Muscle StrengthNCT01346995
The Effect of Experimental Knee Pain During Strengthening Exercises on Muscle Strength Gain
A study testing Experimental knee pain in people with Muscle Strength, run by Frederiksberg University Hospital.
Trial summary
The purpose of this study is to evaluate the effects of experimental knee pain on the muscle strength gain after 8 weeks of strengthening exercises for the quadriceps. It is hypothesized that experimental knee pain will reduce the muscle strength gain following strengthening exercises in healthy volunteers. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Strength
- What is being tested?
- Experimental knee pain
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Aug 2010
- 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 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- aged between 20 to 35 years
- healthy
- untrained (non-regular exercise participation [i.e. < 1 day/week])
Who cannot join
- symptomatic musculoskeletal diseases
- history of traumatic injuries to muscles, tendons or joints of the lower extremity
- knee joint pain within a month prior to enrollment
About this study
The purpose of this study is to evaluate the effects of experimental knee pain on the muscle strength gain after 8 weeks of strengthening exercises for the quadriceps. It is hypothesized that experimental knee pain will reduce the muscle strength gain following strengthening exercises in healthy volunteers.
- Conditions
- Muscle Strength
- Being tested
- Experimental knee pain, Non-painful control injections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental knee painOther
Injection of 1 ml hypertonic saline (5.8%) into the infrapatellar fat pad
Non-painful control injectionsOther
Injection of isotonic saline into the infrapatellar fat pad
| Study group | Role | What they receive |
|---|---|---|
| Experimental Knee Pain | Experimental | Experimental knee pain induced by injections of 1 ml hypertonic saline in to the infrapatellar fat pad Receives: Other: Experimental knee pain |
| Control | Active comparator | non-painful injections of isotonic saline into the infrapatellar fatpad. Receives: Other: Non-painful control injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isokinetic knee muscle strength
Measured: At baseline and after 8 weeks of exercise
Secondary outcomes (1)
One-leg chair rise
Measured: At baseline and after 8 weeks of exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2011 (estimated)
- Study startFeb 2010
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle StrengthStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frederiksberg University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346995
- Sponsor's protocol ID
- 072.07
- Status last verified
- Feb 2010
- First submitted
- 2 May 2011
- Last updated
- 4 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Sorensen TJ, Langberg H, Hodges PW, Bliddal H, Henriksen M. Experimental knee joint pain during strength training and muscle strength gain in healthy subjects: a randomized controlled trial. Arthritis Care Res (Hoboken). 2012 Jan;64(1):108-16. doi: 10.1002/acr.20618.
PubMed 21905254
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Experimental Knee Pain During Strengthening Exercises on Muscle Strength Gain
- ClinicalTrials.gov ID
- NCT01346995
- Acronym / sponsor ID
- 072.07
- Conditions
- Muscle Strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Frederiksberg University HospitalUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 4 May 2011 (estimated)
- 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 purpose of this study is to evaluate the effects of experimental knee pain on the muscle strength gain after 8 weeks of strengthening exercises for the quadriceps. It is hypothesized that experimental knee pain will reduce the muscle strength gain following strengthening exercises in healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Knee Pain | Experimental | Other: Experimental knee painExperimental knee pain induced by injections of 1 ml hypertonic saline in to the infrapatellar fat pad |
| Control | Active comparator | Other: Non-painful control injectionsnon-painful injections of isotonic saline into the infrapatellar fatpad. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- aged between 20 to 35 years
- healthy
- untrained (non-regular exercise participation [i.e. < 1 day/week])
Key exclusion criteria (3 listed)
- symptomatic musculoskeletal diseases
- history of traumatic injuries to muscles, tendons or joints of the lower extremity
- knee joint pain within a month prior to enrollment
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 |
|---|---|---|
| Experimental knee painInjection of 1 ml hypertonic saline (5.8%) into the infrapatellar fat pad | Other | Experimental Knee Pain |
| Non-painful control injectionsInjection of isotonic saline into the infrapatellar fat pad | Other | Control |
Primary outcome
Isokinetic knee muscle strength
Time frame: At baseline and after 8 weeks of exercise
1 secondary outcome
One-leg chair rise
Time frame: At baseline and after 8 weeks of exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2011.
- Derived from this study: PubMed 21905254Sorensen TJ, Langberg H, Hodges PW, Bliddal H, Henriksen M. Experimental knee joint pain during strength training and muscle strength gain in healthy subjects: a randomized controlled trial. Arthritis Care Res (Hoboken). 2012 Jan;64(1):108-16. doi: 10.1002/acr.20618.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental knee pain in people with Muscle Strength, run by Frederiksberg University Hospital.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 4 May 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Isokinetic knee muscle strength (time frame: At baseline and after 8 weeks of exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01346995, which also lists 1 linked publication.
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 4 May 2011.