Breathlessness Clinical Trial
Official title:
Dysfunctional Breathing: Multidimensional Characterisation and Assessment Tool
Dysfunctional breathing (DB) is a respiratory condition characterised by an abnormal
breathing pattern, among other complaints, that can occur either in the absence of other
pathophysiology (primary DB), e.g. anxiety-related factors, or secondary to cardiopulmonary
disease (secondary DB), e.g. asthma. As a consequence, patients may experience breathlessness
and present with periods of increased ventilation or erratic breathing, interspersed with
episodes of breath holding or deep sighs. In addition to respiratory symptoms, DB also
generates non- respiratory symptoms (e.g. dizziness and increased heart rate). It is
estimated 1 in 10 people in the United Kingdom (UK) have DB. However, DB remains poorly
understood, with no standardised approach to diagnosis and assessment.
The purposes of this study are:
Study 1) To identify physiological, functional and psychological characteristics of
participants with DB compared to healthy participants.
Firstly, symptoms, lung function, respiratory gas analysis, exercise capacity, respiratory
muscle function, respiratory motion, level of physical activity, quality of life and anxiety
& depression scores will be assessed in 20 participants with primary DB, 20 with secondary DB
and compared to 20 healthy participants.
Study 2) To develop an assessment tool based on physiological, functional or psychological
variables found to be different between any of the 3 groups in Study 1.
In order to do that, 54 people with DB (between primary and secondary) and 27 people
presenting with breathlessness secondary to restrictive lung disease will be assessed.
Analysis of these data will determine whether these variables can be used as a diagnostic
tool capable of distinguishing DB from restrictive lung diseases characterised by
breathlessness.
The recruitment period will be 1-2 years, with an individual participation of 9 days; 1-day
on site testing, plus 7-day home activity monitoring, and 1 day to return the activity
monitor (which will happen whenever the participant needs to return to the site).
In this research, the aims are: 1) to characterise and compare participants with primary
dysfunctional breathing (DB), secondary DB and healthy participants, 2) to develop an
assessment and identification tool for the population with DB, 3) to identify subgroups of
people with DB based on their functional, physiological and psychological characteristics.
In order to do that, in Study 1, there will be a comparison of many different aspects
(described below) between three groups of 20 participants each: primary DB, secondary DB and
healthy participants. With the results of these comparisons, it will be possible to know more
about the differences people with DB have in relation to the healthy population, and to
describe their main characteristics. Based on that, in Study 2, it will be possible to select
the variables that are different between groups and replicate those tests in an extra 54
participants DB (primary and secondary) and 27 with breathlessness secondary to restrictive
lung disease (DB excluded). The second stage will suggest tests to be used when identifying
and evaluating this population, and statistically identify subgroups of people with DB based
on their characteristics.
It is important to note why the inclusion of healthy participants and participants with
breathlessness secondary to restrictive lung disease is important in this research programme.
Firstly, it is essential to know the main characteristics of DB in relation to the healthy
population. Secondly, the assessment tool has to be able to suggest probability of negative
diagnosis of DB for people who do not have DB, and not only positive diagnosis for those who
have.
There are no standardised criteria available to diagnose DB. However, experienced chest
physicians at Guy's and St Thomas' Foundation Trust (GSTFT) identify probable DB, and provide
a clinical diagnosis (CD) according to the following criteria: patients presenting with
symptoms that are not concordant with the severity of the underlying health condition (in
case of secondary DB), patients presenting with symptoms that persist despite optimal disease
management and/or no objective markers of deterioration/exacerbation (in case of secondary
DB), patients presenting with symptoms in the presence of negative tests for organic
cause/medically unexplained (in case of primary DB), patients presenting with symptoms that
are considered functional (in case of primary DB).
Ability to comprehend and/or perform the procedures of this research, as well as the presence
of major orthopaedic, neurological or cardiac conditions will be checked by Leyla Osman and
the Chest physicians via medical records and when the possible participant is approached to
receive information about the study. For example: health conditions in which patients present
with an impairment of mental faculties and/or motor function (inability to cycle with no
discomfort).
Healthy participants will be contacted via email list at Brunel University London, and via
flyers placed on the University's and Hospital's website and murals (attached). Participants
with restrictive lung disease will be reached in person or via telephone call when they are
referred to respiratory physiotherapy, or via flyers placed on the Hospital's murals. Because
there are not plenty of patients with DB, those who are already registered on the Hospital's
system as presenting with DB (assessed by a chest physician) will be called. New patients
with DB will be contacted in person or via telephone call by the respiratory physiotherapist
of the clinical team (Leyla Osman).
If those contacted about this research are interested in taking part in this study, they will
be provided with the participant information sheet, have the opportunity to ask any questions
they may have and it will be checked if they meet the inclusion criteria. Before starting the
assessments, they will be asked to sign the informed consent.
When signing the informed consent, participants will be asked a few questions:
Please, tick this box if you authorise the researchers of this study to have access to your
medical records Please, tick this box if you are aware that your General practitioner will be
informed about your participation in this research Please, tick this box if you would like to
receive a report with your results of the tests performed in this study (within 30 days from
the end of your assessments) Please, tick this box if you would like us to contact you in the
future to inform you about the final results of this study Please, tick this box if you are
participating in other study/ies at this moment. If yes, please mention below what this/these
study/ies is/are about and the contact of the person responsible for it The assessments will
be performed by Lais Silva Vidotto (respiratory physiotherapist and researcher) at the
Hospital/University over a period of approximately 3 hours. Many of these assessments form
part of routine hospital investigations for patients with DB. Duration may vary depending on
individual needs and limitations, such as time given to recover from any physical or mental
effort. Secondly, a physical activity monitor will be given to all participants, which will
be returned to the researchers on the next medical appointment at the Hospital/classes at the
University (classes at the University in case of healthy participants). During the 3-hour
assessment they will have the opportunity to rest whenever is necessary and snacks and
refreshments will be provided in the intervals (caffeine-free ingredients).
Assessments and their approximate duration are as follows: demographic information (10
minutes), health-related quality of life questionnaire (SF-36) (5 minutes), Hospital anxiety
and depression scale (HADS) (5 minutes), Nijmegen questionnaire (NQ) (5 minutes),
Self-evaluation of breathing questionnaire (SEBQ) (5 minutes), Asthma Questionnaire (only for
asthmatics) (5 minutes), lung function test (30 minutes), respiratory muscle function (30
minutes, assessment of the respiratory movements (MARM) (10 minutes), breath-hold test (BHT)
(20 minutes), slow-breathing task (15 minutes) and the sub-maximal exercise test (10 minutes)
(during the two last tests participants will be wearing small and light-weight devices that
monitor heart activity, breathing function and blood pressure and take 15 minutes to be
placed all together).
Day 1: Hospital assessments (~3 hours) The tests will be performed in a private room at St
Thomas' Hospital or Brunel University London. Participants will be advised to stay 48 hours
without practicing exercise. Also, they will be instructed to take all the medicines they
normally use and to report their names and doses to the examiner.
1. Patients will be asked about their medical history, date of birth and symptoms. Also,
participants' weight and height will be measured.
2. Chest movements while breathing:
At this stage, participants are going to stand still while the researcher will place
their hands on the back of their chests in order to evaluate its movements while
participants are breathing. This is going to take about 10 minutes.
3. Slow-breathing task:
Participants will be instructed on how to breathe slower (6-10 bpm) for a few minutes
(5-15 minutes) and will keep wearing the mask, the heart rate monitor and the arterial
blood pressure monitor during this task.
4. Exercise test, breathing and cardiovascular function:
Light-weight devices will be attached to participants' chest (cardiac monitor), in order
to evaluate heart function, to their faces (mask-gas analyser) to assess respiratory
function, and to their non-dominant arm (arm and finger), to assess blood pressure. The
device used to assess blood pressure continuously measures the pulse of the finger,
calibrated by an arm cuff, with no discomfort to the participant. Those assessments will
be performed while participants rest for five minutes, while they cycle on a bicycle
with moderate resistance for six minutes, and while they rest for five more minutes.
Just before the exercise test, at the third minute, and just after it, participants will
be asked about any leg or breathing discomfort and how mindful they are in relation to
discomfort related to the task. Approximate time of this task: 16 minutes.
5. Questionnaires:
Participants will be asked to fill in some questionnaires that will ask about their
breathing and quality of life and will take about 25 minutes to complete. Participants
will be asked to complete these questionnaires after having the opportunity to ask
questions about them.
6. Breath hold test:
Participants will be asked to hold their breath for as long as they can for 3 times,
resting for 5 minutes after each one of them, and the researcher will use a stopwatch in
order to count the time they are able to do it. The whole task will last in
approximately 20 minutes.
7. Lung and respiratory muscle function assessments:
Researchers will use three devices to measure the function of participants' lungs and
respiratory muscles. They will be asked to breathe in and out in several different ways,
wearing a nose clip, so that researchers can record their general breathing function. This is
going to take about one hour to finish.
At the end of the assessment session, participants will be instructed on how to use a device
that measures the level of physical activity.
Days 2-8: Physical Activity Monitoring Participants will be asked to wear two small activity
monitors attached to their hip for 7 consecutive days, keeping their routine as normal as
possible. Participants will have to use the equipment for at least 8 hours/day while they are
awake, excluding water activities (e.g. shower) and sleeping, writing down the exact time
they put it on and the time they took this off.
Day 9: Return of the activity monitors Participants recruited from Brunel University London
will return their physical activity monitors to the researchers on their next visit to the
University (for classes, meetings etc.); those recruited from GSTFT will return it on their
next hospital appointment.
Although this study requires a cross-sectional design, it may take a long period to be
completed, since patients with DB are not easily identified and referred to other health
professionals to receive specific diagnosis or treatment. Considering this difficulty in
finding participants with DB, justified by the fact that there is no established way of
identifying these patients, this research may take 1-2 years to be completed. However, It
will enable the researchers to look at every single result and be rigorous with the quality
of the data collected. In order to do that, the researchers will not wait for all assessments
to be finished to process and plot the data. Every time a participant is evaluated, their
results will be organised and plotted within the next few days. It will also enable the data
to be statistically analysed when needed.
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