- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03359382
The Rehabilitation Effect of Exercise Training in Cruciate Ligament Reconstruction Patients.
November 27, 2017 updated by: Wei-Hsiu Hsu, Chang Gung Memorial Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
180
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Chiayi City, Taiwan, 613
- Recruiting
- Sports Medicine Center, Chang Gung Memorial Hospital
-
Contact:
- Wei-Hsiu Hsu, Dr.
- Phone Number: 2855 886-5-3621000
- Email: 7572@cgmh.org.tw
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- cruciate ligament rupture patients
Exclusion Criteria:
- Central nervous or peripheral neuropathy, or those with cardiovascular disease.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: exercise
|
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 ) |
No Intervention: control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from preoperative muscle mass
Time Frame: One day after rupture of the cruciate ligament, one day before operative, postoperative 4 months, 7 months, 12 months, 24 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from preoperative motion analysis
Time Frame: One day after rupture of the cruciate ligament, one day before operative, postoperative 4 months, 7 months, 12 months, 24 months
|
An optoelectronic eight-camera Vicon motion analysis system (T20; Oxford Metrics Ltd., Oxford, United Kingdom) was used to capture three dimensional (3D) kinematic data at 100 Hz during five walking trials.
Two force plates (OR6, AMTI, Watertown, Massachusetts) embedded in the floor were synchronised with the motion capture system to record ground reaction force (GRF) during walking at a sampling rate of 1000 Hz.
|
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
Time Frame: One day after rupture of the cruciate ligament, one day before operative, postoperative 4 months, 7 months, 12 months, 24 months
|
The muscle strength of the lower extremity including hip flexor/extensor, knee flexor/extensor, and ankle plantar flexor/dorsiflexor were tested by HUMAC NORM system (CSMi, U.S.A.) with the mode of concentric/concentric contraction at the angular velocity of 60 degree/s.
|
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
Time Frame: One day after rupture of the cruciate ligament, one day before operative, postoperative 4 months, 7 months, 12 months, 24 months
|
Body composition was assessed using an eight-polar tactile-electrode impedance meter (InBody 720; Biospace, Seoul, Korea), which simultaneously recorded bodyweight, total body fat mass, total body muscle mass, lean body mass, bone mineral content and basal metabolic rate.
|
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
Time Frame: One day after rupture of the cruciate ligament, one day before operative, postoperative 4 months, 7 months, 12 months, 24 months
|
Quadriceps and hamstrings EMG amplitudes were assessed during walking with stand phase using surface electromyography (EMG) sampled at 1000 Hz (BioNomadix, BIOPAC systems, Inc, Goleta, CA) with electrodes placed over the vastus medialis (VM), vastus lateralis (VL), rectus femoris (RF) and biceps femoris (BF).
|
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
Time Frame: One day after rupture of the cruciate ligament, one day before operative, postoperative 4 months, 7 months, 12 months, 24 months
|
Include: single leg vertical hop, Single leg forward one-step hop, Single leg three-step hop, single leg three-step crossover hop.
Record hop height, distance and completion of action time.
|
One day after rupture of the cruciate ligament, one day before operative, postoperative 4 months, 7 months, 12 months, 24 months
|
Change from preoperative fitness
Time Frame: One day after rupture of the cruciate ligament, one day before operative, postoperative 4 months, 7 months, 12 months, 24 months
|
Fitness of all subjects was evaluated using the HELMAS Physical Fitness Management System (Seoul, Korea).
Several dimensions of health-related fitness were evaluated, including muscular strength (grip strength and back strength); balance (closed-eye foot balance); cardiorespiratory endurance (step test); flexibility (sitting trunk flexion and trunk extension); muscle endurance (sit-ups); and agility (reaction time and side steps).
|
One day after rupture of the cruciate ligament, one day before operative, postoperative 4 months, 7 months, 12 months, 24 months
|
Marx activity rating scales questionnaire assessment
Time Frame: one day before operative
|
The Marx activity rating scales is a patient-reported instrument.
Contrary to the construction of activity level in the Tegner, which is based on participation in specific work and sports activities, activity level of the Marx is determined by measuring some components of physical function that are common to the most sporting activities.
|
one day before operative
|
Change from preoperative SF-36 questionnaire assessment
Time Frame: One day after rupture of the cruciate ligament, one day before operative, postoperative 4 months, 7 months, 12 months, 24 months
|
SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
The lower score the more disability.
The higher the score the less disability.
Eight sections including physical function, role limitation due to physical problems, bodily pain, general health, vitality, social functioning, role limitation due to emotional problems, and mental health.
Additionally, the eight health domains can be used to provide a physical component summary and mental component summary score.
|
One day after rupture of the cruciate ligament, one day before operative, postoperative 4 months, 7 months, 12 months, 24 months
|
Change from preoperative KOOS questionnaire assessment
Time Frame: One day after rupture of the cruciate ligament, one day before operative, postoperative 4 months, 7 months, 12 months, 24 months
|
KOOS contains 5 subscales with a total of 42 items: 1) pain, 2) other symptoms, 3) function in daily living (ADL), 4) function in sport and recreation and 5) knee-related quality of life.
Each question receives a score from 0 to 4 and the scores are transformed to a 0-100 score (0, extreme symptoms, 100, no symptoms).
The User's Guide, is available from www.koos.nu.
|
One day after rupture of the cruciate ligament, one day before operative, postoperative 4 months, 7 months, 12 months, 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Wei-Hsiu Hsu, Dr., Sports Medicine Center, Chang Gung Memorial Hospital at Chia Yi, Chia Yi, Taiwan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2017
Primary Completion (Anticipated)
December 31, 2020
Study Completion (Anticipated)
December 31, 2020
Study Registration Dates
First Submitted
November 19, 2017
First Submitted That Met QC Criteria
November 27, 2017
First Posted (Actual)
December 2, 2017
Study Record Updates
Last Update Posted (Actual)
December 2, 2017
Last Update Submitted That Met QC Criteria
November 27, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CORPG6G0271-3
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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