Dyspnea Clinical Trial
Official title:
Recalled Exertional Breathlessness and Improved Predicted Exercise Capacity: A Randomized Controlled Trial
Breathlessness during exertion is a major limiting factor for patients' physical capacity and
activity. Increased exertional breathlessness often results in impaired activity, spiraling
deconditioning and further worsening of exertional breathlessness, quality of life and
prognosis.
Recalled symptoms (from memory) can differ substantially from the actually experienced
symptoms.The recall of symptom intensity is affected by several factors including the
experienced peak intensity and the intensity at the end of the episode. This 'Peak-end-rule'
has been reported in studies of pain, and in breathlessness in daily life and during
exercise. A randomized trial reported that adding a time period with decreased pain at the
end of a colonoscopy decreased the patient's recalled total pain of the event, improved their
overall perception of the event and made them more willing to participate in similar
procedures in the future.
Pulmonary rehabilitation training is the first line treatment for exertional breathlessness
and deconditioning in cardiorespiratory disease. However, the training as well as physical
activities of daily life are often limited by the person's perception of his/her capacity,
which is based on recalled breathlessness during exertion. The person's predicted
breathlessness - that is, the level of breathlessness that the person predicts will occur
during a future activity, is likely a major determinant of his/her willingness to participate
in training as well as of the level of physical activity in daily life.
To improve the effectiveness of cardio-pulmonary rehabilitation training and the patients'
health status, new approaches for decreasing the perceived exertional breathlessness and
optimize training are needed.
The investigators hypothesize that adding a period of lower breathlessness intensity at the
end of training might be a way to manipulate the recalled (remembered) symptom intensity
during the training, and to improve the subject's perceived future exercise capacity and
willingness to participate in physical exercise/ training.
The primary purpose is to test whether adding a period of lower level of exertional
breathlessness at the end of an exercise test decreases the overall level of recalled
breathlessness for the test.
Secondly the investigators aim to evaluate factors that affect the level of recalled
breathlessness, and whether decreased exertional breathlessness results in the participant's
reporting lower predicted future exertional breathlessness and higher exercise capacity.
Information about the study and the pre-test questionnaire will be sent home to patients
referred for standard cycle exercise testing. The pre-test questionnaire is completed by the
participant at home or before the exercise test. Eligibility is confirmed and written
informed consent is obtained for all participants by the investigator before starting the
exercise test. All patients included in the RCT (randomized clinical trial), randomizations,
and patients included in the observational sub-study are registered in a log file including
study ID, Swedish identification number and test date, stored securely at the Department of
Clinical Physiology.
Standard exercise test is performed according to clinical practice, current international
guidelines and guidelines from the Swedish association for Clinical Physiology. Testing is
done on bicycle ergometers with small incremental increases in workload every minute. The
level of breathlessness is self-reported by the participant each 2 minutes on a modified Borg
CR10 (mBorg) scale between 0 (none) and 10 (maximal). The level of perceived exertion is
self-reported by the participant on the Borg RPE (rating of perceived exertion) scale between
7 (none) and 20 (maximal), and standard parameters of exercise testing are measured according
to clinical routine practice.
At the end of the regular exercise test conducted according to clinical practice, with the
participant still on the test cycle, a sealed opaque envelope is broken by the staff with a
code that randomly allocates the participant in a 1:1 ratio to either an additional 2 minutes
of low intensity exercise testing (intervention group), or to no additional testing (control
group). During the intervention period. The workload used will be about 50% of the maximal
workload but lowered if needed, and assessments are conducted including of breathlessness,
perceived exertion, breathing frequency and blood pressure. A period of a few minutes of
lower exertion ('cool down') at the end of the exercise test is clinical practice in many
laboratories including in the USA, and is not expected to affect the safety or diagnostic
properties of the exercise test. As an added precaution the investigators have obtained
opinions from well-known experts in cardiac stress testing (Dr. Olle Pahlm and Dr. Paul
Kligfield). In additions to this ST loops will also be used to further enhance the diagnostic
properties of the test. ST loops are not currently used by default in the study laboratory.
A post-test questionnaire is completed by the participant 30-90 min after the exercise test.
Patients completing the exercise test who fulfill the inclusion criteria and give their
written informed consent are included in an observational longitudinal follow-up study. The
study data are cross-linked with medical records and governmental public registries regarding
diagnoses, procedures and hospitalizations (National Patient Register) and mortality (Causes
of Death Register) with up to 10 years follow-up.
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