Ignite Creation Date:
2024-07-17 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06485063
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-10
Brief Title:
Myofascial Reorganization on Performance and Biomechanical Viscoelastic and Thermographic Properties of Athletes
Sponsor:
University of the State of Santa Catarina
Organization:
University of the State of Santa Catarina
Study Overview
Official Title:
Effects of Myofascial Reorganization on Running Performance and Lower Limb Biomechanical Viscoelastic and Thermographic Properties of Triathletes a Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a two-group randomized clinical trial includes an experimental and a placebo group to verify the effects of the Myofascial Reorganization RMF compared to the placebo-RMF technique on running performance and thermographic biomechanical and viscoelastic proprieties of lower limbs of male triathletes Data collection will be carried out one week before the first intervention session and one week after the last intervention session Anthropometric characteristics height and weight lower limbs and biomechanical viscoelastic and thermographic properties will be collected before any exercise tests After this the athlete will be submitted to a 10-minute protocol to verify running economy on the treadmill followed by an incremental test on the treadmill and a time to exhaustion test Evaluation procedures will carried out one week before 0 weeks and one week after 7th week the experimentalplacebo intervention Intervention sessions will occur during six weeks twice a week each session lasting up to 30 minutes
Detailed Description:
1 This study was approved by the Ethical Committee involving Research with Human Beings of the University of Santa Catarina UDESC under protocol number 56498722100000118 Consolidated Standards of Reporting Trials will be followed
21 General objectives to verify the effects of the Myofascial Reorganization RMF technique compared to the placebo-RMF technique on running performance and thermographic biomechanical and viscoelastic proprieties of lower limbs of athletes
22 Specific objectives intragroup and intergroup comparisons of running-related performance variables lower limb skin temperature and biomechanical and viscoelastic properties
3 Sample Athletes volunteers living in Florianópolis SC Brazil if they meet inclusion criteria and do not meet exclusion criteria
4 Sampling will be non-probabilistic by convenience and snowball participants will be recruited by social media flyers and by referral of other participants
5 Data collection procedures the athletes will be evaluated before 0 weeks and after 7 weeks a 6-week intervention protocol
51 Anthropometric measures height centimeters will be collected using a stadiometer and body mass kilograms will be measured using a weighting balance
52 Lower limb skin temperature Thermographic characteristics of lower limbs will be measured in a dark and controlled room at an ambient temperature of 24C1 and relative air humidity of 50 after 15 minutes of acclimatation Anterior and posterior lower limb regions of interest will be included
53 Biomechanical and viscoelastic properties
Biomechanical and viscoelastic properties State of tension biomechanical and viscoelastic properties of the myofascial tissue of lower limbs and thoracolumbar region will be assessed using a non-invasive digital palpation device These properties will be
F Frequency
S Dynamic Stiffness
D logarithmic decrement
R Relaxation time
C Creep These measures will be taken bilaterally on the anterior and posterior regions of the tights the iliotibial tract and the thoracolumbar region
54 Performance-related tests all exercise tests to analyze running performance-related variables will be carried out on a treadmill while monitoring the heart rate using a frequency meter and analyzing the gas exchange parameters using a gas analyzer in an open circuit breath-by-breath
541 Running Economy is the oxygen consumption at a common velocity chosen to be under the first lactate threshold The athletes will run at a constant velocity of 7 kilometers per hour while measuring their oxygen consumption VO2 and monitoring the heart rate for 10 minutes
543 Incremental 3-minute graded test The maximal volume of oxygen consumption VO2 max the maximal velocity of the incremental test and lactate thresholds will be determined by an incremental graded test until volitional exhaustion using stages of 3min and an increment of 1kmh per stage with a slope of 1 on the treadmill Between each stage capillary blood from the ear lobe will be collected to determine lactate blood concentrations The perceived effort will be measured using the 10-point scale for perceived effort
544 Lactate thresholds blood lactate concentrations bLa will be derived from blood samples collected from the ear lobe during the incremental test and the first LT1 and the second lactate threshold LT2 will be determined
545 Time to Exhaustion Test to determine the time to exhaustion in a maximal effort and as a verification of the VO2max After the 20-minute rest after the incremental test a re-warm of 3 minutes will be taken at a velocity of 50 of the maximal velocity reached by the incremental test Then the athlete will perform the test at 100 of the maximal velocity until volitional exhaustion
6 Groups and Interventions
After an evaluation 0 weeks the participants will be randomized into one of the two groups a Myofascial Reorganization RMF or b PLACEBO Myofascial Reorganization RMFplacebo They will be blinded to the group of intervention The randomization will be enrolled using sealed envelopes and the allocation will be carried out in blocks of 4 by a non-investigatorBoth groups will receive 6 weeks of experimentalplacebo intervention twice a week Each session will last approximately 30 minutes The RMF group will receive a specific mechanical load directed to the fascial system real technique while the placebo group will receive a simulation of the technique a light touch to the skin added to lower limb voluntary movements The real technique consists of a specific 45 oblique mechanical load applied to the fascial system and it includes an additional shear load provoked passively by the therapist and then actively provoked by the participants voluntary movementThe re-tests will be carried out one week after the last session of intervention in the 7th weekRMF will be applied
61 Thoracolumbar fascia insertion using one proximal hand closer to the participants head and a distal hand closer to the participants feet Proximal hand - three fingers on the iliolumbar ligament Distal hand - three fingers on the lateral edge of the sacrum Passive load first stage the therapist applies a progressive then sustained oblique 45 load with both hands directing the force vector to the pelvis center with additional craniocaudal shear load using the fingers both hands working synchronically Active load second stage the participant lying in the supine position contralateral and ipsilateral lower limbs initially relaxed both feet placed in the stretcher and hips and knees flexed at 9090 hands on the thorax starts with ipsilateral lower limb will perform an active movement a hip external rotation added to dorsal flexion of the ankle and flexion of the knee and hip joints b followed by the movement of hip internal rotation added to plantar flexion of the ankle and extension knee and hip joints
62 Abdominal muscles fascia The therapists hands are placed on a virtual triangle formed by the anterior iliac spine the umbilical scar and the pubic symphysis closer to the insertion of the abdominis muscles on the pelvis where the fascia of rectus abdominis muscle and the obliques muscles separate First stage the therapists fingers will be directed to the center of the pelvis the hands working synchronically The therapist applies a progressive mechanical oblique load directing the force vector to the pelvis center adding a subsequent shear load in the craniocaudal direction with both hands working synchronically The participant lies on the stretcher in supine contralateral and ipsilateral lower limbs initially relaxed both feet placed in the stretcher hips and knees flexed at 9090 and the hands on the thorax In the second stage the participant will add anteretroversion of the pelvis to promote the active shear load
63 Quadriceps femoris muscle The therapist will use a proximal and a distal hand Proximal hand acting as an anchor - the hypothenar region in parallel with the lateral side of the participant contemplating the surface between both anterior and inferior iliac spines to perform that anchor the therapist will bring the skin excess and apply a soft and sustained mechanical load until they find the fascial barrier Distal hand the therapists hand will embrace the distal portion of the tight contemplating the patella the first finger on the lateral side of the knee region and the other fingers on the medial side the fingers will create an anchor promoting an intention to separate the quadriceps femoris muscle from the iliotibial tract and the insertion of the sartorius gracious and semitendinosus muscles At the same time using these fingers the caudal hand will apply the mechanical load with the subsequent shear load First stage the mechanical oblique load is applied with a subsequent shear load in the proximal-distal direction Second stage passive shear load is replaced by the active shear load movement with the ipsilateral lower limb The participant will be in the supine position The ipsilateral lower limb lies on the therapists tight that acts as a cushion under the knee region knee flexed between 40 and 50 foot resting on the stretcher The contralateral lower limb foot resting on the stretcher keeping 9090 hip and knee flexion The ipsilateral will perform slowly and with a short range of motion cycles of knee flexion added to dorsiflexion followed by knee extension and plantar flexion The cycle is repeated during the stage time
64 a Fascia lata tensor muscle and iliotibial tract the therapist will place one hand right beside the other with the thumbs relaxed and the other fingers semi-flexed as if the hands formed a C The hands will mirror each other the carpi bones of the right hand almost touching the ones of the left hand Both hands will be placed on the supra-trochanteric region Stage one The load will be applied using the hypothenar region of the right and left hands and the lateral surface of the 5th right and left fingers The mechanical oblique load will be directed to the center of the pelvis and knee with a passive shear load in the mediolateral direction Stage two the participant will be in lateral decubitus relaxed with the ipsilateral hip in light flexion the knee in extension and the contralateral lower limb with hip and knee flexed at 9090 The ipsilateral lower limb executes a hip and knee flexion added to ankle dorsal flexion then a hip and knee extension added to an ankle plantar flexion repeatedly
64 b Fascia lata tensor muscle and iliotibial tract the therapist will use a medial hand placed on the medial side of the knee acting as an anchor and one lateral hand lateral side of the knee that will apply the mechanical load Anchor medial hand the thumb embraces medial the region of the knee Mechanical load lateral hand on the lateral region of the tight 5cm above the articular line on the insertion of the iliotibial tract the hypothenar region of the hand will apply the load 5cm above the joint line of the knee the distal third of the iliotibial tract Stage one The lateral hand applies the mechanical oblique load vector directed to the center of the pelvis and to the ceiling with the shear load applied in the mediolateral direction Stage two the participant already in lateral decubitus with the contralateral lower limb in 9090 hip and knee flexion and the ipsilateral initially the hip in light flexion and the knee in extension will perform a very short range of motion of hip internal rotation and then returns to the initial position repeatedly with the ipsilateral lower limb
64 c Fascia lata tensor muscle and iliotibial tract from the abovementioned position only the second stage active shear load is repeated but the therapists mechanical load hand lateral hand is now on the proximal insertion of the iliotibial tract
65 Hamstrings muscles The participant will be in the supine position contralateral lower limb with the foot resting on the stretcher keeping the hip and the knee flexed at 9090 The participants ipsilateral knee initially rested on the therapists shoulder The therapist uses one hand to stabilize the participants knee and the other hand to promote the mechanical load Stabilizing hand on the distal region of the thigh involving the knee and stabilizing the participants limb Mechanical load hand the therapist will apply the mechanical load using the diaphysis of the distal phalanges on the proximal third of the tight close to the insertion of the ipsilateral hamstring muscles Stage one progressive then sustained 45 oblique load force vector directed to the center of the pelvis added to a shear load in the proximal-distal direction from the ischiatic bone to the knee repeatedly Stage two the participants ipsilateral lower limb performs knee flexionextension not full extension
66 Adductor muscles The participant will be in the supine position The Ipsilateral lower limb with the foot resting on the stretcher the tight resting against the therapists tight maintaining a hip and knee flexion of approximately 6060 and slight hip external rotation The contralateral lower limb with the foot resting in the stretcher maintaining 9090 of hip and knee flexion The therapist will use one hand as an anchor while the other applies the mechanical load Anchor the thumb performs an oblique 45load directed to the center of the pelvis on the region that designs a virtual triangle formed by the umbilical scar the anterior superior iliac spine and the pubic symphysis Hand of the mechanical load performing thumb opponency while the second and third fingers remain together in interphalangeal and metacarpophalangeal flexion forming a C this hand promotes a continuous mechanical load 15cm distant to the pubic symphysis Stage one progressive then sustained 45 oblique load force vector directed to the center of the pelvis with additional shear load on the proximal-distal direction from the pelvis to the knee and vice-versa Stage two the participant will perform with the ipsilateral lower limb hip internalexternal rotation repeatedly
The placebo technique will repeat all the stages except the therapist will apply a light touch to the skin during stages one and two The movements of stage two will be performed
7Statistical Analysis The data will be processed using IBM Statistical Package for the Social Sciences version 200 The Shapiro-Wilk test will determine the normality of data and an analysis of variance ANOVA 2x2 will be conducted to compare between conditions experimentalplacebo and between the baseline 0 weeks and post-intervention 7th week All analyses will be bidirectional and set to a significance level of p005 The effect size will be conducted
21 General objectives to verify the effects of the Myofascial Reorganization RMF technique compared to the placebo-RMF technique on running performance and thermographic biomechanical and viscoelastic proprieties of lower limbs of athletes
22 Specific objectives intragroup and intergroup comparisons of running-related performance variables lower limb skin temperature and biomechanical and viscoelastic properties
3 Sample Athletes volunteers living in Florianópolis SC Brazil if they meet inclusion criteria and do not meet exclusion criteria
4 Sampling will be non-probabilistic by convenience and snowball participants will be recruited by social media flyers and by referral of other participants
5 Data collection procedures the athletes will be evaluated before 0 weeks and after 7 weeks a 6-week intervention protocol
51 Anthropometric measures height centimeters will be collected using a stadiometer and body mass kilograms will be measured using a weighting balance
52 Lower limb skin temperature Thermographic characteristics of lower limbs will be measured in a dark and controlled room at an ambient temperature of 24C1 and relative air humidity of 50 after 15 minutes of acclimatation Anterior and posterior lower limb regions of interest will be included
53 Biomechanical and viscoelastic properties
Biomechanical and viscoelastic properties State of tension biomechanical and viscoelastic properties of the myofascial tissue of lower limbs and thoracolumbar region will be assessed using a non-invasive digital palpation device These properties will be
F Frequency
S Dynamic Stiffness
D logarithmic decrement
R Relaxation time
C Creep These measures will be taken bilaterally on the anterior and posterior regions of the tights the iliotibial tract and the thoracolumbar region
54 Performance-related tests all exercise tests to analyze running performance-related variables will be carried out on a treadmill while monitoring the heart rate using a frequency meter and analyzing the gas exchange parameters using a gas analyzer in an open circuit breath-by-breath
541 Running Economy is the oxygen consumption at a common velocity chosen to be under the first lactate threshold The athletes will run at a constant velocity of 7 kilometers per hour while measuring their oxygen consumption VO2 and monitoring the heart rate for 10 minutes
543 Incremental 3-minute graded test The maximal volume of oxygen consumption VO2 max the maximal velocity of the incremental test and lactate thresholds will be determined by an incremental graded test until volitional exhaustion using stages of 3min and an increment of 1kmh per stage with a slope of 1 on the treadmill Between each stage capillary blood from the ear lobe will be collected to determine lactate blood concentrations The perceived effort will be measured using the 10-point scale for perceived effort
544 Lactate thresholds blood lactate concentrations bLa will be derived from blood samples collected from the ear lobe during the incremental test and the first LT1 and the second lactate threshold LT2 will be determined
545 Time to Exhaustion Test to determine the time to exhaustion in a maximal effort and as a verification of the VO2max After the 20-minute rest after the incremental test a re-warm of 3 minutes will be taken at a velocity of 50 of the maximal velocity reached by the incremental test Then the athlete will perform the test at 100 of the maximal velocity until volitional exhaustion
6 Groups and Interventions
After an evaluation 0 weeks the participants will be randomized into one of the two groups a Myofascial Reorganization RMF or b PLACEBO Myofascial Reorganization RMFplacebo They will be blinded to the group of intervention The randomization will be enrolled using sealed envelopes and the allocation will be carried out in blocks of 4 by a non-investigatorBoth groups will receive 6 weeks of experimentalplacebo intervention twice a week Each session will last approximately 30 minutes The RMF group will receive a specific mechanical load directed to the fascial system real technique while the placebo group will receive a simulation of the technique a light touch to the skin added to lower limb voluntary movements The real technique consists of a specific 45 oblique mechanical load applied to the fascial system and it includes an additional shear load provoked passively by the therapist and then actively provoked by the participants voluntary movementThe re-tests will be carried out one week after the last session of intervention in the 7th weekRMF will be applied
61 Thoracolumbar fascia insertion using one proximal hand closer to the participants head and a distal hand closer to the participants feet Proximal hand - three fingers on the iliolumbar ligament Distal hand - three fingers on the lateral edge of the sacrum Passive load first stage the therapist applies a progressive then sustained oblique 45 load with both hands directing the force vector to the pelvis center with additional craniocaudal shear load using the fingers both hands working synchronically Active load second stage the participant lying in the supine position contralateral and ipsilateral lower limbs initially relaxed both feet placed in the stretcher and hips and knees flexed at 9090 hands on the thorax starts with ipsilateral lower limb will perform an active movement a hip external rotation added to dorsal flexion of the ankle and flexion of the knee and hip joints b followed by the movement of hip internal rotation added to plantar flexion of the ankle and extension knee and hip joints
62 Abdominal muscles fascia The therapists hands are placed on a virtual triangle formed by the anterior iliac spine the umbilical scar and the pubic symphysis closer to the insertion of the abdominis muscles on the pelvis where the fascia of rectus abdominis muscle and the obliques muscles separate First stage the therapists fingers will be directed to the center of the pelvis the hands working synchronically The therapist applies a progressive mechanical oblique load directing the force vector to the pelvis center adding a subsequent shear load in the craniocaudal direction with both hands working synchronically The participant lies on the stretcher in supine contralateral and ipsilateral lower limbs initially relaxed both feet placed in the stretcher hips and knees flexed at 9090 and the hands on the thorax In the second stage the participant will add anteretroversion of the pelvis to promote the active shear load
63 Quadriceps femoris muscle The therapist will use a proximal and a distal hand Proximal hand acting as an anchor - the hypothenar region in parallel with the lateral side of the participant contemplating the surface between both anterior and inferior iliac spines to perform that anchor the therapist will bring the skin excess and apply a soft and sustained mechanical load until they find the fascial barrier Distal hand the therapists hand will embrace the distal portion of the tight contemplating the patella the first finger on the lateral side of the knee region and the other fingers on the medial side the fingers will create an anchor promoting an intention to separate the quadriceps femoris muscle from the iliotibial tract and the insertion of the sartorius gracious and semitendinosus muscles At the same time using these fingers the caudal hand will apply the mechanical load with the subsequent shear load First stage the mechanical oblique load is applied with a subsequent shear load in the proximal-distal direction Second stage passive shear load is replaced by the active shear load movement with the ipsilateral lower limb The participant will be in the supine position The ipsilateral lower limb lies on the therapists tight that acts as a cushion under the knee region knee flexed between 40 and 50 foot resting on the stretcher The contralateral lower limb foot resting on the stretcher keeping 9090 hip and knee flexion The ipsilateral will perform slowly and with a short range of motion cycles of knee flexion added to dorsiflexion followed by knee extension and plantar flexion The cycle is repeated during the stage time
64 a Fascia lata tensor muscle and iliotibial tract the therapist will place one hand right beside the other with the thumbs relaxed and the other fingers semi-flexed as if the hands formed a C The hands will mirror each other the carpi bones of the right hand almost touching the ones of the left hand Both hands will be placed on the supra-trochanteric region Stage one The load will be applied using the hypothenar region of the right and left hands and the lateral surface of the 5th right and left fingers The mechanical oblique load will be directed to the center of the pelvis and knee with a passive shear load in the mediolateral direction Stage two the participant will be in lateral decubitus relaxed with the ipsilateral hip in light flexion the knee in extension and the contralateral lower limb with hip and knee flexed at 9090 The ipsilateral lower limb executes a hip and knee flexion added to ankle dorsal flexion then a hip and knee extension added to an ankle plantar flexion repeatedly
64 b Fascia lata tensor muscle and iliotibial tract the therapist will use a medial hand placed on the medial side of the knee acting as an anchor and one lateral hand lateral side of the knee that will apply the mechanical load Anchor medial hand the thumb embraces medial the region of the knee Mechanical load lateral hand on the lateral region of the tight 5cm above the articular line on the insertion of the iliotibial tract the hypothenar region of the hand will apply the load 5cm above the joint line of the knee the distal third of the iliotibial tract Stage one The lateral hand applies the mechanical oblique load vector directed to the center of the pelvis and to the ceiling with the shear load applied in the mediolateral direction Stage two the participant already in lateral decubitus with the contralateral lower limb in 9090 hip and knee flexion and the ipsilateral initially the hip in light flexion and the knee in extension will perform a very short range of motion of hip internal rotation and then returns to the initial position repeatedly with the ipsilateral lower limb
64 c Fascia lata tensor muscle and iliotibial tract from the abovementioned position only the second stage active shear load is repeated but the therapists mechanical load hand lateral hand is now on the proximal insertion of the iliotibial tract
65 Hamstrings muscles The participant will be in the supine position contralateral lower limb with the foot resting on the stretcher keeping the hip and the knee flexed at 9090 The participants ipsilateral knee initially rested on the therapists shoulder The therapist uses one hand to stabilize the participants knee and the other hand to promote the mechanical load Stabilizing hand on the distal region of the thigh involving the knee and stabilizing the participants limb Mechanical load hand the therapist will apply the mechanical load using the diaphysis of the distal phalanges on the proximal third of the tight close to the insertion of the ipsilateral hamstring muscles Stage one progressive then sustained 45 oblique load force vector directed to the center of the pelvis added to a shear load in the proximal-distal direction from the ischiatic bone to the knee repeatedly Stage two the participants ipsilateral lower limb performs knee flexionextension not full extension
66 Adductor muscles The participant will be in the supine position The Ipsilateral lower limb with the foot resting on the stretcher the tight resting against the therapists tight maintaining a hip and knee flexion of approximately 6060 and slight hip external rotation The contralateral lower limb with the foot resting in the stretcher maintaining 9090 of hip and knee flexion The therapist will use one hand as an anchor while the other applies the mechanical load Anchor the thumb performs an oblique 45load directed to the center of the pelvis on the region that designs a virtual triangle formed by the umbilical scar the anterior superior iliac spine and the pubic symphysis Hand of the mechanical load performing thumb opponency while the second and third fingers remain together in interphalangeal and metacarpophalangeal flexion forming a C this hand promotes a continuous mechanical load 15cm distant to the pubic symphysis Stage one progressive then sustained 45 oblique load force vector directed to the center of the pelvis with additional shear load on the proximal-distal direction from the pelvis to the knee and vice-versa Stage two the participant will perform with the ipsilateral lower limb hip internalexternal rotation repeatedly
The placebo technique will repeat all the stages except the therapist will apply a light touch to the skin during stages one and two The movements of stage two will be performed
7Statistical Analysis The data will be processed using IBM Statistical Package for the Social Sciences version 200 The Shapiro-Wilk test will determine the normality of data and an analysis of variance ANOVA 2x2 will be conducted to compare between conditions experimentalplacebo and between the baseline 0 weeks and post-intervention 7th week All analyses will be bidirectional and set to a significance level of p005 The effect size will be conducted
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None