CopdNCT04201548

Different Modalities of Exercise Training in COPD With Chronic Respiratory Failure (CRF)

A study testing Endurance Training, Long High Intensity Interval Training and Short High Intensity Interval Training in people with Copd and Chronic Hypoxemic Respiratory Failure, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Advanced Chronic Obstructive Pulmonary Disease (COPD) is a condition with a negative prognosis that causes symptoms such as wheezing and fatigue that dramatically reduce the quality of life of the person with the disease. Read more about this study

Who is it for?: Ages 51 years and older
Conditions the study is for: Copd, Chronic Hypoxemic Respiratory Failure
What is being tested?: Endurance Training, Long High Intensity Interval Training and Short High Intensity Interval Training
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 1 siteItaly
Study dates: 28 Aug 2019to 30 Jun 2024
Phase: Interventional
Are there results?: None posted in the registry

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 51 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

age> 50 years
clinical definition of COPD according to GOLD guidelines (10) with FEV1 / FVC G 70% and FEV1 <50% of the above
PaO2 in air-ambient lower than 60 mmHg evaluated through arterial blood gas analysis
oxygen therapy prescription for more than 18 hours/ day for at least one month
clinical stable condition

Who cannot join

presence of pulmonary diseases other than COPD
respiratory tract infections in the last 4 weeks
termination

Trial locations and contacts

1 site in 1 country.

Italy1 site

ICS Maugeri IRCCS, Respiratory Rehabilitation of the Institute of Lumezzane
Lumezzane, Brescia, 25065

Other trials in Italy

About this study

Official title: Comparison of Clinical and Physiological Response Among Three Modalities of Exercise Training in COPD With Chronic Respiratory Failure (CRF)

Typically, the advanced stage of COPD is characterized by a fluctuating pattern and recurrent hospitalizations, and by a vicious circle in which dyspnoea increases and exercise tolerance reduces, causing depression with social isolation, low quality of life and increased risk of death.

Muscle dysfunction in these patients contributes together with dynamic hyperinflation to increased fatigue and dyspnoea during exercise, leading to early interruption of exertion, before reaching the maximal aerobic capacity.

The European and American guidelines of the American Thoracic Society / European Respiratory Society relating to the patient with COPD emphasize the need for the patient to undergo Respiratory Rehabilitation (RR) programs. The RR should include training programs as they improve exercise capacity, dyspnoea and quality of life more than programs that do not include training.

To our knowledge, no study has been performed in COPD with chronic respiratory failure (CRF) patients to evaluate the effects of High Interval Training compared to continuous submaximal training. Moreover, no different interval training protocols have been compared. However, studies conducted on healthy subjects or on other pathologies, show how the interval training protocol induces, in a specific and diversified way, physiological modifications to the cardio-respiratory and muscular systems.

In COPD patients with respiratory failure with marked muscular dysfunction and associated systemic changes (systemic inflammation, vascular changes, pulmonary hypertension, right heart failure, etc.), the evaluation of the best training program would reinforce the rehabilitative indications not yet fully proposed in the Guidelines. Moreover, the evaluation of the response to different training stimuli could provide important information on the reversibility of the intolerance to the effort in this patient population.

Primary aim of this study will be to evaluate the physiological effects on exercise tolerance of three training modalities performed in an intra-hospital setting (classic endurance training compared to two high-intensity interval programs - Long Interval Training and Short Interval training) in a population of COPD patients with chronic hypoxemic respiratory failure.

Read the detailed description

Advanced (Chronic Obstructive Pulmonary Disease) COPD is a condition with a negative prognosis that causes symptoms such as wheezing and fatigue that dramatically reduce the quality of life of the person with the disease.

Typically, the advanced stage of COPD is characterized by a fluctuating pattern and recurrent hospitalizations, and by a vicious circle in which dyspnoea increases and exercise tolerance reduces, which in turn causes depression and associated social isolation, low quality of life and increased risk of death.

The European and American guidelines of the American Thoracic Society / European Respiratory Society relating to the patient with Chronic Obstructive Pulmonary Disease (COPD) emphasize the need for the patient to undergo Respiratory Rehabilitation (RR) programs. The RR should include training programs as they improve exercise capacity, dyspnoea and quality of life more than programs that do not include training.

However, although there are many studies referring to the benefits of physical exercise in patients with COPD with mild-to-moderate severity, the recent guidelines provide few recommendations for types of training and its efficacy for patients with advanced disease that have already developed Chronic Respiratory Failure (CRF) and use of Long Term Oxygen Therapy (LTOT).

Thanks to a retrospective study on 1047 patients, the Authors have previously shown that patients with COPD with CRF respond to a rehabilitation program (in terms of exercise tolerance, blood gases, dyspnoea and quality of life) as well as COPD patients without CRF.

A recent meta-analysis conducted by Paneroni et al. supports the effectiveness of exercise in improving quality of life and functional capacity in patients with severe COPD (FEV1 <35%), with or without CRF. The study showed that so far the training proposed to these patients is mainly of moderate-intensity endurance and performed primarily through the continuous use of exercise bikes or free walking. In a similar way to patients with moderate or mild severity, the setting of the exercise was mainly proposed using a speed or a load that approximates around 70% of the maximum value reached in an incremental test.

Regarding the type of exercise to be used in patients with COPD, several recent papers suggest the opportunity to use interval training even in high intensity. The purpose of the High Interval Training is to repeatedly stress the cardio-respiratory and muscular system, above "what is normally required for normal activities, through" bouts of high intensity and short duration exercise".

In subjects with COPD, this type of training could guarantee a delay in the development of the dynamic hyperinflation mechanism typical of the pathology and could guarantee greater physiological modifications regarding the classical submaximal continuous training. Despite some physiological studies that have tested this effect, the results of the clinical application of these interventions appear - in subjects with moderate COPD - similar to that got with continuing training. However, the protocols proposed to date appear to be diversified in terms of approach, especially concerning the intensity and duration of the active and passive phases.

To our knowledge, no study has been performed in COPD with CRF patients to evaluate the effects of High Interval Training compared to continuous submaximal training and no protocols on different interval training have been compared. Indeed, studies conducted on healthy subjects or on other pathologies, show how the interval training protocol induces, in a specific and diversified way, physiological modifications to the cardiorespiratory and muscular systems.

In patients with respiratory failure with marked muscular dysfunction and associated systemic changes (systemic inflammation, vascular changes, pulmonary hypertension, right heart failure, etc.), the evaluation of the best training program would reinforce the rehabilitative indications not yet fully proposed in the Guidelines. Moreover, the evaluation of the response to different training stimuli could provide important information on the reversibility of the intolerance to the effort in this patient population.

Conditions: Copd, Chronic Hypoxemic Respiratory Failure
Being tested: Endurance Training, Long High Intensity Interval Training, Short High Intensity Interval Training
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Endurance TrainingOther
Also called ET, Active Comparator
These patients will perform an aerobic exercise with a moderate intensity cycle ergometer. The exercise session on an exercise bike will last 33 minutes at a constant load, starting from an intensity equal to the load of 60% of the maximum load (max watt) achieved at the incremental test.
Working volume = 60 X 33 = 1980
Long High Intensity Interval TrainingOther
Also called Long-HIIT, Experimental 1
The patients assigned to the Long-HIIT group will perform a 32-minute interval work with 4x4 protocol (active phase x passive phase) performing 4 minutes at an intensity of 80-85% of the Max Watt (active phase) spaced from 4 minutes to 40% of the Max Watt (passive phase). The goal of high intensity work will be to bring the heart rate to a level close to 85-90% of the maximum cardiac frequency achieved in the incremental exercise test. If this target is not reached within the session, the load of the next one will be increased in the following session with 10 watt steps.
Working volume = 16 X 85 + 16 x 40 = 2000
Short High Intensity Interval TrainingOther
Also called Short-HIIT, Experimental 2
The patients assigned to the Short-HIIT group will perform an interval work with initial intensity equal to 100% of the Max Watt highlighted in the incremental exercise stress test in the phase (30 seconds) followed by a passive phase of 30 seconds at 50% of the Max Watt for a period of 26 minutes a day. The intensity will be gradually increased during the sessions with symptom-based progression, according to the protocol of Maltais et al. with steps of 10 watts each increment.
Working volume = 13 X 100 + 13 x 50 = 2050

Study groups in NCT04201548
Study group	Role	What they receive
Active Comparator	Active comparator	This is the constant-load Endurance Training (ET) group which will constitute the control group. Receives: Other: Endurance Training
Long High Intensity Interval Training	Experimental	This is the Long High Intensity Interval Training (Long-HIIT) group. Receives: Other: Long High Intensity Interval Training
Short High Intensity Interval Training	Experimental	This is the Short High Intensity Interval Training (Short-HIIT) group. Receives: Other: Short High Intensity Interval Training

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in effort tolerance
We will evaluate the time to exhaustion (Tlim) of a Constant Load Endurance Test (CLET) taht will be set at load corresponding to 80% of the Watts max achieved at the incremental cicloergometer test.
Measured: at baseline, 1 month and 7 months
Changes in the maximal work load
Another way to evaluate changes in effort tolerance will be to evaluate the maximal work load (Watts max) that patients will achive during a cicloergometer incremental test.
Measured: at baseline and 1 month
Changes in walking distance
Another way to evaluate changes in effort tolerance will be to evaluate meters walked during a 6 minute walking test (6MWT).
Measured: at baseline, 1 month and 7 months

Secondary outcomes (11)

Percentage of drop out patients
To evaluate feasibility of the study, we will calculate the percentage of patients dropped out at the end of the rehabilitation period
Measured: at 1 month
Patient's satisfaction: Likert scale
To evaluate feasibility of the study, we will administer to patients a questionnaire of satisfaction at the end of the rehabilitation period. Likert scale will be from 0 to 4, where 0= completely unsatisfied and 4= very satisfied)
Measured: at 1 month
Change in dyspnoea
We will evaluated dyspnea by Barthel index Dyspnea, a scale measuring dyspnea during basal activities of daily living (ADL). It is a 10-item scale ranging from 0= absence of dyspnea to 100= maximal dyspnea)
Measured: at baseline, 1 month and 7 months
Changes in quadriceps volume
We will evaluate changes in muscle volume (quadricips) by ecography
Measured: at baseline, 1 month and 7 months
Change in ADL performance
We will evaluate the activities of daily life through the Glittre-ADL test. This consists in a circuit of 5-serie of activities (lifting a chair, walking, lifting 2 steps, moving the weight up and down from a shelf). We will evaluate the total time spent to complete the performance.
Measured: at baseline, 1 month and 7 months
Change in fatigue (physiological evaluation)
We will evaluate the change in force generated by a Maximal Volontary Contraction (MVC) and an Electrically stimulated muscular contractions at rest [Resting Twitch (RT)] of the quadriceps muscle (Q) after a fatiguing task ( CLET). Subjects will be seated upright with a back support. The hip and knee will be flexed at 90 ° and the force will be measured by a force transducer.
Electromyographic evaluation: the M waves will be recorded by the Q muscle (vastus lateralis). The EMG signals will be amplified with a bandwidth of 10 Hz-1 kHz and digitized online at a sampling frequency of 5 kHz. Voluntary electromyographic activation of the quadriceps muscle during MVC will be evaluated using a superimposed contraction technique.
Measured: at baseline, 1 month and 7 months
Change in fatigue (qualitative evaluation)
For the qualitative evaluation, we will use the Fatigue severity scale that is a 9-item scale ranging from 7= absence of fatigue to 63= maximal presence of fatigue).
Measured: at baseline, 1 month and 7 months
Change in Endothelial function
The endothelial function will be evaluated by an ultrasound evaluation of the common femoral artery before and after the application of the short Passive Leg Movement (sPLM) technique.
Measured: at baseline, 1 month and 7 months
Change in Balance
To evaluate balance and consequent risk of falls, a Berg scale will be used. Berg scale is composed by 14 balance related tasks, ranging from score 0=worse balance to 56= best balance.
Measured: at 1 month and 7 months
Change in quality of life
COPD Assessment Test (CAT) scale will be used. CAT is a 8-item scale, ranging from score 0 to 40 (where 0=best and 40=worse) evaluating quality of life and well-being
Measured: 1 month and 7 months
Change in quality of life
MRF scale will be used. MRF is a 28-item questionnaire to assess health outcomes in Chronic Respiratory Failure (CRF). MRF ranges from 26=worse to best = 0
...
Measured: at 1 month and 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Aug 201930 Jun 2024

First posted17 Dec 2019
Study start28 Aug 2019
Primary completion16 Jun 2023
Study completion30 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (28)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: None (open label)
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04201548
Sponsor's protocol ID: CE2288
Status last verified: Oct 2024
First submitted: 28 Nov 2019
Last updated: 31 Oct 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Mirza S, Clay RD, Koslow MA, Scanlon PD. COPD Guidelines: A Review of the 2018 GOLD Report. Mayo Clin Proc. 2018 Oct;93(10):1488-1502. doi: 10.1016/j.mayocp.2018.05.026.
PubMed 30286833
Charususin N, Dacha S, Gosselink R, Decramer M, Von Leupoldt A, Reijnders T, Louvaris Z, Langer D. Respiratory muscle function and exercise limitation in patients with chronic obstructive pulmonary disease: a review. Expert Rev Respir Med. 2018 Jan;12(1):67-79. doi: 10.1080/17476348.2018.1398084. Epub 2017 Nov 6.
PubMed 29072087
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.
PubMed 24127811
Carone M, Patessio A, Ambrosino N, Baiardi P, Balbi B, Balzano G, Cuomo V, Donner CF, Fracchia C, Nava S, Neri M, Pozzi E, Vitacca M, Spanevello A. Efficacy of pulmonary rehabilitation in chronic respiratory failure (CRF) due to chronic obstructive pulmonary disease (COPD): The Maugeri Study. Respir Med. 2007 Dec;101(12):2447-53. doi: 10.1016/j.rmed.2007.07.016. Epub 2007 Aug 28.
PubMed 17728121
Paneroni M, Simonelli C, Vitacca M, Ambrosino N. Aerobic Exercise Training in Very Severe Chronic Obstructive Pulmonary Disease: A Systematic Review and Meta-Analysis. Am J Phys Med Rehabil. 2017 Aug;96(8):541-548. doi: 10.1097/PHM.0000000000000667.
PubMed 28099192
Sabapathy S, Kingsley RA, Schneider DA, Adams L, Morris NR. Continuous and intermittent exercise responses in individuals with chronic obstructive pulmonary disease. Thorax. 2004 Dec;59(12):1026-31. doi: 10.1136/thx.2004.026617.
PubMed 15563700
Beauchamp MK, Nonoyama M, Goldstein RS, Hill K, Dolmage TE, Mathur S, Brooks D. Interval versus continuous training in individuals with chronic obstructive pulmonary disease--a systematic review. Thorax. 2010 Feb;65(2):157-64. doi: 10.1136/thx.2009.123000. Epub 2009 Dec 8.
PubMed 19996334
Buchheit M, Laursen PB. High-intensity interval training, solutions to the programming puzzle: Part I: cardiopulmonary emphasis. Sports Med. 2013 May;43(5):313-38. doi: 10.1007/s40279-013-0029-x.
PubMed 23539308
Choudhury G, Rabinovich R, MacNee W. Comorbidities and systemic effects of chronic obstructive pulmonary disease. Clin Chest Med. 2014 Mar;35(1):101-30. doi: 10.1016/j.ccm.2013.10.007.
PubMed 24507840
Norman G. Likert scales, levels of measurement and the "laws" of statistics. Adv Health Sci Educ Theory Pract. 2010 Dec;15(5):625-32. doi: 10.1007/s10459-010-9222-y. Epub 2010 Feb 10.
PubMed 20146096
Vogelmeier CF, Criner GJ, Martinez FJ, Anzueto A, Barnes PJ, Bourbeau J, Celli BR, Chen R, Decramer M, Fabbri LM, Frith P, Halpin DM, Lopez Varela MV, Nishimura M, Roche N, Rodriguez-Roisin R, Sin DD, Singh D, Stockley R, Vestbo J, Wedzicha JA, Agusti A. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease 2017 Report: GOLD Executive Summary. Arch Bronconeumol. 2017 Mar;53(3):128-149. doi: 10.1016/j.arbres.2017.02.001. Epub 2017 Mar 6. English, Spanish.
PubMed 28274597
American Thoracic Society; American College of Chest Physicians. ATS/ACCP Statement on cardiopulmonary exercise testing. Am J Respir Crit Care Med. 2003 Jan 15;167(2):211-77. doi: 10.1164/rccm.167.2.211. No abstract available.
PubMed 12524257
Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.
PubMed 25359355
Parshall MB, Schwartzstein RM, Adams L, Banzett RB, Manning HL, Bourbeau J, Calverley PM, Gift AG, Harver A, Lareau SC, Mahler DA, Meek PM, O'Donnell DE; American Thoracic Society Committee on Dyspnea. An official American Thoracic Society statement: update on the mechanisms, assessment, and management of dyspnea. Am J Respir Crit Care Med. 2012 Feb 15;185(4):435-52. doi: 10.1164/rccm.201111-2042ST.
PubMed 22336677
Gulart AA, Araujo CLP, Munari AB, Santos KD, Karloh M, Foscarini BG, Dal Lago P, Mayer AF. The minimal important difference for Glittre-ADL test in patients with chronic obstructive pulmonary disease. Braz J Phys Ther. 2020 Jan-Feb;24(1):54-60. doi: 10.1016/j.bjpt.2018.11.009. Epub 2018 Nov 20.
PubMed 30497829

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Copd trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Clinical and Physiological Response Among Three Modalities of Exercise Training in COPD With Chronic Respiratory Failure (CRF)
ClinicalTrials.gov ID: NCT04201548
Acronym / sponsor ID: CE2288
Conditions: Copd, Chronic Hypoxemic Respiratory Failure
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
Collaborators: Universita di Verona
Study start: 28 Aug 2019 (actual)
Primary completion: 16 Jun 2023 (actual)
Study completion: 30 Jun 2024 (actual)
First posted: 17 Dec 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.

Detailed description

Typically, the advanced stage of COPD is characterized by a fluctuating pattern and recurrent hospitalizations, and by a vicious circle in which dyspnoea increases and exercise tolerance reduces, which in turn causes depression and associated social isolation, low quality of life and increased risk of death.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Active Comparator	Active comparator	Other: Endurance TrainingThis is the constant-load Endurance Training (ET) group which will constitute the control group.
Long High Intensity Interval Training	Experimental	Other: Long High Intensity Interval TrainingThis is the Long High Intensity Interval Training (Long-HIIT) group.
Short High Intensity Interval Training	Experimental	Other: Short High Intensity Interval TrainingThis is the Short High Intensity Interval Training (Short-HIIT) group.

Who may qualify

Ages: 51 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

age> 50 years
clinical definition of COPD according to GOLD guidelines (10) with FEV1 / FVC G 70% and FEV1 <50% of the above
PaO2 in air-ambient lower than 60 mmHg evaluated through arterial blood gas analysis
oxygen therapy prescription for more than 18 hours/ day for at least one month
clinical stable condition

Key exclusion criteria (3 listed)

presence of pulmonary diseases other than COPD
respiratory tract infections in the last 4 weeks
termination

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
Endurance TrainingAlso: ET, Active ComparatorThese patients will perform an aerobic exercise with a moderate intensity cycle ergometer. The exercise session on an exercise bike will last 33 minutes at a constant load, starting from an intensity equal to the load of 60% of the maximum load (max watt) achieved at the incremental test. Working volume = 60 X 33 = 1980	Other	Active Comparator
Long High Intensity Interval TrainingAlso: Long-HIIT, Experimental 1The patients assigned to the Long-HIIT group will perform a 32-minute interval work with 4x4 protocol (active phase x passive phase) performing 4 minutes at an intensity of 80-85% of the Max Watt (active phase) spaced from 4 minutes to 40% of the Max Watt (passive phase). The goal of high intensity work will be to bring the heart rate to a level close to 85-90% of the maximum cardiac frequency achieved in the incremental exercise test. If this target is not reached within the session, the load of the next one will be increased in the following session with 10 watt steps. Working volume = 16 X 85 + 16 x 40 = 2000	Other	Long High Intensity Interval Training
Short High Intensity Interval TrainingAlso: Short-HIIT, Experimental 2The patients assigned to the Short-HIIT group will perform an interval work with initial intensity equal to 100% of the Max Watt highlighted in the incremental exercise stress test in the phase (30 seconds) followed by a passive phase of 30 seconds at 50% of the Max Watt for a period of 26 minutes a day. The intensity will be gradually increased during the sessions with symptom-based progression, according to the protocol of Maltais et al. with steps of 10 watts each increment. Working volume = 13 X 100 + 13 x 50 = 2050	Other	Short High Intensity Interval Training

Primary outcome

Changes in effort tolerance
Time frame: at baseline, 1 month and 7 months
We will evaluate the time to exhaustion (Tlim) of a Constant Load Endurance Test (CLET) taht will be set at load corresponding to 80% of the Watts max achieved at the incremental cicloergometer test.
Changes in the maximal work load
Time frame: at baseline and 1 month
Another way to evaluate changes in effort tolerance will be to evaluate the maximal work load (Watts max) that patients will achive during a cicloergometer incremental test.
Changes in walking distance
Time frame: at baseline, 1 month and 7 months
Another way to evaluate changes in effort tolerance will be to evaluate meters walked during a 6 minute walking test (6MWT).

11 secondary outcomes

Percentage of drop out patients
Time frame: at 1 month
Patient's satisfaction: Likert scale
Time frame: at 1 month
Change in dyspnoea
Time frame: at baseline, 1 month and 7 months
Changes in quadriceps volume
Time frame: at baseline, 1 month and 7 months
Change in ADL performance
Time frame: at baseline, 1 month and 7 months
Change in fatigue (physiological evaluation)
Time frame: at baseline, 1 month and 7 months
Change in fatigue (qualitative evaluation)
Time frame: at baseline, 1 month and 7 months
Change in Endothelial function
Time frame: at baseline, 1 month and 7 months
Change in Balance
Time frame: at 1 month and 7 months
Change in quality of life
Time frame: 1 month and 7 months
Change in quality of life
Time frame: at 1 month and 7 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
Background: PubMed 30286833Mirza S, Clay RD, Koslow MA, Scanlon PD. COPD Guidelines: A Review of the 2018 GOLD Report. Mayo Clin Proc. 2018 Oct;93(10):1488-1502. doi: 10.1016/j.mayocp.2018.05.026.
Background: PubMed 29072087Charususin N, Dacha S, Gosselink R, Decramer M, Von Leupoldt A, Reijnders T, Louvaris Z, Langer D. Respiratory muscle function and exercise limitation in patients with chronic obstructive pulmonary disease: a review. Expert Rev Respir Med. 2018 Jan;12(1):67-79. doi: 10.1080/17476348.2018.1398084. Epub 2017 Nov 6.
Background: PubMed 24127811Spruit 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.
Background: PubMed 17728121Carone M, Patessio A, Ambrosino N, Baiardi P, Balbi B, Balzano G, Cuomo V, Donner CF, Fracchia C, Nava S, Neri M, Pozzi E, Vitacca M, Spanevello A. Efficacy of pulmonary rehabilitation in chronic respiratory failure (CRF) due to chronic obstructive pulmonary disease (COPD): The Maugeri Study. Respir Med. 2007 Dec;101(12):2447-53. doi: 10.1016/j.rmed.2007.07.016. Epub 2007 Aug 28.
Background: PubMed 28099192Paneroni M, Simonelli C, Vitacca M, Ambrosino N. Aerobic Exercise Training in Very Severe Chronic Obstructive Pulmonary Disease: A Systematic Review and Meta-Analysis. Am J Phys Med Rehabil. 2017 Aug;96(8):541-548. doi: 10.1097/PHM.0000000000000667.
Background: PubMed 15563700Sabapathy S, Kingsley RA, Schneider DA, Adams L, Morris NR. Continuous and intermittent exercise responses in individuals with chronic obstructive pulmonary disease. Thorax. 2004 Dec;59(12):1026-31. doi: 10.1136/thx.2004.026617.
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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. This study is not recruiting at the moment.

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?

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 5 inclusion and 3 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: finished, as of the sponsor's last update on 31 Oct 2024. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in effort tolerance (time frame: at baseline, 1 month and 7 months). The study lists 3 primary outcomes in all. 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 NCT04201548, which also lists 28 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 31 Oct 2024.