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

NCT ID: NCT06225388

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-20
• Study Completion Date: 2025-07-30

Brief Summary

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.

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.

Conditions

Muscle Soreness; Perceived Recovery; Perceived Exertion; Affective Response; Heart Rate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Compression socks

Intervention Type: 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

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.

Group Type: PLACEBO_COMPARATOR

Placebo socks

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centro Universitário Augusto Motta

OTHER

Sponsor Role: lead

Responsible Party

Gustavo Telles

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Leandro AC Nogueira, PhD

Role: STUDY_CHAIR

Centro Universitário Augusto Motta

Locations

Centro Universitário Augusto Motta

Rio de Janeiro, , Brazil

Countries

Brazil

Other Identifiers

01

Identifier Type: -

Identifier Source: org_study_id