The Rehabilitation Effect of Exercise Training in Cruciate Ligament Reconstruction Patients.
Primary Purpose
ACL Injury, ACL - Anterior Cruciate Ligament Rupture, ACL - Anterior Cruciate Ligament Deficiency
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Resistance or home exercise combined with eccentric exercise
Sponsored by
About this trial
This is an interventional basic science trial for ACL Injury
Eligibility Criteria
Inclusion Criteria:
- cruciate ligament rupture patients
Exclusion Criteria:
- Central nervous or peripheral neuropathy, or those with cardiovascular disease.
Sites / Locations
- Sports Medicine Center, Chang Gung Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
control
exercise
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change from preoperative motion analysis
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.
Change from preoperative muscle strength
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.
Change from preoperative body composition questionnaire assessment
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.
Change from preoperative surface electromyography
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).
Change from preoperative hop test
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.
Change from preoperative fitness
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).
Marx activity rating scales questionnaire assessment
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.
Change from preoperative SF-36 questionnaire assessment
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.
Change from preoperative KOOS questionnaire assessment
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.
Full Information
NCT ID
NCT03359382
First Posted
November 19, 2017
Last Updated
November 27, 2017
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03359382
Brief Title
The Rehabilitation Effect of Exercise Training in Cruciate Ligament Reconstruction Patients.
Official Title
The Rehabilitation Effect of Exercise Training in Cruciate Ligament Reconstruction Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL Injury, ACL - Anterior Cruciate Ligament Rupture, ACL - Anterior Cruciate Ligament Deficiency
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
No Intervention
Arm Title
exercise
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Resistance or home exercise combined with eccentric exercise
Intervention Description
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 )
Primary Outcome Measure Information:
Title
Change from preoperative muscle mass
Description
Muscle mass measurement is measured by dual-energy x-ray absorptiometry (DXA). DXA measures the muscle mass of the whole body
Time Frame
One day after rupture of the cruciate ligament, one day before operative, postoperative 4 months, 7 months, 12 months, 24 months
Secondary Outcome Measure Information:
Title
Change from preoperative motion analysis
Description
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.
Time Frame
One day after rupture of the cruciate ligament, one day before operative, postoperative 4 months, 7 months, 12 months, 24 months
Title
Change from preoperative muscle strength
Description
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.
Time Frame
One day after rupture of the cruciate ligament, one day before operative, postoperative 4 months, 7 months, 12 months, 24 months
Title
Change from preoperative body composition questionnaire assessment
Description
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.
Time Frame
One day after rupture of the cruciate ligament, one day before operative, postoperative 4 months, 7 months, 12 months, 24 months
Title
Change from preoperative surface electromyography
Description
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).
Time Frame
One day after rupture of the cruciate ligament, one day before operative, postoperative 4 months, 7 months, 12 months, 24 months
Title
Change from preoperative hop test
Description
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.
Time Frame
One day after rupture of the cruciate ligament, one day before operative, postoperative 4 months, 7 months, 12 months, 24 months
Title
Change from preoperative fitness
Description
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).
Time Frame
One day after rupture of the cruciate ligament, one day before operative, postoperative 4 months, 7 months, 12 months, 24 months
Title
Marx activity rating scales questionnaire assessment
Description
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.
Time Frame
one day before operative
Title
Change from preoperative SF-36 questionnaire assessment
Description
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.
Time Frame
One day after rupture of the cruciate ligament, one day before operative, postoperative 4 months, 7 months, 12 months, 24 months
Title
Change from preoperative KOOS questionnaire assessment
Description
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.
Time Frame
One day after rupture of the cruciate ligament, one day before operative, postoperative 4 months, 7 months, 12 months, 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
cruciate ligament rupture patients
Exclusion Criteria:
Central nervous or peripheral neuropathy, or those with cardiovascular disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei-Hsiu Hsu, Dr.
Phone
886-5-3621000
Ext
2855
Email
7572@cgmh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei-Hsiu Hsu, Dr.
Organizational Affiliation
Sports Medicine Center, Chang Gung Memorial Hospital at Chia Yi, Chia Yi, Taiwan
Official's Role
Study Chair
Facility Information:
Facility Name
Sports Medicine Center, Chang Gung Memorial Hospital
City
Chiayi City
ZIP/Postal Code
613
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei-Hsiu Hsu, Dr.
Phone
886-5-3621000
Ext
2855
Email
7572@cgmh.org.tw
12. IPD Sharing Statement
Learn more about this trial
The Rehabilitation Effect of Exercise Training in Cruciate Ligament Reconstruction Patients.
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