Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06225388
Other study ID # 01
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
See also
  Status Clinical Trial Phase
Completed NCT03832205 - Validation of Respiratory Rate and Heart Rate Measurements by Capaciflectors Placed in Four Locations on the Chest
Completed NCT03723954 - Heart Rate Variations of Golf Fans During the 2018 the Ryder Cup
Withdrawn NCT01026961 - Safety of Phenylephrine Hydrochloride, Acetaminophen, Dimethindene Maleate Compared to Phenylephrine Hydrochloride Alone in Healthy Volunteers Phase 1/Phase 2
Completed NCT00760253 - Compare the Side Effects and Difference Awake Level of Three TCI Propofol Formula in TVOR Patients N/A
Completed NCT00380341 - Effects of Instrument-Applied Spinal Manipulative Therapy on Postureal Control and Autonomic Balance N/A
Completed NCT04179279 - Comparative Analysis of a Non-contact Respiratory and Heart Rate Monitor Vs. a Conventional Clinically Validated Reference Monitor
Completed NCT02469844 - Heart Rate Variability (HRV) Analysis in Patients With Nocturnal Epileptic Seizures
Not yet recruiting NCT00503282 - Urinary Catheter Exchange on Admission of Septic Elderly With Permanent Catheter Before Initiation of Antibiotics N/A
Completed NCT05160207 - Intubation-induced Decrease in Heart Rate as an Indicator for Intraoperative Bradycardia
Withdrawn NCT01701960 - Effect of Local Anesthetic on Hemodynamic Measures During Nasal Surgery N/A
Completed NCT02997800 - The Effect of Intraoperative Labetalol on Time to Discharge Phase 2
Completed NCT03359928 - Acute Physiological and Perceptual Responses to Novel Forms of High-intensity Interval Exercise N/A
Completed NCT05600725 - Novel Cardiac Pacing to Initiate Cardiac Remodeling in Heart Failure N/A
Completed NCT05366049 - The Effect of Methods Used in Oral Antipyretic Administration on the Vital Findings of the Child With Fever N/A
Recruiting NCT05401435 - Reliability of Measuring Blood Pressure With a Smartwatch N/A
Completed NCT01638169 - The Contribution of Heels for Walking Quality Among Children With Muscular Dystrophy N/A
Completed NCT00143988 - Heart Rate and Blood Pressure Response During Exercise and Sexual Activity in Normotensive and Hypertensive Volunteers N/A
Completed NCT03131375 - Dexmedetomidine Reduces Emergence Delirium in Children Undergoing Tonsillectomy With Propofol Anesthesia Phase 2/Phase 3
Completed NCT01612130 - Valerian for Conscious Sedation in Patients Submitted to Impacted Lower Third Molars Surgery N/A
Completed NCT06095635 - Acute Influence of Resveratrol Supplementation and Beet Extract in Recovery After Exercise in Coronary Paths N/A