NCT06225388

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2024

Completed
18 days until next milestone

Study Start

First participant enrolled

January 20, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

August 15, 2024

Status Verified

August 1, 2024

Enrollment Period

1.4 years

First QC Date

January 2, 2024

Last Update Submit

August 12, 2024

Conditions

Keywords

runnergarmentspainstockingkneesports

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Lower limb muscle soreness.

    5 minutes post-intervention, and 48 hours post-intervention.

  • Perceived recovery.

    5 minutes post-intervention, 24 hours, and 48 hours post-intervention.

  • Perceived exertion

    5 minutes post-intervention.

  • Affective response

    5 minutes post-intervention.

  • Heart rate

    Through the intervention, an average of 30 minutes.

Study Arms (2)

Compression socks

EXPERIMENTAL

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

Placebo socks

PLACEBO COMPARATOR

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

Interventions

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.

Compression 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.

Placebo socks

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Universitário Augusto Motta

Rio de Janeiro, 21041-020, Brazil

Location

MeSH Terms

Conditions

MyalgiaPain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Leandro AC Nogueira, PhD

    Centro Universitário Augusto Motta

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 2, 2024

First Posted

January 25, 2024

Study Start

January 20, 2024

Primary Completion

July 1, 2025

Study Completion

July 30, 2025

Last Updated

August 15, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

The author will share the study's statistical analysis plan.

Shared Documents
SAP
Access Criteria
The statistical analysis plan will be available upon request.

Locations