Trial Outcomes & Findings for Impact of Muscle Temperature on Muscle Growth and Breakdown: Cooling During Resistance Training (NCT NCT05302791)

NCT ID: NCT05302791

Last Updated: 2024-10-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

4-hours post Exercise

Results posted on

2024-10-08

Participant Flow

Unit of analysis: experimental (cooling) or control

Participant milestones

Participant milestones
Measure	All Participants all participants have one leg serving as the experimental (10 degrees C cooling wrap) and the other as the control (no cooling) before, during, and after resistance exercise.
Overall Study STARTED	12 24
Overall Study Experimental (Cooling)	12 12
Overall Study Control (no Cooling)	12 12
Overall Study COMPLETED	12 24
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=12 Participants all participants have one leg serving as the experimental (10 degrees C cooling wrap) and the other as the control (no cooling) before, during, and after resistance exercise.
Age, Continuous	26.5 years STANDARD_DEVIATION 2.9 • n=12 Participants
Sex: Female, Male Female	4 Participants n=12 Participants
Sex: Female, Male Male	8 Participants n=12 Participants
Region of Enrollment United States	12 participants n=12 Participants
height	1.71 meters STANDARD_DEVIATION .08 • n=12 Participants
weight	77.3 kg STANDARD_DEVIATION 15.9 • n=12 Participants
body composition	20.8 % fat STANDARD_DEVIATION 13.5 • n=12 Participants

PRIMARY outcome

Timeframe: 4-hours post Exercise

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.

Outcome measures

Outcome measures
Measure	Muscle Cooling n=12 legs The intervention will be applying a cooling wrap during the bilateral resistance exercise. Muscle Cooling: Cooling wrap will be set to 10°C Resistance Exercise: Resistance Machines (Leg Press and Knee extension). 12 rep Max	Control n=12 legs There will be no temperature alteration for this leg during bilateral resistance exercise. Resistance Exercise: Resistance Machines (Leg Press and Knee extension). 12 rep Max
RT-qPCR for Forkhead Box O3 (FOXO3a)	1.24 fold change Standard Deviation .69	1.30 fold change Standard Deviation .98

PRIMARY outcome

Timeframe: 4-hours post Exercise

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.

Outcome measures

Outcome measures
Measure	Muscle Cooling n=12 legs The intervention will be applying a cooling wrap during the bilateral resistance exercise. Muscle Cooling: Cooling wrap will be set to 10°C Resistance Exercise: Resistance Machines (Leg Press and Knee extension). 12 rep Max	Control n=12 legs There will be no temperature alteration for this leg during bilateral resistance exercise. Resistance Exercise: Resistance Machines (Leg Press and Knee extension). 12 rep Max
RT-qPCR for Tripartite Motif Containing 63 (TRIM63)	3.59 fold change Standard Deviation 3.4	3.50 fold change Standard Deviation 4.43

PRIMARY outcome

Timeframe: 4-hours post Exercise

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.

Outcome measures

Outcome measures
Measure	Muscle Cooling n=12 legs The intervention will be applying a cooling wrap during the bilateral resistance exercise. Muscle Cooling: Cooling wrap will be set to 10°C Resistance Exercise: Resistance Machines (Leg Press and Knee extension). 12 rep Max	Control n=12 legs There will be no temperature alteration for this leg during bilateral resistance exercise. Resistance Exercise: Resistance Machines (Leg Press and Knee extension). 12 rep Max
RT-qPCR for Growth/Differentiation Factor 8 (MSTN)	.44 fold change Standard Deviation .3	.44 fold change Standard Deviation .29

PRIMARY outcome

Timeframe: 4-hours post Exercise

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.

Outcome measures

Outcome measures
Measure	Muscle Cooling n=12 legs The intervention will be applying a cooling wrap during the bilateral resistance exercise. Muscle Cooling: Cooling wrap will be set to 10°C Resistance Exercise: Resistance Machines (Leg Press and Knee extension). 12 rep Max	Control n=12 legs There will be no temperature alteration for this leg during bilateral resistance exercise. Resistance Exercise: Resistance Machines (Leg Press and Knee extension). 12 rep Max
RT-qPCR for Myogenic Factor 5 (MYF5)	.51 fold change Standard Deviation .21	.83 fold change Standard Deviation .55

PRIMARY outcome

Timeframe: 4-hours post Exercise

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.

Outcome measures

Outcome measures
Measure	Muscle Cooling n=12 legs The intervention will be applying a cooling wrap during the bilateral resistance exercise. Muscle Cooling: Cooling wrap will be set to 10°C Resistance Exercise: Resistance Machines (Leg Press and Knee extension). 12 rep Max	Control n=12 legs There will be no temperature alteration for this leg during bilateral resistance exercise. Resistance Exercise: Resistance Machines (Leg Press and Knee extension). 12 rep Max
RT-qPCR for Myogenic Factor 6 (MYF6)	2.2 fold change Standard Deviation 1.7	1.32 fold change Standard Deviation .47

PRIMARY outcome

Timeframe: 4-hours post Exercise

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.

Outcome measures

Outcome measures
Measure	Muscle Cooling n=12 legs The intervention will be applying a cooling wrap during the bilateral resistance exercise. Muscle Cooling: Cooling wrap will be set to 10°C Resistance Exercise: Resistance Machines (Leg Press and Knee extension). 12 rep Max	Control n=12 legs There will be no temperature alteration for this leg during bilateral resistance exercise. Resistance Exercise: Resistance Machines (Leg Press and Knee extension). 12 rep Max
RT-qPCR for Myocyte Enhancer Factor 2A (MEF2a)	1.44 fold change Standard Deviation 1.28	1.91 fold change Standard Deviation 2.12

PRIMARY outcome

Timeframe: 4-hours post Exercise

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.

Outcome measures

Outcome measures
Measure	Muscle Cooling n=12 legs The intervention will be applying a cooling wrap during the bilateral resistance exercise. Muscle Cooling: Cooling wrap will be set to 10°C Resistance Exercise: Resistance Machines (Leg Press and Knee extension). 12 rep Max	Control n=12 legs There will be no temperature alteration for this leg during bilateral resistance exercise. Resistance Exercise: Resistance Machines (Leg Press and Knee extension). 12 rep Max
RT-qPCR for Myogenic Differentiation 1 (MYOD1)	2.08 fold change Standard Deviation 1.73	1.92 fold change Standard Deviation 1.6

PRIMARY outcome

Timeframe: 4-hours post Exercise

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.

Outcome measures

Outcome measures
Measure	Muscle Cooling n=12 legs The intervention will be applying a cooling wrap during the bilateral resistance exercise. Muscle Cooling: Cooling wrap will be set to 10°C Resistance Exercise: Resistance Machines (Leg Press and Knee extension). 12 rep Max	Control n=12 legs There will be no temperature alteration for this leg during bilateral resistance exercise. Resistance Exercise: Resistance Machines (Leg Press and Knee extension). 12 rep Max
RT-qPCR for Myogenin (MYOG)	1.88 fold change Standard Deviation 1.75	2.62 fold change Standard Deviation 1.33

PRIMARY outcome

Timeframe: 4-hours post Exercise

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.

Outcome measures

Outcome measures
Measure	Muscle Cooling n=12 legs The intervention will be applying a cooling wrap during the bilateral resistance exercise. Muscle Cooling: Cooling wrap will be set to 10°C Resistance Exercise: Resistance Machines (Leg Press and Knee extension). 12 rep Max	Control n=12 legs There will be no temperature alteration for this leg during bilateral resistance exercise. Resistance Exercise: Resistance Machines (Leg Press and Knee extension). 12 rep Max
RT-qPCR for Ribosomal Protein S3 (RPS3)	1.46 fold change Standard Deviation 1.55	1.29 fold change Standard Deviation .69

PRIMARY outcome

Timeframe: 4-hours post Exercise

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.

Outcome measures

Outcome measures
Measure	Muscle Cooling n=12 legs The intervention will be applying a cooling wrap during the bilateral resistance exercise. Muscle Cooling: Cooling wrap will be set to 10°C Resistance Exercise: Resistance Machines (Leg Press and Knee extension). 12 rep Max	Control n=12 legs There will be no temperature alteration for this leg during bilateral resistance exercise. Resistance Exercise: Resistance Machines (Leg Press and Knee extension). 12 rep Max
RT-qPCR for Ribosomal Protein L3 Like (RPL3L)	1.55 fold change Standard Deviation 1.57	.78 fold change Standard Deviation .34

SECONDARY outcome

Timeframe: 4-hours post Exercise

Intramuscular Temperature

Outcome measures

Outcome measures
Measure	Muscle Cooling n=12 legs The intervention will be applying a cooling wrap during the bilateral resistance exercise. Muscle Cooling: Cooling wrap will be set to 10°C Resistance Exercise: Resistance Machines (Leg Press and Knee extension). 12 rep Max	Control n=12 legs There will be no temperature alteration for this leg during bilateral resistance exercise. Resistance Exercise: Resistance Machines (Leg Press and Knee extension). 12 rep Max
Muscle Temperature	26.09 degrees C Standard Deviation 3	35.07 degrees C Standard Deviation 1.04

SECONDARY outcome

Timeframe: 4-hours post Exercise

Surface Temperature of the skin

Outcome measures

Outcome measures
Measure	Muscle Cooling n=12 legs The intervention will be applying a cooling wrap during the bilateral resistance exercise. Muscle Cooling: Cooling wrap will be set to 10°C Resistance Exercise: Resistance Machines (Leg Press and Knee extension). 12 rep Max	Control n=12 legs There will be no temperature alteration for this leg during bilateral resistance exercise. Resistance Exercise: Resistance Machines (Leg Press and Knee extension). 12 rep Max
Skin Temperature	20.4 degrees C Standard Deviation 2.01	31.65 degrees C Standard Deviation 2.04

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dustin Slivka

University of Montana

Phone: 406-243-2389

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place