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Status unknownNCT03359382Updated Dec 2, 2017

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

An interventional study of Resistance or home exercise combined with eccentric exercise in ACL Injury, ACL - Anterior Cruciate Ligament Rupture and ACL - Anterior Cruciate Ligament Deficiency, sponsored by Chang Gung Memorial Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-02.

Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Nov 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Non-randomized
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • ACL Injury
  • ACL - Anterior Cruciate Ligament Rupture
  • ACL - Anterior Cruciate Ligament Deficiency
03

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • cruciate ligament rupture patients

Exclusion criteria

Exclusion Criteria:

  • Central nervous or peripheral neuropathy, or those with cardiovascular disease.
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
180 participants (estimated)

Study arms

  • No intervention
    control
  • Experimental
    exercise

    Other: Resistance or home exercise combined with eccentric exercise

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 )

05

What researchers measure

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

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

Secondary outcomes

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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).

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

  5. 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.

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

  6. 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).

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

  7. 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.

    Time frame: one day before operative

  8. 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.

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

  9. 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.

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

06

Study locations

1 of 1 sites recruiting
  • Sports Medicine Center, Chang Gung Memorial Hospital
    Chiayi City, 613, Taiwan
    Recruiting
07

Registry details

Key details

Study ID
NCT03359382
Lead sponsor
Chang Gung Memorial Hospital
Responsible party
Wei-Hsiu Hsu (PI, Chang Gung Memorial Hospital) — Principal investigator
First posted
Dec 2, 2017
Start date
Nov 1, 2017
Primary completion
Dec 31, 2020 (estimated)
Completion
Dec 31, 2020 (estimated)
Last update
Dec 2, 2017

Study contacts

Wei-Hsiu Hsu, Dr.
Contact
7572@cgmh.org.tw
886-5-3621000 ext. 2855
Wei-Hsiu Hsu, Dr.
study chair · Sports Medicine Center, Chang Gung Memorial Hospital at Chia Yi, Chia Yi, Taiwan

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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