Runner's KneeNCT05656755
Strengthening Running Program in Novice Runners
A study testing Strengthening and Running in people with Runner's Knee, run by Université Catholique de Louvain at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Runner's Knee
- What is being tested?
- Strengthening and Running
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- They were also excluded if they had sustained an injury in the last 6 months or suffered from any musculoskeletal or neurological disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Runner's Knee
- Being tested
- Strengthening, Running
- Keywords
- Running, Running related injuries, strengthening program, prevention, performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StrengtheningOther
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
RunningOther
running for two supervised training sessions of one hour, and one free session of 30 minutes per week during 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| strengthening running program | Experimental | The experimental group will undergo a specific running training based on leg strength training and interval running Receives: Other: Strengthening; Other: Running |
| Running program | Active comparator | This running group will serve as control and will undergo a traditional running program composed of only running Receives: Other: Running |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aerobic performance
aerobic performance testing using VAM-EVAL procedure
Measured: at baseline
Aerobic performance
aerobic performance testing using VAM-EVAL procedure
Measured: at 21 weeks of training
Secondary outcomes (2)
Incidence of running related injuries
number of injuries due to running participation
Measured: from baseline to 21weeks, up to 21 weeks total
drop-out
abandon from the running program for any reason except running related injuries
Measured: from baseline to 21weeks, up to 21 weeks total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start1 Jan 2022
- Primary completion1 Jun 2022
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Runner's KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised control trial (pilot study)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656755
- Sponsor's protocol ID
- 2019-502
- Status last verified
- Dec 2022
- First submitted
- 17 Nov 2022
- Last updated
- 19 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Specific Training Based on Strengthening on Running Related-injuries in a Novice Runner Population: a Pilot Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT05656755
- Acronym / sponsor ID
- 2019-502
- Conditions
- Runner's Knee
- Keywords
- Running, Running related injuries, strengthening program, prevention, performance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 19 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised control trial (pilot study)
| Arm | Type | Receives |
|---|---|---|
| strengthening running program | Experimental | Other: Strengthening, Other: RunningThe experimental group will undergo a specific running training based on leg strength training and interval running |
| Running program | Active comparator | Other: RunningThis running group will serve as control and will undergo a traditional running program composed of only running |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- They were also excluded if they had sustained an injury in the last 6 months or suffered from any musculoskeletal or neurological disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StrengtheningThe 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 | Other | strengthening running program |
| Runningrunning for two supervised training sessions of one hour, and one free session of 30 minutes per week during 24 weeks | Other | Running program, strengthening running program |
Primary outcome
Aerobic performance
Time frame: at baseline
aerobic performance testing using VAM-EVAL procedure
Aerobic performance
Time frame: at 21 weeks of training
aerobic performance testing using VAM-EVAL procedure
2 secondary outcomes
Incidence of running related injuries
Time frame: from baseline to 21weeks, up to 21 weeks total
drop-out
Time frame: from baseline to 21weeks, up to 21 weeks total
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strengthening and Running in people with Runner's Knee, run by Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aerobic performance (time frame: at baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2022.