NCT04929418

Brief Summary

In recent years there has been a significant increase in the number of participants in high intensity and duration sports events. This type of physical exercise has been reported to lead to an apparently transitory deterioration in kidney function. The injury mechanisms involved in this process have not been fully studied, but several have been proposed as potential causes, such as tissue ischemia, disruption of the permeability of the glomerular basement membrane, damage to the ultra-structure of skeletal muscle, structural involvement of the renal parenchyma, exercise-associated hyperthermia or insufficient hydration during exercise. Urinary biomarkers, which are a more precise tool than serum creatinine when it comes to detecting subclinical kidney damage, may be key to elucidate the characteristics of exercise-related kidney injury. The aim of this study is to carry out an integrative analysis of the development of exercise-associated subclinical acute kidney injury.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

12 months

First QC Date

June 11, 2021

Last Update Submit

April 26, 2026

Conditions

Acute Kidney Injury

Keywords

Acute kidney injury

Outcome Measures

Primary Outcomes (2)

  • Absolute change in urinary Neutrophil Gelatinase-Associated Lipocalin (NGAL) levels

    24 hours

  • Absolute change in urinary Kidney Injury Molecule-1 (KIM-1) levels

    24 hours

Secondary Outcomes (2)

  • Absolute change in serum creatinine levels

    24 hours

  • Absolute change in proteinuria

    24 hours

Study Arms (2)

10 km continuous running

OTHER

Participants will perform a test of 10 km coninuous running.

Other: 10 km continuous runningOther: 1.5 km continuous swimming

1.5 km swimming

OTHER

Participants will perform a test of 1.5 km coninuous swimming.

Other: 10 km continuous runningOther: 1.5 km continuous swimming

Interventions

10 km continuous runningOTHER

Trial participants will perform a 10 km continuous running exercise

1.5 km swimming10 km continuous running
1.5 km continuous swimmingOTHER

Trial participants will perform a 1.5 km continuous swimming exercise.

1.5 km swimming10 km continuous running

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years.
  • Able to understand the objectives of the study and to provide informed consent.
  • Body mass index between 18.5 and 29.9 kg / m2
  • Active sportsman/woman (defined as previous experience with the planned tests and performing vigorous-intensity aerobic activity at least three times per week).

You may not qualify if:

  • History of chronic kidney disease, hypertension, uncontrolled diabetes (defined as fasting glucose levels ≥200 mg/dl or HbA1c ≥9%), peripheral vascular disease, heart disease, neurological disease or thyroid disease.
  • Use of NSAIDs in the 72h prior to the test.
  • Consumption of statins or anabolic steroids.
  • Some kind of major physical injury in the four months prior to the tests.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínico Universitario

Valladolid, Valladolid, 47003, Spain

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Model Details: Trial participants will participate sequentially in two tests that involve high intensity physical exercise (10 km continuous running and 1.5 km continuous swimming). Both tests will be separated from each other a minimum of 30 days.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSc, phD

Study Record Dates

First Submitted

June 11, 2021

First Posted

June 18, 2021

Study Start

January 1, 2019

Primary Completion

December 31, 2019

Study Completion

March 20, 2020

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)