Effect of Wearing a Compression Sock During Running on Muscle Soreness in Distance Runners.

August 12, 2024 updated by: Gustavo Telles, Centro Universitário Augusto Motta

Effect of Wearing a Compression Sock During Running on Delayed Onset Muscle Soreness in Distance Runners: A Randomised, Double-blind, Sham-controlled, Crossover Trial.

Running is the most popular physical activity worldwide. Although running provides many health benefits, it is often associated with injuries and symptoms such as delayed onset muscle soreness. There is still a paucity of interventions that can effectively minimise these symptoms in distance runners.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Our primary aim is to explore the effect of compression socks during running on delayed onset muscle soreness after running. Our secondary aims are to explore the effects of compression socks during running on perceived recovery, perceived exertion, affective response, and heart rate after running. This is a randomised, double-blind, sham-controlled crossover trial. Forty-four participants will be recruited via social media, running clubs and the running coaches' network of the research team. Participants will be randomised to complete a running protocol under two conditions (compression socks or sham socks). After that, there will be a wash-out period of 7 to 10 days, and participants will repeat the running protocol under the other conditions. Primary outcome: lower limb muscle soreness will be collected, using a 0-100 numerical pain scale, immediately, 24 hours and 48 hours after the running protocol, with 24 hours post-protocol being the primary timepoint. Secondary outcomes: perceived recovery will be collected, using a 0-10 scale immediately, 24 hours and 48 hours after the running protocol. Perceived exertion, affective response, and heart rate will be registered only immediately after the protocol. Between-group differences will be explored using linear mixed models.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Brazil
      • Rio De Janeiro, Brazil, 21041-020
        • Centro Universitário Augusto Motta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Run consistently in the last six months (at least three times a week and at least 10 kilometres per week);
  • Runners who did not run further than 42 kilometres in the last month.

Exclusion Criteria:

  • Pregnancy;
  • Any lower limbs fracture in the last 12 months;
  • History of lower limb arthroplasty or osteotomy, previous venous thrombosis, kidney disease;
  • Any running-related injury in the last six months. A running-related injury will be considered the presence of lower limb pain that caused restriction, stoppage of running (distance, speed, duration, or training) for at least seven days or three consecutive scheduled training sessions or the need for a health professional treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Compression socks
For the intervention, compression socks will be used, composed of 81% polyamide, 15% elastane and 4% polypropylene (Kendall sports, Kendall, São Paulo, Brazil). The sock offers compression of 20 to 30 mmHg in a decreasing manner with greater pressure at the ankle and less pressure at the knee joint line. Based on the manufacturer's guidelines, the sock size will be determined by measuring the calf and ankle circumference.
Other: Compression socks
A pair of socks corresponding to the intervention allocated will be given to the participant, by an investigator who will not participate in the evaluation, in a dark plastic bag to avoid any visual influence. We will adopt strategies to prevent information about the socks from influencing the participants' behaviour: (1) the compression and placebo socks will have the same colour, any visual detail and branding will be covered. Words or logos from the compression sock will be covered, so participants are unable to differentiate them. (2) After performing the running protocol, participants will remove their socks and return them to the investigator.
Placebo Comparator: Placebo socks
The placebo sock will be represented by a commercial sock composed of 70% polyamide, 24% cotton and 5% elastodiene without the purpose of providing compression.
Other: Placebo socks
The compression and placebo socks will have the same colour, any visual detail and branding will be covered. Words or logos from the compression sock will be covered, so participants are unable to differentiate them. (2) After performing the running protocol, participants will remove their socks and return them to the investigator.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Lower limb muscle soreness.
Time Frame: 24 hours post-intervention.
A visual analogue scale (VAS) will be used to measure the intensity of muscle soreness. This scale ranges from 0 (no pain) to 100 (worst possible pain).
24 hours post-intervention.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Lower limb muscle soreness.
Time Frame: 5 minutes post-intervention, and 48 hours post-intervention.
A visual analogue scale (VAS) will be used to measure the intensity of muscle soreness. This scale ranges from 0 (no pain) to 100 (worst possible pain).
5 minutes post-intervention, and 48 hours post-intervention.
Perceived recovery.
Time Frame: 5 minutes post-intervention, 24 hours, and 48 hours post-intervention.
The Perceived Recovery Status Scales will assess participants' perceived recovery. This scale ranges from 0 (very poorly recovered / extremely tired) to 10 (very well recovered / highly energetic). Values from 0 to 2 indicate "expect declined performance", values from 4 to 6 indicate "expect similar performance", and values from 8 to 10 represent "expect improved performance". Values 3 and 7 are considered transitional conditions. The value 3 means that it is not clear that the participants will be able to maintain their performance, and the value 7 means the participants are not fully recovered
5 minutes post-intervention, 24 hours, and 48 hours post-intervention.
Perceived exertion
Time Frame: 5 minutes post-intervention.
The Borg Rating of Perceived Exertion (Borg RPE 6-20) will be used assess how hard and strenuous the running protocol was. This scale ranges from 6 (no exertion at all) to 20 (maximal exertion).
5 minutes post-intervention.
Affective response
Time Frame: 5 minutes post-intervention.
The Feeling Scale is a bipolar scale that measures the affective response (pleasure/displeasure) related to exercise. This scale ranges from + 5 (very good) to - 5 (very bad). Zero is considered neutral; positive values represent pleasure, and negative values represent displeasure.
5 minutes post-intervention.
Heart rate
Time Frame: Through the intervention, an average of 30 minutes.
The average heart rate in beats per minute will be monitored through a smartwatch.
Through the intervention, an average of 30 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centro Universitário Augusto Motta

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Leandro AC Nogueira, PhD, Centro Universitário Augusto Motta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 2, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 25, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 01 (Leona M. and Harry B. Helmsley Charitable Trust)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The author will share the study's statistical analysis plan.

IPD Sharing Access Criteria

The statistical analysis plan will be available upon request.

IPD Sharing Supporting Information Type

  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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