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

Heart Rate Clinical Trial

Official 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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06225388
• Other study ID #: 01
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 20, 2024
• Est. completion date: May 30, 2024

Study information

• Verified date: January 2024
• Source: Centro Universitário Augusto Motta
• Contact: Gustavo F Telles, Msc
• Phone: +5521988085464
• Email: gustavo.telles[@]souunisuam.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: May 30, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Rate
• Muscle Soreness
• Myalgia
• Perceived Exertion

Intervention

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 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centro Universitário Augusto Motta

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower limb muscle soreness.	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	Lower limb muscle soreness.	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.
Secondary	Perceived recovery.	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.
Secondary	Perceived exertion	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.
Secondary	Affective response	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.
Secondary	Heart rate	The average heart rate in beats per minute will be monitored through a smartwatch.	Through the intervention, an average of 30 minutes.