BronchiectasisNCT02731482
Short-and Long-term Effects of a Home-based Rehabilitation Program in Patients With Bronchiectasis
A study testing Training Group in people with Bronchiectasis, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
This study will investigate the short-and long-term effects of the home-based pulmonary rehabilitation on peripheral muscle strength, functional capacity and quality of life in patients with bronchiectasis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- Training Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2016to Aug 2019
- 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
- Clinical diagnosis and/or tomographic bronchiectasis Clinically stable (no change in symptoms of dyspnea, in the amount and color of the secretion) Have completed the outpatient pulmonary rehabilitation for more than a year Not engaged in a regular physical activity.
Who cannot join
- Smokers With other lung related diseases (asthma, COPD and cystic fibrosis) Severe cardiovascular diseases Musculoskeletal limitation Unable to perform the tests and the training protocol due desaturation (pulse oxygen saturation ≤ 80%) over the recommended exercise intensity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-and Long-term Effects of a Home-based Rehabilitation Program on Functional Capacity, Peripheral Muscle Strength and Quality of Life in Patients With Bronchiectasis: Randomized Controlled Trial
This study will investigate the short-and long-term effects of the home-based pulmonary rehabilitation on peripheral muscle strength, functional capacity and quality of life in patients with bronchiectasis. The participants will be randomized into two groups: control group (usual care and recommendations for practice exercise) and training group, that will perform aerobic (stepping training) and resistance training (lower and upper limbs) for eight weeks, three times a week. At baseline, immediately after finishing and after six months the patients will undergo assessments.
Read the detailed description
Home-based pulmonary rehabilitation (HBPR) has been used in patients with chronic obstructive pulmonary disease, asthma and pulmonary fibrosis. Results from HBPR have been similar to those observe in the outpatient pulmonary rehabilitation such improvement in exercise capacity, symptoms and quality of life. However, HBPR has not yet been investigated in patients with bronchiectasis, a progressive and debilitating disease with a high socioeconomic impact. Objective: To investigate the short-and long-term effects of the home rehabilitation program in peripheral muscle strength, functional capacity and quality of life in patients with bronchiectasis. Methods: Patients diagnosed with bronchiectasis will be recruited from the Obstructive Diseases Outpatient Clinic of the Hospital das Clínicas - Medicine School, University of São Paulo. Participants will be randomized into two groups: control group (usual care and recommendations for performing exercises and respiratory physiotherapy) and training group, that will perform aerobic (stepping training) and resistance training (lower and upper limbs) for eight weeks, three times a week. All patients will receive a phone call once a week and patients allocated to the training group, additionally, will get a home visit every 15 days. At baseline, immediately after finishing and after six months of the HBPR patients will undergo to assessments. Expected results: HBPR will have positive effects on exercise tolerance and quality of life. Also, this study will contribute to future guidelines on the recommendation of HBPR for patients with bronchiectasis.
- Conditions
- Bronchiectasis
- Being tested
- Training Group, Control Group
- Keywords
- Bronchiectasis, Rehabilitation, Quality of Life, Physiotherapy Specialty
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training GroupOther
Also called Physical training intervention
Three sessions per week, each lasting 50 minutes, during eight weeks.
- Aerobic training in stepping training.
- Resistance training: Three sets of eight repetitions each, in both simultaneous members, using an elastic band. The trained muscles are quadriceps, hamstrings, deltoid and biceps.
- Once a week, patients will receive a phone call and every two weeks, patients will get a visit of the researcher at his home.
Control GroupOther
Also called Physical activity intervention
- The participants will receive verbal and written information about the importance of physical activity and walk in moderate intensity, at least, three times a week for 30 minutes.
- Participants will not receive any supervised physical training.
- Once a week, patients will receive a phone call to provide support and general advice.
| Study group | Role | What they receive |
|---|---|---|
| Training Group | Experimental | Patients with bronchiectasis in home-based pulmonary rehabilitation Receives: Other: Training Group |
| Control Group | Active comparator | Patients with bronchiectasis in usual care and recommendations for performing exercises Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance, in meters, performed in the Incremental Shuttle Walk Test
Measurement of functional capacity and exercise tolerance
Measured: up to 9 months
Secondary outcomes (5)
Time, in seconds, performed in the Endurance Shuttle Walk Test
Measurement of functional capacity and exercise tolerance
Measured: up to 9 monthsst
Number of steps performed in the Incremental Step Test
Measurement of functional capacity and exercise tolerance
Measured: up to 9 months
Physical functioning domain scale in the Quality of Life Questionnaire-Bronchiectasis (QoL-B)
Quality of Life Questionnaire
Measured: up to 9 months
Kilogram-force (kgf) of quadriceps femoris
Peripheral Muscle Strength
Measured: up to 9 months
Number of steps per day, measured by a pedometer
Physical activity in daily life
Measured: up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2016 (estimated)
- Study startJun 2016
- Primary completionAug 2019
- Study completionAug 2019
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo
- Responsible party
- Principal investigator, Anderson José, University of Nove de Julho
- Investigators
- Simone Dal Corso, PT, PhD, Study director, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02731482
- Sponsor's protocol ID
- Bronchiectasis Rehabilitation
- Status last verified
- Aug 2019
- First submitted
- 30 Mar 2016
- Last updated
- 16 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Jose A, Holland AE, Oliveira CS, Selman JPR, Castro RAS, Athanazio RA, Rached SZ, Cukier A, Stelmach R, Corso SD. Does home-based pulmonary rehabilitation improve functional capacity, peripheral muscle strength and quality of life in patients with bronchiectasis compared to standard care? Braz J Phys Ther. 2017 Nov-Dec;21(6):473-480. doi: 10.1016/j.bjpt.2017.06.021. Epub 2017 Aug 19.
PubMed 28869119
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-and Long-term Effects of a Home-based Rehabilitation Program on Functional Capacity, Peripheral Muscle Strength and Quality of Life in Patients With Bronchiectasis: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02731482
- Acronym / sponsor ID
- Bronchiectasis Rehabilitation
- Conditions
- Bronchiectasis
- Keywords
- Bronchiectasis, Rehabilitation, Quality of Life, Physiotherapy Specialty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Collaborators
- University of Sao Paulo
- Study start
- Jun 2016
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 7 Apr 2016 (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.
This study will investigate the short-and long-term effects of the home-based pulmonary rehabilitation on peripheral muscle strength, functional capacity and quality of life in patients with bronchiectasis. The participants will be randomized into two groups: control group (usual care and recommendations for practice exercise) and training group, that will perform aerobic (stepping training) and resistance training (lower and upper limbs) for eight weeks, three times a week. At baseline, immediately after finishing and after six months the patients will undergo assessments.
Detailed description
Home-based pulmonary rehabilitation (HBPR) has been used in patients with chronic obstructive pulmonary disease, asthma and pulmonary fibrosis. Results from HBPR have been similar to those observe in the outpatient pulmonary rehabilitation such improvement in exercise capacity, symptoms and quality of life. However, HBPR has not yet been investigated in patients with bronchiectasis, a progressive and debilitating disease with a high socioeconomic impact. Objective: To investigate the short-and long-term effects of the home rehabilitation program in peripheral muscle strength, functional capacity and quality of life in patients with bronchiectasis. Methods: Patients diagnosed with bronchiectasis will be recruited from the Obstructive Diseases Outpatient Clinic of the Hospital das Clínicas - Medicine School, University of São Paulo. Participants will be randomized into two groups: control group (usual care and recommendations for performing exercises and respiratory physiotherapy) and training group, that will perform aerobic (stepping training) and resistance training (lower and upper limbs) for eight weeks, three times a week. All patients will receive a phone call once a week and patients allocated to the training group, additionally, will get a home visit every 15 days. At baseline, immediately after finishing and after six months of the HBPR patients will undergo to assessments. Expected results: HBPR will have positive effects on exercise tolerance and quality of life. Also, this study will contribute to future guidelines on the recommendation of HBPR for patients with bronchiectasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training Group | Experimental | Other: Training GroupPatients with bronchiectasis in home-based pulmonary rehabilitation |
| Control Group | Active comparator | Other: Control GroupPatients with bronchiectasis in usual care and recommendations for performing exercises |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis and/or tomographic bronchiectasis Clinically stable (no change in symptoms of dyspnea, in the amount and color of the secretion) Have completed the outpatient pulmonary rehabilitation for more than a year Not engaged in a regular physical activity.
Key exclusion criteria (1 listed)
- Smokers With other lung related diseases (asthma, COPD and cystic fibrosis) Severe cardiovascular diseases Musculoskeletal limitation Unable to perform the tests and the training protocol due desaturation (pulse oxygen saturation ≤ 80%) over the recommended exercise intensity.
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 |
|---|---|---|
| Training GroupAlso: Physical training interventionThree sessions per week, each lasting 50 minutes, during eight weeks. * Aerobic training in stepping training. * Resistance training: Three sets of eight repetitions each, in both simultaneous members, using an elastic band. The trained muscles are quadriceps, hamstrings, deltoid and biceps. * Once a week, patients will receive a phone call and every two weeks, patients will get a visit of the researcher at his home. | Other | Training Group |
| Control GroupAlso: Physical activity intervention* The participants will receive verbal and written information about the importance of physical activity and walk in moderate intensity, at least, three times a week for 30 minutes. * Participants will not receive any supervised physical training. * Once a week, patients will receive a phone call to provide support and general advice. | Other | Control Group |
Primary outcome
Distance, in meters, performed in the Incremental Shuttle Walk Test
Time frame: up to 9 months
Measurement of functional capacity and exercise tolerance
5 secondary outcomes
Time, in seconds, performed in the Endurance Shuttle Walk Test
Time frame: up to 9 monthsst
Number of steps performed in the Incremental Step Test
Time frame: up to 9 months
Physical functioning domain scale in the Quality of Life Questionnaire-Bronchiectasis (QoL-B)
Time frame: up to 9 months
Kilogram-force (kgf) of quadriceps femoris
Time frame: up to 9 months
Number of steps per day, measured by a pedometer
Time frame: up to 9 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 16 Aug 2019.
- Derived from this study: PubMed 28869119Jose A, Holland AE, Oliveira CS, Selman JPR, Castro RAS, Athanazio RA, Rached SZ, Cukier A, Stelmach R, Corso SD. Does home-based pulmonary rehabilitation improve functional capacity, peripheral muscle strength and quality of life in patients with bronchiectasis compared to standard care? Braz J Phys Ther. 2017 Nov-Dec;21(6):473-480. doi: 10.1016/j.bjpt.2017.06.021. Epub 2017 Aug 19.
- Individual participant dataSharing planned: No
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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.
Simone Dal Corso, PT, PhD study director
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 Training Group 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 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: finished, as of the sponsor's last update on 16 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?
Distance, in meters, performed in the Incremental Shuttle Walk Test (time frame: up to 9 months). 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 NCT02731482, 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 16 Aug 2019.