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Enrolling by Invitation

NCT Number: NCT06225388

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

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.

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Key information

Conditions

Muscle Soreness Affective Response Heart Rate Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Myalgia Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Perceived Exertion Perceived Recovery Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Universitário Augusto Motta

Rio de Janeiro, 21041-020, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Compression socks

Other

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 socks

Other

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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

  3. 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).

  4. 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. 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.

Sponsors and collaborators

Lead sponsor

Centro Universitário Augusto Motta

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 25, 2024
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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