Non-cystic Fibrosis BronchiectasisNCT02883101
The Effects of Pulmonary Rehabilitation in Patients With Non-cystic Fibrosis Bronchiectasis
A study testing Pulmonary Rehabilitation in people with Non-cystic Fibrosis Bronchiectasis, run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
Number of Patients: Study group - Bronchiectasis that is not attributable to Cystic fibrosis Group 1 - Pulmonary Rehabilitation Group 2 - Standard care Sample size - 20 in each arm Study Design: Randomised controlled trial (RCT) All patients who qualify for the study will undergo a detailed evaluation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-cystic Fibrosis Bronchiectasis
- What is being tested?
- Pulmonary Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2015to Dec 2016
- 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
- Age ≥ 18 years
- Diagnosed bronchiectasis that is not attributable to cystic fibrosis, confirmed radiologically on high resolution computed tomography
- Exertional dyspnoea (Modified Medical Research Council (mMRC) score ≥ 2 and a history of at least two exacerbations in the past year
- Willing to give informed consent
Who cannot join
- Smoking history ≥ 10 pack years or physician diagnosis of chronic obstructive pulmonary disease
- A clinical diagnosis of asthma
- Interstitial lung disease (clinical/radiological diagnosis)
- Medical conditions which could place the individual at risk during exercise testing or training (eg. angina) or conditions that may restrict the participant's ability to exercise (eg. severe orthopaedic or neurologic impairments);
- Participation in a PR program within the last 12 months.
- Patient having an exacerbation of bronchiectasis
Trial locations and contacts
1 site in 1 country.
India1 site
Dr. Rohit Kumar
New Delhi, National Capital Territory of Delhi, 110016
About this study
Official title: The Effects of Pulmonary Rehabilitation in Patients With Non-cystic Fibrosis Bronchiectasis: A Randomised Controlled Trial
Number of Patients:
Study group - Bronchiectasis that is not attributable to Cystic fibrosis
Read more
- Group 1 - Pulmonary Rehabilitation
- Group 2 - Standard care
Sample size - 20 in each arm
Study Design:
- Randomised controlled trial (RCT)
All patients who qualify for the study will undergo a detailed evaluation. Baseline assessment will include the following parameters:
- Anthropometry
- Pulmonary Function Tests and Respiratory muscle strength
- Cardiopulmonary Exercise Testing (CPET)
- Six Minute Walk Test (6MWT)
- Severity of dyspnoea (Dyspnoea scale)
- Limb muscle strength
- Inflammatory markers in the serum - C-reactive protein
- Quality of Life
Patients will then be randomized (using table of random numbers) to either the pulmonary rehabilitation group or the standard arm group. After 8 weeks of pulmonary rehabilitation, patients will again be reassessed by the aforementioned tools.
Read the detailed description
METHODOLOGY
Type of study - Randomised controlled trial (RCT)
Study period - March 2014 to July 2016
Place of study - Department of Pulmonary Medicine and Sleep Disorders, All India Institute of Medical Sciences, New Delhi
Study group - Bronchiectasis that is not attributable to Cystic fibrosis
- Group 1 - Pulmonary Rehabilitation (PR)
- Group 2 - Standard care
Sample size - 20 in each arm
The study requires patients to attend the pulmonary rehabilitation program twice a week for 8 weeks.
Consent will be taken from all patients prior to enrollment.
Exacerbations of bronchiectasis will be defined by the following criteria:
At least four of the following clinical signs and symptoms suggestive of an acute exacerbation of bronchiectasis over two consecutive days:
- Increase in sputum quantity
- Change in sputum colour
- Change in sputum viscosity
- Increase in cough
- Increase in dyspnoea
- Increase in fatigue/lethargy
- Fever (self-reported)
- Episode of haemoptysis
The number of acute pulmonary exacerbations per year in the previous years will be recorded.
All patients attending the out patient department of pulmonary department of All India Institute of Medical Sciences will be screened for recruitment in the study.
Baseline evaluation
All patients who qualify for the study will undergo a detailed evaluation. This will include demographic data, complete medical history and clinical examination including anthropometry. Baseline assessment will include the following parameters:
- Anthropometry ii. Pulmonary Function Tests and Respiratory muscle strength iii. Cardiopulmonary Exercise Testing (CPET) iv. Six Minute Walk Test (6MWT)
- Severity of dyspnoea (Dyspnoea scale) vi. Limb muscle strength vii. Inflammatory markers in the serum - C-reactive protein viii. Quality of Life
The participants will then be randomly assigned to receive either standard care alone or pulmonary rehabilitation. The randomisation will be completed by the creation of a random numbers table.
Intervention
Standard care group
Candidates randomized to the "standard care group" will receive standard care for bronchiectasis according to current guidelines. These participants will receive instruction and review of airway clearance therapy (ACT). Each participant will be provided with written information about bronchiectasis and education regarding self-management of the condition. Participants who have not been previously instructed in any ACT will be taught the active cycle of breathing technique. These participants will not receive any supervised exercise training.
Pulmonary rehabilitation group
Participants randomised to the Pulmonary Rehabilitation group will receive exercise training and regular instruction in self-management of ACT along with standard care. Patients will be enrolled into the pulmonary rehabilitation programme, in the Department of Pulmonary Medicine and Sleep disorders, All India Institute of Medical Sciences.
The total duration of the programme would be 8 weeks, with thrice weekly sessions of exercise training of 1 hour duration each. Of these sessions, at least 2 will be supervised while one will be at home. The patient will be asked to maintain a personal log recording the date, time, duration and type of exercise performed to ensure compliance, and these will be regularly reviewed and monitored.
The Rehabilitation Programme will include the following:
- Patient education ii. Exercise training iii. Ventilator and breathing exercises
Outcome Assessment
The patients will be reassessed at the end of the 8 week training programme.
Primary outcome measures:
- Maximum exercise capacity - measured with the 6MWT (the primary outcome is the greatest distance walked) and the CPET (VO2 max)
- HRQoL measured with the St. George Respiratory Questionnaire
Secondary outcome measures:
- Change in the Leicester Cough Questionnaire
- Change in the C- reactive protein
- Change in the lung Functions
- Change in the anxiety and depressions score
- Change in the hand grip dynamometry
- Conditions
- Non-cystic Fibrosis Bronchiectasis
- Being tested
- Pulmonary Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary RehabilitationBehavioural
Also called The Rehabilitation Programme
The Rehabilitation Programme will include the following :
- Patient education ii. Exercise training iii. Ventilator and breathing exercises
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary rehabilitation group | Active comparator | Participants randomised to the PR group will receive exercise training and regular instruction in self-management of ACT along with standard care. Patients will be enrolled into the pulmonary rehabilitation programme, in the Department of Pulmonary Medicine and Sleep disorders, All India Institute of Medical Sciences.
The total duration of the programme would be 8 weeks, with thrice weekly sessions of exercise training of 1 hour duration each. Of these sessions, at least 2 will be supervised while one will be at home. The patient will be asked to maintain a personal log recording the date, time, duration and type of exercise performed to ensure compliance, and these will be regularly reviewed and monitored.
The Rehabilitation Programme will include the following:
i. Patient education ii. Exercise training iii. Ventilator and breathing exercises Receives: Behavioral: Pulmonary Rehabilitation |
| Standard care group | No intervention | Candidates randomized to the "standard care group" will receive standard care for bronchiectasis according to current guidelines. These participants will receive instruction and review of airway clearance therapy (ACT). Each participant will be provided with written information about bronchiectasis and education regarding self-management of the condition. Participants who have not been previously instructed in any ACT will be taught the active cycle of breathing technique. These participants will not receive any supervised exercise training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise capacity
Assessed using 6 minute walk distance and cardiopulmonary exercise testing
Measured: 8 weeks
Secondary outcomes (4)
Cough related QoL
Assessed using Leicester Cough Questionnaire
Measured: 8 weeks
Health Related Quality of Life
Assessed using St George Respiratory questionnaire
Measured: 8 weeks
Lung Functions
Assessed using pulmonary function testing
Measured: 8 weeks
Anxiety and depressions score
Assessed using Depression Anxiety and Stress Scale (DASS)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startJun 2015
- Primary completionOct 2016
- Study completionDec 2016
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Rohit Kumar, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02883101
- Sponsor's protocol ID
- IESC/T-345
- Status last verified
- Jul 2017
- First submitted
- 14 Aug 2016
- Last updated
- 5 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Pulmonary Rehabilitation in Patients With Non-cystic Fibrosis Bronchiectasis: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02883101
- Acronym / sponsor ID
- IESC/T-345
- Conditions
- Non-cystic Fibrosis Bronchiectasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 30 Aug 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.
Number of Patients:
Study group - Bronchiectasis that is not attributable to Cystic fibrosis
- Group 1 - Pulmonary Rehabilitation
- Group 2 - Standard care
Sample size - 20 in each arm
Study Design:
- Randomised controlled trial (RCT)
All patients who qualify for the study will undergo a detailed evaluation. Baseline assessment will include the following parameters:
- Anthropometry
- Pulmonary Function Tests and Respiratory muscle strength
- Cardiopulmonary Exercise Testing (CPET)
- Six Minute Walk Test (6MWT)
- Severity of dyspnoea (Dyspnoea scale)
- Limb muscle strength
- Inflammatory markers in the serum - C-reactive protein
- Quality of Life
Patients will then be randomized (using table of random numbers) to either the pulmonary rehabilitation group or the standard arm group. After 8 weeks of pulmonary rehabilitation, patients will again be reassessed by the aforementioned tools.
Detailed description
METHODOLOGY
Type of study - Randomised controlled trial (RCT)
Study period - March 2014 to July 2016
Place of study - Department of Pulmonary Medicine and Sleep Disorders, All India Institute of Medical Sciences, New Delhi
Study group - Bronchiectasis that is not attributable to Cystic fibrosis
- Group 1 - Pulmonary Rehabilitation (PR)
- Group 2 - Standard care
Sample size - 20 in each arm
The study requires patients to attend the pulmonary rehabilitation program twice a week for 8 weeks.
Consent will be taken from all patients prior to enrollment.
Exacerbations of bronchiectasis will be defined by the following criteria:
At least four of the following clinical signs and symptoms suggestive of an acute exacerbation of bronchiectasis over two consecutive days:
- Increase in sputum quantity
- Change in sputum colour
- Change in sputum viscosity
- Increase in cough
- Increase in dyspnoea
- Increase in fatigue/lethargy
- Fever (self-reported)
- Episode of haemoptysis
The number of acute pulmonary exacerbations per year in the previous years will be recorded.
All patients attending the out patient department of pulmonary department of All India Institute of Medical Sciences will be screened for recruitment in the study.
Baseline evaluation
All patients who qualify for the study will undergo a detailed evaluation. This will include demographic data, complete medical history and clinical examination including anthropometry. Baseline assessment will include the following parameters:
- Anthropometry ii. Pulmonary Function Tests and Respiratory muscle strength iii. Cardiopulmonary Exercise Testing (CPET) iv. Six Minute Walk Test (6MWT)
- Severity of dyspnoea (Dyspnoea scale) vi. Limb muscle strength vii. Inflammatory markers in the serum - C-reactive protein viii. Quality of Life
The participants will then be randomly assigned to receive either standard care alone or pulmonary rehabilitation. The randomisation will be completed by the creation of a random numbers table.
Intervention
Standard care group
Candidates randomized to the "standard care group" will receive standard care for bronchiectasis according to current guidelines. These participants will receive instruction and review of airway clearance therapy (ACT). Each participant will be provided with written information about bronchiectasis and education regarding self-management of the condition. Participants who have not been previously instructed in any ACT will be taught the active cycle of breathing technique. These participants will not receive any supervised exercise training.
Pulmonary rehabilitation group
Participants randomised to the Pulmonary Rehabilitation group will receive exercise training and regular instruction in self-management of ACT along with standard care. Patients will be enrolled into the pulmonary rehabilitation programme, in the Department of Pulmonary Medicine and Sleep disorders, All India Institute of Medical Sciences.
The total duration of the programme would be 8 weeks, with thrice weekly sessions of exercise training of 1 hour duration each. Of these sessions, at least 2 will be supervised while one will be at home. The patient will be asked to maintain a personal log recording the date, time, duration and type of exercise performed to ensure compliance, and these will be regularly reviewed and monitored.
The Rehabilitation Programme will include the following:
- Patient education ii. Exercise training iii. Ventilator and breathing exercises
Outcome Assessment
The patients will be reassessed at the end of the 8 week training programme.
Primary outcome measures:
- Maximum exercise capacity - measured with the 6MWT (the primary outcome is the greatest distance walked) and the CPET (VO2 max)
- HRQoL measured with the St. George Respiratory Questionnaire
Secondary outcome measures:
- Change in the Leicester Cough Questionnaire
- Change in the C- reactive protein
- Change in the lung Functions
- Change in the anxiety and depressions score
- Change in the hand grip dynamometry
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary rehabilitation group | Active comparator | Behavioral: Pulmonary RehabilitationParticipants randomised to the PR group will receive exercise training and regular instruction in self-management of ACT along with standard care. Patients will be enrolled into the pulmonary rehabilitation programme, in the Department of Pulmonary Medicine and Sleep disorders, All India Institute of Medical Sciences. The total duration of the programme would be 8 weeks, with thrice weekly sessions of exercise training of 1 hour duration each. Of these sessions, at least 2 will be supervised while one will be at home. The patient will be asked to maintain a personal log recording the date, time, duration and type of exercise performed to ensure compliance, and these will be regularly reviewed and monitored. The Rehabilitation Programme will include the following: i. Patient education ii. Exercise training iii. Ventilator and breathing exercises |
| Standard care group | No intervention | –Candidates randomized to the "standard care group" will receive standard care for bronchiectasis according to current guidelines. These participants will receive instruction and review of airway clearance therapy (ACT). Each participant will be provided with written information about bronchiectasis and education regarding self-management of the condition. Participants who have not been previously instructed in any ACT will be taught the active cycle of breathing technique. These participants will not receive any supervised exercise training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Diagnosed bronchiectasis that is not attributable to cystic fibrosis, confirmed radiologically on high resolution computed tomography
- Exertional dyspnoea (Modified Medical Research Council (mMRC) score ≥ 2 and a history of at least two exacerbations in the past year
- Willing to give informed consent
Key exclusion criteria (6 listed)
- Smoking history ≥ 10 pack years or physician diagnosis of chronic obstructive pulmonary disease
- A clinical diagnosis of asthma
- Interstitial lung disease (clinical/radiological diagnosis)
- Medical conditions which could place the individual at risk during exercise testing or training (eg. angina) or conditions that may restrict the participant's ability to exercise (eg. severe orthopaedic or neurologic impairments);
- Participation in a PR program within the last 12 months.
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: The Rehabilitation ProgrammeThe Rehabilitation Programme will include the following : i. Patient education ii. Exercise training iii. Ventilator and breathing exercises | Behavioural | Pulmonary rehabilitation group |
Primary outcome
Exercise capacity
Time frame: 8 weeks
Assessed using 6 minute walk distance and cardiopulmonary exercise testing
4 secondary outcomes
Cough related QoL
Time frame: 8 weeks
Health Related Quality of Life
Time frame: 8 weeks
Lung Functions
Time frame: 8 weeks
Anxiety and depressions score
Time frame: 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 5 Jul 2017.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Non-cystic Fibrosis Bronchiectasis, run by All India Institute of Medical Sciences at 1 site in India.
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 5 Jul 2017. 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 India. 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 (time frame: 8 weeks). 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 5 Jul 2017.