Exercise Therapy in Patients With Knee Osteoarthritis
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|ClinicalTrials.gov Identifier: NCT02024126|
Recruitment Status : Unknown
Verified January 2020 by Björn O. Äng, Karolinska Institutet.
Recruitment status was: Active, not recruiting
First Posted : December 31, 2013
Last Update Posted : January 3, 2020
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Osteoarthritis (OA) is one of the most common form of chronic diseases in the adult population, and approximately 800 000 people in Sweden (population of 9 million people) suffer from this disease, which causes joint pain, stiffness, swelling, loss of function and sick leave. There is increasing evidence that exercise therapy is effective for patients with knee OA. However, there is little knowledge on long-term effects and what type of exercises dosage is most effective. In this present clinical trial, which is a Nordic collaborative project with researchers from different research groups in Sweden and Norway, we intend to investigate short and long-term effects comparing high dosage exercise therapy (each treatment lasting 80 to 90 min) vs. a relatively low dosage exercise program (25 to 30 min) in patients diagnosed with knee OA. Patients in both intervention groups receive three treatments a week for 12 weeks making a total of 36 treatments. Primary outcome is pain-ratings and function (The Knee Injury and Osteoarthritis Outcome Score (KOOS)). Secondary outcome concerns various health-ratings and objective functional tests. Regarding predictors for outcome, we plan also to investigate different psychosocial variables as well as patient's beliefs regarding exercise. Feasibility of how high-dose exercise therapy actually works in primary care health care settings is also planned to be reported.
Patients are being assessed by blinded assessor at inclusion, at end of intervention (3 mo), and at six and 12 mo after end of treatment. We plan to include a total of 200 subjects from primary health care settings, two in Norway and two in Sweden, with radiographic-verified knee OA with knee pain and decreased function. The patients have to be within the 45 to 85 age group. Patients are excluded if they have been scheduled for knee surgery or have some other form of illness/disease that limits the exercise tolerance (e.g. heart disease or systemic/metabolic diseases or chronic obstructive airways disease). A major goal is to grade exercises so that they are performed pain-free or close to pain-free in both intervention groups. The principle of deloading is used to meet this goal using a high number of repetitions in sets as pain modulation. The results from this study will give new information about the effectiveness of graded exercise therapy in patients with knee OA, and new knowledge if outcome can be related to the exercise dosage performed.
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis||Other: Exercise therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||189 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Exercise Therapy in Patients With Knee Osteoarthritis|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||August 31, 2017|
|Estimated Study Completion Date :||September 30, 2021|
Experimental: High dosage exercise therapy
The high-dosage exercise treatment will be conducted under supervision of experienced physiotherapists, and it follows an exercise protocol previously described as Medical Exercise Therapy, MET. The regimen contains different semi-global and local exercises for the knee. To be able to reach a high number of repetitions despite ongoing pain, the principle of de-loading (reducing weight) will be applied. The use of de-loading allows high number of repetitions nearly or entirely pain free. Later, as the patient improves and tolerates increased loading, the exercises are adapted to be more functional, using closed chain exercises without de-loading the body. Each of the exercises will be performed in 3 sets of 30 repetitions with 30-60s rest in between. Global exercises using a stationary bike will be performed three times during one treatment-session; first 20 minutes as global pain modulation, ten minutes in the middle of the treatment, and then ten minutes at the end of the treatment.
Other: Exercise therapy
Active Comparator: Lower dosage exercise therapy
Patients in the comparison-/control group will perform six exercises, of which, five will be in 2 sets of 10 repetitions combining local and semi-global exercises, again using the principle of de-loading. The five semi-global and local exercises are the same as performed in the MET-group, and the regimen will be supervised in the same manner as for the MET-group. The therapy starts with 10 minutes using a stationary bike, and the same principles will be applied as for the MET-group regarding grading and follow-up with exercises and adjusting the exercises so that they are performed close to pain-free.
Other: Exercise therapy
- Change from baseline in Self-assessed function (KOOS) at three months follow-up (other follow-ups with this measure includes six and 12 months follow-up). [ Time Frame: At three months follow-up, i.e. after end of treatment (primary end point). In addition, during the intervention period, the KOOS are assessed after every sixth treatment meaning after 2, 4, 6, 8, 10 weeks, as well as at 6 and 12 months follow-up. ]The primary outcome measure is the disease specific Knee injury and Osteoarthritis Outcome Score (KOOS). The KOOS assesses the patients' self-report of pain, other symptoms, activities of daily living, sport and recreation function, and knee-related quality of life, answering 42 questions which take about 10 minutes to complete. The KOOS is scored from 0 to 100, separately for each subscale, 0 indicating extreme problems and 100 indicating no problems.
- Patient Satisfaction [ Time Frame: After treatment at three months follow-up ]Reflects patients satisfaction with treatment, using self-rated Patient Satisfaction scale (6 point scale)
- Anxiety and depression [ Time Frame: At baseline, at three months, at six months and at one year follow-up ]Hospital Anxiety and Depression scale (HAD), measured with HAD questionnaire.
- Catastrophizing [ Time Frame: At baseline, at three months, at six months and at one year follow-up ]Patients level of catastrophizing using Catastrophizing Scale (PCS)
- Tama Scale of Kinesiophobia (TSK) [ Time Frame: At baseline, at three months, at six months and at one year follow-up ]Patients beliefs and attitudes regarding pain and physical activity using the self-rated Tampa Scale of Kinesiophobia (TSK).
- Change from baseline in self assessed pain using a visal analogue scale (VAS) at three months follow-up (other follow-ups with this measure includes six and 12 months follow-up) [ Time Frame: At three months follow-up, i.e. after end of treatment. In addition, during the intervention period, the VAS are assessed after every sixth treatment meaning after 2, 4, 6, 8, 10 weeks, as well as at 6 and 12 months follow-up. ]Pain is measured using a 100 mm long line with no pain at 0 and the worst imaginable pain at 100 mm. The patient make a line vertically on the 100mm long line according to the pain experience.
- 20 min walk test. [ Time Frame: At inclusion and at three months follow-up, i.e. after end of treatment ]20 m walk test. Patients are asked to walk between two visible lines marked on the floor; first with their usual pace, and then at the maximal pace the patient feel secure.
- 30s Maximal Repeated Unilateral Knee Bending test [ Time Frame: At inclusion and at three months follow-up, i.e. after end of treatment ]The test evaluates the maximum number of knee bends in 30 seconds performed on one leg in standing. Both (legs)knees are tested
- the Five Time Repeated Chair Stands. [ Time Frame: At inclusion and at three months follow-up, i.e. after end of treatment ]The patient is seated in a standard chair (seat height, 40 cm) without armrests, and is instructed to rise to a fully erect standing position five times as fast as possible without using their hands. Outcome is time the patient use to perform the five time repeated chair stands.
- Pain and sensory threshold assessment. [ Time Frame: At inclusion and at three months follow-up, i.e. after end of treatment ]Using a Cefar PainMatcher, a pain and sensory threshold assessment tool, subjects will have their baseline and pos-treatment pain thresholds recorded.
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|Ages Eligible for Study:||45 Years to 85 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- age 45-85 yrs with an x-ray verified knee osteoarthritis with pain and decreased function.
- Inflammatory joint disease, current anterior cruciate ligament injury, hip symptoms more aggravating than the knee symptoms, scheduled to have knee replacement surgery within 12 months, and co-morbidities not allowing exercise like cardiovascular, respiratory, systemic, or metabolic conditions limiting exercise tolerance.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02024126
|Huddinge, Stockholm, Sweden, SE-14183|
|Principal Investigator:||Björn O Äng, Assoc.prof||Karolinska Institutet|
|Responsible Party:||Björn O. Äng, Associate professor, Karolinska Institutet|
|Other Study ID Numbers:||
KI-TOM-TOR-2013 ( Other Identifier: 0 )
|First Posted:||December 31, 2013 Key Record Dates|
|Last Update Posted:||January 3, 2020|
|Last Verified:||January 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Plan Description:||This is currently not planned, but may be necessary depending on the requirements of future financiers (it will then be necessary to compliment our ethical application). Data monitoring ("yes", as indicated above) concerns an external person that will monitor our data, and log results in a notebook|