AsthmaticNCT02383069
Pulmonary Rehabilitation in Asthmatic Patient
A study testing Intervention Group in people with Asthmatic and Children, run by Fernanda de Cordoba Lanza at 1 site in Brazil.
Trial summary
Asthma is one of the main chronic diseases in childhood and it is characterized by the inflammation of airways. Individuals with chronic lung disease are more susceptible to present reduction in exercise tolerance due to pulmonary limitations. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- What is being tested?
- Intervention Group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2015to Aug 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- between six and 18 years old
- asthma-diagnosed patients
- under medical treatment and disease control
Who cannot join
- fail to carry out the protocol evaluations
- interrupt the medical care and/or drug-based treatment
- acute lung infection or other chronic lung diseases
- other comorbidities (neuropathies, heart disease)
- missing in more than 20% the rehabilitation protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pulmonary Rehabilitation in Asthmatic Pediatric Patients: Randomized Clinical Trial
Asthma is one of the main chronic diseases in childhood and it is characterized by the inflammation of airways. Individuals with chronic lung disease are more susceptible to present reduction in exercise tolerance due to pulmonary limitations. The pulmonary rehabilitation may improve the physical capacity in asthmatic patients, as observed in other chronic lung diseases.
Read the detailed description
The asthmatic patient's clinical changes may impair their functional capacity and exercise tolerance. Thus, the treatment of these individuals should be extended to pulmonary rehabilitation. Randomized clinical trials have shown interesting results, whether in cardiopulmonary conditions, quality of life or in the number of crises, after applying pulmonary rehabilitation program in asthmatic children and adolescents. In a systematic review on physical training with asthmatic children and adolescents the authors concluded that physical activity should be recommended to this population, although some issues have not yet been clarified due to limitations in the clinical trial. The control of the disease has not been evaluated by specific questionnaires in any study. The assessment of inflammatory markers was rarely addressed and the same occurred in the quality of life after physical training. In addition, it is possible to question the intensity and frequency of training, factors that can significantly contribute to the intervention results. All these information let us know that is necessary a randomized control trial to answer questions about physical characteristics, quality of life, inflammatory markers, and muscles strength.
- Being tested
- Intervention Group, Control Group
- Keywords
- Pulmonary rehabilitation, Asthma, Children, Teenager, Physical capacity
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupOther
Also called Pulmonary Rehabilitation
Aerobic training
Control GroupOther
Also called Chest Physiotherapy
Chest physiotherapy: Flutter and muscle stretching
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The intervention group will have supervised rehabilitation program held twice a week, each session will have 60 minutes duration, with minimum interval of 24 hours, for a period of 8 weeks. Each session will consist of three parts: aerobic training, strength training and respiratory physiotherapy. The aerobic training will be held for 35 minutes (10 min of warm up, 20 min on target load and 5 min of slowdown) with initial intensity of 60% of the maximum load obtained in the maximal cardiopulmonary exercise testing or in incremental shuttle walk test (ISWT). The intensity will be gradually increased up to 80%, so that fatigue or dyspnea values are kept between 4 and 6, according to the modified Borg scale. Receives: Other: Intervention Group |
| Control Group | Active comparator | The control group will be subjected to supervised respiratory physiotherapy and stretching exercises twice a week, each session with duration of 60 minutes, with minimum interval of 24 hours, for a period of 8 weeks. The oral high-frequency oscillation device (Flutter®) will be used for 10 minutes, 5 minutes in each lateral decubitus, followed by the stretching of upper and lower limbs for 40 minutes. All exercises will be active, performed in sitting and lying positions without increasing the heart rate. The remaining 10 minutes will be used to discuss doubts about the disease and the use of the booklet. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical capacity as measure by distance walked of shuttle walk test and oxygen consumption (VO2)
Modified shuttle test was conducted
Measured: Physiscal capacity will be measured at the beginning and at the end of the protocol (after 8 weeks)
Secondary outcomes (4)
Muscle strength as measure by electromyography (EMG)
1 maximal repetition was performed
Measured: Muscles strenght will be measured at the begening and at the end of the protocol (after 8 weeks).
Muscle endurance as measure by electromyography (EMG)
Measured: Muscles endurance will be measured at the begening and at the end of the protocol (after 8 weeks).
Quality of life measured by Pediatric questionnaire
Measured: Quesitionnaire will be measured at the begening and at the end of the protocol (after 8 weeks).
Inflammatory markers as measure by interleukines
Measured: Inflamatory markers will be measured at the begening and at the end of the protocol (after 8 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionJul 2016
- Study completionAug 2018
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 AsthmaticStudies 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
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fernanda de Cordoba Lanza
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nove de Julho, Fundação de Amparo à Pesquisa do Estado de São Paulo, Federal University of Minas Gerais
- Responsible party
- Sponsor-investigator, Fernanda de Cordoba Lanza, University of Nove de Julho
- Investigators
- Dirceu Solé, PhD, Study chair, Unifesp, Federal University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02383069
- Sponsor's protocol ID
- CPR-UNI9
- Status last verified
- Aug 2019
- First submitted
- 10 Feb 2015
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Silva EP, Soares BA, Reimberg MM, Ritti-Dias R, Nascimento KS, Anjos FS, Wandalsen GF, Sole D, Dal Corso S, Lanza FC. Heart rate recovery in asthmastic children and adolescents after clinical field test. BMC Pulm Med. 2021 Feb 19;21(1):61. doi: 10.1186/s12890-020-01355-9.
PubMed 33607978Reimberg MM, Castro RA, Selman JP, Meneses AS, Politti F, Mallozi MC, Wandalsen GF, Sole D, De Angelis K, Dal Corso S, Lanza FC. Effects of a pulmonary rehabilitation program on physical capacity, peripheral muscle function and inflammatory markers in asthmatic children and adolescents: study protocol for a randomized controlled trial. Trials. 2015 Aug 13;16:346. doi: 10.1186/s13063-015-0876-x.
PubMed 26268930
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Rehabilitation in Asthmatic Pediatric Patients: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02383069
- Acronym / sponsor ID
- CPR-UNI9
- Keywords
- Pulmonary rehabilitation, Asthma, Children, Teenager, Physical capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Fernanda de Cordoba LanzaUniversity, hospital or other
- Collaborators
- University of Nove de Julho, Fundação de Amparo à Pesquisa do Estado de São Paulo, Federal University of Minas Gerais
- Study start
- Feb 2015 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 9 Mar 2015 (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.
Asthma is one of the main chronic diseases in childhood and it is characterized by the inflammation of airways. Individuals with chronic lung disease are more susceptible to present reduction in exercise tolerance due to pulmonary limitations. The pulmonary rehabilitation may improve the physical capacity in asthmatic patients, as observed in other chronic lung diseases.
Detailed description
The asthmatic patient's clinical changes may impair their functional capacity and exercise tolerance. Thus, the treatment of these individuals should be extended to pulmonary rehabilitation. Randomized clinical trials have shown interesting results, whether in cardiopulmonary conditions, quality of life or in the number of crises, after applying pulmonary rehabilitation program in asthmatic children and adolescents. In a systematic review on physical training with asthmatic children and adolescents the authors concluded that physical activity should be recommended to this population, although some issues have not yet been clarified due to limitations in the clinical trial. The control of the disease has not been evaluated by specific questionnaires in any study. The assessment of inflammatory markers was rarely addressed and the same occurred in the quality of life after physical training. In addition, it is possible to question the intensity and frequency of training, factors that can significantly contribute to the intervention results. All these information let us know that is necessary a randomized control trial to answer questions about physical characteristics, quality of life, inflammatory markers, and muscles strength.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Intervention GroupThe intervention group will have supervised rehabilitation program held twice a week, each session will have 60 minutes duration, with minimum interval of 24 hours, for a period of 8 weeks. Each session will consist of three parts: aerobic training, strength training and respiratory physiotherapy. The aerobic training will be held for 35 minutes (10 min of warm up, 20 min on target load and 5 min of slowdown) with initial intensity of 60% of the maximum load obtained in the maximal cardiopulmonary exercise testing or in incremental shuttle walk test (ISWT). The intensity will be gradually increased up to 80%, so that fatigue or dyspnea values are kept between 4 and 6, according to the modified Borg scale. |
| Control Group | Active comparator | Other: Control GroupThe control group will be subjected to supervised respiratory physiotherapy and stretching exercises twice a week, each session with duration of 60 minutes, with minimum interval of 24 hours, for a period of 8 weeks. The oral high-frequency oscillation device (Flutter®) will be used for 10 minutes, 5 minutes in each lateral decubitus, followed by the stretching of upper and lower limbs for 40 minutes. All exercises will be active, performed in sitting and lying positions without increasing the heart rate. The remaining 10 minutes will be used to discuss doubts about the disease and the use of the booklet. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- between six and 18 years old
- asthma-diagnosed patients
- under medical treatment and disease control
Key exclusion criteria (5 listed)
- fail to carry out the protocol evaluations
- interrupt the medical care and/or drug-based treatment
- acute lung infection or other chronic lung diseases
- other comorbidities (neuropathies, heart disease)
- missing in more than 20% the rehabilitation protocol
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 |
|---|---|---|
| Intervention GroupAlso: Pulmonary RehabilitationAerobic training | Other | Intervention Group |
| Control GroupAlso: Chest PhysiotherapyChest physiotherapy: Flutter and muscle stretching | Other | Control Group |
Primary outcome
Physical capacity as measure by distance walked of shuttle walk test and oxygen consumption (VO2)
Time frame: Physiscal capacity will be measured at the beginning and at the end of the protocol (after 8 weeks)
Modified shuttle test was conducted
4 secondary outcomes
Muscle strength as measure by electromyography (EMG)
Time frame: Muscles strenght will be measured at the begening and at the end of the protocol (after 8 weeks).
Muscle endurance as measure by electromyography (EMG)
Time frame: Muscles endurance will be measured at the begening and at the end of the protocol (after 8 weeks).
Quality of life measured by Pediatric questionnaire
Time frame: Quesitionnaire will be measured at the begening and at the end of the protocol (after 8 weeks).
Inflammatory markers as measure by interleukines
Time frame: Inflamatory markers will be measured at the begening and at the end of the protocol (after 8 weeks).
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 7 Aug 2019.
- Derived from this study: PubMed 33607978Silva EP, Soares BA, Reimberg MM, Ritti-Dias R, Nascimento KS, Anjos FS, Wandalsen GF, Sole D, Dal Corso S, Lanza FC. Heart rate recovery in asthmastic children and adolescents after clinical field test. BMC Pulm Med. 2021 Feb 19;21(1):61. doi: 10.1186/s12890-020-01355-9.
- Derived from this study: PubMed 26268930Reimberg MM, Castro RA, Selman JP, Meneses AS, Politti F, Mallozi MC, Wandalsen GF, Sole D, De Angelis K, Dal Corso S, Lanza FC. Effects of a pulmonary rehabilitation program on physical capacity, peripheral muscle function and inflammatory markers in asthmatic children and adolescents: study protocol for a randomized controlled trial. Trials. 2015 Aug 13;16:346. doi: 10.1186/s13063-015-0876-x.
- Individual participant dataSharing planned: No
Related trials for Asthmatic
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
Dirceu Solé, PhD study chair
Unifesp, Federal University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Asthmatic and Children, run by Fernanda de Cordoba Lanza 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 5 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 7 Aug 2019. 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?
Physical capacity as measure by distance walked of shuttle walk test and oxygen consumption (VO2) (time frame: Physiscal capacity will be measured at the beginning and at the end of the protocol (after 8 weeks)). 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 NCT02383069, 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 7 Aug 2019.