COPD (Chronic Obstructive Pulmonary Disease)COPD_CPilatesNCT07267858
Clinical Pilates Programme on People With COPD Gold A: a Rehabilitation Nursing Approach.
A study testing Clinical Pilates for people with COPD Gold A. in people with COPD (Chronic Obstructive Pulmonary Disease), run by University of Trás-os-Montes and Alto Douro at 1 site in Portugal.
Trial summary
The main objective of this study is to evaluate the effects of a Clinical Pilates-based exercise programme on chest mobility, lung function, motor performance, physical activity levels, sleep quality and Health-Related Quality of Life (HRQoL) in individuals with Gold A COPD. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- Clinical Pilates for people with COPD Gold A.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePortugal
- Study dates
- 7 Nov 2024to 24 Jul 2026
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Anyone diagnosed with COPD at GOLD stage A, duly identified in SClínico, registered with the USF and residing in the geographical area covered by the Guimarães UCC, whose participation is validated by their family doctor. Inclusion in the study implies participation in at least 60% of the programme sessions, namely 10.
Who cannot join
- People with a history of exacerbation of the disease less than 4 weeks ago, as the guidelines of the European Respiratory Society and the American Thoracic Society (2017) make a conditional recommendation on pulmonary rehabilitation after exacerbation and recommend waiting at least 3 weeks, severe osteoarticular limitation that prevents physical exercise, psychiatric illness or severe cognitive dysfunction, unstable comorbidities such as unstable ischaemic disease or decompensated heart failure, and exercise-induced hypoxemia refractory to oxygen administration.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Unidade de Cuidados na Comunidade de Guimarães
Guimarães, 4800
About this study
Official title: Effect of a Clinical Pilates Programme on Individuals With Gold A COPD on Lung Function, Motor Performance, Chest Mobility, Sleep and Physical Activity, and Health-related Quality of Life: an Interactive Approach Between Rehabilitation Nursing and Sports Sciences.
The main objective of this study is to evaluate the effects of a Clinical Pilates-based exercise programme on chest mobility, lung function, motor performance, physical activity levels, sleep quality and Health-Related Quality of Life (HRQoL) in individuals with Gold A COPD. Based on our research question, 'What is the effect of a Clinical Pilates programme on thoracic mobility, pulmonary function, motor performance, physical activity levels, sleep quality, and HRQoL in people with Gold A COPD?', we propose the following research hypotheses:
H1: The Clinical Pilates programme contributed to improved thoracic mobility in people with Gold A COPD.
Read more
H2: The Clinical Pilates programme contributed to improved lung function in people with Gold A COPD.
H3: The Clinical Pilates programme positively influences the motor performance of people with Gold A COPD.
H4: The Clinical Pilates programme positively influences the physical activity levels of people with COPD Gold A.
H5: The Clinical Pilates programme positively influences the sleep quality of people with COPD Gold A.
H6: The Clinical Pilates programme contributes to improving the HRQoL levels of people with COPD Gold A.
- Being tested
- Clinical Pilates for people with COPD Gold A.
- Keywords
- COPD, Clinical Pilates, Rehabilitation Nursing
- 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.
Clinical Pilates for people with COPD Gold A.Behavioural
8-week programme with face-to-face sessions twice a week, lasting approximately 60 minutes per session, using equipment such as soft balls and elastic bands.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Pilates Group (CPG) | Experimental | Group of individuals with ongoing rehabilitation nursing consultations who participate in the CP programme consisting of 16 sessions of 60 minutes each. Receives: Behavioral: Clinical Pilates for people with COPD Gold A. |
| Control Group (CG) | No intervention | Group that only underwent follow-up rehabilitation nursing consultations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of a Clinical Pilates programme, as a tool in the field of Rehabilitation Nursing, on thoracic mobility in people with COPD Gold A.
Chirometric tests of the Thorax (Lanza et al., 2013).
- The person stands with their hands on their hips, chest bare, with the investigator in front of them;
- A tape measure is placed over the patient's rib cage in the axillary region;
- The zero point of the tape measure is fixed in the anterior region of the chest at each level: axillary, with the tape passing through the axillary fold, and xiphoid, with the tape fixed to the xiphoid process. The other end of the tape goes around the chest and is pulled by the examiner over this fixed point, exerting as little pressure as possible on the person's body (the tape is adjusted but not tightened, ensuring that the contour of the soft tissues remains unchanged).
- The person is asked to take a maximum breath in, followed by a maximum breath out, holding each for at least 2 seconds.
- The measurement (cm) is recorded at the end of the breath out and the breath in.
- The measurement is repeated.
Measured: Applied pre-intervention and post-intervention (with a 2-month interval). Both in Experimental and control group.
Effect of a Clinical Pilates programme, as a tool in the field of Rehabilitation Nursing on pulmonary function in people with COPD Gold A.
Peak expiratory flow - Peak Flow (Miler et al., 2005).
- The person sits with their neck in a neutral position, looking straight ahead;
- They hold the Peak Flow meter and place it close to their mouth (ensuring that the indicator needle is set at 0);
- The person takes a deep breath, places the Peak Flow in their mouth, between their teeth and with their tongue under the mouthpiece, and blows as hard as possible without pausing;
- The highest value of at least three readings is recorded, with only readings that do not differ by more than 20L/min being considered;
- Invalidate the result in case of excess saliva in the mouthpiece or coughing during exhalation;
- The measurement range is between 50-800 L/min in accordance with the applicable standard ISO 23747:2015.
Measured: Applied pre-intervention and post-intervention (with a 2-month interval). Both in Experimental and control group.
Effect of a Clinical Pilates programme, as a tool in the field of Rehabilitation Nursing on motor performance in people with COPD Gold A.
One-minute sit-to-stand test (Vaidya et al., 2016) and modified Borg scale (Borg, 1982).
- The person sits on a chair leaning against the wall, with knees and hips bent at 90º, feet flat on the floor and hands resting on their legs;
- The person is asked to stand up and sit down from the chair as quickly as possible without support for one minute.
- The number of repetitions is counted.
- At the end, the 'Modified Borg Scale' is applied.
- The scale is placed in front of the person and they are asked to rate the degree of dyspnoea they perceive.
- The rating ranges from 0 to 10, with 0 being 'No shortness of breath' and 10 being 'Maximum shortness of breath'.
- The person indicates the number corresponding to the dyspnoea they feel.
Measured: Applied pre-intervention and post-intervention (with a 2-month interval). Both in Experimental and control group.
Effect of a Clinical Pilates programme, as a tool in the field of Rehabilitation Nursing on physical activity levels in people with COPD Gold A.
Actigraph® GT3X+ accelerometer. The brand protocol requires wearing the device for a period of 4 days, including 2 days at the weekend.
The device will be programmed for 6 hours on the first day of assessment and recordings will be made every 15 seconds.
A record sheet will be provided to indicate the times when the accelerometer is put on and taken off.
The device is placed on the non-dominant wrist and daily recording of at least 600 minutes (10 hours) is mandatory.
Measured: Applied pre-intervention and post-intervention (with a 2-month interval). Both in Experimental and control group.
Effect of a Clinical Pilates programme, as a tool in the field of Rehabilitation Nursing on sleep quality in people with COPD Gold A.
The brand protocol requires wearing the device for a period of 4 days, including 2 days at the weekend.
The device will be programmed for 6 hours on the first day of assessment and recordings will be made every 15 seconds.
A record sheet will be provided to indicate the times when the accelerometer is put on and taken off.
The device is placed on the non-dominant wrist and daily recording of at least 600 minutes (10 hours) is mandatory.
Measured: Applied pre-intervention and post-intervention (with a 2-month interval). Both in Experimental and control group.
Effect of a Clinical Pilates programme, as a tool in the field of Rehabilitation Nursing on Health-related quality of life (HRQoL) in people with COPD Gold A.
EQ-5D-5L (Ferreira et al., 2023).
Likert scale (1 to 5) self-assessment that considers 5 domains:
- Mobility: from 'I have no mobility problems' to 'I am unable to walk';
- Personal care: 'I have no problems washing or dressing myself' to 'I am unable to wash or dress myself';
- Usual activities (e.g. domestic, leisure or family activities): 'I have no problem performing my usual activities' to 'I am unable to perform my usual activities';
- Pain/Discomfort: 'I have no pain or discomfort' to 'I have extreme pain or discomfort';
- Anxiety/Depression: 'I am not anxious and/or depressed' to 'I am extremely anxious and/or depressed';
- Visual scale from 0 to 100, where 0 is 'worst health imaginable' and 100 is 'best health imaginable.' The person is asked to place an X on the scale to indicate how they feel about their health at the moment.
Measured: Applied pre-intervention and post-intervention (with a 2-month interval). Both in Experimental and control group.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start7 Nov 2024
- Primary completion11 Nov 2025
- Study completion24 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies 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
- Model description
- Sample of participants, divided into an experimental group and a control group: 1. Clinical Pilates Group (CPG), a group of people receiving follow-up rehabilitation nursing consultations and participating in the CP programme, which included 20 people. 2. Control Group (CG), a group that only underwent follow-up rehabilitation nursing consultations, in which 18 people participated. Randomisation was performed by organising the individuals who met the inclusion criteria in alphabetical order and alternately removing them for each of the groups.
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Trás-os-Montes and Alto Douro
- Sponsor type
- University, hospital or other
- Collaborators
- Unidade Local de Saúde do Alto Ave, EPE
- Responsible party
- Principal investigator, Cristiana Marques, University of Trás-os-Montes and Alto Douro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267858
- Sponsor's protocol ID
- 142/2024-CAF
- Acronym
- COPD_CPilates
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Clinical Pilates Programme on Individuals With Gold A COPD on Lung Function, Motor Performance, Chest Mobility, Sleep and Physical Activity, and Health-related Quality of Life: an Interactive Approach Between Rehabilitation Nursing and Sports Sciences.
- ClinicalTrials.gov ID
- NCT07267858
- Acronym / sponsor ID
- COPD_CPilates / 142/2024-CAF
- Keywords
- COPD, Clinical Pilates, Rehabilitation Nursing
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of Trás-os-Montes and Alto DouroUniversity, hospital or other
- Collaborators
- Unidade Local de Saúde do Alto Ave, EPE
- Study start
- 7 Nov 2024 (actual)
- Primary completion
- 11 Nov 2025 (actual)
- Study completion
- 24 Jul 2026 (estimated)
- First posted
- 5 Dec 2025 (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.
The main objective of this study is to evaluate the effects of a Clinical Pilates-based exercise programme on chest mobility, lung function, motor performance, physical activity levels, sleep quality and Health-Related Quality of Life (HRQoL) in individuals with Gold A COPD. Based on our research question, 'What is the effect of a Clinical Pilates programme on thoracic mobility, pulmonary function, motor performance, physical activity levels, sleep quality, and HRQoL in people with Gold A COPD?', we propose the following research hypotheses:
H1: The Clinical Pilates programme contributed to improved thoracic mobility in people with Gold A COPD.
H2: The Clinical Pilates programme contributed to improved lung function in people with Gold A COPD.
H3: The Clinical Pilates programme positively influences the motor performance of people with Gold A COPD.
H4: The Clinical Pilates programme positively influences the physical activity levels of people with COPD Gold A.
H5: The Clinical Pilates programme positively influences the sleep quality of people with COPD Gold A.
H6: The Clinical Pilates programme contributes to improving the HRQoL levels of people with COPD Gold A.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Sample of participants, divided into an experimental group and a control group: 1. Clinical Pilates Group (CPG), a group of people receiving follow-up rehabilitation nursing consultations and participating in the CP programme, which included 20 people. 2. Control Group (CG), a group that only underwent follow-up rehabilitation nursing consultations, in which 18 people participated. Randomisation was performed by organising the individuals who met the inclusion criteria in alphabetical order and alternately removing them for each of the groups.
| Arm | Type | Receives |
|---|---|---|
| Clinical Pilates Group (CPG) | Experimental | Behavioral: Clinical Pilates for people with COPD Gold A.Group of individuals with ongoing rehabilitation nursing consultations who participate in the CP programme consisting of 16 sessions of 60 minutes each. |
| Control Group (CG) | No intervention | –Group that only underwent follow-up rehabilitation nursing consultations. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Anyone diagnosed with COPD at GOLD stage A, duly identified in SClínico, registered with the USF and residing in the geographical area covered by the Guimarães UCC, whose participation is validated by their family doctor. Inclusion in the study implies participation in at least 60% of the programme sessions, namely 10.
Key exclusion criteria (1 listed)
- People with a history of exacerbation of the disease less than 4 weeks ago, as the guidelines of the European Respiratory Society and the American Thoracic Society (2017) make a conditional recommendation on pulmonary rehabilitation after exacerbation and recommend waiting at least 3 weeks, severe osteoarticular limitation that prevents physical exercise, psychiatric illness or severe cognitive dysfunction, unstable comorbidities such as unstable ischaemic disease or decompensated heart failure, and exercise-induced hypoxemia refractory to oxygen administration.
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 |
|---|---|---|
| Clinical Pilates for people with COPD Gold A.8-week programme with face-to-face sessions twice a week, lasting approximately 60 minutes per session, using equipment such as soft balls and elastic bands. | Behavioural | Clinical Pilates Group (CPG) |
Primary outcome
Effect of a Clinical Pilates programme, as a tool in the field of Rehabilitation Nursing, on thoracic mobility in people with COPD Gold A.
Time frame: Applied pre-intervention and post-intervention (with a 2-month interval). Both in Experimental and control group.
Chirometric tests of the Thorax (Lanza et al., 2013). * The person stands with their hands on their hips, chest bare, with the investigator in front of them; * A tape measure is placed over the patient's rib cage in the axillary region; * The zero point of the tape measure is fixed in the anterior region of the chest at each level: axillary, with the tape passing through the axillary fold, and xiphoid, with the tape fixed to the xiphoid process. The other end of the tape goes around the chest and is pulled by the examiner over this fixed point, exerting as little pressure as possible on the person's body (the tape is adjusted but not tightened, ensuring that the contour of the soft tissues remains unchanged). * The person is asked to take a maximum breath in, followed by a maximum breath out, holding each for at least 2 seconds. * The measurement (cm) is recorded at the end of the breath out and the breath in. * The measurement is repeated.
Effect of a Clinical Pilates programme, as a tool in the field of Rehabilitation Nursing on pulmonary function in people with COPD Gold A.
Time frame: Applied pre-intervention and post-intervention (with a 2-month interval). Both in Experimental and control group.
Peak expiratory flow - Peak Flow (Miler et al., 2005). * The person sits with their neck in a neutral position, looking straight ahead; * They hold the Peak Flow meter and place it close to their mouth (ensuring that the indicator needle is set at 0); * The person takes a deep breath, places the Peak Flow in their mouth, between their teeth and with their tongue under the mouthpiece, and blows as hard as possible without pausing; * The highest value of at least three readings is recorded, with only readings that do not differ by more than 20L/min being considered; * Invalidate the result in case of excess saliva in the mouthpiece or coughing during exhalation; * The measurement range is between 50-800 L/min in accordance with the applicable standard ISO 23747:2015.
Effect of a Clinical Pilates programme, as a tool in the field of Rehabilitation Nursing on motor performance in people with COPD Gold A.
Time frame: Applied pre-intervention and post-intervention (with a 2-month interval). Both in Experimental and control group.
One-minute sit-to-stand test (Vaidya et al., 2016) and modified Borg scale (Borg, 1982). * The person sits on a chair leaning against the wall, with knees and hips bent at 90º, feet flat on the floor and hands resting on their legs; * The person is asked to stand up and sit down from the chair as quickly as possible without support for one minute. * The number of repetitions is counted. * At the end, the 'Modified Borg Scale' is applied. * The scale is placed in front of the person and they are asked to rate the degree of dyspnoea they perceive. * The rating ranges from 0 to 10, with 0 being 'No shortness of breath' and 10 being 'Maximum shortness of breath'. * The person indicates the number corresponding to the dyspnoea they feel.
Effect of a Clinical Pilates programme, as a tool in the field of Rehabilitation Nursing on physical activity levels in people with COPD Gold A.
Time frame: Applied pre-intervention and post-intervention (with a 2-month interval). Both in Experimental and control group.
Actigraph® GT3X+ accelerometer. The brand protocol requires wearing the device for a period of 4 days, including 2 days at the weekend. The device will be programmed for 6 hours on the first day of assessment and recordings will be made every 15 seconds. A record sheet will be provided to indicate the times when the accelerometer is put on and taken off. The device is placed on the non-dominant wrist and daily recording of at least 600 minutes (10 hours) is mandatory.
Effect of a Clinical Pilates programme, as a tool in the field of Rehabilitation Nursing on sleep quality in people with COPD Gold A.
Time frame: Applied pre-intervention and post-intervention (with a 2-month interval). Both in Experimental and control group.
The brand protocol requires wearing the device for a period of 4 days, including 2 days at the weekend. The device will be programmed for 6 hours on the first day of assessment and recordings will be made every 15 seconds. A record sheet will be provided to indicate the times when the accelerometer is put on and taken off. The device is placed on the non-dominant wrist and daily recording of at least 600 minutes (10 hours) is mandatory.
Effect of a Clinical Pilates programme, as a tool in the field of Rehabilitation Nursing on Health-related quality of life (HRQoL) in people with COPD Gold A.
Time frame: Applied pre-intervention and post-intervention (with a 2-month interval). Both in Experimental and control group.
EQ-5D-5L (Ferreira et al., 2023). Likert scale (1 to 5) self-assessment that considers 5 domains: * Mobility: from 'I have no mobility problems' to 'I am unable to walk'; * Personal care: 'I have no problems washing or dressing myself' to 'I am unable to wash or dress myself'; * Usual activities (e.g. domestic, leisure or family activities): 'I have no problem performing my usual activities' to 'I am unable to perform my usual activities'; * Pain/Discomfort: 'I have no pain or discomfort' to 'I have extreme pain or discomfort'; * Anxiety/Depression: 'I am not anxious and/or depressed' to 'I am extremely anxious and/or depressed'; * Visual scale from 0 to 100, where 0 is 'worst health imaginable' and 100 is 'best health imaginable.' The person is asked to place an X on the scale to indicate how they feel about their health at the moment.
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 5 Dec 2025.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Pilates for people with COPD Gold A. in people with COPD (Chronic Obstructive Pulmonary Disease), run by University of Trás-os-Montes and Alto Douro at 1 site in Portugal.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 5 Dec 2025. 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 Portugal. 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?
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?
Effect of a Clinical Pilates programme, as a tool in the field of Rehabilitation Nursing, on thoracic mobility in people with COPD Gold A. (time frame: Applied pre-intervention and post-intervention (with a 2-month interval). Both in Experimental and control group.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2025.