Effect of Exercise on Biomarkers in SCT

NCT ID: NCT04273022

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-27
• Study Completion Date: 2024-12-31

Brief Summary

This study measures the effect of exercise on a variety of biomarkers in blood and urine selected to evaluate the physiological pathways of hemolysis, myolysis, thrombosis, inflammation, and renal function in subjects with sickle cell trait. These pathways have been shown to be associated with adverse events in athletes and warfighters with SCT upon protracted, repeated, strenuous exertion. Changes in biomarkers post-exercise compared to pre-exercise (and compared to healthy controls) suggest activation of the associated pathway(s) which may contribute to exercise-related events in athletes and warfighters and subclinical complications in non-athletes.

Detailed Description

Subjects with sickle cell trait and healthy controls will be subjected to a single bout of moderate, controlled exercise on a treadmill. Blood and urine samples will be collected before exercise, immediately after exercise, and 24 hours after exercise. Fifteen biomarkers, three selected to evaluate each of the five physiologic pathways previously listed, will be tested at each of the three time points. Abnormal biomarkers before exercise suggest chronic pathway activation while exacerbated levels after exercise suggest further activation stimulated by exercise. Biomarker levels 24 hours post-exercise will be used to evaluate continued pathway activation or pathway recovery. By definition, 95% of health controls will show normal biomarker levels pre-exercise and biomarker patterns post-exercise will serve as the expected standard by which to compare the test subjects.

Conditions

Sickle Cell Trait

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

SCT Group

Fifteen SCT subjects will be recruited, consented, screened, and enrolled if they meet inclusion and exclusion criteria. Each subject will undergo a single bout of standardized exercise on a treadmill. Subjects will self-select treadmill speed at 0% grade and begin. After 3 minutes the grade will be increased by 1% every 2 minutes until the target heart rate (70% of heart rate reserve) is reached. Speed and grade will be held constant for 15 minutes, marking the end of the session.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

A single bout of standardized, moderate exercise

Control Group

Five healthy subjects will be recruited, consented, screened, and enrolled if they meet inclusion and exclusion criteria. Each subject will undergo a single bout of standardized exercise on a treadmill. Subjects will self-select treadmill speed at 0% grade and begin. After 3 minutes the grade will be increased by 1% every 2 minutes until the target heart rate (70% of heart rate reserve) is reached. Speed and grade will be held constant for 15 minutes, marking the end of the session.

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: OTHER

A single bout of standardized, moderate exercise

Interventions

Exercise

A single bout of standardized, moderate exercise

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Health subjects with sickle cell trait (AS)
• Ages 18-70 years

• Healthy subjects without sickle cell trait (AA)
• Ages 18-70 years

Exclusion Criteria

Subjects will be excluded if they:

• weigh less than 110 pounds,
• are pregnant,
• have hemoglobinopathies (other than sickle cell trait) as determined by Hb electrophoresis,
• have other self-reported conditions known to cause blood coagulation activation, myocyte destruction, hemolysis, chronic inflammation, or renal disease
• any condition that places subjects at risk during exercise.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Society for Clinical Laboratory Science

UNKNOWN

Sponsor Role: collaborator

St. Louis University

OTHER

Sponsor Role: lead

Responsible Party

Tim Randolph, PhD, MT (ASCP)

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tim R Randolph, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Louis University

Locations

Saint Louis University

St Louis, Missouri, United States

Countries

United States

Other Identifiers

30577

Identifier Type: -

Identifier Source: org_study_id