An interventional study of Self-management program and Neuromuscular exercise therapy in Exercise Therapy, sponsored by Peking University People's Hospital. Status unknown at 1 site in China. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2018-04-06.
Sponsored by Peking University People's Hospital · Not applicable, Interventional, and Treatment
Osteoarthritis is the most common chronic disabling disease,the importance of patient's self-management in chronic disease has been paid more and more attention internationally. Currently, the self-management of OA patients in China is lack of instructions from professional clinicians, and leads to inappropriate excise, irregular drug medication. OAKP (Osteoarthritis of the Knee Self-Management Program) is a program initiated from University of Southern Denmark, follows clinical guidelines of OA, formatted for easy use by patients and clinicians, including customized neuromuscular exercise therapy, educational sessions of what is OA and how to control body weight to protect the knee.
The main purpose of this study is to verify the effectiveness of neuromuscular exercise therapy and OAKP, see whether it can help patients to relief the symptom and improve life quality.
The study plans to enroll patients above 50 years old who suffered from knee OA, but patients meets any of the exclusion criteria will not be enrolled. 400 patients of knee OA will be randomly divided into A, B, C, D four parallel groups with fully informed, each group will enroll 100 patients, A for control group, B for neuromuscular exercise, C for self-management program, D for neuromuscular exercise and self-management program, respectively. Each collaborate hospital would enroll patients as a multicenter clinical trial. Patient will receive a baseline and 3m, 6m, 12m follow-up evaluation of their knee physical function. Primary outcome measure is KOOS (Knee Injury and Osteoarthritis Outcome Score), secondary evaluation include VAS, EQ-5D, Arthritis self-efficacy score, 6-minutes Walk test, TUG test, 20 meters quick walk test,Stand up test in 30 seconds, Balance test, Kellgren\& Lawrence（KL）, Pain medication. Outcome will compare the mean difference between baseline survey and 12 months of follow-up in each group, using t-test or chi-square test,respectively.
3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.
This study's planned enrollment of 400 is above the median of 69 across 2,808 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Peking University People's Hospital is the lead sponsor of 603 studies on the registry; 241 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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1.Clinical diagnosis of knee osteoarthritis, Diagnostic criteria is based on the Chinese medical association's 2007 diagnosis and treatment guidelines for osteoarthritis:
2.VAS≥4分; 3.No surgical treatment is planned within 6 months;
Exclusion Criteria:
The patients in this group will only receive health education intervention.
Behavioral: Health education
The patients in this group will receive exercise therapy intervention.Besides, health education will be performed for every group.
Behavioral: Neuromuscular exercise therapy · Behavioral: Health education
The patients in this group will receive self-management intervention.Besides, health education will be performed for every group.
Behavioral: Self-management program · Behavioral: Health education
The patients in this group will receive exercise therapy and self-management intervention.Besides, health education will be performed for every group.
Behavioral: Self-management program · Behavioral: Neuromuscular exercise therapy · Behavioral: Health education
Self-management diary will record the frequency of pain, fatigue and injury of knee joint due to knee OA, if patients maintain proper activities, it will be also recorded by an smart phone APP. Patients diet and intake calorie will also be recorded in the diary，which help clinicians to adjust their diet, control their body weight.
The exercise therapy is basically combined with neuromuscular training and anti resistance training. The aim is to improve the stability of the joints, enhance sensory motor control of lower extremities, reconstruct neutral position line. The exercise mode, frequency, intensity and duration will be adjusted individually through monitoring patient's pain.
All four groups of patient will receive two times of health education in the first week.
The Western Ontario and McMaster Universities Osteoarthritis Index，WOMAC
WOMAC grade is a reliable knee osteoarthritis patients' self-reported therapeutic effect evaluation system, including three dimensions: pain, stiffness, daily activities and quality of life, and each dimension includes several questions scale from 0(worst) to 4(best) , total score of each dimension range from zero (worst) to 100 (best). Score of each question add together will be the total score. Baseline, 3 months, 6 months, 12 months, through visit or telephone follow-up will be recorded. Compare the mean difference of WOMAC grade between baseline survey and 12 months of follow-up in each group.
Time frame: Baseline, 3 months, 6 months, 12months
Visual Analog Score（VAS）
Visual Analogue Scale of pain is a scale to extimate pain, and its score ranges from 0(worst) to 10(best). The higher the score is, the more severe pain the patient is feeling.
Time frame: Baseline, 3 months, 6 months, 12months
EuroQol Five Dimensions Questionnaire（EQ-5D）
EQ-5D is a scale to extimate health condition and quality of life, and its score ranges from -0.6 to 1.0. The higher the score is, the healthier the patient is.
Time frame: Baseline, 3 months, 6 months, 12months
Kellgren& Lawrence（KL）
The higher the KL score is ,the more severe the patient is. Baseline,through visit or telephone follow-up.
Time frame: Baseline
Plan to share: Undecided
Started Apr 2018 (actual). Primary completion is estimated for Dec 2019, 20 months after the start.
Of 1,143 non-industry interventional studies with no phase under Osteoarthritis, Knee, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's planned 20 months is above that.
Counting every sponsor, half of 1,285 studies reached it within 18 months; a quarter within 8 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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