Chronic Obstructive Pulmonary DiseaseNCT01944072
Pulmonary Rehabilitation in COPD: Effects of Two Aerobic Exercise Intensity in Patient-centered Outcomes
A study testing Aerobic exercise training intensity in people with Chronic Obstructive Pulmonary Disease, run by Universidade Nova de Lisboa.
Trial summary
Trial design: An equivalence/non-inferiority randomized controlled trial with parallel group design studied the effect of two aerobic exercise-training intensities in COPD patient-centered outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Aerobic exercise training intensity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Mar 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically stable COPD
- FEV1/FVC < 70%
- Exercise training medical referral
Who cannot join
- Unable to attend 3-times/week program
- Infectious disease
- Metastatic cancer
- Unstable heart disease
- Neuromusculoskeletal disorder
- Cognitive or psychiatric disorder
About this study
Official title: Pulmonary Rehabilitation in COPD: Effects of Two Aerobic Exercise Intensity in Patient-centered Outcomes - a Randomized Controlled Trial
Trial design: An equivalence/non-inferiority randomized controlled trial with parallel group design studied the effect of two aerobic exercise-training intensities in COPD patient-centered outcomes. Methods: Thirty-four COPD clinically stable patients stratified from mild to very severe GOLD stages, were blinded to 60 or 80%Wmax aerobic exercise training intensity in an outpatient pulmonary rehabilitation program, between 2009-2010. Outcomes were assessed with St.George's respiratory questionnaire (primary outcome), Mahler dyspnea index, London Chest activity of daily living scale, 6-minute walk, constant load and incremental exercise tests. Patient's allocation sequence was computer-generated, with consignment in a safe deposit box.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Aerobic exercise training intensity
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, Pulmonary rehabilitation, Aerobic exercise, CEDOC, FCM, UNL, NOVA MEDICAL SCHOOL
- 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.
Aerobic exercise training intensityOther
| Study group | Role | What they receive |
|---|---|---|
| 60% | Other | aerobic exercise training intensity of 60%Wmax Receives: Other: Aerobic exercise training intensity |
| 80% | Other | aerobic exercise training intensity of 80%Wmax Receives: Other: Aerobic exercise training intensity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality-of-life measured by the St.George's respiratory questionnaire
Measured: 8 weeks (20 sessions)
Secondary outcomes (2)
Symptoms control measured by the Mahler dyspnea index
Measured: 8 weeks (20 sessions)
Exercise Tolerance
exercise tolerance assessed by the London-Chest activity of daily-living scale, 6-minute walk test, incremental exercise test and constant-load exercise test
Measured: 8 weeks (20 sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startSep 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Nova de Lisboa
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Hospitalar Lisboa Norte, Centro de Estudos de Doenças Crónicas
- Responsible party
- Sponsor
- Investigators
- Catarina Santos, PT, MSc, Principal investigator, Centro Hospitalar Lisboa OcidentalFátima Rodrigues, MD, MSc, Study chair, Centro Hospitalar Lisboa NorteCristina Bárbara, MD, PhD, Study director, Centro Hospitalar Lisboa Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01944072
- Sponsor's protocol ID
- NOVA-FCM-MSAR-001
- Status last verified
- Sep 2013
- First submitted
- 9 Sep 2013
- Last updated
- 17 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Santos C, Rodrigues F, Santos J, Morais L, Barbara C. Pulmonary Rehabilitation in COPD: Effect of 2 Aerobic Exercise Intensities on Subject-Centered Outcomes--A Randomized Controlled Trial. Respir Care. 2015 Nov;60(11):1603-9. doi: 10.4187/respcare.03663. Epub 2015 Jul 28.
PubMed 26221044
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Rehabilitation in COPD: Effects of Two Aerobic Exercise Intensity in Patient-centered Outcomes - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01944072
- Acronym / sponsor ID
- NOVA-FCM-MSAR-001
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, Pulmonary rehabilitation, Aerobic exercise, CEDOC, FCM, UNL, NOVA MEDICAL SCHOOL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Universidade Nova de LisboaUniversity, hospital or other
- Collaborators
- Centro Hospitalar Lisboa Norte, Centro de Estudos de Doenças Crónicas
- Study start
- Sep 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 17 Sep 2013 (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.
Trial design: An equivalence/non-inferiority randomized controlled trial with parallel group design studied the effect of two aerobic exercise-training intensities in COPD patient-centered outcomes. Methods: Thirty-four COPD clinically stable patients stratified from mild to very severe GOLD stages, were blinded to 60 or 80%Wmax aerobic exercise training intensity in an outpatient pulmonary rehabilitation program, between 2009-2010. Outcomes were assessed with St.George's respiratory questionnaire (primary outcome), Mahler dyspnea index, London Chest activity of daily living scale, 6-minute walk, constant load and incremental exercise tests. Patient's allocation sequence was computer-generated, with consignment in a safe deposit box.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 60% | Other | Other: Aerobic exercise training intensityaerobic exercise training intensity of 60%Wmax |
| 80% | Other | Other: Aerobic exercise training intensityaerobic exercise training intensity of 80%Wmax |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinically stable COPD
- FEV1/FVC < 70%
- Exercise training medical referral
Key exclusion criteria (6 listed)
- Unable to attend 3-times/week program
- Infectious disease
- Metastatic cancer
- Unstable heart disease
- Neuromusculoskeletal disorder
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 |
|---|---|---|
| Aerobic exercise training intensity | Other | 60%, 80% |
Primary outcome
Health-related quality-of-life measured by the St.George's respiratory questionnaire
Time frame: 8 weeks (20 sessions)
2 secondary outcomes
Symptoms control measured by the Mahler dyspnea index
Time frame: 8 weeks (20 sessions)
Exercise Tolerance
Time frame: 8 weeks (20 sessions)
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 17 Sep 2013.
- Derived from this study: PubMed 26221044Santos C, Rodrigues F, Santos J, Morais L, Barbara C. Pulmonary Rehabilitation in COPD: Effect of 2 Aerobic Exercise Intensities on Subject-Centered Outcomes--A Randomized Controlled Trial. Respir Care. 2015 Nov;60(11):1603-9. doi: 10.4187/respcare.03663. Epub 2015 Jul 28.
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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.
Catarina Santos, PT, MSc principal investigator
Centro Hospitalar Lisboa Ocidental
Fátima Rodrigues, MD, MSc study chair
Centro Hospitalar Lisboa Norte
Cristina Bárbara, MD, PhD study director
Centro Hospitalar Lisboa Norte
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise training intensity in people with Chronic Obstructive Pulmonary Disease, run by Universidade Nova de Lisboa.
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 3 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 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Health-related quality-of-life measured by the St.George's respiratory questionnaire (time frame: 8 weeks (20 sessions)). 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 NCT01944072, which also lists 1 linked publication.
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 17 Sep 2013.