Anterior Cruciate Ligament InjuryNCT04957810
Evaluation of the Effect of Using WeChat Applet to Intervene in the Home Functional Exercise of Patients After Anterior Cruciate Ligament Reconstruction Based on the Health Belief Model
A study testing WeChat Mini Program in people with Anterior Cruciate Ligament Injury, run by Peking University Third Hospital at 1 site in China.
Trial summary
Based on the home rehabilitation exercise of patients undergoing ACL reconstruction, the existing WeChat applet of sports medicine of the Third Hospital of Beijing Medical University is optimized to be used as a health education tool to guide patients undergoing home rehabilitation exercise after ACL reconstruction. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Anterior Cruciate Ligament Injury
- What is being tested?
- WeChat Mini Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 1 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
- Between 18 years old (including 18 years old) and 45 years old;
- Patients who underwent simple ACL reconstruction for the first time, combined with cartilage trimming and partial meniscus resection, and had the same postoperative rehabilitation plan;
- Those who have basic literacy and communication skills;
- Those who have a smartphone, can use WeChat or can learn to use WeChat;
Who cannot join
- Have a history of joint infection, joint tuberculosis or osteomyelitis, or have undergone surgery in the lower limbs within 6 months;
- Combined with severe heart, brain, kidney, and other organ dysfunction;
- Patients with other severe knee joint disease injuries;
- The patient is accompanied by mental illness or cognitive impairment, unable to study and participate in rehabilitation training;
- Those who have participated in other similar rehabilitation function training programs, or transferred to other medical institutions for rehabilitation after being discharged from the hospital;
- Those who have not signed the informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Based on the home rehabilitation exercise of patients undergoing ACL reconstruction, the existing WeChat applet of sports medicine of the Third Hospital of Beijing Medical University is optimized to be used as a health education tool to guide patients undergoing home rehabilitation exercise after ACL reconstruction.
Read the detailed description
With the development of national fitness and sports, the incidence of ACL injury is increasing year by year. ACL reconstruction is the best way to treat ACL injuries, and the success rate of the operation is high, but patients still need to recover after surgery, otherwise, it will be difficult to fully restore knee joint function. However, my country's rehabilitation medical resources are obviously insufficient. After discharge from the hospital, ACL reconstruction patients usually go home and exercise at home according to the rehabilitation plan formulated by the surgeon or rehabilitation physician. However, compliance is still poor, and rehabilitation is relatively difficult to achieve the expected results, which affects the lives of patients quality. The WeChat official account and its affiliated mini-programs have been widely used in different health fields as a means of health communication. The health belief model is a guiding theory commonly used in the field of health education to guide patients to make behavior changes. This study intends to use the functional advantages of the WeChat applet to explore the optimization of the existing Peking University Third Hospital Sports Medicine WeChat applet based on the health belief model and to use the postoperative rehabilitation of patients undergoing ACL injury reconstruction as a pilot to evaluate the optimized The WeChat Mini Program can improve the intervention effect of patients' home functional exercise compliance after ACL injury reconstruction, to provide effective health education for more extensive sports medicine-related home functional exercises, improve their rehabilitation effects and quality of life, and better To ensure the efficacy of surgery.
- Conditions
- Anterior Cruciate Ligament Injury
- Being tested
- WeChat Mini Program
- 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 Mini ProgramBehavioural
Through the WeChat applet, it provides services such as visit content configuration, self-image configuration, self-image measurement configuration, and visit reminders.
| Study group | Role | What they receive |
|---|---|---|
| Patients who are given regular home functional exercises and discharged from the hospital | No intervention | Discharge guidance using regular home function exercises, that is, existing regular missions and paper-based brochures |
| Patients who are guided by conventional discharge guidance and the optimized WeChat official account | Active comparator | Use regular discharge guidance and optimized WeChat public account guidance Receives: Behavioral: WeChat Mini Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in range of motion of knee joint
Changes in range of motion of the knee between two time points
Measured: 2 weeks, 6 weeks and 12 weeks after surgery
Secondary outcomes (2)
Visual pain score during knee motion angle exercise
Visual pain score during knee motion angle exercise were measured at 2,6 and 12 weeks.
Measured: 2 weeks, 6 weeks and 12 weeks after surgery
SF-12 quality of life scale
SF-12 means the 12-items Short Form Health Survey.Patients' scores were measured at 2,6 and 12 weeks ,and the higher the score ,the better the quality of life.
Measured: 2 weeks, 6 weeks and 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 posted12 Jul 2021
- Study start1 Mar 2019
- Primary completion1 Jul 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuryStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University
- Responsible party
- Sponsor
- Investigators
- yuping yang, Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957810
- Sponsor's protocol ID
- M2019069
- Status last verified
- Jun 2021
- First submitted
- 25 Jun 2021
- Last updated
- 12 Jul 2021
- Results posted
- No
- Data monitoring committee
- 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 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Using WeChat Applet to Intervene in the Home Functional Exercise of Patients After Anterior Cruciate Ligament Reconstruction Based on the Health Belief Model
- ClinicalTrials.gov ID
- NCT04957810
- Acronym / sponsor ID
- M2019069
- Conditions
- Anterior Cruciate Ligament Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Peking University
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 12 Jul 2021 (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.
Based on the home rehabilitation exercise of patients undergoing ACL reconstruction, the existing WeChat applet of sports medicine of the Third Hospital of Beijing Medical University is optimized to be used as a health education tool to guide patients undergoing home rehabilitation exercise after ACL reconstruction.
Detailed description
With the development of national fitness and sports, the incidence of ACL injury is increasing year by year. ACL reconstruction is the best way to treat ACL injuries, and the success rate of the operation is high, but patients still need to recover after surgery, otherwise, it will be difficult to fully restore knee joint function. However, my country's rehabilitation medical resources are obviously insufficient. After discharge from the hospital, ACL reconstruction patients usually go home and exercise at home according to the rehabilitation plan formulated by the surgeon or rehabilitation physician. However, compliance is still poor, and rehabilitation is relatively difficult to achieve the expected results, which affects the lives of patients quality. The WeChat official account and its affiliated mini-programs have been widely used in different health fields as a means of health communication. The health belief model is a guiding theory commonly used in the field of health education to guide patients to make behavior changes. This study intends to use the functional advantages of the WeChat applet to explore the optimization of the existing Peking University Third Hospital Sports Medicine WeChat applet based on the health belief model and to use the postoperative rehabilitation of patients undergoing ACL injury reconstruction as a pilot to evaluate the optimized The WeChat Mini Program can improve the intervention effect of patients' home functional exercise compliance after ACL injury reconstruction, to provide effective health education for more extensive sports medicine-related home functional exercises, improve their rehabilitation effects and quality of life, and better To ensure the efficacy of surgery.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients who are given regular home functional exercises and discharged from the hospital | No intervention | –Discharge guidance using regular home function exercises, that is, existing regular missions and paper-based brochures |
| Patients who are guided by conventional discharge guidance and the optimized WeChat official account | Active comparator | Behavioral: WeChat Mini ProgramUse regular discharge guidance and optimized WeChat public account guidance |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Between 18 years old (including 18 years old) and 45 years old;
- Patients who underwent simple ACL reconstruction for the first time, combined with cartilage trimming and partial meniscus resection, and had the same postoperative rehabilitation plan;
- Those who have basic literacy and communication skills;
- Those who have a smartphone, can use WeChat or can learn to use WeChat;
Key exclusion criteria (6 listed)
- Have a history of joint infection, joint tuberculosis or osteomyelitis, or have undergone surgery in the lower limbs within 6 months;
- Combined with severe heart, brain, kidney, and other organ dysfunction;
- Patients with other severe knee joint disease injuries;
- The patient is accompanied by mental illness or cognitive impairment, unable to study and participate in rehabilitation training;
- Those who have participated in other similar rehabilitation function training programs, or transferred to other medical institutions for rehabilitation after being discharged from the hospital;
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 Mini ProgramThrough the WeChat applet, it provides services such as visit content configuration, self-image configuration, self-image measurement configuration, and visit reminders. | Behavioural | Patients who are guided by conventional discharge guidance and the optimized WeChat official account |
Primary outcome
Changes in range of motion of knee joint
Time frame: 2 weeks, 6 weeks and 12 weeks after surgery
Changes in range of motion of the knee between two time points
2 secondary outcomes
Visual pain score during knee motion angle exercise
Time frame: 2 weeks, 6 weeks and 12 weeks after surgery
SF-12 quality of life scale
Time frame: 2 weeks, 6 weeks and 12 weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
- Individual participant dataSharing planned: No
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Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
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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 study director
Peking University Third Hospital
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 Mini Program in people with Anterior Cruciate Ligament Injury, 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: finished, as of the sponsor's last update on 12 Jul 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in range of motion of knee joint (time frame: 2 weeks, 6 weeks and 12 weeks after surgery). 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 12 Jul 2021.