NCT03890848

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 26, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

April 26, 2019

Status Verified

April 1, 2019

Enrollment Period

8 months

First QC Date

March 11, 2019

Last Update Submit

April 24, 2019

Conditions

Anterior Cruciate Ligament RuptureRehabilitation

Keywords

functional exercisehealth belief model

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    12 weeks after surgery

Secondary Outcomes (3)

  • Visual Analogue Scale

    2，6，12 weeks after surgery

  • SF-12 scale

    2，6，12 weeks after surgery

  • International Knee Documentation Committee (IKDC) Subjective Knee Form

    2，6，12 weeks after surgery

Study Arms (2)

Wechat application intervention

EXPERIMENTAL

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

Behavioral: Wechat application reminder intervention

routine guidance during discharge

ACTIVE COMPARATOR

rehabilitation exercise guidance during routine discharge

Behavioral: routine guidance during discharge

Interventions

Wechat application reminder interventionBEHAVIORAL

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

Wechat application intervention
routine guidance during dischargeBEHAVIORAL

rehabilitation exercise guidance during routine discharge

routine guidance during discharge

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • (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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Yuping Yang, doctor

    Peking University Health Science Center

    STUDY DIRECTOR

Central Study Contacts

Yang

CONTACT

+8613611000816yyyyppvip@sina.com

Chu

CONTACT

+86-0108226667118810530974@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2019

First Posted

March 26, 2019

Study Start

April 1, 2019

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

April 26, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)