Respiratory Muscle WeaknessNCT06772922
Effects of a Pulmonary and Cardiovascular Rehabilitation Program
A study testing Exercise in people with Respiratory Muscle Weakness and Quality of Lifte, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
Non-communicable chronic diseases (NCDs) affect approximately 30% of the adult global population, significantly impacting respiratory function and quality of life. Pulmonary and cardiovascular rehabilitation has proven to be an effective therapeutic intervention for managing respiratory symptoms and cardiovascular and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Muscle Weakness, Quality of Lifte, Dyspnea; Asthmatic
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Mar 2019to 20 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidates for the pulmonary rehabilitation program: users diagnosed with chronic obstructive pulmonary disease (COPD), pulmonary emphysema, pulmonary fibrosis, asthma or other lung disease.
- Candidates for the cardiovascular rehabilitation program: users diagnosed with acute myocardial infarction, myocardial revascularization surgery, coronary angioplasty, stable angina, valve replacement, chronic heart failure and who meet the criteria for phase III of cardiovascular rehabilitation.
- Referral with medical clearance for rehabilitation
Who cannot join
- Patients with any contraindication to aerobic or muscle-strengthening physical exercise, such as significant arrhythmias, untreated heart disease, myocarditis, recent or untreated pulmonary embolism, and uncontrolled systemic arterial hypertension, among other conditions.
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
Unicamp
Campinas, São Paulo
Letícia Baltieri, +55(19)35218936, lbaltieri@yahoo.com.br
About this study
Non-communicable chronic diseases (NCDs) affect approximately 30% of the adult global population, significantly impacting respiratory function and quality of life. Pulmonary and cardiovascular rehabilitation has proven to be an effective therapeutic intervention for managing respiratory symptoms and cardiovascular and improving functional capacity in patients with chronic respiratory conditions. The objective of this study is to evaluate the effects of the pulmonary and cardiovascular rehabilitation program on users of the physical therapy service of CECOM of UNICAMP related to functional capacity, quality of life and respiratory variables after 3 months of the program. Candidates for the pulmonary rehabilitation program are users diagnosed with chronic obstructive pulmonary disease (COPD), pulmonary emphysema, pulmonary fibrosis, asthma or other lung disease. Candidates for the cardiovascular rehabilitation program are users diagnosed with: infarction (AMI), myocardial revascularization surgery, coronary angioplasty, stable angina, valve replacement, chronic heart failure and who meet the criteria for phase III of cardiovascular rehabilitation. They should be referred to physical therapy by the cardiologist with complementary exams and exercise test. The program's assessment will consist of: anamnesis, analysis and recording of complementary exams, physical assessment (weight, height, BMI, cardiac and pulmonary auscultation, blood pressure, heart rate, peripheral oxygen saturation, respiratory muscle strength), functional capacity (six-minute walk test) and quality of life (questionnaire). The program will include aerobic exercises on a treadmill or stationary bike with an intensity between 50-70% of the reserve HR, below the ischemic thresholds. It will also include peripheral muscle strength exercises for the upper and lower limbs, in addition to respiratory muscle training for lung disease patients.
- Conditions
- Respiratory Muscle Weakness, Quality of Lifte, Dyspnea; Asthmatic, Dyspnea; Cardiac, Dyspnea
- Being tested
- Exercise
- Keywords
- pulmonary rehabilitation, Non-communicable chronic diseases, cardiovascular disease, cardiac rehabilitation
- Medical subject headings
- Dyspnea, Asthma, Noncommunicable Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
effect of exercise after three months (comparison of the patient with himself)
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Other | Not described Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Capacity
The Six-Minute Walk Test (6MWT) is used to measure functional capacity. For the test, the study participant walks in a flat 30-meter corridor for 6 minutes and the evaluator marks the final distance covered. This distance is normalized according to age and individual anthropometric characteristics in a solution validated in the literature. This distance represents the functional capacity that can be within or below that predicted by the literature.
Measured: three months
Inspiratory muscle strength
Using an analog manometer, inspiratory muscle strength was assessed by means of maximum inspiratory pressure (MIP) in cmH2O. During this procedure, the patient was comfortably seated in a chair with his/her feet flat on the floor and, using a nose clip, was instructed to take a maximal deep inspiration into the mouthpiece of the device after a complete exhalation. The average of three dimensions was recorded. Both the absolute value of the estimates and the predicted value according to the literature were recorded using the following equations according to Neder et al., 1999
Measured: three months
Expiratory muscle strength
Using an analog manometer, exspiratory muscle strength was assessed by means of maximum inspiratory pressure (MEP) in cmH2O. During this procedure, the patient was comfortably seated in a chair with his/her feet flat on the floor and, using a nose clip, was instructed to take a maximal deep expiration into the mouthpiece of the device after a complete inspiration. The average of three dimensions was recorded. Both the absolute value of the estimates and the predicted value according to the literature were recorded using the following equations according to Neder et al., 1999
Measured: three months
Secondary outcomes (1)
Quality of life
We will use the St. George's Respiratory Questionnaire or SF-36
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start3 Mar 2019
- Primary completion3 Nov 2024
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Muscle WeaknessStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Letícia Baltieri, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06772922
- Sponsor's protocol ID
- 4.004.580
- Status last verified
- Jan 2025
- First submitted
- 7 Jan 2025
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Pulmonary and Cardiovascular Rehabilitation Program
- ClinicalTrials.gov ID
- NCT06772922
- Acronym / sponsor ID
- 4.004.580
- Conditions
- Respiratory Muscle Weakness, Quality of Lifte, Dyspnea; Asthmatic, Dyspnea; Cardiac, Dyspnea
- Keywords
- pulmonary rehabilitation, Non-communicable chronic diseases, cardiovascular disease, cardiac rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- 3 Mar 2019 (actual)
- Primary completion
- 3 Nov 2024 (actual)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 14 Jan 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.
Non-communicable chronic diseases (NCDs) affect approximately 30% of the adult global population, significantly impacting respiratory function and quality of life. Pulmonary and cardiovascular rehabilitation has proven to be an effective therapeutic intervention for managing respiratory symptoms and cardiovascular and improving functional capacity in patients with chronic respiratory conditions. The objective of this study is to evaluate the effects of the pulmonary and cardiovascular rehabilitation program on users of the physical therapy service of CECOM of UNICAMP related to functional capacity, quality of life and respiratory variables after 3 months of the program. Candidates for the pulmonary rehabilitation program are users diagnosed with chronic obstructive pulmonary disease (COPD), pulmonary emphysema, pulmonary fibrosis, asthma or other lung disease. Candidates for the cardiovascular rehabilitation program are users diagnosed with: infarction (AMI), myocardial revascularization surgery, coronary angioplasty, stable angina, valve replacement, chronic heart failure and who meet the criteria for phase III of cardiovascular rehabilitation. They should be referred to physical therapy by the cardiologist with complementary exams and exercise test. The program's assessment will consist of: anamnesis, analysis and recording of complementary exams, physical assessment (weight, height, BMI, cardiac and pulmonary auscultation, blood pressure, heart rate, peripheral oxygen saturation, respiratory muscle strength), functional capacity (six-minute walk test) and quality of life (questionnaire). The program will include aerobic exercises on a treadmill or stationary bike with an intensity between 50-70% of the reserve HR, below the ischemic thresholds. It will also include peripheral muscle strength exercises for the upper and lower limbs, in addition to respiratory muscle training for lung disease patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Other | Other: Exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Candidates for the pulmonary rehabilitation program: users diagnosed with chronic obstructive pulmonary disease (COPD), pulmonary emphysema, pulmonary fibrosis, asthma or other lung disease.
- Candidates for the cardiovascular rehabilitation program: users diagnosed with acute myocardial infarction, myocardial revascularization surgery, coronary angioplasty, stable angina, valve replacement, chronic heart failure and who meet the criteria for phase III of cardiovascular rehabilitation.
- Referral with medical clearance for rehabilitation
Key exclusion criteria (1 listed)
- Patients with any contraindication to aerobic or muscle-strengthening physical exercise, such as significant arrhythmias, untreated heart disease, myocarditis, recent or untreated pulmonary embolism, and uncontrolled systemic arterial hypertension, among other conditions.
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 |
|---|---|---|
| Exerciseeffect of exercise after three months (comparison of the patient with himself) | Other | Exercise |
Primary outcome
Functional Capacity
Time frame: three months
The Six-Minute Walk Test (6MWT) is used to measure functional capacity. For the test, the study participant walks in a flat 30-meter corridor for 6 minutes and the evaluator marks the final distance covered. This distance is normalized according to age and individual anthropometric characteristics in a solution validated in the literature. This distance represents the functional capacity that can be within or below that predicted by the literature.
Inspiratory muscle strength
Time frame: three months
Using an analog manometer, inspiratory muscle strength was assessed by means of maximum inspiratory pressure (MIP) in cmH2O. During this procedure, the patient was comfortably seated in a chair with his/her feet flat on the floor and, using a nose clip, was instructed to take a maximal deep inspiration into the mouthpiece of the device after a complete exhalation. The average of three dimensions was recorded. Both the absolute value of the estimates and the predicted value according to the literature were recorded using the following equations according to Neder et al., 1999
Expiratory muscle strength
Time frame: three months
Using an analog manometer, exspiratory muscle strength was assessed by means of maximum inspiratory pressure (MEP) in cmH2O. During this procedure, the patient was comfortably seated in a chair with his/her feet flat on the floor and, using a nose clip, was instructed to take a maximal deep expiration into the mouthpiece of the device after a complete inspiration. The average of three dimensions was recorded. Both the absolute value of the estimates and the predicted value according to the literature were recorded using the following equations according to Neder et al., 1999
1 secondary outcome
Quality of life
Time frame: three months
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 14 Jan 2025.
- 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.
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 in people with Respiratory Muscle Weakness and Quality of Lifte, run by University of Campinas, Brazil 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 3 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 14 Jan 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 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. 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 Letícia Baltieri (+55(19)35218936, lbaltieri@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Capacity (time frame: three 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?
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 14 Jan 2025.