ACL InjuryNCT06063915
Isoinertial Rehabilitation in Recovering Hamstring Strength Following Surgical Anterior Cruciate Ligament Reconstruction
A study testing Isoinertial training and Strength Training in people with ACL Injury and ACL Sprain, run by Università degli studi di Roma Foro Italico.
Trial summary
The present experimental study aims to evaluate the effectiveness and tolerability of isoinertial strength training of the hamstrings using machines in patients with ACL-R during the intermediate post-intervention phases. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- ACL Injury, ACL Sprain, ACL Tear
- What is being tested?
- Isoinertial training and Strength Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 31 Oct 2024
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- having undergone ACL-R surgery following a unilateral rupture
- with reconstructive surgical technique using autograft tendon from the semitendinosus and gracilis muscles (ST-GR), also in the presence of meniscal injuries treated with selective meniscectomy or meniscal suturing.
- Participants must report a level of physical activity between 5 and 10 assessed using the Tegner scale, and have completed the third month of post-operative rehabilitation
Who cannot join
- concurrent injuries involving other ligaments of the knee, cartilage injuries requiring surgery to repair the damage
- previous ACL reconstruction (re-rupture with a new ACL reconstruction) on the knee affected by the new ACL injury.
- Additionally, if the level of pain prevents the subject from performing the functional tests, they will not be included in the study
About this study
Official title: "Efficacy of Isoinertial Rehabilitation in Recovering Hamstring Strength Following Surgical Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Trial"
The present experimental study aims to evaluate the effectiveness and tolerability of isoinertial strength training of the hamstrings using machines in patients with ACL-R during the intermediate post-intervention phases.
Read the detailed description
A proper post-operative rehabilitation program is essential for a positive outcome after anterior cruciate ligament (ACL) reconstruction surgery, a procedure known to cause morpho-functional issues in the short, medium, and long term in individuals who undergo it. Generally, after an initial rehabilitation phase focused on protecting the healing process of the new ligament and regaining range of motion, the rehabilitation path focuses on muscular strengthening and neuromuscular control of both lower limbs. It has been demonstrated that deficits in extensor and flexor muscle strength, as well as their strength ratios, increase the risk of re-injury. Specifically, in athletes, the rate of recurrence, defined as a new injury to the same or opposite side ACL, is considerably high.
High-intensity resistance training of the operated limb has often been contraindicated in the early post-operative period, as it was considered detrimental to the new ligament, joint cartilage, and surrounding soft tissues. However, recent studies suggest that the early application of progressive eccentric-focused exercises, even with high loads, can be safely used to increase muscle volume and strength levels in individuals undergoing ACL reconstruction (ACL-R). Therefore, eccentric reinforcement can be a valid alternative to traditional concentric work for improving lower limb muscle strength after ACL-R.
Recently, it has been demonstrated that strength training using isoinertial machines in healthy individuals leads to positive chronic adaptations in terms of strength recovery, power, and functional capacities such as sprinting, change of direction, and agility. Isoinertial training allows for exercises in both closed and open kinetic chains, as well as multiplanar motor activities. The combination of concentric phases with subsequent eccentric overload allows for the development of high levels of strength and power with low energy cost, promotes intermuscular coordination, preferentially recruits motor units with high activation thresholds, and increases cortical activity. Increased muscle activation, particularly during eccentric muscle actions, indicates a higher mechanical load and a greater training stimulus, leading to better and earlier protein synthesis and subsequent muscle hypertrophy compared to traditional resistance training. Furthermore, the metabolic cost required for an eccentric contraction is about a quarter of that for a concentric contraction at the same external load. Therefore, at the same contraction velocity, eccentric contractions allow for a higher force expression.
While the use of isoinertial equipment is well-established in healthy individuals, scientific evidence regarding its use in rehabilitation protocols is currently limited. The use of eccentric overload, in addition to improving parameters related to muscle strength and power, seems to promote tendon remodeling due to an increased production of fibroblasts and collagen, generated by the higher mechanical load compared to traditional concentric exercise. In lower limb pathologies, isoinertial rehabilitation following injury can be a valid alternative to traditional strength training for the development of muscle hypertrophy and function. However, specific studies investigating the effects of isoinertial rehabilitation in the intermediate stages of recovery following ACL-R and monitoring the tolerability of the treatment are currently lacking.
- Conditions
- ACL Injury, ACL Sprain, ACL Tear, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Injuries
- Being tested
- Isoinertial training, Strength Training
- 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.
Isoinertial trainingDevice
The subjects included in the study will undergo traditional muscle strengthening for a period of 4 weeks, with 2 sessions per week consisting of strength training using isoinertial machines
Strength TrainingOther
The subjects included in the study will undergo traditional muscle strengthening for a period of 4 weeks, with 2 sessions per week consisting of strength training using classic exercises
| Study group | Role | What they receive |
|---|---|---|
| Gold Rehab + Strength Training | Active comparator | Gold standard rehabilitation plus traditional strength training with overloads Receives: Other: Strength Training |
| Gold Rehab + Isoinertial | Experimental | Gold standard rehabilitation with the inclusion of isoinertial training Receives: Device: Isoinertial training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active and passive range of motion (ROM) of the knee joint
Measured: Day 0
Active and passive range of motion (ROM) of the knee joint
Measured: Day 28
Strength of the thigh flexor and extensor muscles
Measured: Day 0
Strength of the thigh flexor and extensor muscles
Measured: Day 28
Qualitative analysis of the Single Leg Squat
Measured: Day 0
Qualitative analysis of the Single Leg Squat
Measured: Day 28
Maximal Hip Flexion Active Knee Extension Test
Measured: Day 0
Maximal Hip Flexion Active Knee Extension Test
Measured: Day 28
Quantitative analysis of the Drop Jump, with frontal and sagittal views
Measured: Day 0
Quantitative analysis of the Drop Jump, with frontal and sagittal views
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start1 Jan 2024 (estimated)
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli studi di Roma Foro Italico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06063915
- Sponsor's protocol ID
- ISOHAMACL
- Status last verified
- Sep 2023
- First submitted
- 28 Jul 2023
- Last updated
- 3 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Efficacy of Isoinertial Rehabilitation in Recovering Hamstring Strength Following Surgical Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Trial"
- ClinicalTrials.gov ID
- NCT06063915
- Acronym / sponsor ID
- ISOHAMACL
- Conditions
- ACL Injury, ACL Sprain, ACL Tear, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Università degli studi di Roma Foro ItalicoUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 3 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present experimental study aims to evaluate the effectiveness and tolerability of isoinertial strength training of the hamstrings using machines in patients with ACL-R during the intermediate post-intervention phases.
Detailed description
A proper post-operative rehabilitation program is essential for a positive outcome after anterior cruciate ligament (ACL) reconstruction surgery, a procedure known to cause morpho-functional issues in the short, medium, and long term in individuals who undergo it. Generally, after an initial rehabilitation phase focused on protecting the healing process of the new ligament and regaining range of motion, the rehabilitation path focuses on muscular strengthening and neuromuscular control of both lower limbs. It has been demonstrated that deficits in extensor and flexor muscle strength, as well as their strength ratios, increase the risk of re-injury. Specifically, in athletes, the rate of recurrence, defined as a new injury to the same or opposite side ACL, is considerably high.
High-intensity resistance training of the operated limb has often been contraindicated in the early post-operative period, as it was considered detrimental to the new ligament, joint cartilage, and surrounding soft tissues. However, recent studies suggest that the early application of progressive eccentric-focused exercises, even with high loads, can be safely used to increase muscle volume and strength levels in individuals undergoing ACL reconstruction (ACL-R). Therefore, eccentric reinforcement can be a valid alternative to traditional concentric work for improving lower limb muscle strength after ACL-R.
Recently, it has been demonstrated that strength training using isoinertial machines in healthy individuals leads to positive chronic adaptations in terms of strength recovery, power, and functional capacities such as sprinting, change of direction, and agility. Isoinertial training allows for exercises in both closed and open kinetic chains, as well as multiplanar motor activities. The combination of concentric phases with subsequent eccentric overload allows for the development of high levels of strength and power with low energy cost, promotes intermuscular coordination, preferentially recruits motor units with high activation thresholds, and increases cortical activity. Increased muscle activation, particularly during eccentric muscle actions, indicates a higher mechanical load and a greater training stimulus, leading to better and earlier protein synthesis and subsequent muscle hypertrophy compared to traditional resistance training. Furthermore, the metabolic cost required for an eccentric contraction is about a quarter of that for a concentric contraction at the same external load. Therefore, at the same contraction velocity, eccentric contractions allow for a higher force expression.
While the use of isoinertial equipment is well-established in healthy individuals, scientific evidence regarding its use in rehabilitation protocols is currently limited. The use of eccentric overload, in addition to improving parameters related to muscle strength and power, seems to promote tendon remodeling due to an increased production of fibroblasts and collagen, generated by the higher mechanical load compared to traditional concentric exercise. In lower limb pathologies, isoinertial rehabilitation following injury can be a valid alternative to traditional strength training for the development of muscle hypertrophy and function. However, specific studies investigating the effects of isoinertial rehabilitation in the intermediate stages of recovery following ACL-R and monitoring the tolerability of the treatment are currently lacking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gold Rehab + Strength Training | Active comparator | Other: Strength TrainingGold standard rehabilitation plus traditional strength training with overloads |
| Gold Rehab + Isoinertial | Experimental | Device: Isoinertial trainingGold standard rehabilitation with the inclusion of isoinertial training |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- having undergone ACL-R surgery following a unilateral rupture
- with reconstructive surgical technique using autograft tendon from the semitendinosus and gracilis muscles (ST-GR), also in the presence of meniscal injuries treated with selective meniscectomy or meniscal suturing.
- Participants must report a level of physical activity between 5 and 10 assessed using the Tegner scale, and have completed the third month of post-operative rehabilitation
Key exclusion criteria (3 listed)
- concurrent injuries involving other ligaments of the knee, cartilage injuries requiring surgery to repair the damage
- previous ACL reconstruction (re-rupture with a new ACL reconstruction) on the knee affected by the new ACL injury.
- Additionally, if the level of pain prevents the subject from performing the functional tests, they will not be included in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isoinertial trainingThe subjects included in the study will undergo traditional muscle strengthening for a period of 4 weeks, with 2 sessions per week consisting of strength training using isoinertial machines | Device | Gold Rehab + Isoinertial |
| Strength TrainingThe subjects included in the study will undergo traditional muscle strengthening for a period of 4 weeks, with 2 sessions per week consisting of strength training using classic exercises | Other | Gold Rehab + Strength Training |
Primary outcome
Active and passive range of motion (ROM) of the knee joint
Time frame: Day 0
Active and passive range of motion (ROM) of the knee joint
Time frame: Day 28
Strength of the thigh flexor and extensor muscles
Time frame: Day 0
Strength of the thigh flexor and extensor muscles
Time frame: Day 28
Qualitative analysis of the Single Leg Squat
Time frame: Day 0
Qualitative analysis of the Single Leg Squat
Time frame: Day 28
Maximal Hip Flexion Active Knee Extension Test
Time frame: Day 0
Maximal Hip Flexion Active Knee Extension Test
Time frame: Day 28
Quantitative analysis of the Drop Jump, with frontal and sagittal views
Time frame: Day 0
Quantitative analysis of the Drop Jump, with frontal and sagittal views
Time frame: Day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Individual participant dataSharing planned: Undecided
Related trials for ACL Injury
Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
Anterior Cruciate Ligament Injuries
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruiting
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Injuries, Recovery Quality
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Isoinertial training and Strength Training in people with ACL Injury and ACL Sprain, run by Università degli studi di Roma Foro Italico.
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 3 inclusion and 3 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 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Active and passive range of motion (ROM) of the knee joint (time frame: Day 0). The study lists 10 primary outcomes in all. 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 3 Oct 2023.