High-intensity Resistance Training in Post-exacerbation COPD

NCT07302425 | Recruiting

• 1 other identifier: ICS Maugeri CET6L 0034063/25
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COPD Exacerbation

Keywords

COPD; Exacerbation; Early Rehabilitation; High-intensity exercise

Outcome Measures

Primary Outcomes (1)

• Dyspnea during daily activities measured by the Barthel Dyspnea Index (BDI)

  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 Outcomes (16)

• Distance walked on the Six-Minute Walk Test (6MWT)

  From the date of randomization to the End of the program (up to 3 weeks)

• Fatigue Severity Scale (FSS) total score

  From the date of randomization to the End of the program (up to 3 weeks)

• Maximal Voluntary Contraction (MVC) of isometric quadriceps voluntary strength.

  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.

  From the date of randomization to the End of the program (up to 3 weeks)

• Quadriceps muscle thickness (vastus lateralis) via ultrasound scanning

  From the date of randomization to the End of the program (up to 3 weeks)

Study Arms (2)

High-Intensity Resistance Training (HIRT)

EXPERIMENTAL

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

High-Intensity Endurance Training (HIET)

ACTIVE COMPARATOR

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

Interventions

HIRT OTHER

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.

High-Intensity Resistance Training (HIRT)

HIET OTHER

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.

High-Intensity Endurance Training (HIET)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead
• University of Verona, Italy: collaborator

Study Sites (1)

ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Lumezzane

Lumezzane, Brescia, 25065, Italy

RECRUITING

Related Publications (25)

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• Vidotto G, Carone M, Jones PW, Salini S, Bertolotti G; Quess Group. Maugeri Respiratory Failure questionnaire reduced form: a method for improving the questionnaire using the Rasch model. Disabil Rehabil. 2007 Jul 15;29(13):991-8. doi: 10.1080/09638280600926678.

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• Ottonello M, Pellicciari L, Giordano A, Foti C. Rasch analysis of the Fatigue Severity Scale in Italian subjects with multiple sclerosis. J Rehabil Med. 2016 Jul 18;48(7):597-603. doi: 10.2340/16501977-2116.

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  PMID: 33116476 BACKGROUND

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• Luxton N, Alison JA, Wu J, Mackey MG. Relationship between field walking tests and incremental cycle ergometry in COPD. Respirology. 2008 Nov;13(6):856-62. doi: 10.1111/j.1440-1843.2008.01355.x.

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• Global Initiative for Chronic Obstructive Lung Disease (GOLD) Global Strategy for Prevention, Diagnosis and Management of COPD: 2024 Report. Bethesda: GOLD; https://goldcopd.org/2024-gold-report

  BACKGROUND

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  BACKGROUND

• Troosters T, Probst VS, Crul T, Pitta F, Gayan-Ramirez G, Decramer M, Gosselink R. Resistance training prevents deterioration in quadriceps muscle function during acute exacerbations of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2010 May 15;181(10):1072-7. doi: 10.1164/rccm.200908-1203OC. Epub 2010 Feb 4.

  PMID: 20133927 BACKGROUND

• Probst VS, Troosters T, Pitta F, Decramer M, Gosselink R. Cardiopulmonary stress during exercise training in patients with COPD. Eur Respir J. 2006 Jun;27(6):1110-8. doi: 10.1183/09031936.06.00110605. Epub 2006 Mar 15.

  PMID: 16540501 BACKGROUND

• Greening NJ, Williams JE, Hussain SF, Harvey-Dunstan TC, Bankart MJ, Chaplin EJ, Vincent EE, Chimera R, Morgan MD, Singh SJ, Steiner MC. An early rehabilitation intervention to enhance recovery during hospital admission for an exacerbation of chronic respiratory disease: randomised controlled trial. BMJ. 2014 Jul 8;349:g4315. doi: 10.1136/bmj.g4315.

  PMID: 25004917 BACKGROUND

• Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Molken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST.

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  PMID: 16537849 BACKGROUND

• Wedzicha JA Ers Co-Chair, Miravitlles M, Hurst JR, Calverley PM, Albert RK, Anzueto A, Criner GJ, Papi A, Rabe KF, Rigau D, Sliwinski P, Tonia T, Vestbo J, Wilson KC, Krishnan JA Ats Co-Chair. Management of COPD exacerbations: a European Respiratory Society/American Thoracic Society guideline. Eur Respir J. 2017 Mar 15;49(3):1600791. doi: 10.1183/13993003.00791-2016. Print 2017 Mar.

  PMID: 28298398 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mara Paneroni, PhD, MSc

  ICS Maugeri IRCCS, respiratory rehabilitation of the Institute of Lumezzane

  STUDY DIRECTOR

Central Study Contacts

Mara Paneroni, PhD, MSc

CONTACT

+0039+030+8253; mara.paneroni@icsmaugeri.it

Tiziana Bachetti, Pharm

CONTACT

+0039+0382+593; tiziana.bachetti@icsmaugeri.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 24, 2025
• Study Start: October 30, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: December 24, 2025

Record last verified: 2025-11

Locations

IT (1)