NCT05302791

Brief Summary

The purpose of this study is to examine the effect of human skeletal muscle temperature during resistance exercise on myogenic and proteolytic signaling. Subjects will perform bilateral resistance exercise bouts at an intensity that should stimulate a muscle growth response in the Vastus Lateralis. During the resistance exercise, the subjects will receive a cold (10°C) intervention on the experimental limb, while receiving a neutral temperature intervention (22°C) on the control limb.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

March 7, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
19 days until next milestone

Study Start

First participant enrolled

April 19, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

April 24, 2024

Completed
Last Updated

October 8, 2024

Status Verified

October 1, 2024

Enrollment Period

6 months

First QC Date

March 7, 2022

Results QC Date

January 22, 2024

Last Update Submit

October 3, 2024

Conditions

Keywords

Resistance ExerciseMuscle Cooling

Outcome Measures

Primary Outcomes (10)

  • RT-qPCR for Forkhead Box O3 (FOXO3a)

    RT-qPCR for Forkhead Box O3 (FOXO3a) \[mRNA response FOXO3a\] Fold change calculated using the delta, delta CT method relative to stable reference genes and pre-exercise measures.

    4-hours post Exercise

  • RT-qPCR for Tripartite Motif Containing 63 (TRIM63)

    RT-qPCR for Tripartite Motif Containing 63 (TRIM63) \[mRNA response of TRIM63\] Fold change calculated using the delta, delta CT method relative to stable reference genes and pre-exercise measures.

    4-hours post Exercise

  • RT-qPCR for Growth/Differentiation Factor 8 (MSTN)

    RT-qPCR for Growth/Differentiation Factor 8 (MSTN) \[mRNA response of MSTN\] Fold change calculated using the delta, delta CT method relative to stable reference genes and pre-exercise measures.

    4-hours post Exercise

  • RT-qPCR for Myogenic Factor 5 (MYF5)

    RT-qPCR for Myogenic Factor 5 (MYF5) \[mRNA response of MYF5\] Fold change calculated using the delta, delta CT method relative to stable reference genes and pre-exercise measures.

    4-hours post Exercise

  • RT-qPCR for Myogenic Factor 6 (MYF6)

    RT-qPCR for Myogenic Factor 6 (MYF6) \[mRNA response of MYF6\] Fold change calculated using the delta, delta CT method relative to stable reference genes and pre-exercise measures.

    4-hours post Exercise

  • RT-qPCR for Myocyte Enhancer Factor 2A (MEF2a)

    RT-qPCR for Myocyte Enhancer Factor 2A (MEF2a) \[mRNA response of MEF2a\] Fold change calculated using the delta, delta CT method relative to stable reference genes and pre-exercise measures.

    4-hours post Exercise

  • RT-qPCR for Myogenic Differentiation 1 (MYOD1)

    RT-qPCR for Myogenic Differentiation 1 (MYOD1) \[mRNA response of MYOD1\] Fold change calculated using the delta, delta CT method relative to stable reference genes and pre-exercise measures.

    4-hours post Exercise

  • RT-qPCR for Myogenin (MYOG)

    RT-qPCR for Myogenin (MYOG) \[mRNA response of MYOG\] Fold change calculated using the delta, delta CT method relative to stable reference genes and pre-exercise measures.

    4-hours post Exercise

  • RT-qPCR for Ribosomal Protein S3 (RPS3)

    RT-qPCR for Ribosomal Protein S3 (RPS3) \[mRNA response of RPS3\] Fold change calculated using the delta, delta CT method relative to stable reference genes and pre-exercise measures.

    4-hours post Exercise

  • RT-qPCR for Ribosomal Protein L3 Like (RPL3L)

    RT-qPCR for Ribosomal Protein L3 Like (RPL3L) \[mRNA response of RPL3L\] Fold change calculated using the delta, delta CT method relative to stable reference genes and pre-exercise measures.

    4-hours post Exercise

Secondary Outcomes (2)

  • Muscle Temperature

    4-hours post Exercise

  • Skin Temperature

    4-hours post Exercise

Study Arms (2)

Muscle Cooling

EXPERIMENTAL

The intervention will be applying a cooling wrap during the bilateral resistance exercise.

Device: Muscle CoolingOther: Resistance Exercise

Control

PLACEBO COMPARATOR

There will be no temperature alteration for this leg during bilateral resistance exercise.

Other: Resistance Exercise

Interventions

Cooling wrap will be set to 10°C

Muscle Cooling

Resistance Machines (Leg Press and Knee extension). 12 rep Max

ControlMuscle Cooling

Eligibility Criteria

Age19 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Any male or female who is 19-45 of age and is considered
  • low risk for physical activity based on the American College of Sports Medicine (ACSM) guidelines
  • recreationally active during the 6 weeks prior to participation by meeting the ACSM minimum activity guidelines

You may not qualify if:

  • Any person outside of the age range of 19-45
  • not considered 'low risk' on the ACSM Risk Stratification Form
  • not meeting the exercise requirements for the preceding 6 weeks will be excluded.
  • self-report of a history of joint or muscular injury that would prevent them from safely completing the required activities
  • self-report of taking prescription drugs or supplements that may interfere with this research
  • self-report allergy to Xylocaine
  • pregnant
  • breast feeding
  • self-report sensitivity to heat or cold

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska at Omaha

Omaha, Nebraska, 68182, United States

Location

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Dustin Slivka
Organization
University of Montana

Study Officials

  • Dustin R Slivka, PHD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Each Subject acts as their own control in a de facto repeated measures design, where there is a Single bilateral exercise bout, with experimental and control assignment to individual limbs.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2022

First Posted

March 31, 2022

Study Start

April 19, 2022

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

October 8, 2024

Results First Posted

April 24, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations