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Acute Kidney InjuryHIFRT-KHNCT03678285

Acute Renal Injury During High Intensity Training

A study testing HIFRT Workout in people with Acute Kidney Injury and Exercise, run by University of Wyoming at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Acute Kidney Injury, Exercise
What is being tested?
HIFRT Workout
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteUnited States
Study dates
1 Oct 2018to 30 Jun 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Wyoming

    Laramie, Wyoming, 82071

Other trials in United States

About this study

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

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.

Read the detailed description

The HIT-KH investigation is proposed to take place over the course of two calendar years. During year one collaborations with gyms specializing in High Intensity Resistance and Functional Training style workouts (referred to from this point forward as satellite data collection sites) as well as community and tribal colleges (referred to from this point forward as partner institutions) local to these facilities will be solidified. Also, during the summer of year one data collection will occur on a small subset of individuals (~40) at a data collection site local to the University of Wyoming (Figure 1.). It is our plan to use this first data collection in Laramie, WY as a training session for all students from partner institutions so that the students are prepared when the data collection is expanded to the satellite data collection sites in year 2.

In order to properly power this investigation the investigators have estimated that about 100 participants will be needed. Given that the investigators can expect about 40 participants from the local Larmie data collection gym (CrossFit® 7220)this will require the investigators to partner with other high intensity resistance and functional training gyms around the state of Wyoming in year 2. The investigators have chosen to reach out to CrossFit® gyms specifically because it is common practice for most CrossFit® gyms to program the workout the investigators are interested in observing (Murph), at least once per year. Collection data on 60 additional participants will require partnership with 3 additional gyms (i.e., 20 participants / facility). At this point the investigators have been in contact with 3 gym owners all of whom have offered verbal agreement to assisting with data collection. Among these gyms is CrossFit® Leveler, located on the Wind River Reservation in Fort Washikie, Wyoming. This facility is a Native American owned business and it primarily caters to those Native American's living on the reservation. Because the state of Wyoming is ~2% Native American in population, the inclusion of this facility in our investigation is very important for proper sampling (see attached letter of support from owner Mike Ute). Additional gyms that have been contacted and are in the process of providing written approval are CrossFit® Frontier (Cheyenne), and, Cloud Peak CrossFit® (Sheridan).

Because our data collection will be occurring throughout the state the investigators also plan to partner with local community and tribal colleges local to many of the above satellite data collection sites. Briefly, the investigators plan to incorporate up to three students and one faculty mentor from each of the following educational institutions; Laramie County Community College, Wind River Tribal College, and Sheridan Community College. Regarding the inclusion of Wind River Tribal College and the Wind River Indian Reservation, Investigator Johnson is under the guidance of Dr. Christine Porter who is also in the University of Wyoming Division of Kinesiology and Health. Dr. Porter has successfully implemented several research studies on the Wind River Reservation and is well versed in the intricacies and requirements necessary for the completion of data collection in this partnership. Lastly, the partner institutions are beneficial to the project because the data collection takes place over the course of 5 consecutive days, training and working with local researchers will enable this project to reduce the cost because a large research team from Laramie, Wyoming will not be required for each data collection.

As mentioned above 1-3 students from each of the above institutions will be requested to assist with data collection for HIT-KH. Part of our grant funding is devoted to payment of fees for these student's training. This includes travel fees to travel and stay in Laramie, Wyoming during year 1 for observation and basic level assistance with the initial data collection. During the end of year 1 and/or beginning of year 2 additional funds have been allocated to provide phlebotomy training to interested students. These students will then be utilized during year two data collections to assist with blood draws. Finally, funds have been allocated for travel to and attendance of the Rocky Mountain Regional American College of Sports Medicine conference. It is our goal that at least one student will be able to use the preliminary data from the year 1 data collection to compile a research abstract that will be submitted for presentation. All other students will be offered the ability to attend and participate in the conference during the spring of 2019.

Blood samples will be collected one day before participants take part in the workout, and 24 and 48hrs after completion. Sampling will take place by single venipuncture to an antecubital vein by a trained investigator using sterile technique and universal precautions. Following any needle removal, firm pressure will be applied over the site of the blood draw with gauze to minimize the occurrence of a hematoma. Blood will be drawn into vacutainers specific for each of the analytes to be analyzed later. Tubes will be centrifuged as soon as possible, then the blood plasma, serum, or white blood cells will be removed and aliquoted into separate cryovials. These cryovials will be frozen in the -80C freezer as soon as possible. For satellite data collections, if -80C freezers are not available at the local partner institution, liquid nitrogen will be used to freeze and store samples until the samples can be transported back to the University of Wyoming for more permanent storage.

Urine samples will be collected in 24 hr collection jugs for the period immediately prior to the workout and for two 24hr periods following. Each sample will be weighed for measurement of total volume, evaluated for urine color and urine specific gravity. Dipsticks will be used on fresh samples while three 2mL aliquots of each 24hr sample will be separated and stored at room temperature until the samples are returned to the University of Wyoming where the samples will be frozen at -80C for future analysis.

Fresh 24hr urine samples will be analyzed using traditional dipsticks for the following variables: leukocytes, nitrite, urobilinogen, protein, pH, hemoglobin, ketone, bilirubin, and glucose. Additionally, fresh samples will be evaluated for urine color and specific gravity via handheld refractometer in order to establish hydration state. Further biochemical urinary analysis are reviewed below.

Proenkephalin-A will be analyzed at the Clinical Research Center by the use of a chemiluminometric sandwich immunoassay. The laboratory group in Malmo has previously successfully measured this hormone (Schulz et al., 2017). All remaining blood and urine samples will be analyzed within the Human Integrated Physiology laboratory located at the University of Wyoming using colorimetric enzyme-linked immunosorbent assays (ELISA). These samples will be analyzed for the following variables; serum creatinine, blood urea nitrogen, urinary creatinine, neutrophil gelatinase-associated lipocalin [NGAL], and kidney injury molecule 1 [KIM-1]). All ELISA antibodies will be supplied by "Abcam", (Cambridge, Massachusetts, USA) and microplates will be read according the manufacturer's instructions on spectrophotometer (Epoch 2, Biotek, Winooski, Vermont, USA).

Being tested
HIFRT Workout
Keywords
High intensity exercise, Proenkephalin-A
Medical subject headings
Acute Kidney Injury, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HIFRT WorkoutOther

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

Study groups in NCT03678285
Study groupRoleWhat they receive
HIFRT WorkoutExperimentalConsecutive completion of; 1 mile run, 100 pull ups, 200 push-ups, 300 bodyweight squats, 1 mile run.
Receives: Other: HIFRT Workout

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Concentration of Proenkephalin-A From Baseline to 4 Time-points Surrounding the Workout

    an endogenous opioid polypeptide hormone which, via proteolytic cleavage, produces the enkephalin peptides [Met]enkephalin, and to a lesser extent, [Leu]enkephalin.

    Measured: Baseline, Immediately pre-exercise, immediately post-exercise, 24 hours post-exercise, 48 hours post-exercise

  2. Change in Serum Creatinine

    Marker of kidney function measured as a change in concentration between baseline to 4 time-points surrounding the workout

    Measured: Baseline, Immediately pre-exercise, immediately post-exercise, 24 hours post-exercise, 48 hours post-exercise.

  3. Change in Creatinine Kinase

    Marker of skeletal muscle damage measured as a change in concentration between baseline and 4 time-points surrounding exercise

    Measured: Baseline, Immediately pre-exercise, immediately post-exercise, 24 hours post-exercise, 48 hours post-exercise

  4. Change in 24 Hour Urinary Kidney Injury Molecule 1

    Marker of Kidney Injury measured as a change in concentration between baseline to 2 time points surrounding exercise

    Measured: Baseline, Day 2, Day 3

  5. Change in 24 Hour Urinary Neutrophil Gelatinase-associated Lipocalin

    Marker of kidney damage measured as a change in concentration between baseline and 2 time points surrounding the exercise

    Measured: Baseline, Day 2, Day 3

Secondary outcomes (2)
  1. Change in the Short-form McGill Pain Questionnaire

    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.

    Measured: Baseline, immediately pre-exercise, immediately post-exercise, 24 hours post-exercise, 48 hours post-exercise

  2. Post Exercise Hypotension

    Systolic and Diastolic blood pressure measurements

    Measured: Baseline, immediately pre-exercise, immediately post-exercise, 24 hours post-exercise, 48 hours post-exercise

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2018
  2. Study start1 Oct 2018
  3. Primary completion30 May 2019
  4. Study completion30 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Model description
All participants will take part in the same, single bout, exercise intervention
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03678285
Sponsor's protocol ID
20180607EJ02013
Acronym
HIFRT-KH
Status last verified
Jun 2021
First submitted
30 Aug 2018
Last updated
16 Jul 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Poston WS, Haddock CK, Heinrich KM, Jahnke SA, Jitnarin N, Batchelor DB. Is High-Intensity Functional Training (HIFT)/CrossFit Safe for Military Fitness Training? Mil Med. 2016 Jul;181(7):627-37. doi: 10.7205/MILMED-D-15-00273.

    PubMed 27391615
  • Bergeron MF, Nindl BC, Deuster PA, Baumgartner N, Kane SF, Kraemer WJ, Sexauer LR, Thompson WR, O'Connor FG. Consortium for Health and Military Performance and American College of Sports Medicine consensus paper on extreme conditioning programs in military personnel. Curr Sports Med Rep. 2011 Nov-Dec;10(6):383-9. doi: 10.1249/JSR.0b013e318237bf8a.

    PubMed 22071400
  • Mansour SG, Verma G, Pata RW, Martin TG, Perazella MA, Parikh CR. Kidney Injury and Repair Biomarkers in Marathon Runners. Am J Kidney Dis. 2017 Aug;70(2):252-261. doi: 10.1053/j.ajkd.2017.01.045. Epub 2017 Mar 28.

    PubMed 28363731
  • Schulz CA, Christensson A, Ericson U, Almgren P, Hindy G, Nilsson PM, Struck J, Bergmann A, Melander O, Orho-Melander M. High Level of Fasting Plasma Proenkephalin-A Predicts Deterioration of Kidney Function and Incidence of CKD. J Am Soc Nephrol. 2017 Jan;28(1):291-303. doi: 10.1681/ASN.2015101177. Epub 2016 Jul 8.

    PubMed 27401687

Questions about this trial

What is this clinical trial studying?

A study testing HIFRT Workout in people with Acute Kidney Injury and Exercise, run by University of Wyoming at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Concentration of Proenkephalin-A From Baseline to 4 Time-points Surrounding the Workout (time frame: Baseline, Immediately pre-exercise, immediately post-exercise, 24 hours post-exercise, 48 hours post-exercise). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03678285, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2021.

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