The Study of Neuromuscular Exercise Therapy and Patients Self-management Program in Knee Osteoarthritis

NCT03363490 | Unknown

• 1 other identifier: PLSKNLSMFS2
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Exercise Therapy

Keywords

Self-Management; Neuromuscular Exercise Therapy; Knee osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 3 months, 6 months, 12months

Secondary Outcomes (3)

• Visual Analog Score（VAS）

  Baseline, 3 months, 6 months, 12months

• EuroQol Five Dimensions Questionnaire（EQ-5D）

  Baseline, 3 months, 6 months, 12months

• Kellgren& Lawrence（KL）

  Baseline

Study Arms (4)

Control

OTHER

The patients in this group will only receive health education intervention.

Behavioral: Health education

Neuromuscular exercise therapy

OTHER

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

Self-management program

OTHER

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

Exercise therapy+self-management

OTHER

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

Interventions

Self-management program BEHAVIORAL

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.

Exercise therapy+self-management; Self-management program

Neuromuscular exercise therapy BEHAVIORAL

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.

Exercise therapy+self-management; Neuromuscular exercise therapy

Health education BEHAVIORAL

All four groups of patient will receive two times of health education in the first week.

Control; Exercise therapy+self-management; Neuromuscular exercise therapy; Self-management program

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• VAS≥4分; 3.No surgical treatment is planned within 6 months;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Beijing Jishuitan Hospital: collaborator
• General Hospital of Beijing PLA Military Region: collaborator
• Peking Union Medical College Hospital: collaborator
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator

Study Sites (1)

PekingUPH

Beijing, Beijing Municipality, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 25390299 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Self-Management

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jianhao Lin, MD

  arthritic clinic and research center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yifan Chen

CONTACT

15810031180; chenyifan_cn@163.com

Rujun Li, Attending

CONTACT

15810963512

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessor will not know which group the patients are enrolled when evaluate the baseline and follow-up situation
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Center of Osteoarthritis

Model Details: 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.

Study Record Dates

• First Submitted: November 26, 2017
• First Posted: December 6, 2017
• Study Start: April 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: April 6, 2018

Record last verified: 2018-04

Locations

CN (1)