COPDNCT05708443
Effect of Combined Endurance Training on ADL and Walking in COPD Patients
A study testing LL group and L+UL group in people with COPD, run by Istituti Clinici Scientifici Maugeri SpA at 3 sites in Italy.
Trial summary
Chronic Obstructive Pulmonary Disease (COPD) is a chronic disease with related exercise intolerance and marked disability due to symptoms such as dyspnea and fatigue. Effort intolerance and exercise-induced symptoms cause marked impairment in completing activities of daily living (ADL). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COPD
- What is being tested?
- LL group and L+UL group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesItaly
- Study dates
- 10 Jan 2023to 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- GOLD class 2-3 COPD
- Forced Expiratory Volume in the first second (FEV1) between 30% and 70% of the predicted value
- ability to walk and climb stairs without assistance
- stable clinical condition (pH > 7.35)
Who cannot join
- chronic respiratory insufficiency on long-term oxygen therapy (LTOT)
- severe orthopedic, neurological or cardiological comorbidities
- cognitive impairment
- recent exacerbation (within 15 days) requiring a change in therapy
- presence of lung disease other than COPD
- terminality
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy3 sites, 2 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
- Not yet recruiting
ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Montescano
Montescano, Pavia, 27040
Giancarlo Piaggi, MSc, PT, +0039+0385+247 ext. 402, giancarlo.piaggi@icsmaugeri.it
Rodolfo Murgia, MD, +0039+0385+247 ext. 324, rodolfo.murgia@icsmaugeri.it
- Completed
ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Tradate
Tradate, Varese, 21049
About this study
Official title: Effect of Combined Upper and Lower Extremity Endurance Training Versus Lower Extremity Training Alone on ADL and Walking in COPD Patients
Chronic Obstructive Pulmonary Disease (COPD) is a chronic disease with related exercise intolerance and marked disability due to symptoms such as dyspnea and fatigue. Effort intolerance and exercise-induced symptoms cause marked impairment in completing activities of daily living (ADL). Pulmonary rehabilitation (PR), which has exercise as a major component, is considered a key treatment in the management of COPD since PR is effective in improving exercise tolerance, exercise-induced dyspnea and fatigue, and health-related quality of life. Rehabilitation is also effective in improving the time required to perform ADLs, reducing symptoms and disability. Studies show that rehabilitation protocols with upper limb exercises added to lower limb training are able to give additional benefits in terms of effort tolerance (endurance time at the arm ergometer and oxygen consumption) and reduction of dyspnea at iso-load.
The primary aim of this study is to evaluate whether the combined "arm and leg" training modality, compared to a gold standard protocol -involving only the lower limbs training- is more effective in improving ADL performance in terms of reduction of exercise time for a specific test (GLITTRE test).
Read the detailed description
Background:
Chronic Obstructive Pulmonary Disease (COPD) is a chronic disease with related exercise intolerance and marked disability due to symptoms such as dyspnea and fatigue. Effort intolerance and exercise-induced symptoms cause marked impairment in completing activities of daily living (ADL). COPD patients often rely on a caregiver to perform some ADLs for intolerable dyspnea and fatigue since the early stages of the disease. In fact, even while performing simple ADLs, COPD patients develop dynamic hyperinflation and reach a ventilatory limit that forces them to stop or slow down. Symptoms and disability worsen the patient's quality of life.
Pulmonary rehabilitation (PR), which has exercise as a major component, is considered a key treatment in the management of COPD since PR is effective in improving exercise tolerance, exercise-induced dyspnea, and fatigue, and health-related quality of life. Rehabilitation is also effective in improving the time required to perform ADLs, reducing symptoms and disability.
Lower extremity cycle ergometer training improves peak oxygen uptake, and reduces heart rate, minute ventilation, dyspnea, and leg fatigue at submaximal work speeds. Moreover, upper limb training has been described to reduce dyspnea, increase respiratory muscle strength, and have an effect on patients' global exercise tolerance.
Studies show that rehabilitation protocols with upper limb exercises added to lower limb training are able to give additional benefits in terms of effort tolerance (endurance time at the arm ergometer and oxygen consumption) and reduction of dyspnea at iso-load.
To our knowledge, no study has investigated training programs in COPD patients with similar timing of intervention comparing selective lower extremity endurance training with combined upper and lower extremity training.
The primary aim of this study is to evaluate whether the combined "arm and leg" training modality, compared to a gold standard protocol -involving only the lower limbs training- is more effective in improving ADL performance in terms of reduction of exercise time for a specific test (GLITTRE test). The secondary aims are to evaluate whether the combined training modality, compared to a gold standard protocol involving only the lower limbs, is more effective in a) increasing the effort tolerance of the lower limbs; b) increasing the effort tolerance of the upper limbs and c) reducing the energy cost of walking.
Methods:
This is a multicenter RCT study with a low-risk intervention.
Patients with a diagnosis of COPD, according to the Global Initiative for Lung Disease (GOLD) criteria, will be recruited for this purpose and randomly assigned to two groups: Lower limbs (LL) group and lower plus upper limbs (L+UL) group. The single list of randomization was created by a person external to the healthcare staff.
The treatment in the two groups is reported in the intervention section. All training sessions will be supervised by a physiotherapist. The initial training intensity both for lower and upper limbs will be determined on the basis of the load value performed in the last step of the maximal incremental effort test; the load value will be equal to 60% of the maximal wattage observed. Subsequently, the training intensity will be gradually increased during the sessions with a progression based on the symptoms, according to the protocol of Maltais et al. with steps of 10 watts for the lower limbs and 5 watts for the upper limbs.
During the rehabilitation period, formal education (alone or in groups) concerning the knowledge and management of the disease, healthy lifestyle, airway clearance, and inhaled drugs, will also be offered to all patients. Where indicated, airway clearance techniques and/or adaptation to non-invasive home ventilation will be administered.
At baseline, the investigators will collect clinical evaluations as follows:
- Demographic and anthropometric data
- Post-bronchodilator spirometry and plethysmography (Forced Expiratory Volume at 1 second, Forced Vital Capacity, Residual Volume, Inspiratory Capacity)
- Blood gas analysis in ambient air (PaO2, PaCO2, pH)
- Cumulative Illness Rating Score (CIRS)
Pre and post evaluations will be:
- Barthel Index
- EuroQoL
The Outcome measures are reported in the dedicated section.
The sample size has been calculated considering an improvement of the LL group of 23±20 seconds on the GLITTRE test corresponding to the MCID (Minimal Clinical Important Difference) for a standard GOLD rehabilitation treatment using a T-test for unpaired data with a= 0.05, b= 0.80. Estimating that patients in the L+UL group improve 22±20 seconds more than the LL group, the estimated sample is 30 patients (15 per group). Furthermore, considering a drop-out rate of 20%, it is estimated that 36 patients will be enrolled (12 patients per center).
The statistical evaluation will be conducted with the STATA 11 program (StataCorp LLC). Continuous variables will be expressed as mean and standard deviation (or median and quartiles) while categorical or binary variables as a percentage.
Statistical evaluation will be conducted with the use of appropriate parametric and non-parametric tests to verify differences between groups in treatment response (T-test or Wilcoxon to evaluate the difference between means or medians and chi-square test to evaluate the difference between frequencies). A secondary evaluation by logistic regression will also be performed to verify the baseline characteristics predictive of improvement in responders. A p value <.05 will be considered significant.
- Conditions
- COPD
- Being tested
- LL group, L+UL group
- Keywords
- ADL, COPD, Glittre Test, 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.
LL groupOther
Also called Active Comparator
The program will include daily sessions of 90 minutes, for a total of 14 sessions, consisting of:
- 60 minutes on a stationary bike for the lower limbs (2 sessions per day of 30 minutes) at moderate-high intensity;
- 30 minutes of strengthening exercises for upper limbs (biceps, pectoral, latissimus dorsi) and lower limbs (quadriceps, gluteus and hamstrings) performed free body or with the aid of weights.
All sessions will be supervised by a physiotherapist.
L+UL groupOther
Also called Experimental
These patients will attend a rehabilitation program with daily sessions of 90 minutes, for a total of 14 sessions, consisting of:
- 30 minutes on a stationary bike for the lower limbs (1 session of 30 minutes per day) at moderate-high intensity;
- 30 minutes with arm-ergometer (1 daily session of 30 minutes) at moderate-high intensity;
- 30 minutes of strengthening exercises for upper limbs (biceps, pectoral, latissimus dorsi) and lower limbs (quadriceps, gluteus and hamstrings) performed free body or with the aid of weights.
All sessions will be supervised by a physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| lower limbs (LL) group | Active comparator | These patients will participate in a pulmonary rehabilitation program (usual training) on lower limbs Receives: Other: LL group |
| lower plus upper limbs (L+UL) group | Experimental | These patients will attend a rehabilitation program combining upper and lower extremity training Receives: Other: L+UL group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ADLs (GLITTRE test)
To evaluate the improvement in terms of change of exercise time for a specific test (GLITTRE test)
Measured: Time Frame. From the date of randomization to the End of the program (up to 16 days)
Secondary outcomes (3)
Change in effort tolerance of the lower limbs
To evaluate the improvement in terms of change in the walked distance at 6 minutes walking test (6MWT)
Measured: Time Frame. From the date of randomization to the End of the program (up to 16 days)
Change in effort tolerance of the upper limbs
To evaluate the improvement in terms of change in Tlim (time to exhaustion) in the Unsupported Upper Limb Exercise Test (UULEX)
Measured: Time Frame. From the date of randomization to the End of the program (up to 16 days)
Change in the energy cost of walking (EC)
To evaluate the improvement in terms of change of the energy cost of walking with the EC test performed on a treadmill at a speed of 3.0 km/h for 6 minutes
Measured: Time Frame. From the date of randomization to the End of the program (up to 16 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start10 Jan 2023
- 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 (29)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michele Vitacca, MD, Study director, ICS Maugeri IRCCS, respiratory rehabilitation of the Institute of Lumezzane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708443
- Sponsor's protocol ID
- ICS Maugeri CE2711
- Status last verified
- Jun 2026
- First submitted
- 12 Jan 2023
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Olopade CO, Beck KC, Viggiano RW, Staats BA. Exercise limitation and pulmonary rehabilitation in chronic obstructive pulmonary disease. Mayo Clin Proc. 1992 Feb;67(2):144-57. doi: 10.1016/s0025-6196(12)61316-0.
PubMed 1545579O'Donnell DE, Laveneziana P, Webb K, Neder JA. Chronic obstructive pulmonary disease: clinical integrative physiology. Clin Chest Med. 2014 Mar;35(1):51-69. doi: 10.1016/j.ccm.2013.09.008. Epub 2013 Dec 12.
PubMed 24507837Vaes AW, Wouters EFM, Franssen FME, Uszko-Lencer NHMK, Stakenborg KHP, Westra M, Meijer K, Schols AMWJ, Janssen PP, Spruit MA. Task-related oxygen uptake during domestic activities of daily life in patients with COPD and healthy elderly subjects. Chest. 2011 Oct;140(4):970-979. doi: 10.1378/chest.10-3005. Epub 2011 Mar 17.
PubMed 21415128Bendixen HJ, Waehrens EE, Wilcke JT, Sorensen LV. Self-reported quality of ADL task performance among patients with COPD exacerbations. Scand J Occup Ther. 2014 Jul;21(4):313-20. doi: 10.3109/11038128.2014.899621. Epub 2014 Mar 21.
PubMed 24649946van Helvoort HA, Willems LM, Dekhuijzen PR, van Hees HW, Heijdra YF. Respiratory constraints during activities in daily life and the impact on health status in patients with early-stage COPD: a cross-sectional study. NPJ Prim Care Respir Med. 2016 Oct 13;26:16054. doi: 10.1038/npjpcrm.2016.54.
PubMed 27734959Kapella MC, Larson JL, Covey MK, Alex CG. Functional performance in chronic obstructive pulmonary disease declines with time. Med Sci Sports Exerc. 2011 Feb;43(2):218-24. doi: 10.1249/MSS.0b013e3181eb6024.
PubMed 20543752Spruit 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.
PubMed 24127811Vaes AW, Delbressine JML, Mesquita R, Goertz YMJ, Janssen DJA, Nakken N, Franssen FME, Vanfleteren LEGW, Wouters EFM, Spruit MA. Impact of pulmonary rehabilitation on activities of daily living in patients with chronic obstructive pulmonary disease. J Appl Physiol (1985). 2019 Mar 1;126(3):607-615. doi: 10.1152/japplphysiol.00790.2018. Epub 2018 Nov 29.
PubMed 30496707Thomas MJ, Simpson J, Riley R, Grant E. The impact of home-based physiotherapy interventions on breathlessness during activities of daily living in severe COPD: a systematic review. Physiotherapy. 2010 Jun;96(2):108-19. doi: 10.1016/j.physio.2009.09.006. Epub 2010 Jan 18.
PubMed 20420957Marques A, Gabriel R, Jacome C, Cruz J, Brooks D, Figueiredo D. Development of a family-based pulmonary rehabilitation programme: an exploratory study. Disabil Rehabil. 2015;37(15):1340-6. doi: 10.3109/09638288.2014.964376. Epub 2014 Sep 25.
PubMed 25255297Larson JL, Covey MK, Wirtz SE, Berry JK, Alex CG, Langbein WE, Edwards L. Cycle ergometer and inspiratory muscle training in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1999 Aug;160(2):500-7. doi: 10.1164/ajrccm.160.2.9804067.
PubMed 10430720McKeough ZJ, Velloso M, Lima VP, Alison JA. Upper limb exercise training for COPD. Cochrane Database Syst Rev. 2016 Nov 15;11(11):CD011434. doi: 10.1002/14651858.CD011434.pub2.
PubMed 27846347Hopp L, Walker J. Effectiveness of arm exercise on dyspnea in patients with chronic obstructive pulmonary disease: a systematic review. JBI Libr Syst Rev. 2009;7(31):1353-1372. doi: 10.11124/01938924-200907310-00001.
PubMed 27820307Janaudis-Ferreira T, Hill K, Goldstein R, Wadell K, Brooks D. Arm exercise training in patients with chronic obstructive pulmonary disease: a systematic review. J Cardiopulm Rehabil Prev. 2009 Sep-Oct;29(5):277-83. doi: 10.1097/HCR.0b013e3181b4c8d0.
PubMed 19935139Kathiresan G, Jeyaraman SK, Jaganathan J. Effect of upper extremity exercise in people with COPD. J Thorac Dis. 2010 Dec;2(4):223-36. doi: 10.3978/j.issn.2072-1439.2010.11.4.
PubMed 22263051
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Combined Upper and Lower Extremity Endurance Training Versus Lower Extremity Training Alone on ADL and Walking in COPD Patients
- ClinicalTrials.gov ID
- NCT05708443
- Acronym / sponsor ID
- ICS Maugeri CE2711
- Conditions
- COPD
- Keywords
- ADL, COPD, Glittre Test, exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 1 Feb 2023 (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.
Chronic Obstructive Pulmonary Disease (COPD) is a chronic disease with related exercise intolerance and marked disability due to symptoms such as dyspnea and fatigue. Effort intolerance and exercise-induced symptoms cause marked impairment in completing activities of daily living (ADL). Pulmonary rehabilitation (PR), which has exercise as a major component, is considered a key treatment in the management of COPD since PR is effective in improving exercise tolerance, exercise-induced dyspnea and fatigue, and health-related quality of life. Rehabilitation is also effective in improving the time required to perform ADLs, reducing symptoms and disability. Studies show that rehabilitation protocols with upper limb exercises added to lower limb training are able to give additional benefits in terms of effort tolerance (endurance time at the arm ergometer and oxygen consumption) and reduction of dyspnea at iso-load.
The primary aim of this study is to evaluate whether the combined "arm and leg" training modality, compared to a gold standard protocol -involving only the lower limbs training- is more effective in improving ADL performance in terms of reduction of exercise time for a specific test (GLITTRE test).
Detailed description
Background:
Chronic Obstructive Pulmonary Disease (COPD) is a chronic disease with related exercise intolerance and marked disability due to symptoms such as dyspnea and fatigue. Effort intolerance and exercise-induced symptoms cause marked impairment in completing activities of daily living (ADL). COPD patients often rely on a caregiver to perform some ADLs for intolerable dyspnea and fatigue since the early stages of the disease. In fact, even while performing simple ADLs, COPD patients develop dynamic hyperinflation and reach a ventilatory limit that forces them to stop or slow down. Symptoms and disability worsen the patient's quality of life.
Pulmonary rehabilitation (PR), which has exercise as a major component, is considered a key treatment in the management of COPD since PR is effective in improving exercise tolerance, exercise-induced dyspnea, and fatigue, and health-related quality of life. Rehabilitation is also effective in improving the time required to perform ADLs, reducing symptoms and disability.
Lower extremity cycle ergometer training improves peak oxygen uptake, and reduces heart rate, minute ventilation, dyspnea, and leg fatigue at submaximal work speeds. Moreover, upper limb training has been described to reduce dyspnea, increase respiratory muscle strength, and have an effect on patients' global exercise tolerance.
Studies show that rehabilitation protocols with upper limb exercises added to lower limb training are able to give additional benefits in terms of effort tolerance (endurance time at the arm ergometer and oxygen consumption) and reduction of dyspnea at iso-load.
To our knowledge, no study has investigated training programs in COPD patients with similar timing of intervention comparing selective lower extremity endurance training with combined upper and lower extremity training.
The primary aim of this study is to evaluate whether the combined "arm and leg" training modality, compared to a gold standard protocol -involving only the lower limbs training- is more effective in improving ADL performance in terms of reduction of exercise time for a specific test (GLITTRE test). The secondary aims are to evaluate whether the combined training modality, compared to a gold standard protocol involving only the lower limbs, is more effective in a) increasing the effort tolerance of the lower limbs; b) increasing the effort tolerance of the upper limbs and c) reducing the energy cost of walking.
Methods:
This is a multicenter RCT study with a low-risk intervention.
Patients with a diagnosis of COPD, according to the Global Initiative for Lung Disease (GOLD) criteria, will be recruited for this purpose and randomly assigned to two groups: Lower limbs (LL) group and lower plus upper limbs (L+UL) group. The single list of randomization was created by a person external to the healthcare staff.
The treatment in the two groups is reported in the intervention section. All training sessions will be supervised by a physiotherapist. The initial training intensity both for lower and upper limbs will be determined on the basis of the load value performed in the last step of the maximal incremental effort test; the load value will be equal to 60% of the maximal wattage observed. Subsequently, the training intensity will be gradually increased during the sessions with a progression based on the symptoms, according to the protocol of Maltais et al. with steps of 10 watts for the lower limbs and 5 watts for the upper limbs.
During the rehabilitation period, formal education (alone or in groups) concerning the knowledge and management of the disease, healthy lifestyle, airway clearance, and inhaled drugs, will also be offered to all patients. Where indicated, airway clearance techniques and/or adaptation to non-invasive home ventilation will be administered.
At baseline, the investigators will collect clinical evaluations as follows:
- Demographic and anthropometric data
- Post-bronchodilator spirometry and plethysmography (Forced Expiratory Volume at 1 second, Forced Vital Capacity, Residual Volume, Inspiratory Capacity)
- Blood gas analysis in ambient air (PaO2, PaCO2, pH)
- Cumulative Illness Rating Score (CIRS)
Pre and post evaluations will be:
- Barthel Index
- EuroQoL
The Outcome measures are reported in the dedicated section.
The sample size has been calculated considering an improvement of the LL group of 23±20 seconds on the GLITTRE test corresponding to the MCID (Minimal Clinical Important Difference) for a standard GOLD rehabilitation treatment using a T-test for unpaired data with a= 0.05, b= 0.80. Estimating that patients in the L+UL group improve 22±20 seconds more than the LL group, the estimated sample is 30 patients (15 per group). Furthermore, considering a drop-out rate of 20%, it is estimated that 36 patients will be enrolled (12 patients per center).
The statistical evaluation will be conducted with the STATA 11 program (StataCorp LLC). Continuous variables will be expressed as mean and standard deviation (or median and quartiles) while categorical or binary variables as a percentage.
Statistical evaluation will be conducted with the use of appropriate parametric and non-parametric tests to verify differences between groups in treatment response (T-test or Wilcoxon to evaluate the difference between means or medians and chi-square test to evaluate the difference between frequencies). A secondary evaluation by logistic regression will also be performed to verify the baseline characteristics predictive of improvement in responders. A p value <.05 will be considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lower limbs (LL) group | Active comparator | Other: LL groupThese patients will participate in a pulmonary rehabilitation program (usual training) on lower limbs |
| lower plus upper limbs (L+UL) group | Experimental | Other: L+UL groupThese patients will attend a rehabilitation program combining upper and lower extremity training |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- GOLD class 2-3 COPD
- Forced Expiratory Volume in the first second (FEV1) between 30% and 70% of the predicted value
- ability to walk and climb stairs without assistance
- stable clinical condition (pH > 7.35)
Key exclusion criteria (6 listed)
- chronic respiratory insufficiency on long-term oxygen therapy (LTOT)
- severe orthopedic, neurological or cardiological comorbidities
- cognitive impairment
- recent exacerbation (within 15 days) requiring a change in therapy
- presence of lung disease other than COPD
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 |
|---|---|---|
| LL groupAlso: Active ComparatorThe program will include daily sessions of 90 minutes, for a total of 14 sessions, consisting of: 1. 60 minutes on a stationary bike for the lower limbs (2 sessions per day of 30 minutes) at moderate-high intensity; 2. 30 minutes of strengthening exercises for upper limbs (biceps, pectoral, latissimus dorsi) and lower limbs (quadriceps, gluteus and hamstrings) performed free body or with the aid of weights. All sessions will be supervised by a physiotherapist. | Other | lower limbs (LL) group |
| L+UL groupAlso: ExperimentalThese patients will attend a rehabilitation program with daily sessions of 90 minutes, for a total of 14 sessions, consisting of: 1. 30 minutes on a stationary bike for the lower limbs (1 session of 30 minutes per day) at moderate-high intensity; 2. 30 minutes with arm-ergometer (1 daily session of 30 minutes) at moderate-high intensity; 3. 30 minutes of strengthening exercises for upper limbs (biceps, pectoral, latissimus dorsi) and lower limbs (quadriceps, gluteus and hamstrings) performed free body or with the aid of weights. All sessions will be supervised by a physiotherapist. | Other | lower plus upper limbs (L+UL) group |
Primary outcome
Change in ADLs (GLITTRE test)
Time frame: Time Frame. From the date of randomization to the End of the program (up to 16 days)
To evaluate the improvement in terms of change of exercise time for a specific test (GLITTRE test)
3 secondary outcomes
Change in effort tolerance of the lower limbs
Time frame: Time Frame. From the date of randomization to the End of the program (up to 16 days)
Change in effort tolerance of the upper limbs
Time frame: Time Frame. From the date of randomization to the End of the program (up to 16 days)
Change in the energy cost of walking (EC)
Time frame: Time Frame. From the date of randomization to the End of the program (up to 16 days)
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 24 Jun 2026.
- Background: PubMed 1545579Olopade CO, Beck KC, Viggiano RW, Staats BA. Exercise limitation and pulmonary rehabilitation in chronic obstructive pulmonary disease. Mayo Clin Proc. 1992 Feb;67(2):144-57. doi: 10.1016/s0025-6196(12)61316-0.
- Background: PubMed 24507837O'Donnell DE, Laveneziana P, Webb K, Neder JA. Chronic obstructive pulmonary disease: clinical integrative physiology. Clin Chest Med. 2014 Mar;35(1):51-69. doi: 10.1016/j.ccm.2013.09.008. Epub 2013 Dec 12.
- Background: PubMed 21415128Vaes AW, Wouters EFM, Franssen FME, Uszko-Lencer NHMK, Stakenborg KHP, Westra M, Meijer K, Schols AMWJ, Janssen PP, Spruit MA. Task-related oxygen uptake during domestic activities of daily life in patients with COPD and healthy elderly subjects. Chest. 2011 Oct;140(4):970-979. doi: 10.1378/chest.10-3005. Epub 2011 Mar 17.
- Background: PubMed 24649946Bendixen HJ, Waehrens EE, Wilcke JT, Sorensen LV. Self-reported quality of ADL task performance among patients with COPD exacerbations. Scand J Occup Ther. 2014 Jul;21(4):313-20. doi: 10.3109/11038128.2014.899621. Epub 2014 Mar 21.
- Background: PubMed 27734959van Helvoort HA, Willems LM, Dekhuijzen PR, van Hees HW, Heijdra YF. Respiratory constraints during activities in daily life and the impact on health status in patients with early-stage COPD: a cross-sectional study. NPJ Prim Care Respir Med. 2016 Oct 13;26:16054. doi: 10.1038/npjpcrm.2016.54.
- Background: PubMed 20543752Kapella MC, Larson JL, Covey MK, Alex CG. Functional performance in chronic obstructive pulmonary disease declines with time. Med Sci Sports Exerc. 2011 Feb;43(2):218-24. doi: 10.1249/MSS.0b013e3181eb6024.
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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.
Michele Vitacca, MD study director
ICS Maugeri IRCCS, respiratory rehabilitation of the Institute of Lumezzane
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LL group and L+UL group in people with COPD, run by Istituti Clinici Scientifici Maugeri SpA at 3 sites 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 4 inclusion and 6 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 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 167, 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 ADLs (GLITTRE test) (time frame: Time Frame. From the date of randomization to the End of the program (up to 16 days)). 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 NCT05708443, which also lists 29 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 24 Jun 2026.