- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05656755
Strengthening Running Program in Novice Runners
The Effect of a Specific Training Based on Strengthening on Running Related-injuries in a Novice Runner Population: a Pilot Prospective Randomized Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Hypothesis: A training programme with less running but strengthening exercises based on interval technique and strength could have similar or better results regarding running related injuries and performance compared to a normal training programme.
The experimentation will take place in Louvain-la-Neuve in Belgium. Most of the common trainings will take place on the 400m outdoor track field of of the University. A sample of local university students will be drawned. The sex proportion of the participants should be representative of the population (non-runners population), thus 50/50. They will have to be non-runners in good and healthy condition. A non-runner is defined as someone who did not practice regular running at least twice a week for the last 6 months and could not perform a 10km at enrolment.
50 participants will take part in this experimentation. They will be randomized into 2 groups of 25. The investifator hypothesize that 40 participants will follow the study until the end.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Brussels, Belgium, 1200
- Irec/Nmsk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- They were also excluded if they had sustained an injury in the last 6 months or suffered from any musculoskeletal or neurological disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: strengthening running program
The experimental group will undergo a specific running training based on leg strength training and interval running
|
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
running for two supervised training sessions of one hour, and one free session of 30 minutes per week during 24 weeks
|
|
Active Comparator: Running program
This running group will serve as control and will undergo a traditional running program composed of only running
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running for two supervised training sessions of one hour, and one free session of 30 minutes per week during 24 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Aerobic performance
Time Frame: at baseline
|
aerobic performance testing using VAM-EVAL procedure
|
at baseline
|
|
Aerobic performance
Time Frame: at 21 weeks of training
|
aerobic performance testing using VAM-EVAL procedure
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at 21 weeks of training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of running related injuries
Time Frame: from baseline to 21weeks, up to 21 weeks total
|
number of injuries due to running participation
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from baseline to 21weeks, up to 21 weeks total
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|
drop-out
Time Frame: from baseline to 21weeks, up to 21 weeks total
|
abandon from the running program for any reason except running related injuries
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from baseline to 21weeks, up to 21 weeks total
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2019-502
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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