High-intensity Resistance Training in Post-exacerbation COPD

December 10, 2025 updated by: Istituti Clinici Scientifici Maugeri SpA

The Effect of the High-intensity Resistance Training in COPD Patients Recovering From Hospital Exacerbation: a Pilot Study

After a COPD exacerbation, many individuals experience severe weakness in the leg muscles, especially the quadriceps. This weakness can make daily activities difficult and slow down recovery. Traditional respiratory rehabilitation usually focuses on endurance training, which is effective but often hard to tolerate soon after an exacerbation due to persistent symptoms and limited functional capacity.

This study aims to compare two early rehabilitation approaches during recovery from a COPD exacerbation: a maximal strength training (MST) programme using high loads and few repetitions, and a traditional endurance-based training programme.

The investigators aim to determine whether MST is easier to tolerate, especially in terms of breathlessness, and whether MST can improve muscle strength, efficiency, and overall exercise tolerance as well as or better than endurance training.

The results will help identify the most suitable rehabilitation strategy for individuals recovering from a COPD exacerbation, particularly for those who struggle with high-intensity endurance exercise.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Background

Exacerbations of chronic obstructive pulmonary disease (COPD) represent critical events in the disease trajectory, significantly increasing mortality, hospital readmissions, and reducing quality of life. Following an exacerbation, affected individuals frequently experience higher symptoms and functional decline, which may be either reversible or not.

Individuals recovering from COPD exacerbations often face profound peripheral muscle weakness, particularly in the quadriceps. This is attributed to systemic inflammation, corticosteroid use, chronic inactivity, and nutritional deficits during acute phases.

Current international guidelines advocate for pulmonary rehabilitation (PR) during the post-acute recovery phase of COPD. These programmes integrate exercise training, self-management education, psychological support, and pharmacological optimization. PR programmes must be tailored to each participant's clinical conditions, comorbidities, and needs.

The ideal timing of PR initiation after an acute exacerbation of COPD remains debated. Some evidence shows that early rehabilitation involving endurance training during hospitalization did not reduce readmission rates nor improve long-term physical capacity, and was associated with increased mortality at 12 months, compared to delayed PR. Consequently, guidelines recommend starting PR within three weeks after discharge from acute hospital care to mitigate any risk associated with early initiation during the acute phase.

Regarding modality, the core component of PR programmes is moderate to high-intensity endurance training, recommended as the gold standard to improve exercise tolerance, functional capacity, and health-related quality of life in stable COPD. However, high-intensity endurance sessions may be hard to tolerate for individuals recovering from an exacerbation, who still experience severe symptoms and marked limitations in daily activities.

Alternative types of training that allow the muscles to be trained without triggering marked dyspnoea and fatigue have been investigated. Previous evidence describes lower cardiorespiratory stress induced by resistance training compared with endurance training in individuals with COPD.

In the context of COPD exacerbations, resistance training initiated early during hospitalization has been shown to effectively prevent muscle deterioration, promote anabolic balance, and counteract catabolic processes without exacerbating systemic inflammation. Individuals undergoing resistance training demonstrated significant improvements in quadriceps strength and six-minute walking distance (6MWD), highlighting its potential as a core component of early PR during COPD exacerbation.

Additional evidence indicates that adding resistance training to endurance training during the post-exacerbation phase produces significant increases in muscle strength while yielding comparable benefits in dyspnoea, exercise capacity, and quality of life.

Therefore, resistance training appears feasible and safe both in the acute and post-acute phases of a COPD exacerbation, but whether strength programmes may allow training for individuals unable to tolerate high-intensity endurance sessions remains unknown.

Among resistance training programmes, maximal strength training (MST) has the potential to most effectively improve lower limb function. MST consists of exercising at high loads and few repetitions, requiring participants to develop maximal rate of force mobilization during the concentric phase. Evidence in stable COPD indicates that MST is safe, feasible, and significantly improves quadriceps rate of force development, mechanical efficiency, and effort tolerance.

Currently, no clear guideline exists for the protocol to be used for participants in the initial rehabilitation phase after exacerbation. In clinical practice, during the early phase of the rehabilitation pathway, a high percentage of individuals (estimated between 40% and 50%) are unable to perform endurance training according to the gold standard for stable COPD (intensity at 70% of maximum watt at incremental test).

For this reason, MST could represent a valid alternative for individuals who are not able or not yet able to tolerate high-intensity endurance training after an exacerbation. Due to the lower respiratory involvement associated with this type of training, the investigators hypothesize higher tolerance, greater improvements in dyspnoea and lower limb muscular efficiency, and similar changes in effort tolerance.

Primary aim

The primary objective of this study is to compare the effects of an early MST programme versus a conventional high-intensity endurance training programme on dyspnoea reduction when initiated shortly after hospital discharge for a COPD exacerbation.

Secondary aims

The secondary aims are to compare MST with high-intensity endurance training in terms of:

  1. Functional capacity measured by 6MWD, and exercise tolerance
  2. Fatigue reduction over time measured by the Fatigue Severity Scale
  3. Muscle strength measured as maximum voluntary contraction of the quadriceps and 1-Repetition Maximum (1RM) on the leg press

  4. Impact of the disease and quality of life

    Only for non-dropout participants:

  5. Peripheral muscle fatigue assessed through neuromuscular testing

  6. Walking efficiency assessed by a dedicated treadmill test

    Only after the last training session:

  7. Satisfaction and acceptability of the training programmes

    Material and Methods

    1. Study protocol At enrolment, after providing informed consent, participants will be randomized per block of four by an external operator into two groups (1:1): one group will perform high-intensity resistance training (HIRT, experimental group) and the other conventional endurance training (HIET, control group). Both training programmes will include sessions 5 times/week, of exercises commonly used in respiratory rehabilitation, not involving additional risks compared to normal clinical practice. A senior physiotherapist will supervise all training sessions.

    2. Intervention

      The rehabilitation programme will consist, for the first 15 sessions, of:

    1. High-Intensity Resistance Training (HIRT) - Experimental Group Participants will perform high-intensity strength training with progressive workload increases and low-intensity endurance training without progression.

      Strength training will be performed on a horizontal leg press:

      • Four sets of five repetitions at 90-95% of 1RM

      • Focus on concentric quadriceps contraction from 90° to full extension

      • Two-minute rest between sets
      • Load increased by 2.5 kg when participants exceed five repetitions Endurance training will consist of low-intensity cycling at 20% of maximum workload estimated from 6MWD. Intensity will remain unchanged throughout the study.

      Possible side effects include delayed onset muscle soreness (DOMS), typically resolving within a short period.

      HIRT will be performed in cycles of 2 days on and 1 day off.

    2. High-Intensity Endurance Training (HIET) - Control Group

    Participants will perform:

    • Cycling at 70% of maximum workload estimated by 6MWD for 25 minutes

    • Load increased by 10 watts when dyspnoea and fatigue are rated below 5 on the Borg scale

    • Three-minute warm-up and three-minute warm-down
    • Monitoring of heart rate, blood pressure, oxygen saturation, and symptoms at session end
    • Five sessions/week In addition, participants will perform low-intensity resistance training (20% 1RM), four sets of five repetitions on the same leg press, 6-7 days/week, with no progression.

    After the 15-session programme, all participants will undergo T1 evaluation and continue with a combined programme (HIRT + HIET or HIET + HIRT) until discharge.

    3. Dropouts Withdrawal will be defined if participants cannot complete the first training session without adverse events or side effects.

    Criteria:

    - HIRT group: at least 18/20 repetitions completed

    - HIET group: at least 20 minutes of cycling with ≤1-minute interruption Participants unable to complete the first session will be classified as dropouts and continue training at low intensity.

    4. Measures 4.1 Assessments at enrolment

  1. Anthropometric measurements (age, sex, BMI)
  2. Comorbidities (CIRS scale)
  3. Pulmonary function (spirometry)
  4. Arterial blood gases in ambient air

4.2 Outcome measures Collected at T0 (within 3 days of rehabilitation admission), T1 (after 15 sessions), and T2 (discharge).

Primary outcome

• Dyspnoea during daily activities using the Barthel Dyspnoea Index

Secondary outcomes

  1. Functional Capacity

    • Six-Minute Walk Test (6MWT): distance, speed, heart rate, oxygen saturation, and Borg dyspnoea/fatigue scores.

  2. Fatigue reduction

    • Fatigue Severity Scale (FSS)

  3. Muscle Strength and Structure

    • MVC of quadriceps

    • 1RM on horizontal leg press

    • Ultrasound assessment of quadriceps structure

    • Ultrasound assessment of diaphragm structure

  4. Disease impact • COPD Assessment Test (CAT) • Maugeri Respiratory Failure 26 (MRF-26) questionnaire

Neuromuscular fatigue (per-protocol only) Assessed using the interpolated twitch technique, including MVC, M waves, electrically stimulated resting force (Qtpot), and maximum voluntary activation (MVA).

Walking efficiency Determined through treadmill test at 3.0 km/h with metabolic analysis.

Acceptability and satisfaction Evaluated after last training session using a Likert scale (0-4).

Sample Size Sample size was calculated based on previous clinical data and expert review, estimating a need for 64 participants (32 per group) to detect meaningful differences in dyspnoea improvement.

Statistical Analysis Data will be analysed using descriptive statistics. Both intention-to-treat and per-protocol analyses will be applied. A two-way repeated-measures ANOVA will assess interaction effects between time (pre/post intervention) and group (resistance vs endurance). Statistical significance is set at p < 0.05.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Italy
    • Brescia
      • Lumezzane, Brescia, Italy, 25065
        • Recruiting
        • ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Lumezzane

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • COPD diagnosis according to the GOLD guidelines [11] with FEV1/FVC <70%
  • Stable clinical condition (pH>7.30) [11]
  • Hospital discharge within 3 weeks from an event of hospitalization due to an acute exacerbation of COPD.
  • Absence of significant motor disability, described by the possibility of performing the 6MWT.

Exclusion Criteria:

  • Presence of lung diseases other than COPD
  • Orthopedic and neurological conditions that prevent the execution of functional tests
  • Severe neurological and cardiologic comorbidities or other severe diseases compromise exercise tolerance.
  • Cognitive impairment evaluated by Mini-Mental State Examination (MMSE) score as < 25.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: High-Intensity Resistance Training (HIRT)
This is the group performing high-intensity strength training on the leg press, combined with low-intensity cycling; it is the intervention study group.
Other: HIRT
The HIRT group will perform high-intensity strength training on a horizontal leg press, consisting of 4 sets of 5 repetitions at 90-95% of their maximum strength (1RM). Two-minute rests are given between sets, and the weight is increased by 2.5 kg whenever a patient can do more than 5 repetitions. Training focuses on quadriceps strength, from 90° to full extension. Sessions are scheduled 2 days on, 1 day off. This method has been shown to be safe, with mild muscle soreness as the most likely side effect. In addition, participants will perform low-intensity cycling at 20% of their maximum workload, which remains constant throughout the study, to maintain light endurance activity.
Active Comparator: High-Intensity Endurance Training (HIET)
This is the group performing high-intensity endurance training on the cycle ergometer, combined with low-intensity leg press; it is the active comparator study group (Active Comparator).
Other: HIET
The HIET group will perform high-intensity endurance training on a cycle ergometer for 25 minutes at 70% of their maximum workload, with intensity progression of 10 watts if breathlessness is rated below 5 on the Borg scale. Each session includes a 3-minute warm-up and cool-down, with monitoring of heart rate, blood pressure, oxygen saturation, and symptoms. Participants train 5 days per week. Additionally, they perform low-intensity strength training on the horizontal leg press, 4 sets of 5 repetitions at 20% 1RM, 6-7 days per week, without progression. This combined program maintains both aerobic fitness and light muscle strength during conventional rehabilitation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dyspnea during daily activities measured by the Barthel Dyspnea Index (BDI)
Time Frame: From the date of randomization to the End of the program (up to 3 weeks)
Dyspnea (breathlessness) during routine daily activities will be measured using the Barthel Dyspnea Index (0-100; higher scores indicate greater dyspnea), a questionnaire that evaluates the severity of shortness of breath during common tasks such as walking, dressing, climbing stairs, and bathing. Each activity is scored, and higher scores indicate greater difficulty or breathlessness. The assessment is performed through patient self-report with guidance from a trained clinician. This measure provides a practical evaluation of how dyspnea affects functional independence in everyday life.
From the date of randomization to the End of the program (up to 3 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Distance walked on the Six-Minute Walk Test (6MWT)
Time Frame: From the date of randomization to the End of the program (up to 3 weeks)
Distance walked (meters) in the Six-Minute Walk Test (6MWT), measured to assess effort tolerance. The 6MWT evaluates submaximal functional exercise capacity by recording the total distance a patient can walk in six minutes along a flat corridor. It reflects global functional status and endurance.
From the date of randomization to the End of the program (up to 3 weeks)
Fatigue Severity Scale (FSS) total score
Time Frame: From the date of randomization to the End of the program (up to 3 weeks)
Fatigue severity measured using the Fatigue Severity Scale (FSS; 9 items scored 1-7; higher scores indicate greater fatigue; score range 9 - 63). The FSS assesses the impact of fatigue on daily life and functional performance. Patients rate statements related to fatigue intensity and its effect on physical and social activities.
From the date of randomization to the End of the program (up to 3 weeks)
Maximal Voluntary Contraction (MVC) of isometric quadriceps voluntary strength.
Time Frame: From the date of randomization to the End of the program (up to 3 weeks)
To evaluate whether HIRT, compared to HIET, increases quadriceps strength, measured as maximal voluntary contraction (MVC) in an isometric leg press position.
From the date of randomization to the End of the program (up to 3 weeks)
Lower Limb Strength Assessment with the 1-Repetition Maximum (1-RM) Test.
Time Frame: From the date of randomization to the End of the program (up to 3 weeks)
To evaluate whether HIRT, compared to HIET, improves lower-limb strength assessed with the 1-Repetition Maximum (1-RM) test on the horizontal leg press, recording the highest load lifted with rest intervals between trials.
From the date of randomization to the End of the program (up to 3 weeks)
Quadriceps muscle thickness (vastus lateralis) via ultrasound scanning
Time Frame: From the date of randomization to the End of the program (up to 3 weeks)
Quadriceps (vastus lateralis) muscle thickness, measured in millimeters (mm), assessed via ultrasound imaging. Measurements are taken at standardized anatomical landmarks with participants at rest to evaluate morphological adaptations following the training interventions.
From the date of randomization to the End of the program (up to 3 weeks)
Quadriceps pennation angle (vastus lateralis) via ultrasound scanning
Time Frame: From randomization to the End of the program (up to 3 weeks)
Quadriceps (vastus lateralis) pennation angle, measured in degrees (°), assessed through ultrasound scanning. Changes in muscle architecture provide insights into structural adaptations associated with training-induced hypertrophy and force-production capacity.
From randomization to the End of the program (up to 3 weeks)
Diaphragmatic thickness via ultrasound scanning
Time Frame: From the date of randomization to the End of the program (up to 3 weeks)
Diaphragm thickness measured in millimeters (mm) via ultrasound at end-expiration and end-inspiration. This assessment provides insights into structural changes of the diaphragm following the intervention.
From the date of randomization to the End of the program (up to 3 weeks)
Diaphragmatic excursion via ultrasound scanning
Time Frame: From the date of randomization to the End of the program (up to 3 weeks)
Diaphragmatic excursion, measured in millimeters (mm), assessed via ultrasound during quiet and deep breathing. Excursion reflects diaphragmatic mobility and functional performance.
From the date of randomization to the End of the program (up to 3 weeks)
Impact of the disease (COPD Assessment Test - CAT)
Time Frame: From the date of randomization to the End of the program (up to 3 weeks)
Disease impact assessed by the COPD Assessment Test (CAT; score 0-40; higher scores indicate worse disease impact). The CAT evaluates symptoms, activity limitations, and overall disease burden from the patient's perspective.
From the date of randomization to the End of the program (up to 3 weeks)
Health-related Quality of Life (MRF-26 questionnaire)
Time Frame: From the date of randomization to the End of the program (up to 3 weeks)
Health-related quality of life evaluated using the Maugeri Respiratory Failure 26 questionnaire (MRF-26; score 0-78; higher scores indicate worse quality of life). The questionnaire focuses on physical function, disability, and respiratory-related limitations..
From the date of randomization to the End of the program (up to 3 weeks)
Maximal Voluntary Contraction (MVC)
Time Frame: From the date of randomization to the End of the program (up to 3 weeks)
Maximal Voluntary Contraction (MVC), measured Newtons (N), before and after the standardized fatigue task using dynamometry to quantify voluntary quadriceps force production.
From the date of randomization to the End of the program (up to 3 weeks)
Electrically stimulated resting force (Qtpot)
Time Frame: From the date of randomization to the End of the program (up to 3 weeks)
Electrically stimulated potentiated twitch force (Qtpot), measured in Newtons (N), used to assess peripheral muscle fatigue and contractile function.
From the date of randomization to the End of the program (up to 3 weeks)
Maximal Voluntary Activation (MVA)
Time Frame: From the date of randomization to the End of the program (up to 3 weeks)
Maximal voluntary activation (%) assessed via the interpolated twitch technique, quantifying central drive and central fatigue.
From the date of randomization to the End of the program (up to 3 weeks)
M-wave amplitude
Time Frame: From the date of randomization to the End of the program (up to 3 weeks)
M-wave amplitude recorded through surface electromyography (EMG) and measured in millivolts (mV), to evaluate neuromuscular transmission and peripheral excitability before and after the fatigue task.
From the date of randomization to the End of the program (up to 3 weeks)
Walking efficiency (Walking Energy cost).
Time Frame: From the date of randomization to the End of the program (up to 3 weeks)
To evaluate whether HIRT, compared to HIET, improves walking efficiency, measured as the energy cost of walking on a treadmill for six minutes at 3 km/h, using oxygen consumption data collected via a portable metabolic analyzer.
From the date of randomization to the End of the program (up to 3 weeks)
Acceptability and satisfaction with the training.
Time Frame: From the date of randomization to the End of the program (up to 3 weeks)
To evaluate the acceptability and satisfaction of participants with the training programs, assessed using a Likert scale from 0 (completely unsatisfied) to 4 (very high satisfaction) after the last training session.
From the date of randomization to the End of the program (up to 3 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istituti Clinici Scientifici Maugeri SpA

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Verona, Italy

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Mara Paneroni, PhD, MSc, ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Lumezzane

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 30, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 24, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ICS Maugeri CET6L 0034063/25

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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