NCT06646926

Brief Summary

The goal of this clinical trial is to examine the effects of body tempering on healthy volunteers between the ages of 18-39. The main question it aims to answer is will the intervention have an impact on immediate or 24-hour measures of lower extremity power as measured by the: vertical jump test? standing long jump test? Researchers will compare an alternate intervention of foam rolling self-myofascial release to see if any changes in jump test performance are comparable. Participants will perform a brief warm-up followed by baseline performance of the two jump tests (5 repetitions each). Participants will be randomized into one of two groups: either application of the body tempering intervention or performance of self-myofascial release via foam rolling. Following the intervention, participants will be asked to perform 3 repetitions of each outcome measure (jump test); participants will be asked to return 24 hours later where they will guided through the same warm-up as the day prior and will again perform 5 repetitions of each jump test.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

October 4, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 17, 2024

Completed
15 days until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

November 19, 2024

Status Verified

November 1, 2024

Enrollment Period

2 months

First QC Date

October 4, 2024

Last Update Submit

November 17, 2024

Conditions

Keywords

lower extremitymuscle powerbody temperingfoam rollingmyofascial release

Outcome Measures

Primary Outcomes (2)

  • vertical jump test

    The vertical jump assessment will be performed according to the protocol used by Sayers and colleagues. Participants will cover the fingers of their dominant hand with chalk and stand beside a wall, descend into a squat with a 90-degree knee bend, and, after pausing for two seconds, will jump as high as they are able, reaching up with their dominant hand and placing a mark on the wall. Participants will perform this sequence five times. However, only the last three trials being recorded, which will be unknown to participants. The greatest value obtained from the trials will be used to calculate lower extremity power using the regression formula produced by Sayers and colleagues (Peak Power (W) = (60.7) × (jump height \[cm\]) + 45.3 × (body mass \[kg\]) - 2055). Rest intervals will be the amount of time it takes to complete the measurement for each trial.

    From enrollment to the end of follow up assessment at 24 hours

  • standing long jump assessment

    The standing long jump assessment (SLJ) assessment will be performed for five trials with the best performance on the three experimental trials used to determine lower extremity power. The SLJ will be performed like the protocol used by Mann and colleagues with participants performing horizontal jumps as far as they can and measuring the distance from the start point to the back of the subject's backmost heel. The subject must maintain their balance after landing for the trial to be counted. The farthest distance jumped will then be used to calculate power through the regression formula created by Mann and colleagues (Power \[W\] = 32.49·SLJ \[cm\] + 39.69·Wt \[kg\] - 7,608). Rest time between trials will be the amount of time it takes to measure the distance the subject jumped.

    From enrollment to the end of follow up assessment at 24 hours

Study Arms (2)

Body Tempering

EXPERIMENTAL

Participant will be positioned prone on the Body Tempering Ab Mat with their feet hanging off the end of the mat. The body tempering intervention will be applied by the same investigator for all trials. The body tempering device will be applied dynamically to each participant for 4 minutes, with the device placed on both participants' lower extremities at the same time. First, the examiner will set a timer for two minutes and begin rolling one 80-pound body tempering device along the participant's gastrocnemius-soleus complex at a rate of 30 beats per minute, traveling from the Achilles tendon (medial malleolus) to the inferior aspect of the popliteal fossa, indicated by fibular head. The participant will then take thirty seconds to transition to a supine position and receive tempering with an 80-pound tempering device along their middle to distal quadriceps, set a timer for 2 minutes.

Other: Body tempering

Foam rolling self-myofascial release

ACTIVE COMPARATOR

Participants will be instructed via standardized script to perform self-myofascial release (SMR) on their gastrocnemius-soleus complex and quadriceps muscles. The first SMR sequence will be performed by having the participant place the foam roller behind both calves, beginning the roll at the medial malleolus and ending at the inferior aspect of the popliteal fossa, indicated by the fibular head. The participant will perform this for two minutes, rolling at a tempo of 30 beats per minute. Next, the participant will take thirty seconds to transition to a prone position, placing the foam roller just distal to the hip crease, just inferior to the AIIS, and rolling inferiorly to the area just proximal to the most superior aspect of the patella. This self-release sequence will be performed for two minutes at a tempo of 30 beats per minute. The total time should be four minutes, matching the total time of the experimental intervention group.

Other: Foam rolling self-myofascial release

Interventions

Participant will be positioned prone on the Body Tempering Ab Mat with their feet hanging off the end of the mat. The body tempering intervention will be applied by the same investigator for all trials. The body tempering device will be applied dynamically to each participant for 4 minutes, with the device placed on both participants' lower extremities at the same time. First, the examiner will set a timer for two minutes and begin rolling one 80-pound body tempering device along the participant's gastrocnemius-soleus complex at a rate of 30 beats per minute, traveling from the Achilles tendon (medial malleolus) to the inferior aspect of the popliteal fossa, indicated by fibular head. The participant will then take thirty seconds to transition to a supine position and receive tempering with an 80-pound tempering device along their middle to distal quadriceps, set a timer for 2 minutes.

Body Tempering

Participants will be instructed via standardized script to perform self-myofascial release (SMR) on their gastrocnemius-soleus complex and quadriceps muscles. The first SMR sequence will be performed by having the participant place the foam roller behind both calves, beginning the roll at the medial malleolus and ending at the inferior aspect of the popliteal fossa, indicated by the fibular head. The participant will perform this for two minutes, rolling at a tempo of 30 beats per minute. Next, the participant will take thirty seconds to transition to a prone position, placing the foam roller just distal to the hip crease, just inferior to the AIIS, and rolling inferiorly to the area just proximal to the most superior aspect of the patella. This self-release sequence will be performed for two minutes at a tempo of 30 beats per minute. The total time should be four minutes, matching the total time of the experimental intervention group.

Foam rolling self-myofascial release

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects age 18-39 years old

You may not qualify if:

  • History of knee or hip injury,
  • Hypertension
  • Thrombophlebitis
  • Inflammation
  • Myositis ossificans
  • Osteomyelitis
  • Open wounds
  • Unhealed fractures
  • Hematoma
  • Pregnancy
  • Cancer
  • Burns or Skin grafts
  • Varicose veins
  • Synovitis
  • Currently taking any anticoagulation medications
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Blatt PE Center, University of South Carolina

Columbia, South Carolina, 29208, United States

Location

Related Publications (4)

  • Sayers SP, Harackiewicz DV, Harman EA, Frykman PN, Rosenstein MT. Cross-validation of three jump power equations. Med Sci Sports Exerc. 1999 Apr;31(4):572-7. doi: 10.1097/00005768-199904000-00013.

    PMID: 10211854BACKGROUND
  • Mann JB, Bird M, Signorile JF, Brechue WF, Mayhew JL. Prediction of Anaerobic Power From Standing Long Jump in NCAA Division IA Football Players. J Strength Cond Res. 2021 Jun 1;35(6):1542-1546. doi: 10.1519/JSC.0000000000004043.

    PMID: 33927119BACKGROUND
  • Blazevich AJ, Gill ND, Kvorning T, Kay AD, Goh AG, Hilton B, Drinkwater EJ, Behm DG. No Effect of Muscle Stretching within a Full, Dynamic Warm-up on Athletic Performance. Med Sci Sports Exerc. 2018 Jun;50(6):1258-1266. doi: 10.1249/MSS.0000000000001539.

    PMID: 29300214BACKGROUND
  • Taber CB, Colter RJ, Davis JJ, Seweje PA, Wilson DP, Foster JZ, Merrigan JJ. The Effects of Body Tempering on Force Production, Flexibility and Muscle Soreness in Collegiate Football Athletes. J Funct Morphol Kinesiol. 2022 Jan 11;7(1):9. doi: 10.3390/jfmk7010009.

    PMID: 35076554BACKGROUND

Related Links

Central Study Contacts

Matthew D Geary, DPT, EdD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

October 4, 2024

First Posted

October 17, 2024

Study Start

November 1, 2024

Primary Completion

January 10, 2025

Study Completion

May 1, 2025

Last Updated

November 19, 2024

Record last verified: 2024-11

Locations