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注册号: Registration number: |
ChiCTR-IRR-17013443 |
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最近更新日期: Date of Last Refreshed on: |
2017-11-19 12:13:17 |
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注册时间: Date of Registration: |
2017-11-19 00:00:00 |
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注册号状态: |
补注册 |
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Registration Status: |
Retrospective registration |
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注册题目: |
比较三种物理疗法治疗膝关节骨性关节炎疗效的随机对照试验 |
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Public title: |
Effect of Three Different Physical Therapy Approaches on Function and Disability of The Knee Joint in Patients with Knee Osteoarthritis. Randomized Study. |
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注册题目简写: |
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English Acronym: |
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研究课题的正式科学名称: |
比较三种物理疗法治疗膝关节骨性关节炎疗效的随机对照试验 |
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Scientific title: |
Effect of Three Different Physical Therapy Approaches on Function and Disability of The Knee Joint in Patients with Knee Osteoarthritis. Randomized Study. |
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研究课题代号(代码): Study subject ID: |
TJ2017 |
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在二级注册机构或其它机构的注册号: The registration number of the Partner Registry or other register: |
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申请注册联系人: |
塔里克 |
研究负责人: |
陆敏 |
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Applicant: |
TAREQ FALIH |
Study leader: |
Lu Min |
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申请注册联系人电话: Applicant telephone: |
+86 13129937059 |
研究负责人电话:
Study leader's |
+86 13971268939 |
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申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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申请注册联系人电子邮件: Applicant E-mail: |
dr.ahmed820@gmail.com |
研究负责人电子邮件: Study leader's E-mail: |
lumin.tj@aliyun.com |
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申请单位网址(自愿提供): Applicant website(voluntary supply): |
研究负责人网址(自愿提供): Study leader's website(voluntary supply): |
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申请注册联系人通讯地址: |
中国湖北武汉市解放大道1095号 |
研究负责人通讯地址: |
中国湖北武汉市解放大道1095号 |
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Applicant address: |
1095 Jiefang Avenue, Qiaokou District, Wuhan, Hubei, China |
Study leader's address: |
1095 Jiefang Avenue, Qiaokou District, Wuhan, Hubei, China |
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申请注册联系人邮政编码: Applicant postcode: |
研究负责人邮政编码: Study leader's postcode: |
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申请人所在单位: |
武汉同济医学院 |
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Applicant's institution: |
Tongji Medical College |
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研究负责人所在单位: |
武汉同济医学院 |
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Affiliation of the Leader: |
Tongji Medical College |
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是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
TJ-IRB20170703 |
伦理委员会批件附件: Approved file of Ethical Committee: |
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批准本研究的伦理委员会名称: |
武汉同济医学院同济医院医学研究伦理委员会 |
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Name of the ethic committee: |
ETHICAL Commitee of Tongji Hospital |
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伦理委员会批准日期: Date of approved by ethic committee: |
1990-01-01 00:00:00 | ||
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伦理委员会联系人: |
武汉同济医学院同济医院医学研究伦理委员会 |
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Contact Name of the ethic committee: |
ETHICAL Commitee of Tongji Hospital |
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伦理委员会联系地址: |
中国湖北武汉市解放大道1095号 |
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Contact Address of the ethic committee: |
1095 Jiefang Avenue, Qiaokou District, Wuhan, Hubei, China |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
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研究实施负责(组长)单位: |
同济医院 |
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Primary sponsor: |
Tongji Hospital |
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研究实施负责(组长)单位地址: |
中国湖北武汉市解放大道1095号 |
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Primary sponsor's address: |
1095 Jiefang Avenue, Qiaokou District, Wuhan, Hubei, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
同济医院 |
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Source(s) of funding: |
Tongji Hospital |
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研究疾病: |
膝关节骨性关节炎 |
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Target disease: |
knee osteoarthritis |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
干预性研究 |
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Study type: |
Interventional study |
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研究所处阶段: |
回顾性研究 | ||||||||||||||||||||||
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Study phase: |
Retrospective study |
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研究设计: |
随机抽样 |
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Study design: |
Randomly Sampling |
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研究目的: |
比较三种理疗方法治疗膝关节骨性关节炎疗效 |
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Objectives of Study: |
To investigate the effect of three physical therapy approaches on knee range of motion, pain level, muscle strength and functional condition, and in patients with knee osteoarthritis. |
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药物成份或治疗方案详述: |
Material and Methods Design A randomized study was conducted to investigate the effect of three different physical therapy programs on the overall function and disability of the knee joint in patients with knee OA. The study was conducted after getting the approval of the ethical committee of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. An informed consent was given to each patient prior to participation in this study. All patients were diagnosed with a unilateral OA of the knee by one orthopedic surgeon who utilized clinical findings and imaging, such as X-ray. X-ray was used to confirm stage of arthritis. Patients recruitment All patients in this study were chosen from Rehabilitation medicine and physical therapy clinic, Tongji Hospital, HUST University, Wuhan, China. Eighty patients were initially examined. The inclusion criteria included unilateral knee osteoarthritis based on the radiological and clinical criteria for osteoarthritis diagnosis, the patients were able to walk for 100m or more on a surface that is uneven, having full passive ROM at both left and right knee and they have knee pain lasting over 6 months. The exclusion criteria included any surgical history in the last 6 months on lower extremities, injection of steroids or hyaluronic acid in the articular cartilage, diabetes mellitus, communicative or cognitive impairments, congenital abnormalities, heart problems, neurological disease, unstable angina, total or partial hip or knee replacement, uncontrolled hypertension, traumatic conditions, respiratory diseases, musculoskeletal diseases, chronic kidney or liver diseases and stroke patients. Fourteen patients were excluded after the initial examination, they included eight patients (10 %) did not meet the inclusion criteria and six patients (7.5%) assessed only at the baseline and didnt continue the study. The patients that didnt meet the inclusion criteria were having a total hip replacement (2) uncontrolled hypertension (3) unstable angina. A sample of 66 (82.5%) patients was eligible to participate in this study. Their age ranged from 40 to 70 years old. They were randomized by using randomized permuted blocks to accomplish the balance of the sample sizes among the three groups. The three groups included group A (physical agents and isometric quadriceps muscle exercise) and group B (physical agents and OKC) and group C (physical agents and CKC). The randomization was done by a colleges staff who wasnt involved in this study. The patients were examined both at the baseline and after 5 weeks. The demographic data for group A: age 47.5 ±5.87 years, mean BMI 37.5±3.24 kg/m2, for group B: age 48.5±6 years, mean BMI 37.3±3.24 kg/m2 and group C : age 48±6.16 years, mean BMI 37.1±3.24 kg/m2. Evaluative procedures 1. Knee ROM measurement An electric-goniometer was used to measure the changes in the knee ROM of flexion and extension in this study. Goniometers are considered a validated and reliable measure for assessing the knee ROM in patients with knee OA(26). The electro-goniometer was calibrated in three different angles (180o, 90o and zero). This method of calibration is repeated each time the device was used to allow the accuracy of the measurement each time used. The measurement of the knee ROM was performed according to Reese and Bandy. 2- Knee pain measurement Knee pain severity was measured using visual analog scale (VAS) scale. VAS is a reliable and validated method of measuring pain severity. The VAS horizontal line is 10 cm and was interpreted based on a scale from 0 cm = no pain to 10 cm = severe pain. All patients were given the VAS and asked to indicate a mark on the horizontal line at the point they could feel pain. Quantification of the measurement was done using a ruler then recorded for each patient from left point (no pain) to the mark indicated by the participant. 3. Muscle torque Muscle torque of bilateral knee extensors and flexors was tested at 60, 120, and 180°/s using a Con-Trex isokinetic dynamometer (Con-Trex MJ; CMV AG, Dubendorf, Switzerland) the strength testing was carried out in the order of 120°/s, 180°/s, and then 60°/s to control for the effects of fatigue. Standard positioning was used for this assessment. Participants sat leaning against a backrest inclined 15° backward from vertical and were secured to the machine at the upper chest, pelvis, and distal femur on the tested side. The participants were instructed to extend the knee as far as possible, and then to flex as far as the device allowed. Among the records of the 3 trials at each speed, the highest values were recorded as the peak torque. All data were corrected for the gravity. 4. Knee functional condition Functional condition of the knee was measured based on the WOMAC scale. The WOMAC scale includes 17 items on physical function with response categories from 1 = none to 5 = extreme. Total scores are created by summing up the scores for each item. This WOMAC index is known to be a responsive, validated and reliable measure of knee osteoarthritis effects like functional condition. Treatment procedures The physical therapy program for three groups was equal in time (60 min/session, 3seesions/week for 5 weeks). Group A It included 22 patients who were given physical agents and isometric quadriceps exercise. The physical agents were performed according to the protocol of Fransen et al because it is the most used protocol for the treatment of knee OA. It included transcutaneous electrical neuromuscular stimulation (T.E.N.S), hot pack, and ultrasound (U.S). Conventional TENS by using physiodyn-Basic electro therapy device (physiomed elektromedizin, Schnaittach, Germany) was applied to the painful areas of the knee for 30 minutes. The TENS unit was adjusted to a frequency of 100 Hz and a pulse duration of 60 μsn with an intensity accepted by the patients. The hot pack was applied at the knee for 15 minutes. Physioson-basic ultrasound device (physiomed elektromedizin, Schnaittach, Germany) was used with a continuous mode three times a week for 5 weeks (15 treatment sessions) with the frequency of 1 MHz for deep penetration and with an intensity of 1.5 W/cm2 with gel applied. Additionally, the patients performed an isometric quadriceps exercise. Patients lay in a supine position, put rolled towel under the affected knee then ask the patient to contract his\her quadriceps muscle during press on rolled towel and held contraction for 5 seconds. Group B It included 22 patients. They received the same physical agents as group A in addition to OKC exercises. Each exercise involved three sets of ten repetitions and held for about 10 seconds. The first OKC exercise: The patient was positioned in a supine position with bolster placed under the knee. The patient was asked to straighten the affected leg up to full extension for about 10 seconds, and then lower the same leg back gently to the floor. Visual feedback and verbal encouragement were used(15). The second OKC exercise: The patient was positioned in a side-lying position. The patient was asked to adduct the affected leg. The leg that is not affected was in the upward position with flexion of the knee while affected leg placed against the bed. The leg was then lifted up to adduction for about 10 seconds before being lowered gently back. The third OKC exercise: The patient was positioned in a supine position. The patient was asked to perform quadriceps isometric contractions while the ankle is in dorsiflexed to cause proximal patella glide as the knee is held in full extension. Group C It included 22 patients who received the same physical agents as group A performed CKC exercises. Each CKC exercise involved three sets of ten repetitions /session for three sessions/week for five weeks. The first CKC exercise: The patient was positioned in a supine position. The patient was asked to perform leg press while sitting. This included a single or double one-third bending of the knee. The second CKC exercise: The patient was positioned in a supine position. The patient was asked to perform CKC exercise using the rowing machine. The third CKC exercise: The patient was asked to perform step-up and down, the participant performed forward, backward and lateral step-ups and step-downs using a 5cm – high sturdy wooden box. The participants trunk was kept upright and he/she ensured that his/her heel was the last to leave the floor and the last to return in order to emphasize the activities of the quadriceps muscle. The participant performed 10 repetitions of each component of the exercise. This exercise was carried out during the fifth week of the study only. |
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Description for medicine or protocol of treatment in detail: |
Material and Methods Design A randomized study was conducted to investigate the effect of three different physical therapy programs on the overall function and disability of the knee joint in patients with knee OA. The study was conducted after getting the approval of the ethical committee of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. An informed consent was given to each patient prior to participation in this study. All patients were diagnosed with a unilateral OA of the knee by one orthopedic surgeon who utilized clinical findings and imaging, such as X-ray. X-ray was used to confirm stage of arthritis. Patients recruitment All patients in this study were chosen from Rehabilitation medicine and physical therapy clinic, Tongji Hospital, HUST University, Wuhan, China. Eighty patients were initially examined. The inclusion criteria included unilateral knee osteoarthritis based on the radiological and clinical criteria for osteoarthritis diagnosis, the patients were able to walk for 100m or more on a surface that is uneven, having full passive ROM at both left and right knee and they have knee pain lasting over 6 months. The exclusion criteria included any surgical history in the last 6 months on lower extremities, injection of steroids or hyaluronic acid in the articular cartilage, diabetes mellitus, communicative or cognitive impairments, congenital abnormalities, heart problems, neurological disease, unstable angina, total or partial hip or knee replacement, uncontrolled hypertension, traumatic conditions, respiratory diseases, musculoskeletal diseases, chronic kidney or liver diseases and stroke patients. Fourteen patients were excluded after the initial examination, they included eight patients (10 %) did not meet the inclusion criteria and six patients (7.5%) assessed only at the baseline and didnt continue the study. The patients that didnt meet the inclusion criteria were having a total hip replacement (2) uncontrolled hypertension (3) unstable angina. A sample of 66 (82.5%) patients was eligible to participate in this study. Their age ranged from 40 to 70 years old. They were randomized by using randomized permuted blocks to accomplish the balance of the sample sizes among the three groups. The three groups included group A (physical agents and isometric quadriceps muscle exercise) and group B (physical agents and OKC) and group C (physical agents and CKC). The randomization was done by a colleges staff who wasnt involved in this study. The patients were examined both at the baseline and after 5 weeks. The demographic data for group A: age 47.5 ±5.87 years, mean BMI 37.5±3.24 kg/m2, for group B: age 48.5±6 years, mean BMI 37.3±3.24 kg/m2 and group C : age 48±6.16 years, mean BMI 37.1±3.24 kg/m2. Evaluative procedures 1. Knee ROM measurement An electric-goniometer was used to measure the changes in the knee ROM of flexion and extension in this study. Goniometers are considered a validated and reliable measure for assessing the knee ROM in patients with knee OA(26). The electro-goniometer was calibrated in three different angles (180o, 90o and zero). This method of calibration is repeated each time the device was used to allow the accuracy of the measurement each time used. The measurement of the knee ROM was performed according to Reese and Bandy. 2- Knee pain measurement Knee pain severity was measured using visual analog scale (VAS) scale. VAS is a reliable and validated method of measuring pain severity. The VAS horizontal line is 10 cm and was interpreted based on a scale from 0 cm = no pain to 10 cm = severe pain. All patients were given the VAS and asked to indicate a mark on the horizontal line at the point they could feel pain. Quantification of the measurement was done using a ruler then recorded for each patient from left point (no pain) to the mark indicated by the participant. 3. Muscle torque Muscle torque of bilateral knee extensors and flexors was tested at 60, 120, and 180°/s using a Con-Trex isokinetic dynamometer (Con-Trex MJ; CMV AG, Dubendorf, Switzerland) the strength testing was carried out in the order of 120°/s, 180°/s, and then 60°/s to control for the effects of fatigue. Standard positioning was used for this assessment. Participants sat leaning against a backrest inclined 15° backward from vertical and were secured to the machine at the upper chest, pelvis, and distal femur on the tested side. The participants were instructed to extend the knee as far as possible, and then to flex as far as the device allowed. Among the records of the 3 trials at each speed, the highest values were recorded as the peak torque. All data were corrected for the gravity. 4. Knee functional condition Functional condition of the knee was measured based on the WOMAC scale. The WOMAC scale includes 17 items on physical function with response categories from 1 = none to 5 = extreme. Total scores are created by summing up the scores for each item. This WOMAC index is known to be a responsive, validated and reliable measure of knee osteoarthritis effects like functional condition. Treatment procedures The physical therapy program for three groups was equal in time (60 min/session, 3seesions/week for 5 weeks). Group A It included 22 patients who were given physical agents and isometric quadriceps exercise. The physical agents were performed according to the protocol of Fransen et al because it is the most used protocol for the treatment of knee OA. It included transcutaneous electrical neuromuscular stimulation (T.E.N.S), hot pack, and ultrasound (U.S). Conventional TENS by using physiodyn-Basic electro therapy device (physiomed elektromedizin, Schnaittach, Germany) was applied to the painful areas of the knee for 30 minutes. The TENS unit was adjusted to a frequency of 100 Hz and a pulse duration of 60 μsn with an intensity accepted by the patients. The hot pack was applied at the knee for 15 minutes. Physioson-basic ultrasound device (physiomed elektromedizin, Schnaittach, Germany) was used with a continuous mode three times a week for 5 weeks (15 treatment sessions) with the frequency of 1 MHz for deep penetration and with an intensity of 1.5 W/cm2 with gel applied. Additionally, the patients performed an isometric quadriceps exercise. Patients lay in a supine position, put rolled towel under the affected knee then ask the patient to contract his\her quadriceps muscle during press on rolled towel and held contraction for 5 seconds. Group B It included 22 patients. They received the same physical agents as group A in addition to OKC exercises. Each exercise involved three sets of ten repetitions and held for about 10 seconds. The first OKC exercise: The patient was positioned in a supine position with bolster placed under the knee. The patient was asked to straighten the affected leg up to full extension for about 10 seconds, and then lower the same leg back gently to the floor. Visual feedback and verbal encouragement were used(15). The second OKC exercise: The patient was positioned in a side-lying position. The patient was asked to adduct the affected leg. The leg that is not affected was in the upward position with flexion of the knee while affected leg placed against the bed. The leg was then lifted up to adduction for about 10 seconds before being lowered gently back. The third OKC exercise: The patient was positioned in a supine position. The patient was asked to perform quadriceps isometric contractions while the ankle is in dorsiflexed to cause proximal patella glide as the knee is held in full extension. Group C It included 22 patients who received the same physical agents as group A performed CKC exercises. Each CKC exercise involved three sets of ten repetitions /session for three sessions/week for five weeks. The first CKC exercise: The patient was positioned in a supine position. The patient was asked to perform leg press while sitting. This included a single or double one-third bending of the knee. The second CKC exercise: The patient was positioned in a supine position. The patient was asked to perform CKC exercise using the rowing machine. The third CKC exercise: The patient was asked to perform step-up and down, the participant performed forward, backward and lateral step-ups and step-downs using a 5cm – high sturdy wooden box. The participants trunk was kept upright and he/she ensured that his/her heel was the last to leave the floor and the last to return in order to emphasize the activities of the quadriceps muscle. The participant performed 10 repetitions of each component of the exercise. This exercise was carried out during the fifth week of the study only. |
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纳入标准: |
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Inclusion criteria |
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排除标准: |
过去6个月中有下肢手术史、于关节软骨注射激素或透明质酸、糖尿病、交流或认知障碍、认识异常、心脏问题、神经系统疾患、不稳定性心绞痛、全或部分髋关节或膝关节置换术、未控制高血压、外伤、呼吸系统病患、骨骼肌肉系统疾病、慢性肾病或肝脏疾病,以及卒中患者。 |
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Exclusion criteria: |
The exclusion criteria included any surgical history in the last 6 months on lower extremities, injection of steroids or hyaluronic acid in the articular cartilage, diabetes mellitus, communicative or cognitive impairments, congenital abnormalities, heart problems, neurological disease, unstable angina, total or partial hip or knee replacement, uncontrolled hypertension, traumatic conditions, respiratory diseases, musculoskeletal diseases, chronic kidney or liver diseases and stroke patients. |
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研究实施时间: Study execute time: |
从 From 2016-10-11 00:00:00至 To 2017-11-16 00:00:00 |
征募观察对象时间: Recruiting time: |
从 From 2017-07-05 00:00:00 至 To 2017-10-16 00:00:00 |
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干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
结束 /Completed |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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随机方法(请说明由何人用什么方法产生随机序列): |
分段随机 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
They were randomized by using randomized permuted blocks to accomplish the balance of the sample sizes among the three groups. The three groups included group A (physical agents and isometric quadriceps muscle exercise) and group B (physical agents and OKC) and group C (physical agents and CKC). The randomi |
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是否公开试验完成后的统计结果: Calculated Results after the Study Completed public access: |
不公开/Private |
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盲法: |
单盲 |
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Blinding: |
single blinded. |
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是否共享原始数据: IPD sharing |
否No |
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共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址): |
通过ResMan提供原始数据查询 |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
IPD will be public accessable via ResMan |
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数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC: |
Patient’s recruitment All patients in this study were chosen from Rehabilitation medicine and physical therapy clinic, Tongji Hospital, HUST University, Wuhan, China. Eighty patients were initially examined. The inclusion criteria included unilateral knee osteoarthritis based on the radiological and clinical criteria for osteoarthritis diagnosis, the patients were able to walk for 100m or more on a surface that is uneven, having full passive ROM at both left and right knee and they have knee pain lasting over 6 months. The exclusion criteria included any surgical history in the last 6 months on lower extremities, injection of steroids or hyaluronic acid in the articular cartilage, diabetes mellitus, communicative or cognitive impairments, congenital abnormalities, heart problems, neurological disease, unstable angina, total or partial hip or knee replacement, uncontrolled hypertension, traumatic conditions, respiratory diseases, musculoskeletal diseases, chronic kidney or liver diseases and stroke patients. Fourteen patients were excluded after the initial examination, they included eight patients (10 %) did not meet the inclusion criteria and six patients (7.5%) assessed only at the baseline and didn’t continue the study. The patients that didn’t meet the inclusion criteria were having a total hip replacement (2) uncontrolled hypertension (3) unstable angina. A sample of 66 (82.5%) patients was eligible to participate in this study. Their age ranged from 40 to 70 years old. They were randomized by using randomized permuted blocks to accomplish the balance of the sample sizes among the three groups. The three groups included group A (physical agents and isometric quadriceps muscle exercise) and group B (physical agents and OKC) and group C (physical agents and CKC). The randomization was done by a college’s staff who wasn’t involved in this study. The patients were examined both at the baseline and after 5 weeks. The demographic data for group A: age 47.5 ±5.87 years, mean BMI 37.5±3.24 kg/m2, for group B: age 48.5±6 years, mean BMI 37.3±3.24 kg/m2 and group C : age 48±6.16 years, mean BMI 37.1±3.24 kg/m2. |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
Patient’s recruitment All patients in this study were chosen from Rehabilitation medicine and physical therapy clinic, Tongji Hospital, HUST University, Wuhan, China. Eighty patients were initially examined. The inclusion criteria included unilateral knee osteoarthritis based on the radiological and clinical criteria for osteoarthritis diagnosis, the patients were able to walk for 100m or more on a surface that is uneven, having full passive ROM at both left and right knee and they have knee pain lasting over 6 months. The exclusion criteria included any surgical history in the last 6 months on lower extremities, injection of steroids or hyaluronic acid in the articular cartilage, diabetes mellitus, communicative or cognitive impairments, congenital abnormalities, heart problems, neurological disease, unstable angina, total or partial hip or knee replacement, uncontrolled hypertension, traumatic conditions, respiratory diseases, musculoskeletal diseases, chronic kidney or liver diseases and stroke patients. Fourteen patients were excluded after the initial examination, they included eight patients (10 %) did not meet the inclusion criteria and six patients (7.5%) assessed only at the baseline and didn’t continue the study. The patients that didn’t meet the inclusion criteria were having a total hip replacement (2) uncontrolled hypertension (3) unstable angina. A sample of 66 (82.5%) patients was eligible to participate in this study. Their age ranged from 40 to 70 years old. They were randomized by using randomized permuted blocks to accomplish the balance of the sample sizes among the three groups. The three groups included group A (physical agents and isometric quadriceps muscle exercise) and group B (physical agents and OKC) and group C (physical agents and CKC). The randomization was done by a college’s staff who wasn’t involved in this study. The patients were examined both at the baseline and after 5 weeks. The demographic data for group A: age 47.5 ±5.87 years, mean BMI 37.5±3.24 kg/m2, for group B: age 48.5±6 years, mean BMI 37.3±3.24 kg/m2 and group C : age 48±6.16 years, mean BMI 37.1±3.24 kg/m2. |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
有/Yes |