Non-cystic Fibrosis BronchiectasisNCT05369624
Exercise Capacity in Non-cystic Fibrosis Bronchiectasis After a Pulmonary Rehabilitation Home-based Program
A study testing Pulmonary rehabilitation home-based program intervention group (PRHP)(IG) in people with Non-cystic Fibrosis Bronchiectasis and Pulmonary Rehabilitation, run by Hospital Universitario Virgen Macarena at 1 site in Spain.
Trial summary
A number of studies have described low exercise capacity and physical activity in patients with non-cystic fibrosis bronchiectasis (non-CF Bronchiectasis), although little research exists on using the cardiopulmonary exercise test (CPET) to evaluate exercise capacity and its most relevant changes after a pulmonary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-cystic Fibrosis Bronchiectasis, Pulmonary Rehabilitation
- What is being tested?
- Pulmonary rehabilitation home-based program intervention group (PRHP)(IG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- 8 May 2018to 14 Mar 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Certain diagnosis of non-CF bronchiectasis (chest HRCT)
- Over 18 years old, clinically stable in the previous 6 weeks (no need for antibiotic therapy due to exacerbations) and a dyspnea score over 1 according to the modified Medical Research Council (mMRC) dyspnea scale
Who cannot join
- Less of 18 years
- Other airway disease ( Asthma or COPD)
- Physical inability to perform a physical training program (neuromuscular pathology or residual injuries).
- Smokers or former smokers of less than 6 months or with a history of consumption of 15 packs/year.
- Cystic fibrosis.
- Active infections (bronchopulmonary aspergillosis, pulmonary tuberculosis).
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- Active tuberculosis.
- Medical illnesses that put the individual at risk of a decompensation due to the performance of any physical activity or cardiopulmonary stress test (unstable ischemic heart disease, acute myocardial infarction less than 1 month).
- Pregnancy
- Mental disorder that prevents the adequate interpretation of the indications or performance of the tests.
- Attended pulmonary rehabilitation within 1 year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between the Severity of Bronchiectasis and Exercise Capacity in a Pilot Home Pulmonary Rehabilitation Program at the Virgen Macarena University Hospital
A number of studies have described low exercise capacity and physical activity in patients with non-cystic fibrosis bronchiectasis (non-CF Bronchiectasis), although little research exists on using the cardiopulmonary exercise test (CPET) to evaluate exercise capacity and its most relevant changes after a pulmonary rehabilitation home-based program (PRHP). In addition, few studies have addressed tolerance to exercise and physical activity in severe cases of the disease.
Aims:
Read more
To evaluate the exercise capacity of non-CF BQ patients using CPET and physical activity after a pulmonary rehabilitation home-based program.
Methodology:
Our study describes a non-pharmacological clinical trial in non-CF BQ patients at the Virgen Macarena University Hospital (Seville, Spain). The patients were randomized into two groups: the control group (who were provided with training instructions) and the intervention group (who took part in a specific pulmonary rehabilitation home-based program).
Read the detailed description
A signed informed consent form was provided prior to inclusion in the study. The data evaluated was obtained under strict confidentiality rules. All patients passed an initial assessment of the degree of physical activity by means of accelerometers, as well as pulmonary function tests and exercise tolerance (CPET) and 6MWT, stratification severity according to the E-FACED scales, quality of life using the saint george respiratory questionnaire.
- Being tested
- Pulmonary rehabilitation home-based program intervention group (PRHP)(IG)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary rehabilitation home-based program intervention group (PRHP)(IG)Other
Also called Intervention group
The strength training program included upper and lower limb exercises, initially with no weights but progressively adding weights once a week depending on symptoms, in 2 sets with 6-8 repetitions, for at least 5 days a week. The exercises recommended were the 'hanger' (which exercises the latissimus dorsi muscle), 'butterfly' (pectoralis major muscle), 'neck press' (triceps brachii and deltoids), leg flexion (biceps femoris and gastrocnemius) and leg extension (quadriceps femoris).
As resistance training, patients could choose between walking or cycling 3 to 5 days per week, for at least 20 minutes, increasing the duration of the exercise weekly, depending on their symptoms
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary rehabilitation home-based program intervention group (PRHP)(IG) | Experimental | Participants were given two hospital sessions: in the first session the physiotherapist explained the exercises to be performed at home and there was a reminder session at 4 weeks. Reminder call was carried out weekly for 8 weeks. The patients were advised to do the exercises at least 3 times a week. The number of times they performed physical activity and its duration were recorded in a questionnaire Receives: Other: Pulmonary rehabilitation home-based program intervention group (PRHP)(IG) |
| Control group | No intervention | Participants received general written advice and recommendations for physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise capacity of Non-cystic Fibrosis Bronchiectasis ( Non-CF bronchiectasis) after pulmonary rehabilitation home-based program (PRHP). Change in VO2 (oxygen consumption, ml/min)
A measurement by cardiopulmonary exercise test (CPET) with oxygen consumption was performed at baseline and week 8 of the program.
Measured: Baseline and week 8
Secondary outcomes (5)
Level of physical activity (METS) of Non-CF bronchiectasis and its changes after PRHP
Change in level of physical activity assessed using a Multisensor ArmBand accelerometer (METS).
Measured: Baseline and week 8
Impact of quality of life before and after PRHP
Change in St. George's Respiratory Questionnaire (SGRQ) after PRHP: Have 50 items with 3 components Symptoms, Activities, Impact ant total score. Scores range from 0 to 100, with higher scores indicating more limitations.
Measured: Baseline and week 8
Dyspnoea
Change in dyspnoea by modified Medical Research Council (MRC)
Measured: Baseline and week 8
Exacerbations
Numbers of Hospital admissions in previous month
Measured: Baseline, week 4 and week8
Level of physical activity (number of steps) of Non-CF bronchiectasis and its changes after PRHP
Change in level of physical activity assessed using a Multisensor ArmBand accelerometer (number of steps).
Measured: Baseline and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start8 May 2018
- Primary completion14 Mar 2019
- Study completion14 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-cystic Fibrosis 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
- Model description
- Clinical trial with parallel groups (Parallel treatment design): Clinical trial in which one group of patients is assigned to receive the home pulmonary rehabilitation program (PHRP), while another group (control) does not receive PHRP
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Virgen Macarena
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Virginia Almadana, PhD, Study director, Hospital Universitario Virgen Macarena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369624
- Sponsor's protocol ID
- SCHNR15
- Status last verified
- Apr 2022
- First submitted
- 27 Apr 2022
- Last updated
- 18 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It will be available in the repository of the Virgen Macarena University Hospital
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between the Severity of Bronchiectasis and Exercise Capacity in a Pilot Home Pulmonary Rehabilitation Program at the Virgen Macarena University Hospital
- ClinicalTrials.gov ID
- NCT05369624
- Acronym / sponsor ID
- SCHNR15
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Hospital Universitario Virgen MacarenaUniversity, hospital or other
- Study start
- 8 May 2018 (actual)
- Primary completion
- 14 Mar 2019 (actual)
- Study completion
- 14 Mar 2020 (actual)
- First posted
- 11 May 2022 (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.
A number of studies have described low exercise capacity and physical activity in patients with non-cystic fibrosis bronchiectasis (non-CF Bronchiectasis), although little research exists on using the cardiopulmonary exercise test (CPET) to evaluate exercise capacity and its most relevant changes after a pulmonary rehabilitation home-based program (PRHP). In addition, few studies have addressed tolerance to exercise and physical activity in severe cases of the disease.
Aims:
To evaluate the exercise capacity of non-CF BQ patients using CPET and physical activity after a pulmonary rehabilitation home-based program.
Methodology:
Our study describes a non-pharmacological clinical trial in non-CF BQ patients at the Virgen Macarena University Hospital (Seville, Spain). The patients were randomized into two groups: the control group (who were provided with training instructions) and the intervention group (who took part in a specific pulmonary rehabilitation home-based program).
Detailed description
A signed informed consent form was provided prior to inclusion in the study. The data evaluated was obtained under strict confidentiality rules. All patients passed an initial assessment of the degree of physical activity by means of accelerometers, as well as pulmonary function tests and exercise tolerance (CPET) and 6MWT, stratification severity according to the E-FACED scales, quality of life using the saint george respiratory questionnaire.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Clinical trial with parallel groups (Parallel treatment design): Clinical trial in which one group of patients is assigned to receive the home pulmonary rehabilitation program (PHRP), while another group (control) does not receive PHRP
| Arm | Type | Receives |
|---|---|---|
| Pulmonary rehabilitation home-based program intervention group (PRHP)(IG) | Experimental | Other: Pulmonary rehabilitation home-based program intervention group (PRHP)(IG)Participants were given two hospital sessions: in the first session the physiotherapist explained the exercises to be performed at home and there was a reminder session at 4 weeks. Reminder call was carried out weekly for 8 weeks. The patients were advised to do the exercises at least 3 times a week. The number of times they performed physical activity and its duration were recorded in a questionnaire |
| Control group | No intervention | –Participants received general written advice and recommendations for physical activity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Certain diagnosis of non-CF bronchiectasis (chest HRCT)
- Over 18 years old, clinically stable in the previous 6 weeks (no need for antibiotic therapy due to exacerbations) and a dyspnea score over 1 according to the modified Medical Research Council (mMRC) dyspnea scale
Key exclusion criteria (11 listed)
- Less of 18 years
- Other airway disease ( Asthma or COPD)
- Physical inability to perform a physical training program (neuromuscular pathology or residual injuries).
- Smokers or former smokers of less than 6 months or with a history of consumption of 15 packs/year.
- Cystic fibrosis.
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 rehabilitation home-based program intervention group (PRHP)(IG)Also: Intervention groupThe strength training program included upper and lower limb exercises, initially with no weights but progressively adding weights once a week depending on symptoms, in 2 sets with 6-8 repetitions, for at least 5 days a week. The exercises recommended were the 'hanger' (which exercises the latissimus dorsi muscle), 'butterfly' (pectoralis major muscle), 'neck press' (triceps brachii and deltoids), leg flexion (biceps femoris and gastrocnemius) and leg extension (quadriceps femoris). As resistance training, patients could choose between walking or cycling 3 to 5 days per week, for at least 20 minutes, increasing the duration of the exercise weekly, depending on their symptoms | Other | Pulmonary rehabilitation home-based program intervention group (PRHP)(IG) |
Primary outcome
Exercise capacity of Non-cystic Fibrosis Bronchiectasis ( Non-CF bronchiectasis) after pulmonary rehabilitation home-based program (PRHP). Change in VO2 (oxygen consumption, ml/min)
Time frame: Baseline and week 8
A measurement by cardiopulmonary exercise test (CPET) with oxygen consumption was performed at baseline and week 8 of the program.
5 secondary outcomes
Level of physical activity (METS) of Non-CF bronchiectasis and its changes after PRHP
Time frame: Baseline and week 8
Impact of quality of life before and after PRHP
Time frame: Baseline and week 8
Dyspnoea
Time frame: Baseline and week 8
Exacerbations
Time frame: Baseline, week 4 and week8
Level of physical activity (number of steps) of Non-CF bronchiectasis and its changes after PRHP
Time frame: Baseline and week 8
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 18 May 2022.
- Individual participant dataSharing planned: Yes. It will be available in the repository of the Virgen Macarena University Hospital
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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. This study is not recruiting at the moment.
Virginia Almadana, PhD study director
Hospital Universitario Virgen Macarena
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 home-based program intervention group (PRHP)(IG) in people with Non-cystic Fibrosis Bronchiectasis and Pulmonary Rehabilitation, run by Hospital Universitario Virgen Macarena at 1 site in Spain.
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 2 inclusion and 11 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 18 May 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 Spain. 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?
Exercise capacity of Non-cystic Fibrosis Bronchiectasis ( Non-CF bronchiectasis) after pulmonary rehabilitation home-based program (PRHP). Change in VO2 (oxygen consumption, ml/min) (time frame: Baseline and week 8). 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 18 May 2022.