HemoNIRS: a Paradigm Shift in the Process of Musculoskeletal Rehabilitation of ACL Injuries in Cyclic Sports Athletes.

NCT06621355 | Not Yet Recruiting DMC

• 1 other identifier: HemoNIRS-LCA
• Study Type: observational
• Target: 129
• Locations: 0 countries
• Sites: N/A

Brief Summary

Muscle haemodynamics has so far been assessed using at most 2-3 near-infrared spectroscopy devices on isolated muscles and without correlating variables. At the same time, research on musculoskeletal pathologies is limited, and there are no studies that analyse the haemodynamic changes that occur when the anterior cruciate ligament (ACL) is injured and whether these changes last over time. The aim of the study is to monitor and evaluate the physiological changes produced by ACL injury on muscle performance using non-invasive near-infrared spectroscopy (NIRS) devices in trained athletes. This descriptive cross-sectional observational multicentre multicentre study, with Balearic Islands ethics committee IB 5585/24PI, will include males aged 18-65 years who have undergone ACL surgery, divided into 3 groups that: have an evolution of less than 6 months (ACL1), more than 2 years since the surgical intervention and are already practising normal physical-sports activities (ACL2) and the control group (CON) that has never suffered an ACL affectation to date. The 3 groups will perform an incremental intervallic test (4:1) on a cycloergometer or treadmill (according to the specificity of their sport), where different muscular haemodynamic variables will be assessed using 12-24 NIRS devices. The main study variables will be the muscular haemodynamic values of each muscle analysed and their correlation between them: muscular oxygen saturation, absolute capillary haemoglobin, loaded and unloaded with oxygen and relative muscular haemoglobin blood flow, loaded and unloaded with oxygen. Secondary variables will be heart rate, socio-demographic variables (age, toxic habits, injury and sports history) and subjective perception of effort (RPE-20).

Conditions

ACL - Anterior Cruciate Ligament Rupture; ACL Injury; Hemodynamics; Oxygen Consumption Based Assessment of Hemodynamics; Exercise

Keywords

Spectroscopy, Near-Infrared; Hemodynamics; Exercise; Vascular resistance; Oxygen consumption

Outcome Measures

Primary Outcomes (7)

• Muscular Oxygen Saturation (SmO2 - %)

  Percentage of haemoglobin + myoglobin at muscle capillary level loaded with oxygen

  From the start of the test up to 3 minutes after the end of the test

• Absolute Capillary Haemoglobin (ThB - g/dL)

  grams of haemoglobin + myoglobin loaded and unloaded with oxygen divided by decilitres of blood taken up by the devices in the muscle capillaries

  From the start of the test up to 3 minutes after the end of the test

• Oxygen-loaded capillary haemoglobin (O2HHb - g/dL)

  grams of haemoglobin + oxygen-loaded myoglobin divided by the decilitres of blood taken up by the devices in the muscle capillaries

  From the start of the test up to 3 minutes after the end of the test

• Capillary Haemoglobin Oxygen Depleted (HHb - g/dL)

  grams of haemoglobin + oxygen-loaded myoglobin divided by the decilitres of blood taken up by the devices in the muscle capillaries

  From the start of the test up to 3 minutes after the end of the test

• Blood Flow of Relative Muscle Haemoglobin (ThBBF - g/dL/min)

  relative value of haemoglobin blood flow per unit time circulating in the muscle capillary when heart rate values are added.

  From the start of the test up to 3 minutes after the end of the test

• Blood Flow of Oxygen Loaded Relative Muscle Haemoglobin (O2HHbBF - g/dL/min)

  Relative value of oxygen-loaded haemoglobin blood flow per unit time circulating in the muscle capillary when heart rate values are added.

  From the start of the test up to 3 minutes after the end of the test

• Blood Flow of Oxygen Discharged Relative Muscle Haemoglobin (HHbBF - g/dL/min)

  Relative value of the blood flow of oxygen discharged haemoglobin per unit time circulating in the muscle capillary when heart rate values are added.

  From the start of the test up to 3 minutes after the end of the test

Secondary Outcomes (6)

• Heart Rate (ppm)

  From the start of the test up to 3 minutes after the end of the test

• Subjective perception of effort (RPE-20)

  From the start of the test up to 3 minutes after the end of the test. At the end of each quarter minute of test work, during the one minute rest period, the patient will be asked his or her RPE.

• Anthropometry and adiposity indicators: height

  The following variables will only be recorded once, at the beginning of the study, mainly to check that the eligibility criteria are met and to determine at a descriptive statistical level the normality and homogeneity of the sample.

• Anthropometry and adiposity indicators: weight

  The following variables will only be recorded once, at the beginning of the study, mainly to check that the eligibility criteria are met and to determine at a descriptive statistical level the normality and homogeneity of the sample.

• Anthropometry and adiposity indicators: skinfolds

  The following variables will only be recorded once, at the beginning of the study, mainly to check that the eligibility criteria are met and to determine at a descriptive statistical level the normality and homogeneity of the sample.

Study Arms (3)

LCA1

Patients with ACL involvement (with less than 6 months of evolution since the surgical intervention (IQ)) and are in a phase in which they can perform the incremental intervallic test either on a cycloergometer or treadmill.

Other: Physical fitness test: Progressive intervalic test

LCA2

Patients who have recovered from an ACL injury for more than 2 years. And can perform the incremental intervallic test either on a cycloergometer or treadmill.

Other: Physical fitness test: Progressive intervalic test

CON

Patients who have never suffered an ACL injury or involvement to date. And can also perform the test.

Other: Physical fitness test: Progressive intervalic test

Interventions

Physical fitness test: Progressive intervalic test OTHER

An incremental interval test of 4\' of work for 1\' of rest will be performed at an individual intensity below the aerobic threshold. At the end of the rest minute, the load shall be increased slightly. In order to be as adjusted and individualised as possible, the subjective physical condition level stated by the patient during the sociodemographic data collection shall be taken as a reference for the establishment of the initial load, being a value of power (W) in cycle ergometer and speed (km/h) in treadmill. Never less than 50W or 6 km/h, respectively. The minimum incremental values will be 25W or 0.5km/h until you are unable to complete a full interval. An incomplete interval shall also be recorded and analysed. During the one minute rest period, as will have been well emphasised during the explanation of the test, no part of the body may be moved at all, so at the end of the 4 minutes of work, the evaluator will count down for the patient to get ready and remain stil

Also known as: Physical fitness test

CON; LCA1; LCA2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The sample, which will be selected by convenience, will be made up of participants who have a diagnosis of ACL involvement and who have undergone surgery (total or partial), either recently or have had an injury in previous years, may be recruited to participate in the study. Healthy, physically active patients who have never had an ACL injury will also be recruited. The sample will initially come from the Físic Espai de Salut Integral, Centre Re3MOVE, MET Salut, Hospital Universitari Son Espases (HUSE) and San Juan de Déu Palma-Inca centres. Other private and public physiotherapy, rehabilitation and recovery centres, as well as private entities (clubs, federations, associations and organisations) that may contain participants susceptible to being included in the study, are expected to be included as they are accepted by the respective research commissions.

You may qualify if:

• Men aged 18 to 65
• An adipose layer of \<2 cm in areas of NIRS placement, assessed with a plicometer
• Understand written, read and spoken Spanish, English or Catalan.

You may not qualify if:

• Having any cardio-metabolic, hormonal, neurological or other comorbidities that could affect participation in the study (e.g. severe mental illness, end-stage disease).
• Eligibility criteria (LCA1 group)
• Regular athlete with training and/or competition \>3 days/wk prior to injury.
• ACL injury \<6 months after surgery.
• Able to perform an incremental intervallic test on a cycloergometer or treadmill.
• Eligibility criteria (LCA2 group)
• Regular athlete with training and/or competition \>3 days a week.
• ACL injury \>2 years after surgery.
• Able to perform an incremental intervallic test on a cycloergometer or treadmill.
• Eligibility criteria (CON group)
• Regular athlete with training and/or competition \>3 days a week.
• Never suffered an ACL injury in any knee - Able to perform incremental intervallic test on cycleergometer or treadmill.
• \- Incapacitating pain that prevents assessment

Sponsors & Collaborators

• Universitat de Lleida: lead

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Motor Activity

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries; Behavior

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Francesc Valenzuela-Pascual, PhD

  Universitat de Lleida

  STUDY DIRECTOR

• Oriol Martínez-Navarro, PhD

  Universitat de Lleida

  STUDY DIRECTOR

Central Study Contacts

Francisco J. Verdejo-Amengual

CONTACT

+34 670729376; xisco.verdejo@udl.cat

Oriol Martínez-Navarro, PhD

CONTACT

+34 619562618; oriol.martinez@udl.cat

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student and Associate Professor

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: October 1, 2024
• Study Start: December 2, 2024
• Primary Completion: November 30, 2025
• Study Completion (Estimated): December 2, 2026
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF