NCT05656755

Brief Summary

The objectives of the study are comparing the risk of injury and the running performance among novice runners with two different training programmes. The first programme has less running volume but more strengthening than the second one which is a normal running programme with no specific strengthening program. This study will provide necessary information for a multicentric study to come. The information needed for this bigger study are the sample size, the attrition rate, the drop-out rate and the feasibility of the timeline.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 19, 2022

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

December 19, 2022

Status Verified

December 1, 2022

Enrollment Period

5 months

First QC Date

November 17, 2022

Last Update Submit

December 12, 2022

Conditions

Keywords

RunningRunning related injuriesstrengthening programpreventionperformance

Outcome Measures

Primary Outcomes (2)

  • Aerobic performance

    aerobic performance testing using VAM-EVAL procedure

    at baseline

  • Aerobic performance

    aerobic performance testing using VAM-EVAL procedure

    at 21 weeks of training

Secondary Outcomes (2)

  • Incidence of running related injuries

    from baseline to 21weeks, up to 21 weeks total

  • drop-out

    from baseline to 21weeks, up to 21 weeks total

Study Arms (2)

strengthening running program

EXPERIMENTAL

The experimental group will undergo a specific running training based on leg strength training and interval running

Other: StrengtheningOther: Running

Running program

ACTIVE COMPARATOR

This running group will serve as control and will undergo a traditional running program composed of only running

Other: Running

Interventions

The strengthening exercises were executed with the body weight without any additional weight and were composed of exercises like the squats, the lunges, the plank, and the mountain climbers

strengthening running program
RunningOTHER

running for two supervised training sessions of one hour, and one free session of 30 minutes per week during 24 weeks

Running programstrengthening running program

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • they were between 18 and 30 years
  • matched our definition of novice runners
  • had not sustained a musculoskeletal injury in the past six months
  • agreed to subscribe to an online application and to report each running training on this platform.
  • A novice runner was defined as someone who has not been running more than once a week for more than six months. The participants were systematically excluded if they did not match the interval of age, were not considered as novice runners, i.e., ran twice or more times a week for more than six months

You may not qualify if:

  • They were also excluded if they had sustained an injury in the last 6 months or suffered from any musculoskeletal or neurological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Irec/Nmsk

Brussels, 1200, Belgium

Location

MeSH Terms

Interventions

Resistance TrainingRunning

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaLocomotion

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The investigator were blinded for group distribution and randomisation. They also were the outcome assessor and were therefore kept blinded.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomised control trial (pilot study)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2022

First Posted

December 19, 2022

Study Start

January 1, 2022

Primary Completion

June 1, 2022

Study Completion

December 31, 2022

Last Updated

December 19, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations