NCT03363490

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Exercise Therapy

Interventions

Type	Name	Description
BEHAVIORAL	Self-management program	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.
BEHAVIORAL	Neuromuscular exercise therapy	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.
BEHAVIORAL	Health education	All four groups of patient will receive two times of health education in the first week.

Timeline

• Start date: 2018-04-01
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2017-12-06
• Last updated: 2018-04-06

Locations

1 site across 1 country: China