BronchiectasisPCBCQNCT02208830
Physical Capacity in Patients With Bronchiectasis Before and After Rehabilitation Program
A study testing pulmonary rehabilitation and conventional program in people with Bronchiectasis, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
The hypothesis of this study is that the group of patients who will carry out the rehabilitation program associated with respiratory therapy will have higher benefits in physical function, peripheral muscle strength and quality of life compared to the group that will only perform chest physiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- pulmonary rehabilitation and conventional program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2012to Jul 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with clinical and / or CT of bronchiectasis without cystic fibrosis
- Clinically stable (no change in symptoms of dyspnea, quantity and color of the secretion)
- Greater than 18 and / or oxygen dependent at home
- Medical Research Council MRC ≥ 1.
Who cannot join
- Smokers or smoking history> 10 pack / years,
- Cystic fibrosis (CF)
- Chronic obstructive pulmonary disease (COPD)
- Asthma
- Pulmonary fibrosis (PF)
- Musculoskeletal limitations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Pulmonary Rehabilitation Associated With Respiratory Therapy vs Physiotherapy in Physical Capacity, Peripheral Muscle Strength and Quality of Life in Patients With Bronchiectasis: a Randomized Controlled Trial.
The hypothesis of this study is that the group of patients who will carry out the rehabilitation program associated with respiratory therapy will have higher benefits in physical function, peripheral muscle strength and quality of life compared to the group that will only perform chest physiotherapy. Additionally, there will be a negative correlation between inflammatory mediators and measures of physical ability as well as the magnitude of improvement is lower after treatment in patients with higher baseline levels of inflammation. Furthermore, these patients will be reevaluated in 1 and 3 years, as a cohort, studying if exercise capacity may be a predictor of clinical and functional outcomes.
Read the detailed description
All patients will have their dyspnea rated according to the Medical Research Council (MRC) scale. The Saint George Respiratory Questionnaire (SGRQ) and COPD Assessment test (CAT) will also be applied.
Spirometry will be performed according to recommendations of the American Thoracic Society/European Respiratory Society. The forced vital capacity and forced expiratory volume values in the first second will be compared with those predicted for the Brazilian population.
The maximal incremental cycle ergometer test will be carried out on an electromagnetically braked cycle ergometer with gas exchange and ventilatory variables analyzed breath-by-breath. After 2 min at rest and then 2 min pedaling in freewheel, the power (W) will continuously increase in a linear "ramp" pattern (1 to 20 W/min).
The incremental treadmill test will be performed to determine aerobic training load. The modified Balke protocol, according to the basal level of physical fitness (a total time increment between eight and 12 minutes).
The incremental shuttle walking test will be conducted according to the description of Singh et al.
The daily physical activity (DPA) will be assessed with an accelerometer for three days.
Blood sample for inflammatory markers measurements will be collected to analyze of IL-1 beta, IL-6, IL-8, IL-10, TNF-alpha, using Duo Set ELISA kits from R \& D Systems according to manufacturer's instructions.
Muscle strength with one repetition maximum (1RM) will be performed at middle deltoid (MD), biceps brachial (BB) and quadriceps femoris (QF). The following movements will also be evaluated: shoulder abduction, elbow flexion and knee extension.
Patients are going to be randomized to pulmonary rehabilitation or conventional physiotherapy program as follow:
Pulmonary rehabilitation: 8 week, twice weekly exercise program with aerobic treadmill and lower limb strength training.
Conventional program: 8 week, twice weekly conventional program with: L'Expiration Lente Totale Glotte Ouverte en decubitus Latéral (Eltgol), autogenous drainage (AD) and shaker with duration of 30 minutes each.
Patients will be reassessed in 1 and 3 years, measuring maximal incremental cycle ergometer test, incremental treadmill test, incremental shuttle walking test, accelerometer and muscle strength. All tests will follow the same patterns as the first assesment. Adicionally, exacerbations, hospitalization and survival in each year will be evaluated.
- Conditions
- Bronchiectasis
- Being tested
- pulmonary rehabilitation, conventional program
- Keywords
- bronchiectasis, functional capacity, lung functional
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulmonary rehabilitationOther
Also called exercise, rehabilitation, treatment, pulmonary
Pulmonary rehabilitation: 8 week, twice weekly exercise program with aerobic treadmill training and lower limb strength training.
conventional programOther
Also called physiotherapy, treatment respiratory
The conventional program is conducted with duration of 8 week, twice weekly. The techniques used will be: expiration with the glottis open in lateral posture (Eltgol), autogenous drainage (AD) and shaker. Each technique will last for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| conventional program | Experimental | The conventional program is conducted with duration of 8 week, twice weekly. The techniques used will be: expiration with the glottis open in lateral posture (Eltgol), autogenous drainage (AD) and shaker. Each technique will last for 30 minutes. Receives: Other: conventional program |
| pulmonary rehabilitation | Experimental | Duration of 8 week, twice weekly exercise program with: lower limb strength training and aerobic training per 30 minutes. Receives: Other: pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in exercise capacity in patients with bronchiectasis
Exercise capacity is measured by maximal cardiopulmonary exercise test on a cycle ergometer. The protocol will be used in ramp.
Measured: Up to 36 months
Pulmonary Function
For the cohort follow up, forced expiratory volume in the first second will be primary outcome
Measured: Up to 36 months
Exacerbations and Hospitalizations per year
For the cohort follow up, the frequency of exacerbations and hospitalizations will be evaluated
Measured: Up to 36 months
Survival in months
For the cohort follow up, the survival will be evaluated in months.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study startJan 2012
- Primary completionJan 2018
- Study completionJul 2018
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 BronchiectasisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Collaborators
- InCor Heart Institute
- Responsible party
- Principal investigator, Anderson Alves de Camargo, University of Nove de Julho
- Investigators
- Anderson Alves de Camargo, master's, Principal investigator, University of Nove de JulhoRejane Agnelo Silva de Castro, Student, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02208830
- Sponsor's protocol ID
- BCQPC
- Acronym
- PCBCQ
- Status last verified
- Aug 2022
- First submitted
- 7 Mar 2012
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
de Camargo AA, de Castro RAS, Vieira RP, Oliveira-Junior MC, Araujo AA, De Angelis K, Rached SZ, Athanazio RA, Stelmach R, Corso SD. Systemic Inflammation and Oxidative Stress in Adults with Bronchiectasis: Association with Clinical and Functional Features. Clinics (Sao Paulo). 2021 Apr 16;76:e2474. doi: 10.6061/clinics/2021/e2474. eCollection 2021.
PubMed 33886789
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pulmonary Rehabilitation Associated With Respiratory Therapy vs Physiotherapy in Physical Capacity, Peripheral Muscle Strength and Quality of Life in Patients With Bronchiectasis: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02208830
- Acronym / sponsor ID
- PCBCQ / BCQPC
- Conditions
- Bronchiectasis
- Keywords
- bronchiectasis, functional capacity, lung functional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Collaborators
- InCor Heart Institute
- Study start
- Jan 2012
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 5 Aug 2014 (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.
The hypothesis of this study is that the group of patients who will carry out the rehabilitation program associated with respiratory therapy will have higher benefits in physical function, peripheral muscle strength and quality of life compared to the group that will only perform chest physiotherapy. Additionally, there will be a negative correlation between inflammatory mediators and measures of physical ability as well as the magnitude of improvement is lower after treatment in patients with higher baseline levels of inflammation. Furthermore, these patients will be reevaluated in 1 and 3 years, as a cohort, studying if exercise capacity may be a predictor of clinical and functional outcomes.
Detailed description
All patients will have their dyspnea rated according to the Medical Research Council (MRC) scale. The Saint George Respiratory Questionnaire (SGRQ) and COPD Assessment test (CAT) will also be applied.
Spirometry will be performed according to recommendations of the American Thoracic Society/European Respiratory Society. The forced vital capacity and forced expiratory volume values in the first second will be compared with those predicted for the Brazilian population.
The maximal incremental cycle ergometer test will be carried out on an electromagnetically braked cycle ergometer with gas exchange and ventilatory variables analyzed breath-by-breath. After 2 min at rest and then 2 min pedaling in freewheel, the power (W) will continuously increase in a linear "ramp" pattern (1 to 20 W/min).
The incremental treadmill test will be performed to determine aerobic training load. The modified Balke protocol, according to the basal level of physical fitness (a total time increment between eight and 12 minutes).
The incremental shuttle walking test will be conducted according to the description of Singh et al.
The daily physical activity (DPA) will be assessed with an accelerometer for three days.
Blood sample for inflammatory markers measurements will be collected to analyze of IL-1 beta, IL-6, IL-8, IL-10, TNF-alpha, using Duo Set ELISA kits from R \& D Systems according to manufacturer's instructions.
Muscle strength with one repetition maximum (1RM) will be performed at middle deltoid (MD), biceps brachial (BB) and quadriceps femoris (QF). The following movements will also be evaluated: shoulder abduction, elbow flexion and knee extension.
Patients are going to be randomized to pulmonary rehabilitation or conventional physiotherapy program as follow:
Pulmonary rehabilitation: 8 week, twice weekly exercise program with aerobic treadmill and lower limb strength training.
Conventional program: 8 week, twice weekly conventional program with: L'Expiration Lente Totale Glotte Ouverte en decubitus Latéral (Eltgol), autogenous drainage (AD) and shaker with duration of 30 minutes each.
Patients will be reassessed in 1 and 3 years, measuring maximal incremental cycle ergometer test, incremental treadmill test, incremental shuttle walking test, accelerometer and muscle strength. All tests will follow the same patterns as the first assesment. Adicionally, exacerbations, hospitalization and survival in each year will be evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional program | Experimental | Other: conventional programThe conventional program is conducted with duration of 8 week, twice weekly. The techniques used will be: expiration with the glottis open in lateral posture (Eltgol), autogenous drainage (AD) and shaker. Each technique will last for 30 minutes. |
| pulmonary rehabilitation | Experimental | Other: pulmonary rehabilitationDuration of 8 week, twice weekly exercise program with: lower limb strength training and aerobic training per 30 minutes. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with clinical and / or CT of bronchiectasis without cystic fibrosis
- Clinically stable (no change in symptoms of dyspnea, quantity and color of the secretion)
- Greater than 18 and / or oxygen dependent at home
- Medical Research Council MRC ≥ 1.
Key exclusion criteria (6 listed)
- Smokers or smoking history> 10 pack / years,
- Cystic fibrosis (CF)
- Chronic obstructive pulmonary disease (COPD)
- Asthma
- Pulmonary fibrosis (PF)
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 |
|---|---|---|
| pulmonary rehabilitationAlso: exercise, rehabilitation, treatment, pulmonaryPulmonary rehabilitation: 8 week, twice weekly exercise program with aerobic treadmill training and lower limb strength training. | Other | pulmonary rehabilitation |
| conventional programAlso: physiotherapy, treatment respiratoryThe conventional program is conducted with duration of 8 week, twice weekly. The techniques used will be: expiration with the glottis open in lateral posture (Eltgol), autogenous drainage (AD) and shaker. Each technique will last for 30 minutes. | Other | conventional program |
Primary outcome
The change in exercise capacity in patients with bronchiectasis
Time frame: Up to 36 months
Exercise capacity is measured by maximal cardiopulmonary exercise test on a cycle ergometer. The protocol will be used in ramp.
Pulmonary Function
Time frame: Up to 36 months
For the cohort follow up, forced expiratory volume in the first second will be primary outcome
Exacerbations and Hospitalizations per year
Time frame: Up to 36 months
For the cohort follow up, the frequency of exacerbations and hospitalizations will be evaluated
Survival in months
Time frame: Up to 36 months
For the cohort follow up, the survival will be evaluated in months.
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 1 Sep 2022.
- Derived from this study: PubMed 33886789de Camargo AA, de Castro RAS, Vieira RP, Oliveira-Junior MC, Araujo AA, De Angelis K, Rached SZ, Athanazio RA, Stelmach R, Corso SD. Systemic Inflammation and Oxidative Stress in Adults with Bronchiectasis: Association with Clinical and Functional Features. Clinics (Sao Paulo). 2021 Apr 16;76:e2474. doi: 10.6061/clinics/2021/e2474. eCollection 2021.
Related trials for Bronchiectasis
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Recruiting
THERMotherapy Against Persistent Bacterial LUNG Infections
Lung Diseases, Obstructive, Bronchiectasis
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingPhase 1
Investigation of Pharmacokinetics, Safety of HSK31858 in Subjects With Renal Impairment
Non-cystic Fibrosis Bronchiectasis (NCFBE)
Not yet recruitingPhase 3
A Study to Learn How Well People With Bronchiectasis Tolerate Continued Treatment With Verducatib After Earlier Studies (AIRTIVITY®-ON)
Bronchiectasis
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.
Anderson Alves de Camargo, master's principal investigator
University of Nove de Julho
Rejane Agnelo Silva de Castro, Student principal investigator
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulmonary rehabilitation and conventional program in people with Bronchiectasis, run by University of Nove de Julho 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 4 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 1 Sep 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 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?
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?
The change in exercise capacity in patients with bronchiectasis (time frame: Up to 36 months). The study lists 4 primary outcomes in all. 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 NCT02208830, 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 1 Sep 2022.