Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05801302 |
Other study ID # |
4436122 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 1, 2023 |
Est. completion date |
June 3, 2023 |
Study information
Verified date |
May 2024 |
Source |
Federal University of Rio Grande do Sul |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Self-massage is a set of therapeutic techniques performed by the individual using instruments
such as a foam roller (i.e., foam rolling [FR]). This technique has been used in
rehabilitation to recover myofascial dysfunctions and in physical/sports training, to improve
performance in functional and sports activities. Possible changes in the muscle's and
tendon's mechanical properties may help to explain the FR effects, however, the dose-response
relationship is not clear acutely. Furthermore, body composition also seems to influence the
pressure applied to the different tissues during FR, since it can attenuate the forces
applied on the tissues. Therefore, the aim of this study is to verify the acute effects of
different FR volumes on the plantar flexors' musculotendinous properties in healthy
individuals. Twenty healthy subjects (male and female) aged between 18-35 years will perform
three different FR conditions: FR90 (3x30s), FR180 (3x60s), and a control condition (CTRL;
without the application of any intervention) with a seven-day wash-out period. The Achilles
tendon morphological, mechanical, and material properties, medial gastrocnemius passive
muscular stiffness, plantar flexors' muscle architecture, and the adipose tissue's thickness,
skin temperature and the jump height (assessed during the unilateral countermovement jump)
will be obtained. Assessments will be carried out before and immediately after the FR
application in the different conditions. Descriptive statistics (mean, standard deviation,
and standard error) will be used to present the results. The normality and sphericity of the
data will be evaluated using the Shapiro-Wilk and Mauchly tests, respectively. A two-way
ANOVA (condition [FR90, FR180, and CTRL] and moments [pre- and post-intervention]) will be
used to compare the results. A post-hoc Bonferroni test will be used to find possible
differences. A Pearson product-moment correlation test (parametric data) or a Spearman
correlation test (non-parametric data) will be used to verify the association between the
adipose tissue's thickness and the evaluated parameters. The effect size (Cohen's d) of each
condition will be obtained. Responsiveness to conditions (FR90, FR180, and CTRL) will be
determined using the typical error.
Description:
Self-massage is a set of therapeutic technique performed by the individual using instruments
such as a foam roller (i.e., foam rolling [FR]). This technique has been used in
rehabilitation to recover myofascial dysfunctions and in physical/sports training, to improve
performance in functional and sports activities. Possible changes in the muscle's and
tendon's mechanical properties may help to explain the FR effects. Although some studies have
found a decreased muscle stiffness after FR intervention, other studies have reported no
changes in muscle stiffness. Furthermore, a single study investigated the FR effects on the
tendon and found no stiffness changes post-intervention. The between-studies methodological
procedures heterogeneity, especially the different FR protocols (e.g., pressure-volume) may
partially justify conflicting results. However, the dose-response relationship is not clear
acutely. Furthermore, body composition also seems to influence the pressure applied to the
different tissues during FR. Therefore, the aim of this study is to verify the acute effects
of different FR volumes on the plantar flexors' musculotendinous properties in healthy
individuals. Twenty healthy subjects (male and female) aged between 18-35 years will perform
three different FR conditions: FR90 (3x30s), FR180 (3x60s), and a control condition (CTRL;
without the application of any intervention) with a seven-day wash-out period. The
weight-bearing during the FR application will be obtained through ground reaction forces,
measured through force platform. The Achilles tendon morphological properties (length and
cross-sectional area) will be evaluated using ultrasonography. In order to evaluate the
mechanical (stiffness, force, and elongation) and material (Young's modulus, stress, and
strain) properties, three maximum voluntary isometric contractions (MVIC) will be performed
in a plantar flexion ramp in the isokinetic dynamometer with ultrasonography. The tendon
force will be corrected by the tibialis anterior coactivation and adjusted by the tendon
displacement caused by joint rotation during MVIC. The tendon elongation will be monitored
during CMVIC using the ultrasound. The medial gastrocnemius muscle stiffness will be
calculated by the variation in a passive dorsiflexion torque (isokinetic dynamometer) and the
variation in the muscle length (ultrasound). The adipose tissue's thickness also will be
obtained from ultrasound. The skin temperature will be evaluated by a thermographic camera to
investigate possible post-intervention changes. The unilateral countermovement jump
performance will be evaluated by 2D kinematic data measurements, using a video camera.
Assessments will be carried out before and immediately after the FR application in the
different conditions. Descriptive statistics (mean, standard deviation, and standard error)
will be used to present the results. The normality and sphericity of the data will be
evaluated using the Shapiro-Wilk and Mauchly tests, respectively. A two-way ANOVA (condition
[FR90, FR180, and CTRL] and moments [pre- and post-intervention]) will be used to compare the
results. A post-hoc Bonferroni test will be used to localize possible differences. A Pearson
product-moment correlation test (parametric data) or a Spearman correlation test
(non-parametric data) will be used to verify the association between the adipose tissue's
thickness on the evaluated parameters, classified as none (0.0), weak (0.1-0.3), moderate
(0.4-0.6), strong (0.7-0.9), or perfect (1.0). The effect size (Cohen's d) of each condition
will be obtained, classified as small effect size (< 0.20); moderate effect size (0.20-0.50);
or large effect size (>0.80). Responsiveness to conditions (FR90, FR180, and CTRL) will be
determined using the typical error.