Knee OsteoarthritisNCT01538407
Strengthening Exercise and Quadriceps Force During Walking
A study testing Strength Training in people with Knee Osteoarthritis, run by Frederiksberg University Hospital at 2 sites in 2 countries.
Trial summary
This is a longitudinal, randomized, controlled interventional multi centric study on the effects of lower leg strengthening exercise on quadriceps force during walking in people with knee osteoarthritis. At each study centre twenty subjects will be included, for a total of 40 participants. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Strength Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2012to Oct 2013
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A medical doctor will perform the screening of potential participants. Subjects must meet the following inclusion criteria to be eligible for study entry:
- Knee OA diagnosed according to the American College of Rheumatology criteria (26), with clinical symptoms and radiographically verified tibio-femoral osteoarthritis in one or both knees.
- Aged between 40 and 65 yrs.
- Untrained (i.e. less than 2 hours of exercise per week)
- Subject must not be using assistive walking device
- Willing and able to complete study visits and procedures
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- Willing to hold activity and exercise level generally consistent during the study except that encompassed in the study.
- In general good health, in the opinion of the investigator, based on medical history and physical examination and, if necessary, laboratory values. Laboratory tests are prescribed by the medical doctor at the screening visit.
- A body mass index (BMI) of 19<BMI≤32kg/m2
- Speaks, reads and writes Danish and/or English language
Who cannot join
- Subjects who meet any of the following exclusion criteria will be ineligible for study entry:
- Subjects depending on walking device
- Pregnant or breastfeeding
- Radiographic evidence of Patello-femoral knee OA only (and no tibio-femoral OA).
- History of symptoms of autoimmune disorders (e.g., inflammatory bowel disease, multiple sclerosis, lupus, rheumatoid arthritis)
- Planned surgical procedure during the duration of the study
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- History or diagnosis of musculoskeletal injuries or pathologies, including but not limited to:
- Anterior cruciate ligament injuries
- Meniscal injuries related to trauma (degenerative changes allowed)
- Patellofemoral Pain Syndrome
- Low back pain
- History, diagnosis, or signs and symptoms of clinically significant cardiovascular disease, including but not limited to:
- Ischemic heart disease
- Arthrosclerosis
- Peripheral artery disease
- History, diagnosis, or signs and symptoms of diabetes
- History, diagnosis, or signs and symptoms of neurological disorders including but not limited to
- Stroke
- Parkinson's disease
- Multiple sclerosis
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
The College of Health and Human Performance, Department of Exercise and Sport Science, Minges Coliseum
Greenville, North Carolina, 27858
Denmark1 site
The Parker Institute, Frederiksberg University Hospital
Copenhagen, 2000
About this study
Official title: A Study of Strengthening Exercise on Quadriceps Force During Walking
This is a longitudinal, randomized, controlled interventional multi centric study on the effects of lower leg strengthening exercise on quadriceps force during walking in people with knee osteoarthritis. At each study centre twenty subjects will be included, for a total of 40 participants. Subjects will be randomized equally (1:1) into 1 active arm and 1 control arm.
The objective of the study is to evaluate the effect of twelve weeks of quadriceps strengthening on the mechanical output of the quadriceps during locomotion. A secondary purpose is to explore the relationship between quadriceps strengthening and compressive knee loadings. The hypothesis is that quadriceps strength training will not change quadriceps force, power, and work in locomotion in people with knee osteoarthritis.
Primary outcome is quadriceps force during walking, secondary outputs are quadriceps power and work and knee compressive loads during walking. Explorative measures are isometric and concentric isokinetic leg muscle strength, radiographic score of the knee (Kellgren and Lawrence), a one-leg rise from chair test (maximum number of reps) and a lateral step-up test (maximum number of reps).
- Conditions
- Knee Osteoarthritis
- Being tested
- Strength Training
- Keywords
- Strength training, Biomechanics, Quadriceps, Gait
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength TrainingOther
The exercises will be performed in standard strength training equipment. Prior to each of the strengthening exercise sessions, a warm up phase is performed by 5-10 minutes of ergometer cycling at a moderate intensity. Muscle strengthening exercises will be performed according to the standard progressive resistance and overload principle. The exercise programme consists of three exercises performed with three sets of 10 repetitions at 60%-85% of patient's 10RM. Training load will be progressed by means of bi-weekly estimates of muscle strength to ensure a constant load of 60%-85% RM. Exercises are: 1. Leg extension, 2. Leg press, and 3. Forward lunges.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | No intervention group |
| Strength training group | Active comparator | The knee extension strength training intervention period is 12 weeks with training sessions three times per week. Receives: Other: Strength Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in peak quadriceps force during walking at 12 weeks
Estimates of the quadriceps muscle forces during locomotion are calculated using a biomechanical model based on data from gait analysis
Measured: Baseline and at 12 weeks
Secondary outcomes (2)
Change from baseline in quadriceps power and work during walking at 12 weeks
Estimated from gait analysis
Measured: Baseline and after 12 weeks
Change from baseline in knee compressive force during walking at 12 weeks
Estimated from biomechanical modelling of data from gait analysis
Measured: Baseline and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionOct 2013
- Study completionOct 2013
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 Knee OsteoarthritisStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frederiksberg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- East Carolina University
- Responsible party
- Principal investigator, Marius Henriksen, Frederiksberg University Hospital
- Investigators
- Paul Devita, MSc, PhD, Principal investigator, The College of Health and Human Performance, Department of Exercise and Sport Science, Minges Coliseum Greenville, U.S.A.Marius Henriksen, PhD, Study director, The Parker Institute, Frederiksberg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01538407
- Sponsor's protocol ID
- 117.0
- Status last verified
- Jan 2014
- First submitted
- 20 Feb 2012
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
DeVita P, Aaboe J, Bartholdy C, Leonardis JM, Bliddal H, Henriksen M. Quadriceps-strengthening exercise and quadriceps and knee biomechanics during walking in knee osteoarthritis: A two-centre randomized controlled trial. Clin Biomech (Bristol). 2018 Nov;59:199-206. doi: 10.1016/j.clinbiomech.2018.09.016. Epub 2018 Sep 15.
PubMed 30273922
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Strengthening Exercise on Quadriceps Force During Walking
- ClinicalTrials.gov ID
- NCT01538407
- Acronym / sponsor ID
- 117.0
- Conditions
- Knee Osteoarthritis
- Keywords
- Strength training, Biomechanics, Quadriceps, Gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Frederiksberg University HospitalUniversity, hospital or other
- Collaborators
- East Carolina University
- Study start
- Mar 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 24 Feb 2012 (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.
This is a longitudinal, randomized, controlled interventional multi centric study on the effects of lower leg strengthening exercise on quadriceps force during walking in people with knee osteoarthritis. At each study centre twenty subjects will be included, for a total of 40 participants. Subjects will be randomized equally (1:1) into 1 active arm and 1 control arm.
The objective of the study is to evaluate the effect of twelve weeks of quadriceps strengthening on the mechanical output of the quadriceps during locomotion. A secondary purpose is to explore the relationship between quadriceps strengthening and compressive knee loadings. The hypothesis is that quadriceps strength training will not change quadriceps force, power, and work in locomotion in people with knee osteoarthritis.
Primary outcome is quadriceps force during walking, secondary outputs are quadriceps power and work and knee compressive loads during walking. Explorative measures are isometric and concentric isokinetic leg muscle strength, radiographic score of the knee (Kellgren and Lawrence), a one-leg rise from chair test (maximum number of reps) and a lateral step-up test (maximum number of reps).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –No intervention group |
| Strength training group | Active comparator | Other: Strength TrainingThe knee extension strength training intervention period is 12 weeks with training sessions three times per week. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- A medical doctor will perform the screening of potential participants. Subjects must meet the following inclusion criteria to be eligible for study entry:
- Knee OA diagnosed according to the American College of Rheumatology criteria (26), with clinical symptoms and radiographically verified tibio-femoral osteoarthritis in one or both knees.
- Aged between 40 and 65 yrs.
- Untrained (i.e. less than 2 hours of exercise per week)
- Subject must not be using assistive walking device
Key exclusion criteria (20 listed)
- Subjects who meet any of the following exclusion criteria will be ineligible for study entry:
- Subjects depending on walking device
- Pregnant or breastfeeding
- Radiographic evidence of Patello-femoral knee OA only (and no tibio-femoral OA).
- History of symptoms of autoimmune disorders (e.g., inflammatory bowel disease, multiple sclerosis, lupus, rheumatoid arthritis)
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 |
|---|---|---|
| Strength TrainingThe exercises will be performed in standard strength training equipment. Prior to each of the strengthening exercise sessions, a warm up phase is performed by 5-10 minutes of ergometer cycling at a moderate intensity. Muscle strengthening exercises will be performed according to the standard progressive resistance and overload principle. The exercise programme consists of three exercises performed with three sets of 10 repetitions at 60%-85% of patient's 10RM. Training load will be progressed by means of bi-weekly estimates of muscle strength to ensure a constant load of 60%-85% RM. Exercises are: 1. Leg extension, 2. Leg press, and 3. Forward lunges. | Other | Strength training group |
Primary outcome
Change from baseline in peak quadriceps force during walking at 12 weeks
Time frame: Baseline and at 12 weeks
Estimates of the quadriceps muscle forces during locomotion are calculated using a biomechanical model based on data from gait analysis
2 secondary outcomes
Change from baseline in quadriceps power and work during walking at 12 weeks
Time frame: Baseline and after 12 weeks
Change from baseline in knee compressive force during walking at 12 weeks
Time frame: Baseline and after 12 weeks
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 22 Jan 2014.
- Derived from this study: PubMed 30273922DeVita P, Aaboe J, Bartholdy C, Leonardis JM, Bliddal H, Henriksen M. Quadriceps-strengthening exercise and quadriceps and knee biomechanics during walking in knee osteoarthritis: A two-centre randomized controlled trial. Clin Biomech (Bristol). 2018 Nov;59:199-206. doi: 10.1016/j.clinbiomech.2018.09.016. Epub 2018 Sep 15.
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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.
Paul Devita, MSc, PhD principal investigator
The College of Health and Human Performance, Department of Exercise and Sport Science, Minges Coliseum Greenville, U.S.A.
Marius Henriksen, PhD study director
The Parker Institute, Frederiksberg University Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength Training in people with Knee Osteoarthritis, run by Frederiksberg University Hospital at 2 sites in 2 countries.
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 10 inclusion and 20 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 22 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Denmark. 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?
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?
Change from baseline in peak quadriceps force during walking at 12 weeks (time frame: Baseline and at 12 weeks). 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 NCT01538407, 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 22 Jan 2014.