NCT06810271

Brief Summary

After completing novel activity or exercise we may experience exercise-induced muscle damage (EIMD), resulting in a period of reduced muscle function and delayed onset muscle soreness (DOMS). DOMS is characterized by muscle pain and tenderness that typically resolves within a week. While the precise cause of DOMS is unknown, there is growing evidence implicating damage to the connective tissue that surrounds our muscle fibers and is related to a small amount of inflammation. This inflammation is a normal part of our body's ability to recovery from injuries and may be visualized through the use of ultrasound technology. A variety of recovery techniques have been proposed that may help with the recovery of DOMS such as massage and electrical muscle stimulation, but these are not always accessible. Therefore, we are interested in investigating whether the number of daily steps can affect how you experience DOMS.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

January 24, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 5, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

February 5, 2025

Status Verified

January 1, 2025

Enrollment Period

11 months

First QC Date

January 24, 2025

Last Update Submit

January 30, 2025

Conditions

Keywords

Resistance exerciseExercise induced muscle damageUltrasoundSubjective painPhysical activity

Outcome Measures

Primary Outcomes (1)

  • Change in maximal muscle strength between physical activity levels

    Maximal voluntary isometric and isokinetic contraction assessed by peak torque via computerized dynamometer.

    Daily assessment (every 24 hours) across 96 hours post-exercise

Secondary Outcomes (2)

  • Delayed onset muscle soreness (DOMS)

    Daily assessments (every 24 hours) across 96 hours post-exercise

  • Change in muscle and fascial connective tissue thickness

    Daily assessment (every 24 hours) across 96 hours post-exercise

Study Arms (2)

High Activity

EXPERIMENTAL

Requires completion of greater than 10,000 steps per day

Behavioral: Eccentric resistance exercise

Moderate Activity

EXPERIMENTAL

Requires completion of less than 5,000 steps per day

Behavioral: Eccentric resistance exercise

Interventions

150 maximal, unilateral eccentric contractions of the quadriceps muscles on a computerized dynamometer.

High ActivityModerate Activity

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Healthy, recreationally active male and female participants (i.e., weekly MET-minutes \> 3000 assessed by International Physical Activity Questionnaire).
  • Not having a health condition that would compromise their ability to safely participate in the strenuous physical activity involved in our study screened for by the get active questionnaire.
  • Between 18 and 35 years old.
  • Body mass index (BMI) between 18.5-30
  • Self-reported not having engaged in resistance exercise and/or lower body plyometrics for at least 3 months prior to the study.
  • Willing to abide by the compliance rules of this study.
  • Self-reported regular menstrual cycle (25-35d) within the last 3 months (female participants).

You may not qualify if:

  • Inability to adhere to any of the compliance rules judged by the principal investigator or medical doctor.
  • Self-reported regular tobacco use.
  • Regular use of non-steroidal anti-inflammatory drugs (e.g., Advil)
  • Use of oral contraceptives (female participants).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goldring Center for High Performance Sport

Toronto, Ontario, M5S2C9, Canada

Location

MeSH Terms

Conditions

Motor ActivityInflammation

Condition Hierarchy (Ancestors)

BehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Study includes a behavioural intervention of high and moderate physical activity, modelled by step counts, as a "treatment", or method to improve recovery from the exercise-induced muscle damage intervention occurring in both high and moderate activity phases.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 24, 2025

First Posted

February 5, 2025

Study Start

January 24, 2025

Primary Completion

January 1, 2026

Study Completion

May 1, 2026

Last Updated

February 5, 2025

Record last verified: 2025-01

Locations