Pulmonary FibrosisNCT03542318
Effects of Pulmonary Rehabilitation on Functional and Health Status Measures in Pulmonary Fibrosis
An observational study of Pulmonary Fibrosis, run by University of Malta at 1 site in Malta.
Trial summary
The inclusion of Pulmonary Rehabilitation (PR) as part of the management of pulmonary fibrosis although being highly recommended and recommended in guidelines still sees studies exploring the outcomes from such an intervention limited. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Pulmonary Fibrosis
- What is being tested?
- Pulmonary Rehabilitation
- How many people
- 120 participants
- Where
- 1 siteMalta
- Study dates
- 1 Mar 2014to 31 Jan 2016
- Phase
- Observational
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 120 patients were enrolled: 60 patients formed part of the active group (30 male and 30 female), another 60 patients were enrolled in an inactive, control group, 32 of which were male and 28 female participants.
Who may be able to join
- Patients with a confirmed diagnosis of Pulmonary Fibrosis
- Patients had to be medically stable to participate in such a programme
Who cannot join
- Any orthopaedic or neurological condition affecting mobility
- If they required oxygen therapy this had to be used
Trial locations and contacts
1 site in 1 country.
Malta1 site
Faculty of Health Sciences, Physiotherapy Department
Multiple Locations, MSD 2080
About this study
Official title: Effects of a Pulmonary Rehabilitation Programme on Functional and Health Status Measures in Patients With Pulmonary Fibrosis
The inclusion of Pulmonary Rehabilitation (PR) as part of the management of pulmonary fibrosis although being highly recommended and recommended in guidelines still sees studies exploring the outcomes from such an intervention limited. The present study aims to contribute to the available literature by investigating the effects of a high intensity, 12week PR programme on functional and quality of life measures in patients with a diagnosis of pulmonary fibrosis.
Read the detailed description
The inclusion of Pulmonary Rehabilitation (PR) as part of the management of pulmonary fibrosis although being highly recommended and recommended in guidelines still sees studies exploring the outcomes from such an intervention limited. The present study aims to contribute to the available literature by investigating the effects of a high intensity, 12week PR programme on functional and quality of life measures in patients with a diagnosis of pulmonary fibrosis. This study reports outcomes of an observational, quasi experimental type of study. A total of 120 participants were recruited: 60 patients formed part of the active group, another 60 patients were enrolled in an inactive group. Each participant was classified according to the modified Medical Research Council dyspnoea scale and placed in one of 5 categories (0 to 4) according to self-perceived breathlessness during daily activities. The following outcomes were measured: Lung function tests including plethysmography and diffusion capacity of carbon monoxide (DLCO), functional tests (6-minute walking test, Dyspnoea Borg Scale) and Health status measures (St George's Respiratory Questionnaire and HAD score).
- Conditions
- Pulmonary Fibrosis
- Being tested
- Pulmonary Rehabilitation
- Keywords
- Pulmonary Rehabilitation, Functional outcomes, Health Status, Exercise
- Medical subject headings
- Pulmonary Fibrosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary RehabilitationOther
A multidisciplinary PR programme was delivered twice weekly for 12 weeks. Each class was of 2 hours in duration. The first hour had an exercise component. Inspiratory muscle training was carried out using the Respironics IMT Threshold trainer® during the class. Educational sessions covered various aspects of pulmonary fibrosis care and self-management delivered. Patients also received an individualized home exercise programme consisting of exercise similar to what was being carried out during the classes. Each participant was encouraged to perform at least 20 minutes of these exercises per day.
| Study group | Role | What they receive |
|---|---|---|
| Active group (Experimental) | Total of 60 patients were enrolled. All patients were referred for PR from the outpatient clinics of the local general hospital. Pulmonary fibrosis was confirmed through a high resonance computed tomography scan and pulmonary function testing. Participants who required modifications to their drug therapy due to exacerbations were excluded from the study. Each participant was classified according to the modified Medical Research Council dyspnoea scale Receives: Other: Pulmonary Rehabilitation | |
| Inactive control group | A total of 60 patients were enrolled in a control group. All were referred for PR from the outpatient clinics of the local general hospital. In this group patients who requested not to carry out the intervention but participate in the investigations were enrolled. Each participant was classified according to the modified Medical Research Council dyspnoea scale, and placed in one of 5 categories (0 to 4) according to self-perceived breathlessness during daily activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute walk test
The six-minute walking distance test (6MWD) was performed according to the American Thoracic Society guidelines (ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories 2002). Each patient was instructed to walk as rapidly as possible in a 30-meter corridor for the time of this test. The test was repeated twice with an interval of 30 minutes. The longest distance on a 6MWT and oxygen saturation were utilized to measure exercise capacity. Dyspnoea was scored using the Borg Category Ratio Scale (Borg 1982) measuring dyspnoea symptoms before and after the test.
Measured: The 6MWD shall be measures at baseline and on completion of the programme at 12weeks
Secondary outcomes (2)
Hospital Anxiety and Depression score
The HAD scale was specifically developed for recognition of anxiety and depression in patients with somatic conditions. It is a validated tool which explores the symptom severity in patient with chronic diseases who have anxiety and depressive related signs. The HAD scale is divided into an anxiety (HADS-A) and a depression subscale (HADS-D) both of which contain seven items, rated 0-3, with the highest possible score for both domains being that of 21. Scores less than 8 indicate no clinical distress; scores between 8 to 10 indicate possible psychiatric morbidity and scores of 11 or more indicate pathologic levels of distress.
Measured: This outcome shall be measured at baseline and on completion of the PR programme at 12weeks
St George's Respiratory Questionnaire
The SGRQ is a widely used questionnaire to assess health related quality of life, due to its specificity to respiratory diseases. This questionnaire consists of 50 items, separated into three domains: symptoms, activity and impact domains. Scores range from 0 to l00 for the three subscales with a summary total score. Higher scores indicate worse health status; 0 indicates no impairment and 100 indicates maximal impairment.
Measured: This outcome shall be measured at baseline and on completion of the PR programme at 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start1 Mar 2014
- Primary completion31 Jan 2016
- Study completion31 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FibrosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anabel Sciriha, University of Malta
- Investigators
- Anabel Sciriha, Ph.D, Principal investigator, Physiotherapy Department, Faculty of Health Sciences, University of Malta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542318
- Sponsor's protocol ID
- 191/2011
- Status last verified
- May 2018
- First submitted
- 6 May 2018
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Pulmonary Rehabilitation Programme on Functional and Health Status Measures in Patients With Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT03542318
- Acronym / sponsor ID
- 191/2011
- Conditions
- Pulmonary Fibrosis
- Keywords
- Pulmonary Rehabilitation, Functional outcomes, Health Status, Exercise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of MaltaUniversity, hospital or other
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 31 Jan 2016 (actual)
- Study completion
- 31 Jan 2016 (actual)
- First posted
- 31 May 2018 (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.
The inclusion of Pulmonary Rehabilitation (PR) as part of the management of pulmonary fibrosis although being highly recommended and recommended in guidelines still sees studies exploring the outcomes from such an intervention limited. The present study aims to contribute to the available literature by investigating the effects of a high intensity, 12week PR programme on functional and quality of life measures in patients with a diagnosis of pulmonary fibrosis.
Detailed description
The inclusion of Pulmonary Rehabilitation (PR) as part of the management of pulmonary fibrosis although being highly recommended and recommended in guidelines still sees studies exploring the outcomes from such an intervention limited. The present study aims to contribute to the available literature by investigating the effects of a high intensity, 12week PR programme on functional and quality of life measures in patients with a diagnosis of pulmonary fibrosis. This study reports outcomes of an observational, quasi experimental type of study. A total of 120 participants were recruited: 60 patients formed part of the active group, another 60 patients were enrolled in an inactive group. Each participant was classified according to the modified Medical Research Council dyspnoea scale and placed in one of 5 categories (0 to 4) according to self-perceived breathlessness during daily activities. The following outcomes were measured: Lung function tests including plethysmography and diffusion capacity of carbon monoxide (DLCO), functional tests (6-minute walking test, Dyspnoea Borg Scale) and Health status measures (St George's Respiratory Questionnaire and HAD score).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active group (Experimental) | – | Other: Pulmonary RehabilitationTotal of 60 patients were enrolled. All patients were referred for PR from the outpatient clinics of the local general hospital. Pulmonary fibrosis was confirmed through a high resonance computed tomography scan and pulmonary function testing. Participants who required modifications to their drug therapy due to exacerbations were excluded from the study. Each participant was classified according to the modified Medical Research Council dyspnoea scale |
| Inactive control group | – | –A total of 60 patients were enrolled in a control group. All were referred for PR from the outpatient clinics of the local general hospital. In this group patients who requested not to carry out the intervention but participate in the investigations were enrolled. Each participant was classified according to the modified Medical Research Council dyspnoea scale, and placed in one of 5 categories (0 to 4) according to self-perceived breathlessness during daily activities |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 120 patients were enrolled: 60 patients formed part of the active group (30 male and 30 female), another 60 patients were enrolled in an inactive, control group, 32 of which were male and 28 female participants.
Key inclusion criteria (2 listed)
- Patients with a confirmed diagnosis of Pulmonary Fibrosis
- Patients had to be medically stable to participate in such a programme
Key exclusion criteria (2 listed)
- Any orthopaedic or neurological condition affecting mobility
- If they required oxygen therapy this had to be used
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 RehabilitationA multidisciplinary PR programme was delivered twice weekly for 12 weeks. Each class was of 2 hours in duration. The first hour had an exercise component. Inspiratory muscle training was carried out using the Respironics IMT Threshold trainer® during the class. Educational sessions covered various aspects of pulmonary fibrosis care and self-management delivered. Patients also received an individualized home exercise programme consisting of exercise similar to what was being carried out during the classes. Each participant was encouraged to perform at least 20 minutes of these exercises per day. | Other | Active group (Experimental) |
Primary outcome
6 minute walk test
Time frame: The 6MWD shall be measures at baseline and on completion of the programme at 12weeks
The six-minute walking distance test (6MWD) was performed according to the American Thoracic Society guidelines (ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories 2002). Each patient was instructed to walk as rapidly as possible in a 30-meter corridor for the time of this test. The test was repeated twice with an interval of 30 minutes. The longest distance on a 6MWT and oxygen saturation were utilized to measure exercise capacity. Dyspnoea was scored using the Borg Category Ratio Scale (Borg 1982) measuring dyspnoea symptoms before and after the test.
2 secondary outcomes
Hospital Anxiety and Depression score
Time frame: This outcome shall be measured at baseline and on completion of the PR programme at 12weeks
St George's Respiratory Questionnaire
Time frame: This outcome shall be measured at baseline and on completion of the PR programme at 12weeks
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 6 Jun 2018.
- 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.
Anabel Sciriha, Ph.D principal investigator
Physiotherapy Department, Faculty of Health Sciences, University of Malta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Fibrosis, run by University of Malta at 1 site in Malta.
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 2 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 6 Jun 2018. 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 Malta. 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?
6 minute walk test (time frame: The 6MWD shall be measures at baseline and on completion of the programme at 12weeks). 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 6 Jun 2018.