Chronic Obstructive Pulmonary DiseaseETReaCOPDNCT05939999
Effects of Elastic Tape on Pulmonary Rehabilitation of Patients with Chronic Obstructive Pulmonary Disease
A study testing Experimental: Elastic tape (ET) in people with Chronic Obstructive Pulmonary Disease, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Evaluate the effect of the use of elastic tape in chest wall and abdomen in the physical capacity, psychosocial distress levels, quality of life and anxiety, and depression symptoms of individuals with moderate to very severe chronic obstructive pulmonary disease (COPD) undergoing pulmonary rehabilitation. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Experimental: Elastic tape (ET)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteBrazil
- Study dates
- 26 Oct 2023to May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Moderate to very severe COPD diagnosis according to Global Iniciative for Chronic Obstructive Lung Disease (GOLD) 2020
- Clinical stability (i.e., no exacerbations for at least 30 days)
- Male
- Non-obese (BMI ≤29.9 kg/m2)
- No musculoskeletal limitation
- Not included in a pulmonary rehabilitation program in the last 6 months.
- Do not perform home oxygen therapy
Who cannot join
- Present osteoarticular, cognitive, neurological, and/or cardiological dysfunctions that prevent physical training
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Clinical Hospital of São Paulo University medical school (HCFMUSP)
São Paulo, São Paulo, 05360-160
Celso RF Carvalho, PhD, cscarval@usp.br
About this study
Evaluate the effect of the use of elastic tape in chest wall and abdomen in the physical capacity, psychosocial distress levels, quality of life and anxiety, and depression symptoms of individuals with moderate to very severe chronic obstructive pulmonary disease (COPD) undergoing pulmonary rehabilitation.
Read the detailed description
Individuals will be evaluated on two non-consecutive days (7 days apart). On the first visit, wil be obtained: clinical and anthropometric data and assessed clinical control [COPD Assessment Test™(CAT)], health-related quality of life [Chronic Respiratory Questionnaire (CRQ)], and anxiety and depression levels [Hospital Anxiety and Depression Scale (HADS)]. Patients will also perform a complete pulmonary function test. After, the volunteers will receive a triaxial accelerometer to assess their physical activity level (PAL) and will be instructed to return after seven days. On the second visit, patients will undergo the Incremental Shuttle Walking Test (ISWT), and the Endurance Shuttle Walking Test (ESWT), without ET.
After the assessments, the individuals will be randomized. Randomization will be computer generated (www.randomization.com) by an investigator who will not be involved in individual recruitment, evaluation, or intervention. The allocation of individuals will be secret using consecutive numbered, sealed, and opaque envelopes (concealed allocation). Initial and post-intervention assessments will be performed by an investigator who will not be involved in the recruitment, evaluation, or intervention. After inclusion, individuals will start a pulmonary rehabilitation (PR) program for eight weeks; twice a week, individuals in the ET group will have the tape applied at the beginning of each session and removed at the end. After completing the 8-week PR period, individuals will undergo the same tests performed in two visits.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Experimental: Elastic tape (ET), Sham Comparator: Sham (SH)
- Keywords
- rehabilitation, exercise capacity, health-related quality of life, elastic tape
- 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.
Experimental: Elastic tape (ET)Other
The elastic tape will be allocated in the chest wall and abdomen of individuals and will be used during the 8 weeks of rehabilitation protocol.
Sham Comparator: Sham (SH)Other
The micropore tape will be allocated in the chest wall and abdomen of individuals and will be used during the 8 weeks of rehabilitation protocol.
| Study group | Role | What they receive |
|---|---|---|
| Elastic tape (ET) | Experimental | The group that will participate in the 8 weeks pulmonary rehabilitation protocol using the elastic tape. Receives: Other: Experimental: Elastic tape (ET) |
| Sham (SH) | Sham comparator | The group that will participate in the pulmonary rehabilitation protocol using micropore tape. Receives: Other: Sham Comparator: Sham (SH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Exercise Capacity: The total time reached in the Endurance Shuttle Walking Test (ESWT)
The patients will be instructed to walk in a 10-meter corridor limited by cones (with a distance of 9 meters between them), and the speed will be determined by a sound signal issued by cell phone, in this case, the speed will be determined using 85% of the maximum speed reached in the Incremental Shuttle Walking Test (ISWT) and will be constant throughout the test.
Measured: Change from baseline at 8 weeks of intervention.
Secondary outcomes (3)
Clinical Control: COPD Assessment Test™ (CAT) is a specific questionnaire for COPD that assesses the impact of the symptoms of the disease
It consists of eight items related to the health condition and is applied and validated worldwide in several langes. The maximum test score is 40 points, and the questions cover follow symptoms: cough, phlegm production, chest pressure, shortness of breath, activities of daily living, psychological aspects, sleep, and mood. Each question has six options (0-5), and the lower the score, the better the health condition.
Measured: Change from baseline at 8 weeks of intervention.
Symptoms of Anxiety and Depression: Hospital Anxiety and Depression Scale (HADS): The questionnaire was developed to identify symptoms of anxiety and depressive mood.
It consists of 14 multiple-choice questions divided into two subscales: anxiety (HADS-A) and depression (HADS-D), with seven questions each. The domains are categorized by the severity of the stress present: 0-7 - none; 8-10 - likely; >11 - present.
Measured: Change from baseline at 8 weeks of intervention.
Health-related Quality of Life: was assessed by using the Chronic Respiratory Questionnaire (CRQ)
This questionnaire consists of 20 questions, divided into four domains: Fatigue (4 questions), Emotional Function (7 questions), and Self-control (4 questions) evaluated using a Likert scale with seven alternatives ranging from "never" to "always." The dyspnea domain (5 questions) has an individualized assessment in which the individual chooses from a list of 26 daily activities which are the five activities that most cause dyspnea and then grades each one again using a Likert scale with seven alternatives ranging from "unbearable shortness of breath" to "No shortness of breath." Results are expressed as the average score for each domain and the total score, and higher scores indicate a better health-related quality of life.
Measured: Change from baseline at 8 weeks of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start26 Oct 2023
- Primary completionApr 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Celso RF Carvalho, Study director, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939999
- Sponsor's protocol ID
- 2022/09628-1
- Acronym
- ETReaCOPD
- Status last verified
- Dec 2024
- First submitted
- 29 Jun 2023
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Melo Batista Dos Santos J, Pinto TF, Reis ECM, Marques da Silva CCB, Carvalho-Pinto RM, de Lima FF, Carvalho CRF. Elastic tape as an add-on strategy to potentiate pulmonary rehabilitation outcomes in nonobese males with moderate-to-very severe COPD: A randomised clinical trial. Pulmonology. 2026 Dec;32(1):2718606. doi: 10.1080/25310429.2026.2718606. Epub 2026 Aug 19.
PubMed 42614062Pinto TF, Dos Santos JMB, Reis ECM, Marques da Silva CCB, de Lima FF, Carvalho-Pinto RM, Carvalho CRF. Effects of Elastic Tape Associated With Pulmonary Rehabilitation in Male Individuals With Chronic Obstructive Pulmonary Disease: Protocol for a 2-Arm, Assessor-Blinded Randomized Controlled Trial. JMIR Res Protoc. 2026 Feb 27;15:e75029. doi: 10.2196/75029.
PubMed 41773531
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Elastic Tape on Pulmonary Rehabilitation of Patients with Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT05939999
- Acronym / sponsor ID
- ETReaCOPD / 2022/09628-1
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- rehabilitation, exercise capacity, health-related quality of life, elastic tape
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 26 Oct 2023 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the effect of the use of elastic tape in chest wall and abdomen in the physical capacity, psychosocial distress levels, quality of life and anxiety, and depression symptoms of individuals with moderate to very severe chronic obstructive pulmonary disease (COPD) undergoing pulmonary rehabilitation.
Detailed description
Individuals will be evaluated on two non-consecutive days (7 days apart). On the first visit, wil be obtained: clinical and anthropometric data and assessed clinical control [COPD Assessment Test™(CAT)], health-related quality of life [Chronic Respiratory Questionnaire (CRQ)], and anxiety and depression levels [Hospital Anxiety and Depression Scale (HADS)]. Patients will also perform a complete pulmonary function test. After, the volunteers will receive a triaxial accelerometer to assess their physical activity level (PAL) and will be instructed to return after seven days. On the second visit, patients will undergo the Incremental Shuttle Walking Test (ISWT), and the Endurance Shuttle Walking Test (ESWT), without ET.
After the assessments, the individuals will be randomized. Randomization will be computer generated (www.randomization.com) by an investigator who will not be involved in individual recruitment, evaluation, or intervention. The allocation of individuals will be secret using consecutive numbered, sealed, and opaque envelopes (concealed allocation). Initial and post-intervention assessments will be performed by an investigator who will not be involved in the recruitment, evaluation, or intervention. After inclusion, individuals will start a pulmonary rehabilitation (PR) program for eight weeks; twice a week, individuals in the ET group will have the tape applied at the beginning of each session and removed at the end. After completing the 8-week PR period, individuals will undergo the same tests performed in two visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elastic tape (ET) | Experimental | Other: Experimental: Elastic tape (ET)The group that will participate in the 8 weeks pulmonary rehabilitation protocol using the elastic tape. |
| Sham (SH) | Sham comparator | Other: Sham Comparator: Sham (SH)The group that will participate in the pulmonary rehabilitation protocol using micropore tape. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Moderate to very severe COPD diagnosis according to Global Iniciative for Chronic Obstructive Lung Disease (GOLD) 2020
- Clinical stability (i.e., no exacerbations for at least 30 days)
- Male
- Non-obese (BMI ≤29.9 kg/m2)
- No musculoskeletal limitation
Key exclusion criteria (1 listed)
- Present osteoarticular, cognitive, neurological, and/or cardiological dysfunctions that prevent physical training
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 |
|---|---|---|
| Experimental: Elastic tape (ET)The elastic tape will be allocated in the chest wall and abdomen of individuals and will be used during the 8 weeks of rehabilitation protocol. | Other | Elastic tape (ET) |
| Sham Comparator: Sham (SH)The micropore tape will be allocated in the chest wall and abdomen of individuals and will be used during the 8 weeks of rehabilitation protocol. | Other | Sham (SH) |
Primary outcome
Functional Exercise Capacity: The total time reached in the Endurance Shuttle Walking Test (ESWT)
Time frame: Change from baseline at 8 weeks of intervention.
The patients will be instructed to walk in a 10-meter corridor limited by cones (with a distance of 9 meters between them), and the speed will be determined by a sound signal issued by cell phone, in this case, the speed will be determined using 85% of the maximum speed reached in the Incremental Shuttle Walking Test (ISWT) and will be constant throughout the test.
3 secondary outcomes
Clinical Control: COPD Assessment Test™ (CAT) is a specific questionnaire for COPD that assesses the impact of the symptoms of the disease
Time frame: Change from baseline at 8 weeks of intervention.
Symptoms of Anxiety and Depression: Hospital Anxiety and Depression Scale (HADS): The questionnaire was developed to identify symptoms of anxiety and depressive mood.
Time frame: Change from baseline at 8 weeks of intervention.
Health-related Quality of Life: was assessed by using the Chronic Respiratory Questionnaire (CRQ)
Time frame: Change from baseline at 8 weeks of intervention.
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 9 Dec 2024.
- Derived from this study: PubMed 42614062de Melo Batista Dos Santos J, Pinto TF, Reis ECM, Marques da Silva CCB, Carvalho-Pinto RM, de Lima FF, Carvalho CRF. Elastic tape as an add-on strategy to potentiate pulmonary rehabilitation outcomes in nonobese males with moderate-to-very severe COPD: A randomised clinical trial. Pulmonology. 2026 Dec;32(1):2718606. doi: 10.1080/25310429.2026.2718606. Epub 2026 Aug 19.
- Derived from this study: PubMed 41773531Pinto TF, Dos Santos JMB, Reis ECM, Marques da Silva CCB, de Lima FF, Carvalho-Pinto RM, Carvalho CRF. Effects of Elastic Tape Associated With Pulmonary Rehabilitation in Male Individuals With Chronic Obstructive Pulmonary Disease: Protocol for a 2-Arm, Assessor-Blinded Randomized Controlled Trial. JMIR Res Protoc. 2026 Feb 27;15:e75029. doi: 10.2196/75029.
- Individual participant dataSharing planned: No
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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.
Celso RF Carvalho study director
University of Sao Paulo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Elastic tape (ET) in people with Chronic Obstructive Pulmonary Disease, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 7 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: looking for participants now, as of the sponsor's last update on 9 Dec 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 Brazil. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Celso RF Carvalho, PhD (55 11 98415-3234, cscarval@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Exercise Capacity: The total time reached in the Endurance Shuttle Walking Test (ESWT) (time frame: Change from baseline at 8 weeks of intervention.). 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 NCT05939999, which also lists 2 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 9 Dec 2024.