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

Primary Purpose

Anterior Cruciate Ligament Rupture, Rehabilitation

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Wechat application reminder intervention
routine guidance during discharge
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anterior Cruciate Ligament Rupture focused on measuring functional exercise, health belief model

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking University Third HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Wechat application intervention

routine guidance during discharge

Arm Description

precautions and rehabilitation progress reminders and other news by optimized WeChat applet regularly

rehabilitation exercise guidance during routine discharge

Outcomes

Primary Outcome Measures

qualified rate of knee joint activity
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
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
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

Visual Analogue Scale
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. Aitken, R. C. B. (1969). Measurement of feelings using visual analogue scales. Proceedings of the Royal Society of Medicine. 62, 989 - 993 Freyd, M. (1923). The graphic rating scale. Journal of Educational Psychology, 43, 83 - 102 Hayes, M. H. S. & D. G. Patterson (1921). Experimental development of the graphic rating method. Psychological Bulletin, 18, 98-99
SF-12 scale
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
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

Full Information

First Posted
March 11, 2019
Last Updated
April 24, 2019
Sponsor
Peking University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03890848
Brief Title
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

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Rupture, Rehabilitation
Keywords
functional exercise, health belief model

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Wechat application intervention
Arm Type
Experimental
Arm Description
precautions and rehabilitation progress reminders and other news by optimized WeChat applet regularly
Arm Title
routine guidance during discharge
Arm Type
Active Comparator
Arm Description
rehabilitation exercise guidance during routine discharge
Intervention Type
Behavioral
Intervention Name(s)
Wechat application reminder intervention
Intervention Description
precautions and rehabilitation progress reminders and other news by optimized WeChat applet regularly
Intervention Type
Behavioral
Intervention Name(s)
routine guidance during discharge
Intervention Description
rehabilitation exercise guidance during routine discharge
Primary Outcome Measure Information:
Title
qualified rate of knee joint activity
Description
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.
Time Frame
6 weeks after surgery
Title
qualified rate of knee joint activity
Description
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.
Time Frame
2 weeks after surgery
Title
qualified rate of knee joint activity
Description
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.
Time Frame
12 weeks after surgery
Secondary Outcome Measure Information:
Title
Visual Analogue Scale
Description
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. Aitken, R. C. B. (1969). Measurement of feelings using visual analogue scales. Proceedings of the Royal Society of Medicine. 62, 989 - 993 Freyd, M. (1923). The graphic rating scale. Journal of Educational Psychology, 43, 83 - 102 Hayes, M. H. S. & D. G. Patterson (1921). Experimental development of the graphic rating method. Psychological Bulletin, 18, 98-99
Time Frame
2,6,12 weeks after surgery
Title
SF-12 scale
Description
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.
Time Frame
2,6,12 weeks after surgery
Title
International Knee Documentation Committee (IKDC) Subjective Knee Form
Description
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
Time Frame
2,6,12 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yang
Phone
+8613611000816
Email
yyyyppvip@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chu
Phone
+86-01082266671
Email
18810530974@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuping Yang, doctor
Organizational Affiliation
Peking University Health Science Center
Official's Role
Study Director
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang
Phone
+86-13611000816
Email
yyyyppvip@sina.com
First Name & Middle Initial & Last Name & Degree
Yuping Yang
First Name & Middle Initial & Last Name & Degree
Xinying Sun

12. IPD Sharing Statement

Plan to Share IPD
No

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

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