OsteoarthritisNCT01797679
Study of Cartilage Relaxometry and Physical Activity in Osteoarthritis
A study testing Strength Training and Aerobic Exercise in people with Osteoarthritis, run by University Hospital, Akershus at 1 site in Norway.
Trial summary
This study is the radiological component of an earlier registered trial under the title: Efficacy of Exercise on Physical Function and Cartilage Health in Patients With Knee Osteoarthritis. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Strength Training and Aerobic Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2013to Mar 2017
- 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 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women and men aged 45-65 years
- Clinical knee OA according to the American College of Rheumatology Clinical Criteria 17
- Kellgren and Lawrence radiographic OA grade 2 and 3 (mild to moderate radiographic OA)
Who cannot join
- Severe knee OA according to the Kellgren and Lawrence classification (grade 4)
- Other known major musculoskeletal impairments in the lower extremities or the back or prostheses in any joint of the lower extremities
- Known coronary heart diseases or cancer
- Body mass index > 35
- Scheduled for surgery in any joint
- Known mental or psychologic diseases
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- Known drug abuse
- Persons who already perform sports related moderate physical activity more than two times a week
- Contraindications for magnetic resonance imaging (specific point list at Diagnostic Imaging Division, Akershus University Hospital)
- Not speaking Norwegian
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Strength and Aerobic Exercise on the Articular Cartilage of Patients With Mild and Moderate Knee Osteoarthritis Measured by T2 and T1 Rho MR Imaging - A Randomized Controlled Trial
This study is the radiological component of an earlier registered trial under the title: Efficacy of Exercise on Physical Function and Cartilage Health in Patients With Knee Osteoarthritis. The main purpose in this component of the study is to evaluate the efficacy of aerobic exercise and strength training on the T2 and T1 rho relaxation times of the articular cartilage. It has been proven that exercise can improve function and reduce the need for analgesics in patients with osteoarthritis. With this study, we wish to investigate if different kinds of exercise can cause measurable improvements in T2 and T1 rho relaxation times of the articular cartilage, and also if this improvements are transient or permanent.
- Conditions
- Osteoarthritis
- Being tested
- Strength Training, Aerobic Exercise
- Keywords
- Osteoarthritis,Articular Cartilage, Relaxometry, Morphometry, MRI, T2 mapping, T1 rho
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength TrainingOther
Aerobic ExerciseOther
| Study group | Role | What they receive |
|---|---|---|
| Strength Training | Other | The strength group include progressive strength training and neuromuscular exercises. The inclusion will be performed 2-3 times a week for 12 weeks.
Intervention: Other: Strength training Receives: Other: Strength Training |
| Aerobic exercise | Experimental | The aerobic exercise group will cycle on an ergometer bicycle 2-3 times a week for 12 weeks on moderate loading. The loading will be controlled by a heart rate monitor and is defined as 85% of maximal heart rate. Receives: Other: Aerobic Exercise |
| Control Group | No intervention | The control group will do as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative Cartilage Morphology Assessment
Indirect cartilage morphology will by assessed by X-ray Direct cartilage morphology will be assessed by MRI morphometry The biochemical composition of the cartilage will be assessed by relaxometry (T2 and T1 rho relaxation times)
Measured: One year
Secondary outcomes (1)
Semiquantitative Cartilage Assessment
Using semiquantitative techniques, the clinical manifestations of osteoarthritis assessed by MRI such as: cartilage lesions and bone marrow lesions will be assessed and quantified by MRI.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2014 (estimated)
- Study completionMar 2017 (estimated)
Why it stopped: Lack of agreement between the participants and lack og funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway, Oslo University Hospital, Hjelp24, South-Eastern Norway Regional Health Authority
- Responsible party
- Principal investigator, Hasan Banitalebi, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01797679
- Sponsor's protocol ID
- NFR213335/h10
- Status last verified
- Jan 2020
- First submitted
- 21 Feb 2013
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Strength and Aerobic Exercise on the Articular Cartilage of Patients With Mild and Moderate Knee Osteoarthritis Measured by T2 and T1 Rho MR Imaging - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01797679
- Acronym / sponsor ID
- NFR213335/h10
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis,Articular Cartilage, Relaxometry, Morphometry, MRI, T2 mapping, T1 rho
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of agreement between the participants and lack og funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Collaborators
- The Research Council of Norway, Oslo University Hospital, Hjelp24, South-Eastern Norway Regional Health Authority
- Study start
- Mar 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 22 Feb 2013 (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 study is the radiological component of an earlier registered trial under the title: Efficacy of Exercise on Physical Function and Cartilage Health in Patients With Knee Osteoarthritis. The main purpose in this component of the study is to evaluate the efficacy of aerobic exercise and strength training on the T2 and T1 rho relaxation times of the articular cartilage. It has been proven that exercise can improve function and reduce the need for analgesics in patients with osteoarthritis. With this study, we wish to investigate if different kinds of exercise can cause measurable improvements in T2 and T1 rho relaxation times of the articular cartilage, and also if this improvements are transient or permanent.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Strength Training | Other | Other: Strength TrainingThe strength group include progressive strength training and neuromuscular exercises. The inclusion will be performed 2-3 times a week for 12 weeks. Intervention: Other: Strength training |
| Aerobic exercise | Experimental | Other: Aerobic ExerciseThe aerobic exercise group will cycle on an ergometer bicycle 2-3 times a week for 12 weeks on moderate loading. The loading will be controlled by a heart rate monitor and is defined as 85% of maximal heart rate. |
| Control Group | No intervention | –The control group will do as usual. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women and men aged 45-65 years
- Clinical knee OA according to the American College of Rheumatology Clinical Criteria 17
- Kellgren and Lawrence radiographic OA grade 2 and 3 (mild to moderate radiographic OA)
Key exclusion criteria (10 listed)
- Severe knee OA according to the Kellgren and Lawrence classification (grade 4)
- Other known major musculoskeletal impairments in the lower extremities or the back or prostheses in any joint of the lower extremities
- Known coronary heart diseases or cancer
- Body mass index > 35
- Scheduled for surgery in any joint
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 Training | Other | Strength Training |
| Aerobic Exercise | Other | Aerobic exercise |
Primary outcome
Qualitative Cartilage Morphology Assessment
Time frame: One year
Indirect cartilage morphology will by assessed by X-ray Direct cartilage morphology will be assessed by MRI morphometry The biochemical composition of the cartilage will be assessed by relaxometry (T2 and T1 rho relaxation times)
1 secondary outcome
Semiquantitative Cartilage Assessment
Time frame: One year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis
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Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength Training and Aerobic Exercise in people with Osteoarthritis, run by University Hospital, Akershus at 1 site in Norway.
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 10 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: withdrawn, as of the sponsor's last update on 14 Jan 2020. 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 Norway. 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 was withdrawn before enrolling participants, so there are no results.
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?
Qualitative Cartilage Morphology Assessment (time frame: One year). 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 14 Jan 2020.