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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Rupture Rehabilitation Behavioral: Wechat application reminder intervention Behavioral: routine guidance during discharge Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of the Effects of Home-based Functional Exercise on Patients With Anterior Cruciate Ligament Rupture Reconstruction Based on the Health Belief Model
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Wechat application intervention
precautions and rehabilitation progress reminders and other news by optimized WeChat applet regularly
Behavioral: Wechat application reminder intervention
precautions and rehabilitation progress reminders and other news by optimized WeChat applet regularly

Active Comparator: routine guidance during discharge
rehabilitation exercise guidance during routine discharge
Behavioral: routine guidance during discharge
rehabilitation exercise guidance during routine discharge




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.


  3. 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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03890848


Contacts
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Contact: Yang +8613611000816 yyyyppvip@sina.com
Contact: Chu +86-01082266671 18810530974@163.com

Locations
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China, Beijing
Peking University Third Hospital Recruiting
Beijing, Beijing, China, 100191
Contact: Yang    +86-13611000816    yyyyppvip@sina.com   
Principal Investigator: Yuping Yang         
Principal Investigator: Xinying Sun         
Sponsors and Collaborators
Peking University Third Hospital
Investigators
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Study Director: Yuping Yang, doctor Peking University Health Science Center
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Responsible Party: Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT03890848    
Other Study ID Numbers: BMU2018MX030
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peking University Third Hospital:
functional exercise
health belief model
Additional relevant MeSH terms:
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Rupture
Anterior Cruciate Ligament Injuries
Wounds and Injuries
Knee Injuries
Leg Injuries