High-intensity Resistance Training in Post-exacerbation COPD
ConditionCOPD Exacerbation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIstituti Clinici Scientifici Maugeri SpA
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
HIRT
Other interventionThe 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.
HIET
Other interventionThe 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.
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: High-Intensity Resistance Training (HIRT)Experimental treatment 1 intervention
Group B: High-Intensity Endurance Training (HIET)Active comparator 1 intervention
Trial outcomes
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.
Time frame
From the date of randomization to the End of the program (up to 3 weeks)Secondary outcomes
1
Distance walked on the Six-Minute Walk Test (6MWT)
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.
Time frame
From the date of randomization to the End of the program (up to 3 weeks)2
Fatigue Severity Scale (FSS) total score
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.
Time frame
From the date of randomization to the End of the program (up to 3 weeks)3
Maximal Voluntary Contraction (MVC) of isometric quadriceps voluntary strength.
To evaluate whether HIRT, compared to HIET, increases quadriceps strength, measured as maximal voluntary contraction (MVC) in an isometric leg press position.
Time frame
From the date of randomization to the End of the program (up to 3 weeks)4
Lower Limb Strength Assessment with the 1-Repetition Maximum (1-RM) Test.
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.
Time frame
From the date of randomization to the End of the program (up to 3 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Istituti Clinici Scientifici Maugeri SpA
Lead sponsor
Universita di Verona
Collaborator
Source ClinicalTrials.gov