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The Rehabilitation Effect of Exercise Training in Cruciate Ligament Reconstruction Patients.

The Rehabilitation Effect of Exercise Training in Cruciate Ligament Reconstruction Patients.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03359382
Enrollment
180
Registered
2017-12-02
Start date
2017-11-01
Completion date
2020-12-31
Last updated
2017-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ACL - Anterior Cruciate Ligament Deficiency, ACL - Anterior Cruciate Ligament Rupture, ACL Injury

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.

Interventions

OTHERResistance or home exercise combined with eccentric 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 )

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* cruciate ligament rupture patients

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Change from preoperative muscle massOne day after rupture of the cruciate ligament, one day before operative, postoperative 4 months, 7 months, 12 months, 24 monthsMuscle mass measurement is measured by dual-energy x-ray absorptiometry (DXA). DXA measures the muscle mass of the whole body

Secondary

MeasureTime frameDescription
Change from preoperative muscle strengthOne day after rupture of the cruciate ligament, one day before operative, postoperative 4 months, 7 months, 12 months, 24 monthsThe 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 assessmentOne day after rupture of the cruciate ligament, one day before operative, postoperative 4 months, 7 months, 12 months, 24 monthsBody 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 electromyographyOne day after rupture of the cruciate ligament, one day before operative, postoperative 4 months, 7 months, 12 months, 24 monthsQuadriceps 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 testOne day after rupture of the cruciate ligament, one day before operative, postoperative 4 months, 7 months, 12 months, 24 monthsInclude: 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 motion analysisOne day after rupture of the cruciate ligament, one day before operative, postoperative 4 months, 7 months, 12 months, 24 monthsAn 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.
Marx activity rating scales questionnaire assessmentone day before operativeThe 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 assessmentOne day after rupture of the cruciate ligament, one day before operative, postoperative 4 months, 7 months, 12 months, 24 monthsSF-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 assessmentOne day after rupture of the cruciate ligament, one day before operative, postoperative 4 months, 7 months, 12 months, 24 monthsKOOS 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.
Change from preoperative fitnessOne day after rupture of the cruciate ligament, one day before operative, postoperative 4 months, 7 months, 12 months, 24 monthsFitness 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).

Countries

Taiwan

Contacts

Primary ContactWei-Hsiu Hsu, Dr.
7572@cgmh.org.tw886-5-3621000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026