An interventional study of Compression socks and Placebo socks in Muscle Soreness, Perceived Recovery and Perceived Exertion, sponsored by Centro Universitário Augusto Motta. Enrolling by invitation at 1 site in Brazil. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-15.
Sponsored by Centro Universitário Augusto Motta · Not applicable, Interventional, and Treatment
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.
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.
256 studies on the registry are indexed under Myalgia; 46 are open to participants now.
This study's planned enrollment of 44 is close to the median of 44 across 216 interventional studies indexed under Myalgia.
Browse Myalgia studies →Centro Universitário Augusto Motta is the lead sponsor of 39 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
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
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
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.
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.
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).
Time frame: 24 hours post-intervention.
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).
Time frame: 5 minutes post-intervention, and 48 hours post-intervention.
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
Time frame: 5 minutes post-intervention, 24 hours, and 48 hours post-intervention.
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).
Time frame: 5 minutes post-intervention.
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.
Time frame: 5 minutes post-intervention.
Heart rate
The average heart rate in beats per minute will be monitored through a smartwatch.
Time frame: Through the intervention, an average of 30 minutes.
Plan to share: Yes — The author will share the study's statistical analysis plan.
Supporting information: Statistical analysis plan
Access criteria: The statistical analysis plan will be available upon request.
No publications or documents are linked to this record.
Started Jan 2024 (actual). Primary completion is estimated for Jul 2025, 17 months after the start.
Of 101 non-industry interventional studies with no phase under Myalgia, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 16. This study's planned 17 months is above that.
Counting every sponsor, half of 111 studies reached it within 8 months; a quarter within 3 and three quarters within 16.
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Centro Universitário Augusto Motta