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Evaluation of the Effects of Home-based Functional Exercise on Patients With ACL

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ClinicalTrials.gov Identifier: NCT03890848
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Peking University Third Hospital

Tracking Information
First Submitted Date  ICMJE March 11, 2019
First Posted Date  ICMJE March 26, 2019
Last Update Posted Date April 26, 2019
Actual Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2019)
  • qualified rate of knee joint activity [ Time Frame: 6 weeks after surgery ]
    Knee joint activity reaches 125 degrees or above is judged to be qualified. Qualified rate is equal to the number of people who meet the standard divided by the total number in each group.
  • qualified rate of knee joint activity [ Time Frame: 2 weeks after surgery ]
    Knee joint activity reaches 125 degrees or above is judged to be qualified. Qualified rate is equal to the number of people who meet the standard divided by the total number in each group.
  • qualified rate of knee joint activity [ Time Frame: 12 weeks after surgery ]
    Knee joint activity reaches 125 degrees or above is judged to be qualified. Qualified rate is equal to the number of people who meet the standard divided by the total number in each group.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2019)
  • Visual Analogue Scale [ Time Frame: 2,6,12 weeks after surgery ]
    The Visual Analog or Analogue Scale (VAS) is designed to present to the respondent a rating scale with minimum constraints. Respondents mark the location on the 10-centimeter line corresponding to the amount of pain they experienced. This gives them the greatest freedom to choose their pain's exact intensity. It also gives the maximum opportunity for each respondent to express a personal response style. VAS data of this type is recorded as the number of millimeters from the left of the line with the range 0-100.
    1. Aitken, R. C. B. (1969). Measurement of feelings using visual analogue scales. Proceedings of the Royal Society of Medicine. 62, 989 - 993
    2. Freyd, M. (1923). The graphic rating scale. Journal of Educational Psychology, 43, 83 - 102
    3. Hayes, M. H. S. & D. G. Patterson (1921). Experimental development of the graphic rating method. Psychological Bulletin, 18, 98-99
  • SF-12 scale [ Time Frame: 2,6,12 weeks after surgery ]
    The SF-12 scale is a simplified version of the Universal Concise Health-Related Quality of Life Scale SF-36 scale developed by the Boston Institute of Health Education. It includes 12 items and 8 dimensions for assessing physiological and psychological conditions. WARE J Jr,KOSINSKI M,KELLER S D.A 12-Item Short-Form Health Survey:construction of scales and preliminary tests of reliability and validity[J].Med Care,1996,34(3):220-233.
  • International Knee Documentation Committee (IKDC) Subjective Knee Form [ Time Frame: 2,6,12 weeks after surgery ]
    International Knee Documentation Committee (IKDC) score: The IKDC score is divided into pain, stiffness, and difficulty in daily life. The score is 60. The lower the score, the better the knee function. van de Graaf, V. A., Wolterbeek, N., Scholtes, V. A. B., Mutsaerts, E. L. A. R., & Poolman, R. W. (2014). Reliability and Validity of the IKDC, KOOS, and WOMAC for Patients With Meniscal Injuries. The American Journal of Sports Medicine, 42(6), 1408-1416. https://doi.org/10.1177/0363546514524698
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Effects of Home-based Functional Exercise on Patients With ACL
Official Title  ICMJE Evaluation of the Effects of Home-based Functional Exercise on Patients With Anterior Cruciate Ligament Rupture Reconstruction Based on the Health Belief Model
Brief Summary This study will evaluate the effect of home-based functional exercise on patients with anterior cruciate ligament rupture reconstruction based on the health belief model. About 360 participants will be randomly allocated into two groups. One group will randomized to receive precautions and rehabilitation progress reminders and other news by optimized WeChat applet regularly, while the other group will randomized to receive the rehabilitation exercise guidance during routine discharge.
Detailed Description With the development of national fitness and sports, the incidence of anterior cruciate ligament (ACL) injuries has increased. ACL reconstruction is the best treatment for ACL injury. The success rate of surgery is high, but the patient still needs to rehabilitate after surgery, otherwise it is difficult to fully recover knee function. However, the rehabilitation medical resources in China are obviously insufficient. Patients who have undergone ACL reconstruction usually return home to work according to the rehabilitation plan. However, the adherence is still poor, and it is difficult to achieve the expected effect. The WeChat public account and its affiliated applets have been widely used in different health fields. The Health Belief Model (HBM) is a guiding theory commonly used in health education to guide patients for behavioral changes. This study aims to use the WeChat small program to explore the effects of optimized the existing Peking University Third Hospital Sports Medicine WeChat small program by using HBM to improve the adherence of patients with home-based functional exercise after ACL injury reconstruction.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Anterior Cruciate Ligament Rupture
  • Rehabilitation
Intervention  ICMJE
  • Behavioral: Wechat application reminder intervention
    precautions and rehabilitation progress reminders and other news by optimized WeChat applet regularly
  • Behavioral: routine guidance during discharge
    rehabilitation exercise guidance during routine discharge
Study Arms  ICMJE
  • Experimental: Wechat application intervention
    precautions and rehabilitation progress reminders and other news by optimized WeChat applet regularly
    Intervention: Behavioral: Wechat application reminder intervention
  • Active Comparator: routine guidance during discharge
    rehabilitation exercise guidance during routine discharge
    Intervention: Behavioral: routine guidance during discharge
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 25, 2019)
110
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • (1)Age between 18 and 45;
  • (2)The first time to do simple ACL reconstruction, may be combined with cartilage -dressing and partial meniscectomy, patients with consistent postoperative rehabilitation plans;
  • (3)Having the ability of Basic literacy, communication and accessibility;
  • (4)Having a smartphone, using WeChat or can learn to use WeChat.

Exclusion Criteria:

  • (1)Having history of joint infection, joint tuberculosis or osteomyelitis, or surgery in the lower extremities within 6 months;
  • (2)Being combined with severe heart, brain, kidney and other organ dysfunction;
  • (3)Having other serious knee injuries;
  • (4)Being with mental illness or cognitive impairment, unable to learn and participate in rehabilitation training;
  • (5)Having participated in other similar rehabilitation function training programs, or transferred to other medical institutions after discharge;
  • (6)Doing not disagree to participate in the study,and not sign the informed consent.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yang +8613611000816 yyyyppvip@sina.com
Contact: Chu +86-01082266671 18810530974@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03890848
Other Study ID Numbers  ICMJE BMU2018MX030
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Peking University Third Hospital
Study Sponsor  ICMJE Peking University Third Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Yuping Yang, doctor Peking University Health Science Center
PRS Account Peking University Third Hospital
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP