NCT05727332

Brief Summary

The long-term objective of this research line is to identify and implement an effective and feasible intervention capable of preventing and/or reducing the burden of cardiometabolic and obesity-related diseases that affect Mississippians and others. The pursuit of this long-term objective will begin with achieving the specific aims proposed in this pilot project, which are to determine the effect of single sprint training for improving (1) systemic macro-vascular function, (2) local and systemic micro-vascular function, and (3) cardiorespiratory fitness. These aims will be achieved using a randomized controlled trial whereby 40 males and females will be randomized into an intervention group (n=20) or time-matched negative control group (n=20). The intervention group will perform a single maximal effort sprint on a cycle ergometer for twenty seconds 3 days/week for 4 weeks and the control group will be asked to maintain pre-intervention habits/behavior over 4 weeks. All outcome measures are non-invasive, and will be assessed pre-, mid-, and post-intervention, with the exception of cardiorespiratory fitness, which will be measured pre- and post-. To achieve aim 1, brachial artery flow-mediated dilation via ultrasonography and systolic and diastolic blood pressure via automated oscillometry will be measured on the arm. To achieve aim 2, post-occlusive reactive hyperemia via near-infrared spectroscopy and reactive hyperemia via ultrasound will be measured in the arm and leg, respectively. To achieve aim 3, pulmonary gas exchange will be measured during a graded exercise test on a cycle ergometer. All outcomes will be compared across time between conditions and sex with a three-way Bayesian Repeated Measures ANOVA using pre-values as covariates and an uninformed prior. 95% credible intervals will also be calculated to power future investigations using this intervention. If the intervention is found effective, future studies will be conducted to determine the efficacy of the intervention in larger groups and more clinical populations, and to determine the mechanisms mediating the adaptations. If ineffective, the knowledge gained will be used to develop future interventions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 14, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

June 5, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2024

Completed
Last Updated

June 26, 2025

Status Verified

June 1, 2025

Enrollment Period

1.2 years

First QC Date

January 26, 2023

Last Update Submit

June 20, 2025

Conditions

Keywords

VascularCardiorespiratory Fitness

Outcome Measures

Primary Outcomes (2)

  • Change from baseline systemic macrovascular function at 2 weeks and 4 weeks

    Systemic macrovascular changes will be quantified by measuring 1) brachial artery flow-mediated dilation via vascular ultrasound, and 2) resting brachial blood pressure via a standard automated blood pressure cuff.

    week 0, week 2, and week 4

  • Change from baseline local and systemic microvascular function at 2 weeks and 4 weeks

    Systemic changes in microvascular endothelial function will be quantified by using the post-occlusive reactive hyperemia technique in the arm. Local microvascular function will be measured using the passive leg movement technique for reactive hyperemia and post-occlusive reactive hyperemia in the leg.

    week 0, week 2, and week 4

Secondary Outcomes (1)

  • Change from baseline maximal oxygen consumption at 2 weeks and 4 weeks

    week 0, week 2, and week 4

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention group will perform a single maximal effort sprint on a cycle ergometer for twenty seconds 3 days/week for 4 weeks.

Behavioral: Single-Sprint Training

Time-Matched Control

NO INTERVENTION

The control group will be asked to maintain pre-intervention habits/behavior over 4 weeks.

Interventions

A single maximal effort sprint on a cycle ergometer for twenty seconds 3 days/week for 4 weeks

Intervention

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-35 years
  • Untrained (no regular exercise engagement for the previous 6 months)
  • Healthy enough to begin exercise (assessed via Physical Activity Readiness Questionnaire)

You may not qualify if:

  • Illness/injury preventing cycling exercise
  • Prescribed medication to control heart rate
  • Prescribed medication to control blood pressure
  • Use of nicotine within the previous 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Mississippi

University, Mississippi, 38677, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Intervention group and negative control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 26, 2023

First Posted

February 14, 2023

Study Start

June 5, 2023

Primary Completion

July 31, 2024

Study Completion

December 5, 2024

Last Updated

June 26, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

There is no current plan to share individual data outside of the investigators responsible for conducting the study. If data are requested, they will only be shared after being de-identified, unless otherwise required by law.

Locations