该研究尚未获得伦理委员会批准。请于批准后才开始纳入参试者,并与我们联系上传批件 新型冠状病毒肺炎(COVID-19)患者康复护理方案的临床效果研究

注册号:

Registration number:

ChiCTR2000031540 

最近更新日期:

Date of Last Refreshed on:

2020-04-04 00:02:14 

注册时间:

Date of Registration:

2020-04-03 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

该研究尚未获得伦理委员会批准。请于批准后才开始纳入参试者,并与我们联系上传批件 新型冠状病毒肺炎(COVID-19)患者康复护理方案的临床效果研究

Public title:

Study for clinical effect of rehabilitation nursing program for patients with novel coronavirus pneumonia (COVID-19)

注册题目简写:

English Acronym:

研究课题的正式科学名称:

新型冠状病毒肺炎(COVID-19)患者康复护理方案的临床效果研究

Scientific title:

Study for clinical effect of rehabilitation nursing program for patients with novel coronavirus pneumonia (COVID-19)

研究课题代号(代码):

Study subject ID:

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:

申请注册联系人:

黄迪 

研究负责人:

江智霞 

Applicant:

Huang Di 

Study leader:

Jiang ZhiXia 

申请注册联系人电话:

Applicant telephone:

+86 18585854884

研究负责人电话:

Study leader's
telephone:

+86 19385219073

申请注册联系人传真 :

Applicant Fax:

研究负责人传真:

Study leader's fax:

申请注册联系人电子邮件:

Applicant E-mail:

350478705@qq.com

研究负责人电子邮件:

Study leader's E-mail:

jzxhl@126.com

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):

申请注册联系人通讯地址:

贵州省遵义市汇川区大连路149号

研究负责人通讯地址:

贵州省遵义市汇川区大连路149号

Applicant address:

149 Dalian Road, Huichuan District, Zunyi, Guizhou, China

Study leader's address:

149 Dalian Road, Huichuan District, Zunyi, Guizhou, China

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:

申请人所在单位:

遵义医科大学附属医院

Applicant's institution:

Affiliated Hospital of Zunyi Medical University

研究负责人所在单位:

遵义医科大学附属医院

Affiliation of the Leader:

Affiliated Hospital of Zunyi Medical University

是否获伦理委员会批准:

Approved by ethic committee:

No

伦理委员会批件文号:

Approved No. of ethic committee:

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

Name of the ethic committee:

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 00:00:00

伦理委员会联系人:

Contact Name of the ethic committee:

伦理委员会联系地址:

Contact Address of the ethic committee:

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:

研究实施负责(组长)单位:

遵义医科大学附属医院

Primary sponsor:

Affiliated Hospital of Zunyi Medical University

研究实施负责(组长)单位地址:

贵州省遵义市汇川区大连路149号

Primary sponsor's address:

149 Dalian Road, Huichuan District, Zunyi, Guizhou, China

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

贵州

市(区县):

Country:

China

Province:

Guizhou

City:

单位(医院):

遵义医科大学附属医院

具体地址:

贵州省遵义市汇川区大连路149号

Institution
hospital:

Affiliated Hospital of Zunyi Medical University

Address:

149 Dalian Road, Huichuan District, Zunyi

经费或物资来源:

无经费

Source(s) of funding:

Not

研究疾病:

新型冠状病毒肺炎(COVID-19)  

Target disease:

Novel Coronavirus Pneumonia (COVID-19)

研究疾病代码:

Target disease code:

研究类型:

干预性研究

Study type:

Interventional study

研究所处阶段:

I期临床试验 

Study phase:

1

研究设计:

病例对照研究 

Study design:

Case-Control study 

研究目的:

改善新冠肺炎出院患者呼吸困难症状和功能障碍,减少并发症,缓解焦虑抑郁情绪,降低致残率,最大程度恢复日常生活活动能力、提高生活质量。  

Objectives of Study:

To improve the symptoms of dyspnea and dysfunction of patients with new coronary pneumonia discharged from hospital, reduce complications, relieve anxiety and depression, reduce disability, maximize the ability of daily living and improve the quality of life.

药物成份或治疗方案详述:

1.呼吸功能锻炼 缩唇呼吸训练、腹式呼吸训练及全身呼吸操。 (1)轻型及普通型: 训练项目:缩唇呼吸训练、腹式呼吸训练、全身呼吸操。 1)缩唇呼吸训练和腹式呼吸训练,每日4组,每组进行8-10次;分别于7:00-7:15、9:00-9:15、16:00-16:15、22:30-23:00,由医务人员指导或病人自行完成。 2)全身呼吸操:每日2组,每组完成颈部运动、扩胸运动、转身运动、旋腰运动、侧曲运动、蹲起运动、原地踏步各2次。于9:00-9:15、16:00-16:15,在医务人员指导下完成。 (2)重型/危重型: 1)训练方式:遵循由卧位、坐位、离床坐位、站位的顺序依次进行。医务人员监测病人心率、血压、血氧饱和度变化,维持血氧饱和度≥93%,心率≤120次/分。根据病人自觉症状和体征决定是否继续。时间控制在10-15分钟以内。 2)训练项目:缩唇呼吸训练、腹式呼吸训练、全身呼吸操。 ①缩唇呼吸训练和腹式呼吸训练:每日3组,每组8-10次;分别于9:00-9:15、16:00-16:15、22:30-22:45在医务人员监测指导下进行。 ②全身呼吸操: 患者坐位时可完成颈部运动、扩胸运动、转身运动、旋腰运动、侧曲运动;站位时可完成颈部运动、扩胸运动、转身运动、旋腰运动、侧曲运动、原地踏步、蹲起运动;每日2组,分别于9:00-9:15,16:00-16:15,由医务人员监测指导完成。   2.躯体功能训练   (1)有氧运动:针对患者合并的基础疾病和遗留功能障碍问题制订有氧运动处方。轻型及普通型,包括踏步、慢走、快走、慢跑、太极拳、八段锦等运动形式;重型/危重型,对于容易疲劳的患者可采取间歇运动形式进行。 一、轻型及普通型患者: 训练项目:八段锦、太极拳、广播体操、根据患者的运动习惯和爱好选择自选项目(慢走、快走、慢跑、羽毛球、乒乓球、跳绳等) 各训练项目具体安排: 八段锦:每日2次,每次15分钟; 太极拳:每日2次,每次10分钟; 广播体操:每日2次,每次1遍; 自选项目:病人根据身体承受能力以及喜好选择慢走、快走、慢跑、羽毛球、乒乓球、跳绳等其中一项完成,每日2次,每次10分钟。 各项目于每日09:00-11:00、15:00-17:00在医务人员陪同指导下完成。 2)重型/危重型 ①训练方式:遵循由卧位、坐位、离床坐位、站位的顺序依次进行。医务人员监测病人心率、血压、血氧饱和度变化,维持血氧饱和度≥93%,心率≤130次/分,根据病人自觉症状和体征决定是否继续,时间控制在10-15分钟以内。 ②训练项目: A.床上运动 四肢关节肌肉运动(依次进行掌指关节抓握训练、腕关节屈伸、肘关节屈伸、上肢上举及后旋,踝泵训练、屈膝训练、空中踩单车训练)、抬高床头-坐位训练、床上坐位、上下肢踏步机训练;每个动作2个八拍,每天两次,分别于9:30、16:30在医务人员指导下完成。 B.离床运动 上下肢踏步机训练、站立、原地踏步、慢走、八段锦等。 a.上下肢踏步机训练:在无阻力下上下肢各完成4个八拍,每天两次; b.站立/原地踏步/慢走:交替进行,总活动时间控制在10-15分钟; c.八段锦:每日2次,每次运动时间由医务人员以不超过病人基础心率20%为标准,实时评估病人身体状况决定; 离床运动每天两次,分别于09:00-11:00、15:00-17:00在医务人员陪同、指导和监护下进行,以间歇运动形式为主,医务人员根据病人自觉症状并评估病人心率、血压、血氧饱和度、身体情况决定是否继续。其余项目如太极、广播体操等可比照轻型及普型患者,在评估生命体征和患者自觉症状后,根据患者个人喜好选择。 (2)力量训练 训练器械:哑铃。 1)哑铃重量选择:病人首次使用哑铃进行锻炼,能连续完成12次弯举的最大重量为病人选择哑铃重量的基础重量;之后,用以上方法每两周评估一次,以此调整病人训练用哑铃重量。 2)训练项目:哑铃弯举2组,每组12次,组间休息1分钟;哑铃交替锤举2组,每组12次,组间休息1分钟,不同项目间休息3-5分钟;另外,病人可以根据自身情况选择1-2项其他训练项目;训练结束记录每个项目的用时。 3)训练时间:每周3次,每次训练总时间不超过30分钟;时间安排在周一、周 三、周五15:00-16:00。 4)病人评估:病人锻炼前评估病人心率、血压、血氧饱和度以及身体情况;完成哑铃弯举、哑铃交替锤举2个项目后,再次评估病人心率、血压、血氧饱和度以及身体情况。 3.日常生活活动能力训练   根据患者生活能力,鼓励患者参与自我生活护理,逐步恢复至正常。对患者进行日常生活活动指导。轻、普型,包括自理能力、交流、日常家务劳动等;重、危重型,主要是节能技术指导,将穿脱衣、如厕、洗澡等日常生活活动动作分解成小节间歇进行。 1)轻型、普通型 采用指导和督查方式完成以下生活活动能力训练 A.自理方面:更衣、进食、入厕、洗漱、修饰(梳头、刮胡子、化妆、修剪指甲等)。 B.交流方面:识别环境标记、使用电子信息化设备与外界沟通等 C.家务劳动方面:点餐、洗衣、照顾孩子,使用家用器具和环境控制器如电源开关、水龙头和钥匙等,做好消防安全隐患排查。 2)重型/危重型: 采用指导和协助方式将动作分解成小节间歇完成以下生活活动能力训练,随着体力恢复再连贯完成。 A.自理方面:更衣:根据个人喜好选择式样,教会套头式和纽扣/拉链式穿衣方法、进食:根据患者的基础病和饮食喜好搭配营养膳食、入厕:厕所安装安全扶手和马桶,便秘时协助患者通便、洗漱可采用坐位和站立位、修饰(梳头、刮胡子、修剪指甲等)。 B.交流方面:教会老年患者使用手机与家人打电话、视频、聊天、看新闻等。鼓励患者表达自己的想法。 C.家务劳动方面:协助患者整理环境、物品归类放置,指导患者清洗小件衣裤袜。教会患者使用电视、空调遥控器等。 4.心理康复干预 (1)心理评估:了解出院患者心理健康状况,关注重点人群,根据心理评估筛查 结果,及时识别高危人群。 (2)心理干预:运用专业方法进行心理危机干预,避免不良事件的发生。开展心理健康教育、身体扫描练习、工娱疗法、表达性艺术治疗,通过自身体验、讲座、电台诵读及小鱼易连远程心理治疗等进行心理干预。 (3)心理支持:运用心灵加油站互助群平台,同伴互助,携手同行。 5.膳食管理 (1)保证能量充足,确保优质蛋白质类食物的摄入,如瘦肉、蛋、大豆、奶、鱼、虾等。 (2)增加新鲜蔬菜水果的摄入,尽量多吃深色蔬菜。 (3)适当增加富含单不饱和脂肪酸等茶油、橄榄油、菜籽油的摄入,对炎症康复有好处。 (4)保证充足饮水量,可选择白开水或淡茶水,菜汤、鱼汤、鸡汤等。水是营养素运输的载体和保持内环境稳定所必需,也有呼吸器官润滑作用。 (5)三餐吃好,规律作息,保证睡眠。 (6)如有进食不足,可考虑选用营养素补充剂、营养强化食品、奶粉等为补充。 6.睡眠管理 (1)睡眠评估:使用匹兹堡睡眠质量指数(PSQI) 量表对患者的睡眠进行评估。评估频率:每周一次,直至出院。 (2)睡眠干预 1)行为干预:白天进行合理康复运动,如做“八段锦” “呼吸功能锻炼”“广播体操”等保证病人日间活动量;睡前进行“乐眠操”的练习;指导睡前少饮水、排尽小便、足部保暖;睡前1 h不做容易引起兴奋的脑力劳动或看手机、平板等,中途醒来不看电子产品。 2)物理干预:使用中药香薰(香包)疗法、穴位拍打、中药足浴、针灸等。并联合采用睡眠音乐、睡前冥想、腹式呼吸等方法帮助患者进行睡眠。 3)饮食干预:睡前不暴饮暴食或进食不宜消化的食物,睡前4~6 h避免饮用咖啡、浓茶等以免失眠;可饮用热牛奶,且在睡前泡脚,有利于提高睡眠质量; 4)环境干预: 入睡前保持房间安静,尽可能减少噪音,拉上窗帘,以便于营造良好睡眠环境。 5)心理干预:对患者进行心理支持与心理睡眠知识的健康宣教,帮助其提高睡眠质量。 (3)终止标准:患者PSQI ≤ 7 分或患者出院。 

Description for medicine or protocol of treatment in detail:

Respiratory function exercise Reducing lip breathing training, abdominal breathing training and whole body breathing exercises. (1) Light and ordinary: Training items: Reducing lip breathing training, abdominal breathing training, whole body breathing exercises. 1) Lip-reduction breathing training and abdominal breathing training, 4 groups daily, 8-10 times per group; 7: 00-7: 15, 9: 00-9: 15, 16: 00-16: 15 22: 30-23: 00, guided by medical staff or completed by the patient. 2) Whole body breathing exercises: 2 groups daily, each group completes neck exercise, chest expansion exercise, turning exercise, waist rotation exercise, side flexion exercise, squat exercise, and in-situ stepping twice. It will be completed at 9: 00-9: 15, 16: 00-16: 15 under the guidance of medical staff. (2) Heavy / critical: 1) Training method: follow the order from lying position, sitting position, leaving bed position, standing position. Medical staff monitor the changes of patients' heart rate, blood pressure, and blood oxygen saturation, maintain blood oxygen saturation ≥93%, and heart rate ≤120 beats / min. Decide whether to proceed based on the patient's symptoms and signs. The time is controlled within 10-15 minutes. 2) Training items: Reducing lip breathing training, abdominal breathing training, whole body breathing exercises. ① Lip-reducing breathing training and abdominal breathing training: 3 groups daily, 8-10 times each; in the medical service at 9: 00-9: 15, 16: 00-16: 15, 22: 30-22: 45 respectively Under the guidance of personnel monitoring. ② Whole body breathing exercises: The patient can complete neck movement, chest expansion exercise, turning exercise, waist rotation exercise, and side flexion exercise when the patient is seated; neck movement, chest expansion exercise, turning exercise, waist rotation exercise, side curvature exercise, in situ when standing Stepping and squatting exercise; 2 groups daily, 9: 00-9: 15, 16: 00-16: 15, completed by medical staff monitoring and guidance. 2. Physical function training (1) Aerobic exercise: formulate aerobic exercise prescriptions for patients with combined basic diseases and residual dysfunction. Light and ordinary types, including stepping, jogging, brisk walking, jogging, Taijiquan, Baduanjin and other sports; heavy / critical heavy, for patients who are prone to fatigue can take intermittent exercise. 1. Light and common patients: Training items: Baduanjin, Taijiquan, radio gymnastics, choose optional items according to the patient's sports habits and hobbies (slow walking, fast walking, jogging, badminton, table tennis, skipping rope, etc.) Specific arrangements for each training item: Baduanjin: 2 times a day, 15 minutes each time; Taijiquan: 2 times a day, 10 minutes each time; Broadcast gymnastics: 2 times a day, 1 time each time; Optional items: Patients can choose one of jogging, brisk walking, jogging, badminton, table tennis, and rope skipping, etc., twice a day for 10 minutes each time. Each project is completed daily from 09: 00-11: 00 and 15: 00-17: 00 with the guidance of medical staff. 2) Heavy / critical ① Training method: follow the order from lying position, sitting position, out of bed sitting position, standing position. Medical staff monitor the patient's heart rate, blood pressure, and blood oxygen saturation changes, maintain blood oxygen saturation ≥93%, heart rate ≤130 beats / min, and decide whether to continue according to the patient's conscious symptoms and signs, and control the time within 10-15 minutes. ② Training items: A. Bed movements Extremities joint muscle exercise (carpal and knuckle grasping training, wrist flexion and extension, elbow flexion and extension, upper limb lifting and back rotation, ankle pump training, knee flexion training, aerial cycling training), raising the bed head- Sitting training, bed sitting, upper and lower extremity stepper training; 2 eight beats per exercise, twice a day, completed at 9:30 and 16:30 under the guidance of medical staff. B. Out of bed exercises Upper and lower limb stepper training, standing, stepping in place, walking slowly, Baduanjin, etc. a. Upper and lower extremity stepper training: Complete four eight beats for each of the upper and lower extremities without resistance, twice a day; b. Standing / Standing / Walking slowly: Alternately, the total activity time is controlled within 10-15 minutes; c. Baduanjin: 2 times a day, each exercise time is determined by the medical staff to not exceed the patient's basic heart rate by 20% in real time; The out-of-bed exercise is performed twice a day at 09: 00-11: 00, 15: 00-17: 00, accompanied by medical staff, under the guidance and supervision, and is mainly in the form of intermittent exercise. The medical staff evaluates and evaluates the patient's symptoms. The patient's heart rate, blood pressure, blood oxygen saturation, and physical condition determine whether to continue. The remaining items such as Tai Chi and radio gymnastics can be compared with light and general patients. After assessing vital signs and patient's subjective symptoms, they can choose according to the patient's personal preference. (2) Strength training Training equipment: dumbbells. 1) Dumbbell weight selection: The patient uses dumbbells for the first time to exercise, and the maximum weight that can be completed for 12 consecutive curls is the basic weight of the patient's choice of dumbbell weights. After that, the above method is used to evaluate the dumbbells every two weeks to adjust the patient training dumbbell weight. 2) Training items: 2 sets of dumbbell curls, 12 times in each group, 1 minute rest between groups; dumbbells alternately lift 2 sets of 12 times in each group, 1 minute rest between groups, 3-5 minutes rest between different items; , The patient can choose 1-2 other training items according to his own situation; record the time spent for each item at the end of the training. 3) Training time: 3 times a week, the total time of each training does not exceed 30 minutes; the time is arranged on Monday and week Wednesday and Friday 15: 00-16: 00. 4) Patient evaluation: Evaluate the patient's heart rate, blood pressure, blood oxygen saturation, and physical condition before exercise. After completing the two items of dumbbell curl, alternate dumbbell lifting, evaluate the patient's heart rate, blood pressure, blood oxygen saturation, and physical condition again. . 3. Activities of daily living ability training Encourage patients to participate in self-life care and gradually return to normal according to their living ability. Guide daily activities for patients. Light and general, including self-care ability, communication, daily household chores, etc .; heavy and critical, mainly energy-saving technical guidance, breaking down daily life activities such as wearing clothes, using the toilet, bathing, etc. into intermittent intervals. 1) Light and ordinary Use the guidance and inspection methods to complete the following living activity ability training A. Self-care: changing, eating, going to the toilet, washing, grooming (comb hair, shave, make-up, trim nails, etc.). B. Communication: identifying environmental marks, using electronic information equipment to communicate with the outside world, etc. C. Housework: ordering meals, doing laundry, taking care of children, using household appliances and environmental controllers such as power switches, faucets and keys, to do a good job of checking fire safety hazards. 2) Heavy / critical: Use the guidance and assistance methods to break down the movements into sections to complete the following life activity ability training, and then complete it as the physical strength recovers. A. Self-care: changing clothes: choosing styles according to personal preferences, teaching hedging and button / zipper dressing methods, eating: matching nutritional meals according to the patient's basic illness and diet preferences, entering the toilet: installing safety handrails and toilets in the toilet, constipation To help patients laxative, wash and wash can be used in sitting and standing positions, grooming (comb hair, shave, trim nails, etc.). B. Communication: Elderly patients are taught to use their mobile phones to call, video, chat, and watch news with their families. Encourage patients to express their ideas. C. In the field of housework: assist the patient in organizing the environment, categorizing and placing the articles, and instruct the patient to wash small pieces of clothing and pantyhose. Teach patients to use TVs, air-conditioning remotes, and more. 4. Psychological rehabilitation intervention (1) Psychological assessment: understand the mental health status of discharged patients, focus on key populations, and screen based on psychological assessment As a result, high-risk groups are identified in a timely manner. (2) Psychological intervention: use professional methods for psychological crisis intervention to avoid adverse events. Carry out psychological health education, body scanning exercises, work and recreation therapy, expressive art therapy, and conduct psychological intervention through self-experience, lectures, radio reading, and remote fish psychotherapy. (3) Psychological support: Using the mutual help group platform of the spiritual gas station, peers help each other and go hand in hand. 5. Meal Management (1) Ensure sufficient energy and intake of high-quality protein foods, such as lean meat, eggs, soybeans, milk, fish, shrimp, etc. (2) Increase the intake of fresh vegetables and fruits, and eat as many dark vegetables as possible. (3) Properly increasing the intake of tea oil, olive oil, and rapeseed oil rich in monounsaturated fatty acids is good for inflammation and rehabilitation. (4) To ensure sufficient drinking water, you can choose boiling water or light tea, vegetable soup, fish soup, chicken soup, etc. Water is the carrier of nutrients transportation and necessary for keeping the internal environment stable. It also has the function of lubricating the respiratory organs. (5) Eat well for three meals, work regularly to ensure sleep. (6) If you do nt eat enough, consider using nutrient supplements, nutritionally fortified foods, and milk powder as supplements. 6. Sleep Management (1) Sleep assessment: Use the Pittsburgh Sleep Quality Index (PSQI) scale to assess the sleep of patients. Evaluation frequency: once a week until discharged. (2) Sleep intervention 1) Behavioral interventions: Perform reasonable rehabilitation exercises during the day, such as "Ba Duan Jin", "Respiratory Exercises" and "Broadcast Gymnastics" to ensure the patient's daytime activity; practice "music exercises" before bedtime; instruct less before bedtime Drink water, urinate, and keep your feet warm; do not do the mental work that is likely to cause excitement or look at mobile phones, tablets, etc. 1 h before going to bed. 2) Physical intervention: Chinese herbal aromatherapy (sachet) therapy, acupoint tapping, Chinese herbal foot bath, acupuncture, etc. Combined with sleep music, bedtime meditation, and abdominal breathing to help patients sleep. 3) Diet intervention: Do not overeating or eating foods that are not suitable for digestion before going to bed, avoid drinking coffee, strong tea, etc. to avoid insomnia 4 to 6 hours before going to bed; drink hot milk, and soak your feet before going to bed, which will help improve sleep quality; 4) Environmental intervention: Keep the room quiet before falling asleep, reduce noise as much as possible, and close the curtains to create a good sleeping environment. 5) Psychological intervention: Provide health education for patients with psychological support and psychological sleep knowledge to help them improve sleep quality. (3) Termination criteria: Patient PSQI ≤ 7 points or patient discharged. 

纳入标准:

Inclusion criteria

排除标准:

①心率>120次/分或<40次/分。
②.血压<90/60 mmHg或>140/90 mmHg。
③血氧饱和度≤90%或较基线值变化下降>4%。
④.呼吸频率>40次/分。
⑤孕妇或其他特殊人群。

Exclusion criteria:

1. Heart rate> 120 beats / min or <40 beats / min;
2. Blood pressure <90/60 mmHg or> 140/90 mmHg;
3. Blood oxygen saturation is <=90% or the change from baseline value is decreased by> 4%;
4. Respiratory frequency> 40 times / minute;
5. Pregnant women or other special groups.

研究实施时间:

Study execute time:

From 2020-02-05 00:00:00 To 2020-12-05 00:00:00  

征募观察对象时间:

Recruiting time:

From 2020-02-05 00:00:00 To 2020-07-05 00:00:00

干预措施:

Interventions:

组别:

试验组

样本量:

50

Group:

Experimental group

Sample size:

干预措施:

康复护理方案

干预措施代码:

Intervention:

Rehabilitation Nursing Program

Intervention code:

组别:

对照组

样本量:

50

Group:

Control group

Sample size:

干预措施:

常规康复护理

干预措施代码:

Intervention:

Routine rehabilitation care

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

贵州省 

市(区县):

 

Country:

China

Province:

Guizhou

City:

单位(医院):

贵州省将军山医院 

单位级别:

 

Institution
hospital:

Jiang Jun Shan Hospital of Guizhou Province

Level of the institution:

测量指标:

Outcomes:

指标中文名:

六分钟步行试验

指标类型:

主要指标

Outcome:

6minu tewalkingtest,6MWT

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

呼吸困难指数量表

指标类型:

主要指标

Outcome:

mMRC

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Borg自觉疲劳量表

指标类型:

主要指标

Outcome:

Rating of Perceived Exertion Scale

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抑郁自评量表

指标类型:

次要指标

Outcome:

SDS

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

焦虑自评量表

指标类型:

主要指标

Outcome:

SAS

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

失眠严重程度指数量表

指标类型:

次要指标

Outcome:

Insomnia severity index scale

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

改良巴氏指数评定表

指标类型:

次要指标

Outcome:

Improved Pap Index Index

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

徒手肌力检查

指标类型:

次要指标

Outcome:

MMT

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

not applicable

Tissue:

人体标本去向

使用后销毁  

说明

Fate of sample:

Destruction after use  

Note:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 80 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

计算机随机数字生成

Randomization Procedure (please state who generates the random number sequence and by what method):

Computer generated randomly

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

是Yes

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):

试验完成后,以论文的形式在中国知网数据库中公开

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

After the test is completed, it will be published in the CNKI as a paper.

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:

数据采集统一由专人,对患者采用纸质表格统一评估后,双人核对数据,无误后每日登记在EXCEl表格中进行管理。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

The data collection was uniformly performed by a special person. After the patients were uniformly evaluated using a paper form, the data was checked by two persons. After the data was correct, they were registered in the EXCEl form for management.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-04-03 23:52:48