NCT05801302

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 6, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2023

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

3 months

First QC Date

March 10, 2023

Last Update Submit

May 14, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Changes in Achilles tendon stiffness

    Tendon stiffness will be obtained by calculating the slope in the last 10% of the linear region of the force-deformation curve.

    Change from baseline at immediately after intervention

  • Changes in medial gastrocnemius passive muscular stiffness

    The medial gastrocnemius stiffness will be calculated by the variation in passive torque (dorsiflexion) divided by the variation in muscle length (assessed by ultrasound).

    Change from baseline at immediately after intervention

  • Changes in unilateral countermovement jump height

    The unilateral countermovement jump height will be measured using video camera and Tracker software.

    Change from baseline at immediately after intervention

Secondary Outcomes (5)

  • Changes in tendon Young's modulus

    Change from baseline at immediately after intervention

  • Changes in Achilles tendon cross-sectional area

    Change from baseline at immediately after intervention

  • Changes in Achilles tendon length

    Change from baseline at immediately after intervention

  • Changes in muscle Architecture

    Change from baseline at immediately after intervention

  • Changes in skin temperature

    Change from baseline at immediately after intervention

Study Arms (3)

Foam rolling (longer volume)

EXPERIMENTAL

Participants will perform a single session with a longer foam rolling volume. The protocol will be 3 sets of 60 seconds, with between-sets intervals of 30 seconds and a standardized command to the participant to perform the highest pressure possible. The speed will be controlled through metronome (30 bpm). The foam rolling will be performed with the foam roller placed under the plantar flexors and Achilles tendon in a sitting position, with hands supported to the ground, keeping the body out of contact with the ground, with the unassessed leg crossed above the leg of interest. A standard device (smooth foam roller) with dimensions of 30 cm x 15 cm will be used.

Device: Foam rolling (longer volume)

Foam rolling (shorter volume)

ACTIVE COMPARATOR

Participants will perform a single session with a shorter foam rolling volume. The protocol will be 3 sets of 30 seconds, with between-sets intervals of 30 seconds and a standardized command to the participant to perform the highest pressure possible. The speed will be controlled through metronome (30 bpm). The foam rolling will be performed with the foam roller placed under the plantar flexors and Achilles tendon in a sitting position, with hands supported to the ground, keeping the body out of contact with the ground, with the unassessed leg crossed above the leg of interest. A standard device (smooth foam roller) with dimensions of 30 cm x 15 cm will be used.

Device: Foam rolling (shorter volume)

Control condition

NO INTERVENTION

Participants will remain in the intervention position (in a sitting position, with hands supported to the ground, with the unassessed leg crossed above the leg of interest) for 180 seconds (longer volume time), without the application of any intervention

Interventions

A single intervention will be performed (3 sets of 30 seconds, with between-sets intervals of 30 seconds).

Foam rolling (shorter volume)

A single intervention will be performed (3 sets of 60 seconds, with between-sets intervals of 30 seconds).

Foam rolling (longer volume)

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Both male and female;
  • Age between 18 and 35 years;
  • Not involved in strength training for lower limbs;
  • Not using foam rolling regularly;
  • Only women using hormonal contraceptive pills will be included in order to standardize the hormonal cycle.

You may not qualify if:

  • History in the last year of musculoskeletal injuries in the lower limbs that represent a contraindication for the execution of maximum exercises or that may interfere with performance during evaluations and treatment sessions (Achilles tendinopathy, ligament ruptures with or without surgical procedures, recent cases of muscle injury or sprain of ankle);
  • Presenting with inflammation, acute pain or delayed muscle pain on the day of assessment;
  • Performing some type of high-intensity physical activity for up to 72 hours before assessments;
  • Ingestion of some type of analgesic medication, alcohol or caffeine in the last 48 hours before the evaluations;
  • Have respiratory or cardiovascular conditions considered a risk factor or limiting to maximum tests;
  • Use of anabolic steroid supplements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Location

Study Officials

  • Jeam Geremia, Dr

    Federal University of Rio Grande do Sul

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Raters and outcomes assessor will be blinded to the participants' allocation in each group.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 10, 2023

First Posted

April 6, 2023

Study Start

March 1, 2023

Primary Completion

May 20, 2023

Study Completion

June 3, 2023

Last Updated

May 16, 2024

Record last verified: 2024-05

Locations