NCT06356142

Brief Summary

Repeated sprinting ability is key for athletic performance in a variety of sport settings. Significant degradations in work output (i.e. fatigue) have been shown to develop after just one sprinting bout1. This pilot study aims to investigate the effects that noninvasive transient temperature manipulation has on an individual's ability to perform repeated sprints. The investigators aim to enroll 90 healthy individuals, 18-30 years of age. Participants will be randomized into two groups (Group A, and B). All groups will perform a ten-minute warm-up followed by two minutes of rest. Following the warm-up and rest period, all groups will participate in a series of five sprints, 60 meters in total length with two 180 degree changes in direction. Between sprints, participants will have 10 seconds rest. After the first series of five sprints participants will be given a 2-minute rest interval. Then participants will perform another series of five sprints followed by another 2-minute rest interval. During each rest interval, Group A will utilize a palmar cooling device. Group B will utilize a placebo version of the palmar cooling device. All sprints will be timed. Heart rate recovery will be measured during all rest breaks, and a rating of perceived exertion will be measured at the beginning and end of each resting interval. Delayed onset muscle soreness will be assessed 48 hours post sprinting, utilizing a visual analog scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jun 2024

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

March 27, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 10, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

June 28, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2024

Completed
Last Updated

June 6, 2025

Status Verified

June 1, 2024

Enrollment Period

Same day

First QC Date

March 27, 2024

Last Update Submit

June 3, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Participants Sprinting times

    1 day

Secondary Outcomes (3)

  • Participants Heart Rate Recovery

    1 day

  • Participants Rating of Perceived exertion

    1 day

  • Participants Reported Delayed Onset Muscle Soreness

    2 days after the intervention

Study Arms (2)

Intervention Group

EXPERIMENTAL
Device: Palmar Cooling

Control

PLACEBO COMPARATOR
Device: Placebo Palmar Cooling

Interventions

Palmar cooling device will be utilized for 2 minutes during rest breaks.

Intervention Group

Placebo Palmar cooling device will be utilized for 2 minutes during rest breaks

Control

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy individuals 18-30 years of age

You may not qualify if:

  • Participant self-reporting injury or illness that will prevent them from exercising at maximal capacity
  • If participant has been told by their healthcare provider that they should avoid exercising at maximal capacity
  • Has previously used the palmar cooling device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 27, 2024

First Posted

April 10, 2024

Study Start

June 28, 2024

Primary Completion

June 28, 2024

Study Completion

June 28, 2024

Last Updated

June 6, 2025

Record last verified: 2024-06

Locations