COPDNCT02522637
Exercise Training in Severe COPD
A study testing Exercise training in people with COPD, run by Fondazione Salvatore Maugeri at 1 site in Italy.
Trial summary
International guidelines for pulmonary rehabilitation describe pathways dedicated to moderate COPD patients looking at the work setting, programs and frequency of training sessions in an outpatient program of rehabilitation. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteItaly
- Study dates
- May 2015to 30 Jun 2018
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 40 to 80 years
- Diagnosis of moderate to severe COPD ( GOLD III and IV ) with clinical stability ( pH> 7.38 and no need to change prescription of respiratory drugs in the last 10 days).
Who cannot join
- Patients with respiratory failure in absence of COPD
- Patients who had attended a pulmonary rehabilitation program in the last 6 months
- Patients with a recent myocardial infarction (in the last 3 months)
- Patients with congestive heart failure
- Patients with severe orthopedic diseases
- Patients with psychiatric illness and severe cognitive impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: What is the Best Frequency of Exercise Training in Severe COPD?
International guidelines for pulmonary rehabilitation describe pathways dedicated to moderate COPD patients looking at the work setting, programs and frequency of training sessions in an outpatient program of rehabilitation. However, a new population of respiratory patients is growing: these are more serious and older patients, with several comorbidities and recurrent hospitalizations. In this population no guidelines are available to describe the optimum prescription in terms of frequency, intensity, type and timing (FITT) of rehabilitation. In this kind of patients, only few studies are available on the overtraining risk. The aims of the current study are:
- To detect and compare the response in terms of endurance of two endurance training programs with different time-frequencies (1 session / day versus 2 sessions / day) during 30 days of in-hospital admission to a pulmonary rehabilitation center
- To compare the effectiveness in terms of effort tolerance, dyspnea, peripheral and respiratory muscle strength, quality of life and psychological and functional impact of the disease.
Read the detailed description
Rehabilitation in-hospital program
The rehabilitation program (RP) will start the day after the in-hospital admission and will be continuously supervised by a physiotherapist. The patients will use the drugs and the oxygen therapy prescribed. RP will include a training session on cycloergometer at constant load once a day (Group F1) or twice-a day (Group F2) interrupted by at least three hours of rest. The workout will start with a workload of 50% of the theoretical maximum Watts indirectly assessed by the 6-Minutes Walking Test (6MWT) with equation of Luxton et al.
Measures
At baseline (T0) we will gather in both groups the following evaluations:
- Anthropometric parameters (age, BMI)
- Scale of comorbidity CIRS
At the baseline (T0) and end of the program (T1) we will collect, in all patients, the following evaluations:
- 6-minute walking test walk (6MWT) will be performed according to international guidelines. In patients using oxygen during walking, the oxygen flow will be adjusted to increase the oxygen saturation over 96%.The 6MWT at T1 will be performed with the same amount of oxygen used in the initial test (T0).
- Endurance cycloergometer test will be performed at 80% of Watts max predicted by the 6MWT. At the beginning, the test will be performed at charge "zero watts" for 2 minutes, then the workload will be increased to 80% of the theoretical max Watts until muscle exhaustion (Borg score > 8), presence of high dyspnea (Borg score > 8) or the achievement of 90% of theoretical maximal heart rate. The final endurance test will be repeated at the same load (speed 50-60 rpm). The time spent for performing the exercise will be registered. In a subset of patients (belonging to the Institute of Lumezzane) the endurance cycloergometer test on the quadriceps muscle will be executed by the Near Infrared Spectroscopy (NIRS ).
- Scale of the MRC dyspnea
- Arterial blood gas analysis
- Respiratory muscle strength (Maximal lnspiratory Pressure [MIP] and Maximal Espiratory Pressure [MEP])
- Biceps and quadriceps muscle strength evaluated with dynamometer manual
- CAT scale
Only at the end of the program (T1) we will collect:
- patient satisfaction by a Likert scale taking into consideration the quantity, quality, and impact of rehabilitation on hospitalization
- The time consuming for the two programs
- The side effect
- The drop out (waste, flare)
- Conditions
- COPD
- Being tested
- Exercise training
- Keywords
- exercise, training, endurance
- 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.
Exercise trainingOther
The workout will start with a workload of 50% of the theoretical maximum Watts indirectly assessed by the 6-Minutes Walking Test (6MWT) with equation of Luxton et al. Each training session will begin with three minutes of warm-up and cool-down with a low load.
At the end of each session, the physiotherapist will administer the Borg Scale (i.e. for dyspnea and muscle fatigue) and detect the oxygen saturation. The sessions will be conducted at constant load for 25 minutes and increase following the Maltais protocol (the workload increase in the next session will be 10 W, if dyspnea and muscle fatigue, evaluated at the Borg Scale, were each < 5 ).
The patients will perform a supervised 20-min light warm-up gym exercise before the endurance training session. The training will be carried out with the oxygen level necessary to maintain the saturation level ≥ 91%.
| Study group | Role | What they receive |
|---|---|---|
| Exercise training F1 | Active comparator | Patients will be treated with a specific rehabilitation in-hospital program consisting of one daily sessions of 30 minutes of exercise (Frequency 1 : Program F1 ) Receives: Other: Exercise training |
| Exercise training F2 | Experimental | Patients will be treated with a specific rehabilitation in-hospital program consisting of two daily sessions of 30 minutes of exercise (Frequency 2 : Program F2 ) Receives: Other: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endurance cycloergometer test: difference between F1 and F2 programs (time needing for the test execution)
Evaluation of the time needing for the test execution
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startMay 2015
- Primary completion31 Dec 2017
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- 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
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Salvatore Maugeri
- Sponsor type
- University, hospital or other
- Collaborators
- Villa Pineta Hospital
- Responsible party
- Principal investigator, Mara Paneroni, Fondazione Salvatore Maugeri
- Investigators
- Mara Paneroni, PT, Principal investigator, Fondazione Salvatore Maugeri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02522637
- Sponsor's protocol ID
- Fondazione Salvatore Maugeri
- Status last verified
- Mar 2022
- First submitted
- 6 Jul 2015
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Publication
Publications
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 24127811Luxton N, Alison JA, Wu J, Mackey MG. Relationship between field walking tests and incremental cycle ergometry in COPD. Respirology. 2008 Nov;13(6):856-62. doi: 10.1111/j.1440-1843.2008.01355.x.
PubMed 18811884Brooks D, Solway S, Gibbons WJ. ATS statement on six-minute walk test. Am J Respir Crit Care Med. 2003 May 1;167(9):1287. doi: 10.1164/ajrccm.167.9.950. No abstract available.
PubMed 12714344Hook JL, Arcasoy SM, Zemmel D, Bartels MN, Kawut SM, Lederer DJ. Titrated oxygen requirement and prognostication in idiopathic pulmonary fibrosis. Eur Respir J. 2012 Feb;39(2):359-65. doi: 10.1183/09031936.00108111. Epub 2011 Sep 1.
PubMed 21885386Paneroni M, Vogiatzis I, Belli S, Savio G, Visca D, Zampogna E, Aliani M, Carolis V, Maniscalco M, Simonelli C, Vitacca M. Is Two Better Than One? The Impact of Doubling Training Volume in Severe COPD: A Randomized Controlled Study. J Clin Med. 2019 Jul 18;8(7):1052. doi: 10.3390/jcm8071052.
PubMed 31323895
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Best Frequency of Exercise Training in Severe COPD?
- ClinicalTrials.gov ID
- NCT02522637
- Acronym / sponsor ID
- Fondazione Salvatore Maugeri
- Conditions
- COPD
- Keywords
- exercise, training, endurance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Fondazione Salvatore MaugeriUniversity, hospital or other
- Collaborators
- Villa Pineta Hospital
- Study start
- May 2015 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 13 Aug 2015 (estimated)
- 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.
International guidelines for pulmonary rehabilitation describe pathways dedicated to moderate COPD patients looking at the work setting, programs and frequency of training sessions in an outpatient program of rehabilitation. However, a new population of respiratory patients is growing: these are more serious and older patients, with several comorbidities and recurrent hospitalizations. In this population no guidelines are available to describe the optimum prescription in terms of frequency, intensity, type and timing (FITT) of rehabilitation. In this kind of patients, only few studies are available on the overtraining risk. The aims of the current study are:
- To detect and compare the response in terms of endurance of two endurance training programs with different time-frequencies (1 session / day versus 2 sessions / day) during 30 days of in-hospital admission to a pulmonary rehabilitation center
- To compare the effectiveness in terms of effort tolerance, dyspnea, peripheral and respiratory muscle strength, quality of life and psychological and functional impact of the disease.
Detailed description
Rehabilitation in-hospital program
The rehabilitation program (RP) will start the day after the in-hospital admission and will be continuously supervised by a physiotherapist. The patients will use the drugs and the oxygen therapy prescribed. RP will include a training session on cycloergometer at constant load once a day (Group F1) or twice-a day (Group F2) interrupted by at least three hours of rest. The workout will start with a workload of 50% of the theoretical maximum Watts indirectly assessed by the 6-Minutes Walking Test (6MWT) with equation of Luxton et al.
Measures
At baseline (T0) we will gather in both groups the following evaluations:
- Anthropometric parameters (age, BMI)
- Scale of comorbidity CIRS
At the baseline (T0) and end of the program (T1) we will collect, in all patients, the following evaluations:
- 6-minute walking test walk (6MWT) will be performed according to international guidelines. In patients using oxygen during walking, the oxygen flow will be adjusted to increase the oxygen saturation over 96%.The 6MWT at T1 will be performed with the same amount of oxygen used in the initial test (T0).
- Endurance cycloergometer test will be performed at 80% of Watts max predicted by the 6MWT. At the beginning, the test will be performed at charge "zero watts" for 2 minutes, then the workload will be increased to 80% of the theoretical max Watts until muscle exhaustion (Borg score > 8), presence of high dyspnea (Borg score > 8) or the achievement of 90% of theoretical maximal heart rate. The final endurance test will be repeated at the same load (speed 50-60 rpm). The time spent for performing the exercise will be registered. In a subset of patients (belonging to the Institute of Lumezzane) the endurance cycloergometer test on the quadriceps muscle will be executed by the Near Infrared Spectroscopy (NIRS ).
- Scale of the MRC dyspnea
- Arterial blood gas analysis
- Respiratory muscle strength (Maximal lnspiratory Pressure [MIP] and Maximal Espiratory Pressure [MEP])
- Biceps and quadriceps muscle strength evaluated with dynamometer manual
- CAT scale
Only at the end of the program (T1) we will collect:
- patient satisfaction by a Likert scale taking into consideration the quantity, quality, and impact of rehabilitation on hospitalization
- The time consuming for the two programs
- The side effect
- The drop out (waste, flare)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise training F1 | Active comparator | Other: Exercise trainingPatients will be treated with a specific rehabilitation in-hospital program consisting of one daily sessions of 30 minutes of exercise (Frequency 1 : Program F1 ) |
| Exercise training F2 | Experimental | Other: Exercise trainingPatients will be treated with a specific rehabilitation in-hospital program consisting of two daily sessions of 30 minutes of exercise (Frequency 2 : Program F2 ) |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age: 40 to 80 years
- Diagnosis of moderate to severe COPD ( GOLD III and IV ) with clinical stability ( pH> 7.38 and no need to change prescription of respiratory drugs in the last 10 days).
Key exclusion criteria (6 listed)
- Patients with respiratory failure in absence of COPD
- Patients who had attended a pulmonary rehabilitation program in the last 6 months
- Patients with a recent myocardial infarction (in the last 3 months)
- Patients with congestive heart failure
- Patients with severe orthopedic diseases
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 |
|---|---|---|
| Exercise trainingThe workout will start with a workload of 50% of the theoretical maximum Watts indirectly assessed by the 6-Minutes Walking Test (6MWT) with equation of Luxton et al. Each training session will begin with three minutes of warm-up and cool-down with a low load. At the end of each session, the physiotherapist will administer the Borg Scale (i.e. for dyspnea and muscle fatigue) and detect the oxygen saturation. The sessions will be conducted at constant load for 25 minutes and increase following the Maltais protocol (the workload increase in the next session will be 10 W, if dyspnea and muscle fatigue, evaluated at the Borg Scale, were each < 5 ). The patients will perform a supervised 20-min light warm-up gym exercise before the endurance training session. The training will be carried out with the oxygen level necessary to maintain the saturation level ≥ 91%. | Other | Exercise training F1, Exercise training F2 |
Primary outcome
Endurance cycloergometer test: difference between F1 and F2 programs (time needing for the test execution)
Time frame: 30 days
Evaluation of the time needing for the test execution
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 Mar 2022.
- 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 18811884Luxton N, Alison JA, Wu J, Mackey MG. Relationship between field walking tests and incremental cycle ergometry in COPD. Respirology. 2008 Nov;13(6):856-62. doi: 10.1111/j.1440-1843.2008.01355.x.
- Background: PubMed 12714344Brooks D, Solway S, Gibbons WJ. ATS statement on six-minute walk test. Am J Respir Crit Care Med. 2003 May 1;167(9):1287. doi: 10.1164/ajrccm.167.9.950. No abstract available.
- Background: PubMed 21885386Hook JL, Arcasoy SM, Zemmel D, Bartels MN, Kawut SM, Lederer DJ. Titrated oxygen requirement and prognostication in idiopathic pulmonary fibrosis. Eur Respir J. 2012 Feb;39(2):359-65. doi: 10.1183/09031936.00108111. Epub 2011 Sep 1.
- Results publication: PubMed 31323895Paneroni M, Vogiatzis I, Belli S, Savio G, Visca D, Zampogna E, Aliani M, Carolis V, Maniscalco M, Simonelli C, Vitacca M. Is Two Better Than One? The Impact of Doubling Training Volume in Severe COPD: A Randomized Controlled Study. J Clin Med. 2019 Jul 18;8(7):1052. doi: 10.3390/jcm8071052.
- Individual participant dataSharing planned: Yes. Publication
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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, PT principal investigator
Fondazione Salvatore 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 Exercise training in people with COPD, run by Fondazione Salvatore Maugeri 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 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: finished, as of the sponsor's last update on 31 Mar 2022. 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?
Endurance cycloergometer test: difference between F1 and F2 programs (time needing for the test execution) (time frame: 30 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 NCT02522637, which also lists 5 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 Mar 2022.