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ACL InjuryNCT03359382

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

A study testing Resistance or home exercise combined with eccentric exercise in people with ACL Injury and ACL - Anterior Cruciate Ligament Rupture, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
What is being tested?
Resistance or home exercise combined with eccentric exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteTaiwan
Study dates
1 Nov 2017to 31 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • cruciate ligament rupture patients

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site, 1 recruiting
  • Sports Medicine Center, Chang Gung Memorial Hospital

    Chiayi City, 613

    Wei-Hsiu Hsu, Dr., 886-5-3621000 ext. 2855, 7572@cgmh.org.tw

    Recruiting

Other trials in Taiwan

About this study

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.

Being tested
Resistance or home exercise combined with eccentric exercise
Medical subject headings
Anterior Cruciate Ligament Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 )

Study groups in NCT03359382
Study groupRoleWhat they receive
controlNo interventionNot described
exerciseExperimentalNot described
Receives: Other: Resistance or home exercise combined with eccentric exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (9)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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).

    Measured: 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.

    Measured: 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).

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2017
  2. Study start1 Nov 2017
  3. Primary completion31 Dec 2020 (estimated)
  4. Study completion31 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03359382
Sponsor's protocol ID
CORPG6G0271-3
Status last verified
Nov 2017
First submitted
19 Nov 2017
Last updated
2 Dec 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Resistance or home exercise combined with eccentric exercise in people with ACL Injury and ACL - Anterior Cruciate Ligament Rupture, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Wei-Hsiu Hsu, Dr. (886-5-3621000 ext. 2855, 7572@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2017.

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