Clinical trial NCT03890848: Evaluation of the Effects of Home-based Functional Exercise on Patients With ACL
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anterior Cruciate Ligament Rupture
Rehabilitation
Keywords: functional exercise
health belief model
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: qualified rate of knee joint activity
timeFrame: 6 weeks after surgery
measure: qualified rate of knee joint activity
timeFrame: 2 weeks after surgery
measure: qualified rate of knee joint activity
timeFrame: 12 weeks after surgery
Secondary outcomes:
measure: Visual Analogue Scale
timeFrame: 2，6，12 weeks after surgery
measure: SF-12 scale
timeFrame: 2，6，12 weeks after surgery
measure: International Knee Documentation Committee (IKDC) Subjective Knee Form
timeFrame: 2，6，12 weeks after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Health Science Center
name: Yuping Yang, doctor
role: STUDY_DIRECTOR
References: