Chronic Obstructive Pulmonary DiseaseNCT03799354
Study on Impact of Maximal Strength Training in Patients With COPD
A study testing Maximal strenght training (MST) plus endurance training (ET) and Endurance training (ET) in people with Chronic Obstructive Pulmonary Disease, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
Trial summary
In the context of pulmonary rehabilitation of COPD patients, recent guidelines and metanalysis describe that Resistance Training (RT) can be successfully performed alone or in conjunction with Endurance Training (ET) without evidence of adverse events. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Maximal strenght training (MST) plus endurance training (ET) and Endurance training (ET)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 18 Sep 2019to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD clinical definition according to GOLD guidelines with forced expiratory volume (FEV1)/ forced vital capacity (FVC) < 70%, and FEV1 < 50% of predicted
- stable clinical condition
Who cannot join
- pulmonary diseases other than COPD
- type II diabetes or other metabolic diseases
- malign disease
- a respiratory tract infection within the last 4 wks
- long oxygen therapy use.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
ICS Maugeri IRCCS, Respiratory Rehabilitation of the Institute of Lumezzane
Lumezzane, Brescia, 25065
Mara Paneroni, MSc, PT, 0039+030+8253 ext. 122, mara.paneroni@icsmaugeri.it
Michele Vitacca, MD, 0039+030+8253 ext. 182, michele.vitacca@icsmaugeri.it
About this study
Official title: Study on Impact of Maximal Strength Training in Patients With COPD: Physiological and Clinical Implications
In the context of pulmonary rehabilitation of COPD patients, recent guidelines and metanalysis describe that Resistance Training (RT) can be successfully performed alone or in conjunction with Endurance Training (ET) without evidence of adverse events.
Maximal Strength Training (MST) is a kind of RT typically performed at ~85-90% of 1RM with maximal velocity to be developed in the concentric phase. Recent literature indicates a significant amelioration on the Rate of Force Development (RFD) after MST in healthy subjects, post-menopausal woman and older populations.
Read more
When comparing to the conventional ET, MST generates a little change in muscle mass (no hypertrophy), but a much greater improvement in the RFD. It has been described that neural adjustments play a major role in the MST-induced adaptations. MST is also well documented to improve aerobic endurance by improving walking work efficiency.
Only a small cohort study of COPD patients was conducted, describing that MST can meaningfully improve strength and RFD, with an increase of around 32% for mechanical efficiency and a decrease of the perceived effort during submaximal job. This improvement could determine best performances in daily activities and a best quality of life. The main aims of this physiological pilot randomized controlled trail will be to evaluate feasibility and efficacy of the MST compared to standard ET on strength, effort tolerance, fatigue, economy of walking, dyspnea and risk of falls in a populations of COPD patients, in a short and middle term (6 months).
Read the detailed description
Exercise intolerance is a cardinal problem existing in patients with Chronic Obstructive Pulmonary Disease (COPD). Moreover, skeletal muscle dysfunction is a common extra-pulmonary manifestation, leading to fatigue, decrease in activity of daily living (ADL) performance and quality of life and increase of risk of falls, mainly in older patients. In the context of pulmonary rehabilitation, recent guidelines and metanalysis describe that Resistance Training (RT) can be successfully performed alone or in conjunction with Endurance Training (ET) without evidence of adverse events.
As concern the RT programs, metanalysis in COPD describe that training have been mainly performed with the lower limbs and the training intensities are heterogeneous, generally ranging from 40% to 70% of 1-Repetition Maximum (1-RM).
Maximal Strength Training (MST) is a RT typically performed at ~85-90% of 1RM with maximal velocity to be developed in the concentric phase. Recent literature indicates a significant amelioration on the Rate of Force Development (RFD) after MST in healthy subjects, post-menopausal woman and older populations.
When comparing to the conventional ET, MST generates a little change in muscle mass (no hypertrophy), but a much greater improvement in the RFD. It has been described that neural adjustments play a major role in the MST-induced adaptations. MST is also well documented to improve aerobic endurance by improving walking work efficiency.
Although the mechanisms at the base of MST effect on the mechanical efficiency have not been completely clarified, there is evidence that changes in the relationships between power and speed bring to a longer relaxation phase inside the cycle of job, improving the recovery between contractions.
In this field, only a small cohort study of COPD patients was conducted describing that MST can meaningfully improve the strength and the RFD, with an increase of around 32% for mechanical efficiency and a decrease of the perceived effort during submaximal job. This improvement could determine best performances in daily activities and a best quality of life. Nevertheless, this study has been conducted only in a small cohort (twelve patients) of patients with COPD and further studies are necessary to define the impact on the different components that determine the effort intolerance.
The main aim of this physiological pilot randomized controlled trail will be to test the feasibility and the efficacy of the MST compared to standard ET on strength, effort tolerance, fatigue, economy of walking, dyspnea and risk of falls in a populations of COPD patients, in a short and middle term (6 months).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Maximal strenght training (MST) plus endurance training (ET), Endurance training (ET)
- Keywords
- rehabilitation, resistive training, exercise
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maximal strenght training (MST) plus endurance training (ET)Other
Patients will perform an addictive out-patients rehabilitative treatment of 8 weeks (3 times/week, ≥20 training sessions) consisting of:
- MST- It will consist of four sets of five repetitions on a leg-press with a focus on the rate of force development during the concentric contraction of the quadriceps from a 90° to legs complete extension. The load will be 85-90% of 1RM. When a patient will be able to perform more than five repetitions in a set, the load will be increased. All strength training will be performed on a seated horizontal leg press.
- ET - A cycling session will follow the MST and last 40 minutes at constant-load, starting from a load intensity corresponding to patient specific AT. The intensity will be gradually increased with a symptom-based progression.
Endurance training (ET)Other
Patients will perform a usual out-patients rehabilitative treatment of 8 weeks (3 times/week, ≥20 training sessions). They will perform ET by cycling sessions that will last 40 minutes/each at constant-load, starting from a load intensity corresponding to patient specific AT, assessed during the baseline incremental test. The intensity will be gradually increased during the sessions with a symptom-based progression, according to the protocol by Maltais and coworkers. A 3-min warm-up and cool-down will be provided. Heart rate (HR), blood pressure, oxygen pulsoxymetry, and symptoms by Borg CR10 scale will be monitored at the beginning and end of each session.
Out of the training-days, both groups will continue their normal daily living with modest regular activity, as recommended by their physician.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Maximal strenght training (MST) plus endurance training (ET) Receives: Other: Maximal strenght training (MST) plus endurance training (ET) |
| Control group | Active comparator | Endurance training (ET) Receives: Other: Endurance training (ET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in walking efficiency
The text will be executed using a portable metabolimeter detecting oxygen consumption (VO2).
After a 10 min of warm up on a treadmill, the patient will walk 5 min at submaximal steady state walking at 4.5 km/h at 5% incline.
Using the average of VO2 of the last minute of walking, the walking efficiency will be defined as percentage of change as follows: external work accomplished/ energy expenditure x 100.
Measured: baseline and 8 weeks
Secondary outcomes (20)
Change in Leg Strength by 1-Repetition Maximum on leg press
1-Repetition Maximum (1RM) will be evaluated. 1RM will be measured on a horizontal leg press at a knee angle of 90°. 1RM will be recorded as the heaviest lifted load achieved, applying rest periods of ~4 min between test lifts and increments of 5 kg between each trial until failure.
Measured: baseline and 8 weeks
Change in maximal Rate of Force Development (RFD)
Immediately after the maximal test 1-RM (see above), using the same apparatus, maximal rate of Force Development (RFD) will be assessed using a force platform and applying a load corresponding to 75% of the participant's pre-test 1RM. The subjects will be instructed to execute the lift as rapidly as possible in the concentric phase. RFD will be analyzed as the time difference between 10% and 90% of Peak force.
Measured: baseline and 8 weeks
Change in maximal effort tolerance
It will be evaluated by VO2 consumption on maximal cardiopulmonary exercise test (CPET) on cycloergometer
Measured: baseline and 8 weeks
Change in Constant Load Effort tolerance
It will be evaluated by evaluated by time of execution of Cardiopulmonary Constant-Load Endurance Test
Measured: baseline and 8 weeks
Change in Fatigue (physiological evaluation)
To define peripheral and central component of fatigue, before and after CLET, the investigators will test the difference on force produced during a single twitch superimposed on the Maximal Voluntary Contraction (MVC) and the force produced by the electrically evoked Resting Twitch (RT) produced, at rest, 5 seconds after the MVC.
Measured: baseline and 8 weeks
Change in Fatigue (qualitative evaluation)
Fatigue Severity Scale (scale measuring fatigue, 9-item scale ranging from 7 = absence of fatigue to 63= maximal presence of fatigue)
Measured: baseline and 8 weeks
Change in Muscle volume
Sagittal ultrasound images of the Vastus Lateralis (VL) muscle will be recorded with an 8-12 MHz linear transducer. Images will be obtained with a 90° flexion of hip and knee, at 50% of femur length. The pennation angle (hp) of the VL fascicles will be measured as the angle between the VL muscle fascicles and the deep aponeurosis of the insertion.
Measured: baseline and 8 weeks
Change in Dyspnea
Barthel Index Dyspnea (scale measuring dyspnea during basal ADL, 10-item scale ranging from 0 = absence of dyspnea to 100 = maximal dyspnea)
Measured: baseline and 8 weeks
Concentration of CRP
C reactive protein [CRP] (mg/dl)
Measured: baseline and 8 weeks
Change in Low grade Inflammation
Evaluation of neutrophils/ lymphocytes ratio
Measured: baseline and 8 weeks
Concentration of Tumor necrosis factor alpha
TNF-alpha (pg/ml)
Measured: baseline and 8 weeks
Concentration of Interleukin-6
IL6 (pg/ml)
Measured: baseline and 8 weeks
Muscular proteolyses by 3-MeH concentration
Evaluation of urinary 3 Methyl-Histine (3-MeH) (micromol/ml)
Measured: baseline and 8 weeks
Change in Balance (qualitative measure)
BERG scale ( scale measuring balance, composed by 14 balance related tasks, ranging from 0 = worse balance to 56= best balance)
Measured: baseline and 8 weeks
Change in quality of life
EuroQol 5-D (scale measuring quality of life, composed by 2 sessions: one of 5 questions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) with multiple choice ranging from 0 = no problem to 25= very low quality of life and one using Visual Analogic Scale (VAS) to quantify the health status ranging from 0 = worst health condition to 100 = best health condition. The two scale sessions are considered separately.
Measured: baseline and 8 weeks
Patient Satisfaction: Likert Scale
Likert Scale 0-4 ( 0=completely unsatisfied, 4= very satisfied).
Measured: at 8 weeks
Change in Falls
Evaluation of the rate of falls
Measured: baseline and 8 months
Hospitalizations
Evaluation of the rate of hospitalizations
Measured: baseline and 8 months
Mortality
Evaluation of deaths (number)
Measured: baseline and 8 months
Change in Balance (quantitative measure)
The fall risk (FR) assessment will be evaluated by Balance Board.
Measured: baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start18 Sep 2019
- Primary completion28 Feb 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Istituti Clinici Scientifici Maugeri SpAThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Collaborators
- Universita di Verona
- Responsible party
- Sponsor
- Investigators
- Mara Paneroni, MSc, PT, Principal investigator, Istituti Clinici Scientifici Maugeri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03799354
- Sponsor's protocol ID
- ICS Maugeri CE 2241
- Status last verified
- Nov 2026
- First submitted
- 4 Dec 2018
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maltais F, Decramer M, Casaburi R, Barreiro E, Burelle Y, Debigare R, Dekhuijzen PN, Franssen F, Gayan-Ramirez G, Gea J, Gosker HR, Gosselink R, Hayot M, Hussain SN, Janssens W, Polkey MI, Roca J, Saey D, Schols AM, Spruit MA, Steiner M, Taivassalo T, Troosters T, Vogiatzis I, Wagner PD; ATS/ERS Ad Hoc Committee on Limb Muscle Dysfunction in COPD. An official American Thoracic Society/European Respiratory Society statement: update on limb muscle dysfunction in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2014 May 1;189(9):e15-62. doi: 10.1164/rccm.201402-0373ST.
PubMed 24787074Hoff J, Helgerud J, Wisloff U. Maximal strength training improves work economy in trained female cross-country skiers. Med Sci Sports Exerc. 1999 Jun;31(6):870-7. doi: 10.1097/00005768-199906000-00016.
PubMed 10378915Hoff J, Tjonna AE, Steinshamn S, Hoydal M, Richardson RS, Helgerud J. Maximal strength training of the legs in COPD: a therapy for mechanical inefficiency. Med Sci Sports Exerc. 2007 Feb;39(2):220-6. doi: 10.1249/01.mss.0000246989.48729.39.
PubMed 17277584Wang E, Helgerud J, Loe H, Indseth K, Kaehler N, Hoff J. Maximal strength training improves walking performance in peripheral arterial disease patients. Scand J Med Sci Sports. 2010 Oct;20(5):764-70. doi: 10.1111/j.1600-0838.2009.01014.x.
PubMed 19804581
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Impact of Maximal Strength Training in Patients With COPD: Physiological and Clinical Implications
- ClinicalTrials.gov ID
- NCT03799354
- Acronym / sponsor ID
- ICS Maugeri CE 2241
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- rehabilitation, resistive training, exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Collaborators
- Universita di Verona
- Study start
- 18 Sep 2019 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 10 Jan 2019 (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.
In the context of pulmonary rehabilitation of COPD patients, recent guidelines and metanalysis describe that Resistance Training (RT) can be successfully performed alone or in conjunction with Endurance Training (ET) without evidence of adverse events.
Maximal Strength Training (MST) is a kind of RT typically performed at ~85-90% of 1RM with maximal velocity to be developed in the concentric phase. Recent literature indicates a significant amelioration on the Rate of Force Development (RFD) after MST in healthy subjects, post-menopausal woman and older populations.
When comparing to the conventional ET, MST generates a little change in muscle mass (no hypertrophy), but a much greater improvement in the RFD. It has been described that neural adjustments play a major role in the MST-induced adaptations. MST is also well documented to improve aerobic endurance by improving walking work efficiency.
Only a small cohort study of COPD patients was conducted, describing that MST can meaningfully improve strength and RFD, with an increase of around 32% for mechanical efficiency and a decrease of the perceived effort during submaximal job. This improvement could determine best performances in daily activities and a best quality of life. The main aims of this physiological pilot randomized controlled trail will be to evaluate feasibility and efficacy of the MST compared to standard ET on strength, effort tolerance, fatigue, economy of walking, dyspnea and risk of falls in a populations of COPD patients, in a short and middle term (6 months).
Detailed description
Exercise intolerance is a cardinal problem existing in patients with Chronic Obstructive Pulmonary Disease (COPD). Moreover, skeletal muscle dysfunction is a common extra-pulmonary manifestation, leading to fatigue, decrease in activity of daily living (ADL) performance and quality of life and increase of risk of falls, mainly in older patients. In the context of pulmonary rehabilitation, recent guidelines and metanalysis describe that Resistance Training (RT) can be successfully performed alone or in conjunction with Endurance Training (ET) without evidence of adverse events.
As concern the RT programs, metanalysis in COPD describe that training have been mainly performed with the lower limbs and the training intensities are heterogeneous, generally ranging from 40% to 70% of 1-Repetition Maximum (1-RM).
Maximal Strength Training (MST) is a RT typically performed at ~85-90% of 1RM with maximal velocity to be developed in the concentric phase. Recent literature indicates a significant amelioration on the Rate of Force Development (RFD) after MST in healthy subjects, post-menopausal woman and older populations.
When comparing to the conventional ET, MST generates a little change in muscle mass (no hypertrophy), but a much greater improvement in the RFD. It has been described that neural adjustments play a major role in the MST-induced adaptations. MST is also well documented to improve aerobic endurance by improving walking work efficiency.
Although the mechanisms at the base of MST effect on the mechanical efficiency have not been completely clarified, there is evidence that changes in the relationships between power and speed bring to a longer relaxation phase inside the cycle of job, improving the recovery between contractions.
In this field, only a small cohort study of COPD patients was conducted describing that MST can meaningfully improve the strength and the RFD, with an increase of around 32% for mechanical efficiency and a decrease of the perceived effort during submaximal job. This improvement could determine best performances in daily activities and a best quality of life. Nevertheless, this study has been conducted only in a small cohort (twelve patients) of patients with COPD and further studies are necessary to define the impact on the different components that determine the effort intolerance.
The main aim of this physiological pilot randomized controlled trail will be to test the feasibility and the efficacy of the MST compared to standard ET on strength, effort tolerance, fatigue, economy of walking, dyspnea and risk of falls in a populations of COPD patients, in a short and middle term (6 months).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Other: Maximal strenght training (MST) plus endurance training (ET)Maximal strenght training (MST) plus endurance training (ET) |
| Control group | Active comparator | Other: Endurance training (ET)Endurance training (ET) |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- COPD clinical definition according to GOLD guidelines with forced expiratory volume (FEV1)/ forced vital capacity (FVC) < 70%, and FEV1 < 50% of predicted
- stable clinical condition
Key exclusion criteria (5 listed)
- pulmonary diseases other than COPD
- type II diabetes or other metabolic diseases
- malign disease
- a respiratory tract infection within the last 4 wks
- long oxygen therapy use.
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 |
|---|---|---|
| Maximal strenght training (MST) plus endurance training (ET)Patients will perform an addictive out-patients rehabilitative treatment of 8 weeks (3 times/week, ≥20 training sessions) consisting of: 1. MST- It will consist of four sets of five repetitions on a leg-press with a focus on the rate of force development during the concentric contraction of the quadriceps from a 90° to legs complete extension. The load will be 85-90% of 1RM. When a patient will be able to perform more than five repetitions in a set, the load will be increased. All strength training will be performed on a seated horizontal leg press. 2. ET - A cycling session will follow the MST and last 40 minutes at constant-load, starting from a load intensity corresponding to patient specific AT. The intensity will be gradually increased with a symptom-based progression. | Other | Treatment Group |
| Endurance training (ET)Patients will perform a usual out-patients rehabilitative treatment of 8 weeks (3 times/week, ≥20 training sessions). They will perform ET by cycling sessions that will last 40 minutes/each at constant-load, starting from a load intensity corresponding to patient specific AT, assessed during the baseline incremental test. The intensity will be gradually increased during the sessions with a symptom-based progression, according to the protocol by Maltais and coworkers. A 3-min warm-up and cool-down will be provided. Heart rate (HR), blood pressure, oxygen pulsoxymetry, and symptoms by Borg CR10 scale will be monitored at the beginning and end of each session. Out of the training-days, both groups will continue their normal daily living with modest regular activity, as recommended by their physician. | Other | Control group |
Primary outcome
Change in walking efficiency
Time frame: baseline and 8 weeks
The text will be executed using a portable metabolimeter detecting oxygen consumption (VO2). After a 10 min of warm up on a treadmill, the patient will walk 5 min at submaximal steady state walking at 4.5 km/h at 5% incline. Using the average of VO2 of the last minute of walking, the walking efficiency will be defined as percentage of change as follows: external work accomplished/ energy expenditure x 100.
20 secondary outcomes
Change in Leg Strength by 1-Repetition Maximum on leg press
Time frame: baseline and 8 weeks
Change in maximal Rate of Force Development (RFD)
Time frame: baseline and 8 weeks
Change in maximal effort tolerance
Time frame: baseline and 8 weeks
Change in Constant Load Effort tolerance
Time frame: baseline and 8 weeks
Change in Fatigue (physiological evaluation)
Time frame: baseline and 8 weeks
Change in Fatigue (qualitative evaluation)
Time frame: baseline and 8 weeks
Change in Muscle volume
Time frame: baseline and 8 weeks
Change in Dyspnea
Time frame: baseline and 8 weeks
Concentration of CRP
Time frame: baseline and 8 weeks
Change in Low grade Inflammation
Time frame: baseline and 8 weeks
Concentration of Tumor necrosis factor alpha
Time frame: baseline and 8 weeks
Concentration of Interleukin-6
Time frame: baseline and 8 weeks
Muscular proteolyses by 3-MeH concentration
Time frame: baseline and 8 weeks
Change in Balance (qualitative measure)
Time frame: baseline and 8 weeks
Change in quality of life
Time frame: baseline and 8 weeks
Patient Satisfaction: Likert Scale
Time frame: at 8 weeks
Change in Falls
Time frame: baseline and 8 months
Hospitalizations
Time frame: baseline and 8 months
Mortality
Time frame: baseline and 8 months
Change in Balance (quantitative measure)
Time frame: baseline and 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Background: PubMed 24787074Maltais F, Decramer M, Casaburi R, Barreiro E, Burelle Y, Debigare R, Dekhuijzen PN, Franssen F, Gayan-Ramirez G, Gea J, Gosker HR, Gosselink R, Hayot M, Hussain SN, Janssens W, Polkey MI, Roca J, Saey D, Schols AM, Spruit MA, Steiner M, Taivassalo T, Troosters T, Vogiatzis I, Wagner PD; ATS/ERS Ad Hoc Committee on Limb Muscle Dysfunction in COPD. An official American Thoracic Society/European Respiratory Society statement: update on limb muscle dysfunction in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2014 May 1;189(9):e15-62. doi: 10.1164/rccm.201402-0373ST.
- Background: PubMed 10378915Hoff J, Helgerud J, Wisloff U. Maximal strength training improves work economy in trained female cross-country skiers. Med Sci Sports Exerc. 1999 Jun;31(6):870-7. doi: 10.1097/00005768-199906000-00016.
- Background: PubMed 17277584Hoff J, Tjonna AE, Steinshamn S, Hoydal M, Richardson RS, Helgerud J. Maximal strength training of the legs in COPD: a therapy for mechanical inefficiency. Med Sci Sports Exerc. 2007 Feb;39(2):220-6. doi: 10.1249/01.mss.0000246989.48729.39.
- Background: PubMed 19804581Wang E, Helgerud J, Loe H, Indseth K, Kaehler N, Hoff J. Maximal strength training improves walking performance in peripheral arterial disease patients. Scand J Med Sci Sports. 2010 Oct;20(5):764-70. doi: 10.1111/j.1600-0838.2009.01014.x.
- Individual participant dataSharing planned: No
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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.
Mara Paneroni, MSc, PT principal investigator
Istituti Clinici Scientifici Maugeri
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maximal strenght training (MST) plus endurance training (ET) and Endurance training (ET) in people with Chronic Obstructive Pulmonary Disease, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mara Paneroni, MSc, PT (0039+030+8253 ext. 122, mara.paneroni@icsmaugeri.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in walking efficiency (time frame: baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03799354, which also lists 4 linked publications.
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 4 Nov 2026.