Exercise TherapyNCT03363490
The Study of Neuromuscular Exercise Therapy and Patients Self-management Program in Knee Osteoarthritis
A study testing Self-management program, Neuromuscular exercise therapy and Health education in people with Exercise Therapy, run by Peking University People's Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Exercise Therapy
- What is being tested?
- Self-management program, Neuromuscular exercise therapy and Health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
- 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;
Show all 9Show fewer
- 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;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
Rujun Li, Attending contact
China1 site, 1 recruiting
- Recruiting
PekingUPH
Beijing, Beijing Municipality
Yifan Chen, Resident, 15810031180, chenyifan_cn@163.com
Rujun Li, Attending, 15810963512
About this study
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.
Read the 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
- Being tested
- Self-management program, Neuromuscular exercise therapy, Health education
- Keywords
- Self-Management, Neuromuscular Exercise Therapy, Knee osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-management programBehavioural
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.
Neuromuscular exercise therapyBehavioural
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.
Health educationBehavioural
All four groups of patient will receive two times of health education in the first week.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | The patients in this group will only receive health education intervention. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Self-management program; Behavioral: Neuromuscular exercise therapy; Behavioral: Health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months, 6 months, 12months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start1 Apr 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Exercise TherapyStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Jishuitan Hospital, General Hospital of Beijing PLA Military Region, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Fuwai Hospital
- Responsible party
- Principal investigator, Lin Jianhao, Peking University People's Hospital
- Investigators
- Jianhao Lin, MD, Principal investigator, arthritic clinic and research center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03363490
- Sponsor's protocol ID
- PLSKNLSMFS2
- Status last verified
- Apr 2018
- First submitted
- 26 Nov 2017
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25390299
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Neuromuscular Exercise Therapy and Patients Self-management Program in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03363490
- Acronym / sponsor ID
- PLSKNLSMFS2
- Conditions
- Exercise Therapy
- Keywords
- Self-Management, Neuromuscular Exercise Therapy, Knee osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Beijing Jishuitan Hospital, General Hospital of Beijing PLA Military Region, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Fuwai Hospital
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 6 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Behavioral: Health educationThe patients in this group will only receive health education intervention. |
| Neuromuscular exercise therapy | Other | Behavioral: Neuromuscular exercise therapy, Behavioral: Health educationThe patients in this group will receive exercise therapy intervention.Besides, health education will be performed for every group. |
| Self-management program | Other | Behavioral: Self-management program, Behavioral: Health educationThe patients in this group will receive self-management intervention.Besides, health education will be performed for every group. |
| Exercise therapy+self-management | Other | Behavioral: Self-management program, Behavioral: Neuromuscular exercise therapy, Behavioral: Health educationThe patients in this group will receive exercise therapy and self-management intervention.Besides, health education will be performed for every group. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- -
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-management programSelf-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. | Behavioural | Exercise therapy+self-management, Self-management program |
| Neuromuscular exercise therapyThe 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. | Behavioural | Exercise therapy+self-management, Neuromuscular exercise therapy |
| Health educationAll four groups of patient will receive two times of health education in the first week. | Behavioural | Control, Exercise therapy+self-management, Neuromuscular exercise therapy, Self-management program |
Primary outcome
The Western Ontario and McMaster Universities Osteoarthritis Index，WOMAC
Time frame: Baseline, 3 months, 6 months, 12months
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.
3 secondary outcomes
Visual Analog Score（VAS）
Time frame: Baseline, 3 months, 6 months, 12months
EuroQol Five Dimensions Questionnaire（EQ-5D）
Time frame: Baseline, 3 months, 6 months, 12months
Kellgren& Lawrence（KL）
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
- Background: PubMed 25390299Ageberg 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rujun Li, Attending contact
Jianhao Lin, MD principal investigator
arthritic clinic and research center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-management program, Neuromuscular exercise therapy and Health education in people with Exercise Therapy, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yifan Chen (15810031180, chenyifan_cn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Western Ontario and McMaster Universities Osteoarthritis Index，WOMAC (time frame: Baseline, 3 months, 6 months, 12months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03363490, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2018.