OsteoarthritisNCT00049816
Aerobic Exercise Intervention for Knee Osteoarthritis
A study testing Walking exercise and Cycling Exercise in people with Osteoarthritis, run by Mayo Clinic at 1 site in United States.
Trial summary
This trial will test if walking or bicycling exercise is effective as a non-surgical treatment option for patients with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Walking exercise and Cycling Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Apr 2007
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current symptoms of chronic (6 months), stable pain and/or stiffness in one or both knees during weight-bearing activities
- Involved joint is primary factor limiting physical or functional activity
- Radiographic signs of mild or moderate arthritis
- Mild joint space narrowing (at least 2mm remaining)
Who cannot join
- Current participation in a regular exercise program
- Existing medical condition that would preclude increased physical activity
- Subjective complaint of instability (giving way)
- Ligamentous instability greater than Grade I
- Knee flexion contracture greater than 15 degrees
- Asymptomatic osteoarthritis of both knees, incapacitating arthritis, or inflammatory arthritis
Show all 13Show fewer
- Major reconstructive surgery on a lower extremity joint
- Multiple major joint involvement
- Any condition which severely limits local ambulation, such as amputation or stroke
- Gait aids used majority of time for ambulation
- Cannot use step-over-step techniques in either ascending or descending stair conditions
- Not able to undergo MRI scan (e.g., cardiac pacemaker)
- Dementia or inability to give informed consent as determined by a Folstein Mini Mental score greater than 24
Trial locations and contacts
1 site in 1 country.
About this study
This trial will test if walking or bicycling exercise is effective as a non-surgical treatment option for patients with knee osteoarthritis.
Read the detailed description
Traditional, conservative medical treatment of osteoarthritis has been directed at improving functional status through reducing joint pain and inflammation and maintaining or restoring joint function. Exercise is an adjunct therapy in the clinical management of patients with osteoarthritis of the knee. However, it is not uniformly accepted. The central hypothesis of this work is that the Surgeon General's exercise guidelines can be successfully implemented as an effective nonsurgical option for treatment of patients with early stages of knee osteoarthritis.
Patients with knee osteoarthritis will be randomized into a control group, a walking exercise group, and a stationary cycling exercise group. The individuals in the exercise groups will be required to exercise three times per week for one year using emerging public health recommendations for aerobic exercise in the adult and aging population. Patient outcome will be assessed using objective gait analysis measurements, knee radiographs to quantify joint space narrowing, magnetic resonance imaging, a general health questionnaire (SF-36), a disease/site specific questionnaire (WOMAC), and a visual-analog pain scale. All subjects will be studied at 0 and 52 weeks.
- Conditions
- Osteoarthritis
- Being tested
- Walking exercise, Cycling Exercise
- Keywords
- knee, aerobic exercise, walking, cycling, gait, MRI
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking exerciseBehavioural
30 minutes/day, 3 times/week for 52 weeks
Cycling ExerciseBehavioural
30 minutes/day, 3 times/week for 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Participants will receive no intervention and will act as the control group. |
| 2 | Experimental | Participants will partake in a walking exercise program. Receives: Behavioral: Walking exercise |
| 3 | Experimental | Participants will partake in a cycling exercise program. Receives: Behavioral: Cycling Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS, SF-36, WOMAC, and Activity Index questionnaires
Measured: Week 52
Weight-bearing anterior-posterior (AP) and lateral x-rays of the knee
Measured: Week 52
MRI imaging of the knee
Measured: Week 52
Measurements of gait during level walking and stair climbing
Measured: Week 52
Secondary outcomes (1)
Change in consumption of analgesics, reflecting the level of joint pain
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2002 (estimated)
- Study startOct 2002
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Investigators
- Kenton R Kaufman, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00049816
- Sponsor's protocol ID
- R01AR048768
- Other IDs
- R01AR048768, NIAMS-081
- Status last verified
- May 2013
- First submitted
- 14 Nov 2002
- Last updated
- 17 May 2013
- Results posted
- No
Publications
Schmidt JE, Amrami KK, Manduca A, Kaufman KR. Semi-automated digital image analysis of joint space width in knee radiographs. Skeletal Radiol. 2005 Oct;34(10):639-43. doi: 10.1007/s00256-005-0908-9. Epub 2005 May 25.
PubMed 15915340Grochowski SJ, Amrami KK, Kaufman K. Semi-automated digital image analysis of patellofemoral joint space width from lateral knee radiographs. Skeletal Radiol. 2005 Oct;34(10):644-8. doi: 10.1007/s00256-005-0944-5. Epub 2005 Jul 15.
PubMed 16021447Koff MF, Amrami KK, Kaufman KR. Clinical evaluation of T2 values of patellar cartilage in patients with osteoarthritis. Osteoarthritis Cartilage. 2007 Feb;15(2):198-204. doi: 10.1016/j.joca.2006.07.007. Epub 2006 Sep 1.
PubMed 16949313Agnesi F, Amrami KK, Frigo CA, Kaufman KR. Semiautomated digital analysis of knee joint space width using MR images. Skeletal Radiol. 2007 May;36(5):437-44. doi: 10.1007/s00256-006-0245-7. Epub 2007 Jan 23.
PubMed 17242952Khan FA, Koff MF, Noiseux NO, Bernhardt KA, O'Byrne MM, Larson DR, Amrami KK, Kaufman KR. Effect of local alignment on compartmental patterns of knee osteoarthritis. J Bone Joint Surg Am. 2008 Sep;90(9):1961-9. doi: 10.2106/JBJS.G.00633.
PubMed 18762657Agnesi F, Amrami KK, Frigo CA, Kaufman KR. Comparison of cartilage thickness with radiologic grade of knee osteoarthritis. Skeletal Radiol. 2008 Jul;37(7):639-43. doi: 10.1007/s00256-008-0483-y. Epub 2008 May 7.
PubMed 18461323Koff MF, Amrami KK, Felmlee JP, Kaufman KR. Bias of cartilage T2 values related to method of calculation. Magn Reson Imaging. 2008 Nov;26(9):1236-43. doi: 10.1016/j.mri.2008.03.002. Epub 2008 May 7.
PubMed 18467063
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic Exercise Intervention for Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT00049816
- Acronym / sponsor ID
- R01AR048768
- Conditions
- Osteoarthritis
- Keywords
- knee, aerobic exercise, walking, cycling, gait, MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Oct 2002
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 15 Nov 2002 (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 trial will test if walking or bicycling exercise is effective as a non-surgical treatment option for patients with knee osteoarthritis.
Detailed description
Traditional, conservative medical treatment of osteoarthritis has been directed at improving functional status through reducing joint pain and inflammation and maintaining or restoring joint function. Exercise is an adjunct therapy in the clinical management of patients with osteoarthritis of the knee. However, it is not uniformly accepted. The central hypothesis of this work is that the Surgeon General's exercise guidelines can be successfully implemented as an effective nonsurgical option for treatment of patients with early stages of knee osteoarthritis.
Patients with knee osteoarthritis will be randomized into a control group, a walking exercise group, and a stationary cycling exercise group. The individuals in the exercise groups will be required to exercise three times per week for one year using emerging public health recommendations for aerobic exercise in the adult and aging population. Patient outcome will be assessed using objective gait analysis measurements, knee radiographs to quantify joint space narrowing, magnetic resonance imaging, a general health questionnaire (SF-36), a disease/site specific questionnaire (WOMAC), and a visual-analog pain scale. All subjects will be studied at 0 and 52 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Participants will receive no intervention and will act as the control group. |
| 2 | Experimental | Behavioral: Walking exerciseParticipants will partake in a walking exercise program. |
| 3 | Experimental | Behavioral: Cycling ExerciseParticipants will partake in a cycling exercise program. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Current symptoms of chronic (6 months), stable pain and/or stiffness in one or both knees during weight-bearing activities
- Involved joint is primary factor limiting physical or functional activity
- Radiographic signs of mild or moderate arthritis
- Mild joint space narrowing (at least 2mm remaining)
Key exclusion criteria (13 listed)
- Current participation in a regular exercise program
- Existing medical condition that would preclude increased physical activity
- Subjective complaint of instability (giving way)
- Ligamentous instability greater than Grade I
- Knee flexion contracture greater than 15 degrees
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 |
|---|---|---|
| Walking exercise30 minutes/day, 3 times/week for 52 weeks | Behavioural | 2 |
| Cycling Exercise30 minutes/day, 3 times/week for 52 weeks | Behavioural | 3 |
Primary outcome
VAS, SF-36, WOMAC, and Activity Index questionnaires
Time frame: Week 52
Weight-bearing anterior-posterior (AP) and lateral x-rays of the knee
Time frame: Week 52
MRI imaging of the knee
Time frame: Week 52
Measurements of gait during level walking and stair climbing
Time frame: Week 52
1 secondary outcome
Change in consumption of analgesics, reflecting the level of joint pain
Time frame: Week 52
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 17 May 2013.
- Background: PubMed 15915340Schmidt JE, Amrami KK, Manduca A, Kaufman KR. Semi-automated digital image analysis of joint space width in knee radiographs. Skeletal Radiol. 2005 Oct;34(10):639-43. doi: 10.1007/s00256-005-0908-9. Epub 2005 May 25.
- Background: PubMed 16021447Grochowski SJ, Amrami KK, Kaufman K. Semi-automated digital image analysis of patellofemoral joint space width from lateral knee radiographs. Skeletal Radiol. 2005 Oct;34(10):644-8. doi: 10.1007/s00256-005-0944-5. Epub 2005 Jul 15.
- Background: PubMed 16949313Koff MF, Amrami KK, Kaufman KR. Clinical evaluation of T2 values of patellar cartilage in patients with osteoarthritis. Osteoarthritis Cartilage. 2007 Feb;15(2):198-204. doi: 10.1016/j.joca.2006.07.007. Epub 2006 Sep 1.
- Background: PubMed 17242952Agnesi F, Amrami KK, Frigo CA, Kaufman KR. Semiautomated digital analysis of knee joint space width using MR images. Skeletal Radiol. 2007 May;36(5):437-44. doi: 10.1007/s00256-006-0245-7. Epub 2007 Jan 23.
- Results publication: PubMed 18762657Khan FA, Koff MF, Noiseux NO, Bernhardt KA, O'Byrne MM, Larson DR, Amrami KK, Kaufman KR. Effect of local alignment on compartmental patterns of knee osteoarthritis. J Bone Joint Surg Am. 2008 Sep;90(9):1961-9. doi: 10.2106/JBJS.G.00633.
- Results publication: PubMed 18461323Agnesi F, Amrami KK, Frigo CA, Kaufman KR. Comparison of cartilage thickness with radiologic grade of knee osteoarthritis. Skeletal Radiol. 2008 Jul;37(7):639-43. doi: 10.1007/s00256-008-0483-y. Epub 2008 May 7.
- Results publication: PubMed 18467063Koff MF, Amrami KK, Felmlee JP, Kaufman KR. Bias of cartilage T2 values related to method of calculation. Magn Reson Imaging. 2008 Nov;26(9):1236-43. doi: 10.1016/j.mri.2008.03.002. Epub 2008 May 7.
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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.
Kenton R Kaufman, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking exercise and Cycling Exercise in people with Osteoarthritis, run by Mayo Clinic at 1 site in United States.
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 4 inclusion and 13 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 17 May 2013. 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 United States. 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?
VAS, SF-36, WOMAC, and Activity Index questionnaires (time frame: Week 52). The study lists 4 primary outcomes in all. 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 NCT00049816, which also lists 7 linked publications.
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 17 May 2013.