Anterior Cruciate Ligament RuptureNCT03890848
Evaluation of the Effects of Home-based Functional Exercise on Patients With ACL
A study testing Wechat application reminder intervention and routine guidance during discharge in people with Anterior Cruciate Ligament Rupture and Rehabilitation, run by Peking University Third Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Anterior Cruciate Ligament Rupture, Rehabilitation
- What is being tested?
- Wechat application reminder intervention and routine guidance during discharge
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Yang, +86-13611000816, yyyyppvip@sina.com
Yuping Yang
About this study
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
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.
Read the 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.
- Conditions
- Anterior Cruciate Ligament Rupture, Rehabilitation
- Being tested
- Wechat application reminder intervention, routine guidance during discharge
- Keywords
- functional exercise, health belief model
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wechat application reminder interventionBehavioural
precautions and rehabilitation progress reminders and other news by optimized WeChat applet regularly
routine guidance during dischargeBehavioural
rehabilitation exercise guidance during routine discharge
| Study group | Role | What they receive |
|---|---|---|
| Wechat application intervention | Experimental | precautions and rehabilitation progress reminders and other news by optimized WeChat applet regularly Receives: Behavioral: Wechat application reminder intervention |
| routine guidance during discharge | Active comparator | rehabilitation exercise guidance during routine discharge Receives: Behavioral: routine guidance during discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks after surgery
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.
Measured: 2 weeks after surgery
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.
Measured: 12 weeks after surgery
Secondary outcomes (3)
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
Measured: 2，6，12 weeks after surgery
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.
Measured: 2，6，12 weeks after surgery
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
Measured: 2，6，12 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start1 Apr 2019
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuping Yang, doctor, Study director, Peking University Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890848
- Sponsor's protocol ID
- BMU2018MX030
- Status last verified
- Apr 2019
- First submitted
- 11 Mar 2019
- Last updated
- 26 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03890848
- Acronym / sponsor ID
- BMU2018MX030
- Conditions
- Anterior Cruciate Ligament Rupture, Rehabilitation
- Keywords
- functional exercise, health belief model
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wechat application intervention | Experimental | Behavioral: Wechat application reminder interventionprecautions and rehabilitation progress reminders and other news by optimized WeChat applet regularly |
| routine guidance during discharge | Active comparator | Behavioral: routine guidance during dischargerehabilitation exercise guidance during routine discharge |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- (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.
Key exclusion criteria (6 listed)
- (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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wechat application reminder interventionprecautions and rehabilitation progress reminders and other news by optimized WeChat applet regularly | Behavioural | Wechat application intervention |
| routine guidance during dischargerehabilitation exercise guidance during routine discharge | Behavioural | routine guidance during discharge |
Primary outcome
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.
3 secondary outcomes
Visual Analogue Scale
Time frame: 2，6，12 weeks after surgery
SF-12 scale
Time frame: 2，6，12 weeks after surgery
International Knee Documentation Committee (IKDC) Subjective Knee Form
Time frame: 2，6，12 weeks after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuping Yang, doctor study director
Peking University Health Science Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wechat application reminder intervention and routine guidance during discharge in people with Anterior Cruciate Ligament Rupture and Rehabilitation, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang (+8613611000816, yyyyppvip@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
qualified rate of knee joint activity (time frame: 6 weeks after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2019.