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Exercise TrainingNCT05302791

Impact of Muscle Temperature on Muscle Growth and Breakdown: Cooling During Resistance Training

A study testing Muscle Cooling and Resistance Exercise in people with Exercise Training, run by University of Nebraska at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Exercise Training
What is being tested?
Muscle Cooling and Resistance Exercise
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12 participants
Where
1 siteUnited States
Study dates
19 Apr 2022to 1 Oct 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • pregnant
  • breast feeding
  • self-report sensitivity to heat or cold

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Nebraska at Omaha

    Omaha, Nebraska, 68182

Other trials in United States

About this study

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.

Read the detailed description

A total of 2 visits to the laboratory will be required following the signing of informed consent. All visits will take place at the University of Nebraska Exercise Physiology Laboratory.

Initial Visit (~1.5-2 hours):

Height and weight will be measured using a medical scale. Body fat will be assessed with hydrostatic weighing using an electronic load cell based system (Exertech, Dresbach, MN) correcting for residual lung volume, or Bioelectrical Impedance Analysis body composition analyzer (InBodyUSA, Cerritos, CA) if needed.

Subjects will then perform a 12 Repetition (12RM) Max Test for bilateral seated leg press and seated leg extension using the following protocol on isotonic exercise machines at a weight designed to create failure between 8 and 12 repetitions. Following a short warm-up on a cycle ergometer, the subjects proceed with a bilateral leg press warm-up consisting of one set of ten repetitions at a self-determined light load, then one set of 5 repetition at a self-determined moderate load, and one set of 1 repetition at a predicted 12 rep maximum as predicted in relation to their Fat Free Mass. During the warm-up subjects will be coached on form, and observed for their ability to complete the repetition max test. Weight for the test will be altered to suit the subject's ability to complete approximately 12 repetitions. Once the desired weight is determined, subjects will be asked to complete as many repetitions as possible until the subject can no longer complete a repetition using a full range of motion. An identical testing protocol is then performed for the leg extension. This data will be used to estimate a 12RM workload, that would be appropriate for hypertrophic growth using the Watham equation .

Experimental Visit (~6.5-8 hours):

Participants will be instructed to arrive to the lab having fasted overnight, and they will be asked to avoid strenuous activity, alcohol consumption, tobacco use, and drug use for the 24 hour period leading up to experimental trial.

Subjects will complete the following experimental protocol briefly described: consume a small meal, a pre-exercise muscle biopsy, precool for 30 minutes, complete the exercise intervention, immediately post-exercise biopsy, 4 hour recovery with cooling, and post-recovery biopsy. At three time points (pre-exercise, immediately post-exercise, and post-4-hour recovery), skin temperature, muscle temperature, blood flow, and muscle tissue biopsies will be taken.

Details are as followed:

Meal When subjects arrive a consistent meal will be provided to standardize dietary intake. Food choices will be given to participants to create a meal between 700-800 calories, containing approximately 25-35 g of protein, 75-85 g of carbohydrates, and 35-45 g of fat. These foods will be made-up of commercially available pre-packaged foods. They will have approximately 30 minutes to consume their meal.

Cooling protocol Subjects will have Game Ready Med 4 elite thigh wraps around each thigh. This system circulates cooled liquid through a wrap specifically fitted for different body segments. One thigh will be cooled while the other thigh will be wrapped with the cuff, but not have any liquid circulating through it. These wraps do provide slight compression and thus it is important to apply the wraps to both legs. Each leg is assigned to either cold experimental group or control, will be randomized and counter-balanced between subjects. The liquid temperature circulating through the thermal wraps will be set to 10°C. The thermal wraps will be worn during a 30 minute cool down period prior to the exercise bout, during the exercise intervention, and during a 4 hour recovery period.

Exercise Intervention The subjects will complete an intervention designed to stimulate the muscle growth signaling pathway (hypertrophy) in the Vastus Lateralis (outer thigh), via bilateral seated leg press and bilateral seated leg extension on isotonic exercise machines. Subjects will perform four sets of bilateral leg press exercises at the weight determined to be their 12 RM from the repetition max test. This should allow completion to failure of 8-12 repetitions. So, if more than 12 reps are able to be completed, weight will be added to the resistance for the subsequent sets. Conversely, if less than 8 reps lead to failure, the weight should be reduced for the subsequent sets. Constant dialogue with subjects will give investigators the ability to monitor set weights to maximize a hypertrophic response. Subjects will be allowed 2 minute of rest between each set. Upon completion of 4 sets, the subjects will be given 5 minutes of rest prior to repeating this protocol for bilateral leg extensions.

Biopsies A total of 6 muscle biopsies (1 per leg) will be obtained from the vastus lateralis (outer thigh) muscle. One from each leg for each of the 3 collection time-points, pre-exercise, immediately post-exercise, and post-4-hour recovery. Briefly, the area above the vastus lateralis muscle belly will be shaved and cleaned with alcohol. 1% xylocaine is then injected under the skin with a 25 ga hypodermic needle. The area is then further disinfected with betadine, and a sterile fenestrated drape is placed over the biopsy site. Using sterile techniques, a small incision is made through the skin (~5mm) and the Bergstrom biopsy needle is inserted through the incision into the belly of the muscle. The Bergstrom needle then takes a small clip of muscle (~50mg) and is removed from the muscle and stored in a chemical stabilizer. Slight pressure is held over the incision for approximately 2 minutes and is then closed using steri-strips and a band-aid with antibiotic ointment.

Intramuscular Temperature Using the incision from the muscle biopsy, a hypodermic (~26ga) thermocouple (Physitemp Instruments LLC, Clifton, NJ) that is smaller than the needle used to inject the xylocaine will be inserted into the belly of the muscle to measure intramuscular temperature. The thermocouple readings stabilize in approximately 3 seconds and the thermocouple is then removed. Recordings for intramuscular temperature will be collected during the biopsy process following the intervention.

Skin Temperature Skin Temperature will be measured on the surface of each thigh using a skin thermistor (Physitemp Instruments LLC, Clifton, NJ), infrared digital thermometer, and/or using an infrared thermal camera. Measurements will be taken at the same time as the intramuscular. The thermistor is simply placed on the skin for approximately 3 seconds and is then recorded. The infrared thermal camera can measure and record surface temperatures for a field of multiple surfaces.

Being tested
Muscle Cooling, Resistance Exercise
Keywords
Resistance Exercise, Muscle Cooling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Muscle CoolingDevice

    Cooling wrap will be set to 10°C

  • Resistance ExerciseOther

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

Study groups in NCT05302791
Study groupRoleWhat they receive
Muscle CoolingExperimentalThe intervention will be applying a cooling wrap during the bilateral resistance exercise.
Receives: Device: Muscle Cooling; Other: Resistance Exercise
ControlPlacebo comparatorThere will be no temperature alteration for this leg during bilateral resistance exercise.
Receives: Other: Resistance Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 4-hours post Exercise

  2. 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.

    Measured: 4-hours post Exercise

  3. 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.

    Measured: 4-hours post Exercise

  4. 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.

    Measured: 4-hours post Exercise

  5. 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.

    Measured: 4-hours post Exercise

  6. 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.

    Measured: 4-hours post Exercise

  7. 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.

    Measured: 4-hours post Exercise

  8. 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.

    Measured: 4-hours post Exercise

  9. 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.

    Measured: 4-hours post Exercise

  10. 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.

    Measured: 4-hours post Exercise

Secondary outcomes (2)
  1. Muscle Temperature

    Intramuscular Temperature

    Measured: 4-hours post Exercise

  2. Skin Temperature

    Surface Temperature of the skin

    Measured: 4-hours post Exercise

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2022
  2. Study start19 Apr 2022
  3. Primary completion1 Oct 2022
  4. Study completion1 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05302791
Sponsor's protocol ID
0072-22-FB
Status last verified
Oct 2024
First submitted
7 Mar 2022
Last updated
8 Oct 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Muscle Cooling and Resistance Exercise in people with Exercise Training, run by University of Nebraska at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RT-qPCR for Forkhead Box O3 (FOXO3a) (time frame: 4-hours post Exercise). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.

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