NCT03359382

Brief Summary

After anterior cruciate ligament (ACL) injury, the involved quadriceps may demonstrate weakness due to decrease in quadriceps activation. However, elapsed time from the injury may affect muscle strength by restoration of the quadriceps activation. The injury is characterized by joint instability that leads to decreased activity, unsatisfactory knee function, and poor knee-related quality of life in the short term, and it is associated with an increased risk of osteoarthritis on the knee. This study was designed to compare muscle strength, questionnaire and knee function in patients with different exercise training.

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
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 2, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

December 2, 2017

Status Verified

November 1, 2017

Enrollment Period

3.2 years

First QC Date

November 19, 2017

Last Update Submit

November 27, 2017

Conditions

ACL InjuryACL - Anterior Cruciate Ligament RuptureACL - Anterior Cruciate Ligament Deficiency

Outcome Measures

Primary Outcomes (1)

  • Change from preoperative muscle mass

    Muscle mass measurement is measured by dual-energy x-ray absorptiometry (DXA). DXA measures the muscle mass of the whole body

    One day after rupture of the cruciate ligament, one day before operative, postoperative 4 months, 7 months, 12 months, 24 months

Secondary Outcomes (9)

  • Change from preoperative motion analysis

    One day after rupture of the cruciate ligament, one day before operative, postoperative 4 months, 7 months, 12 months, 24 months

  • Change from preoperative muscle strength

    One day after rupture of the cruciate ligament, one day before operative, postoperative 4 months, 7 months, 12 months, 24 months

  • Change from preoperative body composition questionnaire assessment

    One day after rupture of the cruciate ligament, one day before operative, postoperative 4 months, 7 months, 12 months, 24 months

  • Change from preoperative surface electromyography

    One day after rupture of the cruciate ligament, one day before operative, postoperative 4 months, 7 months, 12 months, 24 months

  • Change from preoperative hop test

    One day after rupture of the cruciate ligament, one day before operative, postoperative 4 months, 7 months, 12 months, 24 months

  • +4 more secondary outcomes

Study Arms (2)

control

NO INTERVENTION

exercise

EXPERIMENTAL
Other: Resistance or home exercise combined with eccentric exercise

Interventions

Resistance or home exercise combined with eccentric exerciseOTHER

First year: Progressive resistance exercise (60-80% RM) combined with low intensity eccentric exercise (10%RM). Second year: Progressive resistance exercise (60-80% RM) combined with progressive eccentric exercise (10-80% RM). Third year:Home exercise combined with low intensity eccentric exercise (10% RM )

exercise

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • cruciate ligament rupture patients

You may not qualify if:

  • Central nervous or peripheral neuropathy, or those with cardiovascular disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sports Medicine Center, Chang Gung Memorial Hospital

Chiayi City, 613, Taiwan

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Wei-Hsiu Hsu, Dr.

    Sports Medicine Center, Chang Gung Memorial Hospital at Chia Yi, Chia Yi, Taiwan

    STUDY CHAIR

Central Study Contacts

Wei-Hsiu Hsu, Dr.

CONTACT

886-5-36210007572@cgmh.org.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

November 19, 2017

First Posted

December 2, 2017

Study Start

November 1, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

December 2, 2017

Record last verified: 2017-11

Locations

TW(1)