise time point.
Systolic and Diastolic blood pressure measurements
Outcome measures
| Measure |
HIFRT Workout
n=38 Participants
Consecutive completion of; 1 mile run, 100 pull ups, 200 push-ups, 300 bodyweight squats, 1 mile run.
HIFRT Workout: A single high intensity functional resistance training (HIFRT) exercise bout.
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|---|---|
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Post Exercise Hypotension
diastolic change to immediately post-exercise
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-3 mm/Hg
Standard Deviation 6
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Post Exercise Hypotension
systolic change to immediately pre-exercise
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3 mm/Hg
Standard Deviation 8
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Post Exercise Hypotension
systolic change to immediately post-exercise
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-8 mm/Hg
Standard Deviation 11
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Post Exercise Hypotension
systolic change to 24 hours post-exercise
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-3 mm/Hg
Standard Deviation 7
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Post Exercise Hypotension
systolic change to 48 hours post exercise
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-3 mm/Hg
Standard Deviation 8
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Post Exercise Hypotension
diastolic change to immediately pre-exercise
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2 mm/Hg
Standard Deviation 6
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Post Exercise Hypotension
diastolic change to 24 hours post-exercise
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-3 mm/Hg
Standard Deviation 6
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Post Exercise Hypotension
diastolic change to 48 hours post-exercise
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-2 mm/Hg
Standard Deviation 5
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Adverse Events
HIFRT Workout
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
HIFRT Workout
n=42 participants at risk
Consecutive completion of; 1 mile run, 100 pull ups, 200 push-ups, 300 bodyweight squats, 1 mile run.
HIFRT Workout: A single high intensity functional resistance training (HIFRT) exercise bout.
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|---|---|
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Musculoskeletal and connective tissue disorders
Ankle Strain
|
2.4%
1/42 • Number of events 1 • 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.).
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Musculoskeletal and connective tissue disorders
Muscle Cramping
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2.4%
1/42 • Number of events 1 • 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.).
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place