Back to resultsThe Study of Neuromuscular Exercise Therapy and Patients Self-management Program in Knee Osteoarthritis
Primary Purpose
Exercise Therapy
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Self-management program
Neuromuscular exercise therapy
Health education
Sponsored by
About this trial
This is an interventional treatment trial for Exercise Therapy focused on measuring Self-Management, Neuromuscular Exercise Therapy, Knee osteoarthritis
Eligibility Criteria
Inclusion Criteria:
-
1.Clinical diagnosis of knee osteoarthritis, Diagnostic criteria is based on the Chinese medical association's 2007 diagnosis and treatment guidelines for osteoarthritis:
- Repeated knee joint pain within 1 month;
- X-ray(weight-bearing or not)shows narrowed joint space,sclerosis and (or) cystic degeneration of subchondral bone, osteophytes of the joints;
- The joint fluid (at least twice) is clear and viscous, WBC<2000个/ml;
- Age of patients ≥40 yrs;
- Morning stiffness≤3 min;
- Bone friction in the activity; Note：Combine clinical feature, laboratory and X-ray examination,when the patients meet(1)+(2) or (1)+(3)+(5)+(6) or (1)+(4)+(5)+(6)，they can be diagnosis as knee osteoarthritis.
2.VAS≥4分; 3.No surgical treatment is planned within 6 months;
Exclusion Criteria:
- Other types of arthritis, such us RA(rheumatoid arthritis)
- Severe deformity of knee joint;
- Over obesity patients（BMI>35）;
- Other comorbidities that would severely affect somatic function, such as: cerebral infarction, lumbar disease that meets surgical indications, lower extremity angiopathy;
- Decompensated cardiac dysfunction;
- Severe cardiovascular and cerebrovascular diseases, or the patient is too weak for any kinds of exercise;
- Lack of compliance;
Sites / Locations
- PekingUPHRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Other
Other
Arm Label
Control
Neuromuscular exercise therapy
Self-management program
Exercise therapy+self-management
Arm Description
The patients in this group will only receive health education intervention.
The patients in this group will receive exercise therapy intervention.Besides, health education will be performed for every group.
The patients in this group will receive self-management intervention.Besides, health education will be performed for every group.
The patients in this group will receive exercise therapy and self-management intervention.Besides, health education will be performed for every group.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Kellgren& Lawrence（KL）
The higher the KL score is ,the more severe the patient is. Baseline,through visit or telephone follow-up.
Full Information
NCT ID
NCT03363490
First Posted
November 26, 2017
Last Updated
April 4, 2018
Sponsor
Peking University People's Hospital
Collaborators
Beijing Jishuitan Hospital, General Hospital of Beijing PLA Military Region, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Fuwai Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03363490
Brief Title
The Study of Neuromuscular Exercise Therapy and Patients Self-management Program in Knee Osteoarthritis
Official Title
The Study of Neuromuscular Exercise Therapy and Patients Self-management Program in Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
Collaborators
Beijing Jishuitan Hospital, General Hospital of Beijing PLA Military Region, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Fuwai Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise Therapy
Keywords
Self-Management, Neuromuscular Exercise Therapy, Knee osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Patients of knee OA will be 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.
Masking
Outcomes Assessor
Masking Description
Assessor will not know which group the patients are enrolled when evaluate the baseline and follow-up situation
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Other
Arm Description
The patients in this group will only receive health education intervention.
Arm Title
Neuromuscular exercise therapy
Arm Type
Other
Arm Description
The patients in this group will receive exercise therapy intervention.Besides, health education will be performed for every group.
Arm Title
Self-management program
Arm Type
Other
Arm Description
The patients in this group will receive self-management intervention.Besides, health education will be performed for every group.
Arm Title
Exercise therapy+self-management
Arm Type
Other
Arm Description
The patients in this group will receive exercise therapy and self-management intervention.Besides, health education will be performed for every group.
Intervention Type
Behavioral
Intervention Name(s)
Self-management program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Neuromuscular exercise therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health education
Intervention Description
All four groups of patient will receive two times of health education in the first week.
Primary Outcome Measure Information:
Title
The Western Ontario and McMaster Universities Osteoarthritis Index，WOMAC
Description
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
Secondary Outcome Measure Information:
Title
Visual Analog Score（VAS）
Description
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
Title
EuroQol Five Dimensions Questionnaire（EQ-5D）
Description
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
Title
Kellgren& Lawrence（KL）
Description
The higher the KL score is ,the more severe the patient is. Baseline,through visit or telephone follow-up.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
-
1.Clinical diagnosis of knee osteoarthritis, Diagnostic criteria is based on the Chinese medical association's 2007 diagnosis and treatment guidelines for osteoarthritis:
Repeated knee joint pain within 1 month;
X-ray(weight-bearing or not)shows narrowed joint space,sclerosis and (or) cystic degeneration of subchondral bone, osteophytes of the joints;
The joint fluid (at least twice) is clear and viscous, WBC<2000个/ml;
Age of patients ≥40 yrs;
Morning stiffness≤3 min;
Bone friction in the activity; Note：Combine clinical feature, laboratory and X-ray examination,when the patients meet(1)+(2) or (1)+(3)+(5)+(6) or (1)+(4)+(5)+(6)，they can be diagnosis as knee osteoarthritis.
2.VAS≥4分; 3.No surgical treatment is planned within 6 months;
Exclusion Criteria:
Other types of arthritis, such us RA(rheumatoid arthritis)
Severe deformity of knee joint;
Over obesity patients（BMI>35）;
Other comorbidities that would severely affect somatic function, such as: cerebral infarction, lumbar disease that meets surgical indications, lower extremity angiopathy;
Decompensated cardiac dysfunction;
Severe cardiovascular and cerebrovascular diseases, or the patient is too weak for any kinds of exercise;
Lack of compliance;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yifan Chen
Phone
15810031180
Email
chenyifan_cn@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rujun Li, Attending
Phone
15810963512
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianhao Lin, MD
Organizational Affiliation
arthritic clinic and research center
Official's Role
Principal Investigator
Facility Information:
Facility Name
PekingUPH
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yifan Chen, Resident
Phone
15810031180
Email
chenyifan_cn@163.com
First Name & Middle Initial & Last Name & Degree
Rujun Li, Attending
Phone
15810963512
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25390299
Citation
Ageberg E, Roos EM. Neuromuscular exercise as treatment of degenerative knee disease. Exerc Sport Sci Rev. 2015 Jan;43(1):14-22. doi: 10.1249/JES.0000000000000030.
Results Reference
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The Study of Neuromuscular Exercise Therapy and Patients Self-management Program in Knee Osteoarthritis
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