DyspneaNCT03458182
Breathlessness During Exercise: Experience and Memory
A study testing Added exercise in people with Dyspnea and Breathlessness, run by Magnus Ekström at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dyspnea, Breathlessness
- What is being tested?
- Added exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2018to 31 Dec 2018
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Persons referred and eligible for standard exercise stress testing
- Able to read, write and understand sufficient Swedish to participate
Who cannot join
- Duration of exercise test ≤ 3 minutes
- Maximal breathlessness intensity ≤ 3/10 during the test
- Clinical or cardiovascular instability during the exercise test before randomization as judged by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Dyspnea, Breathlessness
- Being tested
- Added exercise
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Added exerciseOther
After completion of the standard exercise test, an intervention period of 2 minutes of low intensity exercise is added.
| Study group | Role | What they receive |
|---|---|---|
| Added exercise | Experimental | After completion of the standard exercise test, an intervention period of 2 minutes of low intensity exercise is added. Receives: Other: Added exercise |
| No intervention | No intervention | No added exercise period (normal exercise test). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recalled breathlessness
Recalled overall intensity of breathlessness (0-10 mBorg scale) during the exercise test.
Measured: Post-test questionnaire completed by the participant 30-90 min after the exercise test.
Secondary outcomes (11)
Predicted future exertional breathlessness
Predicted future exertional breathlessness (0-10 mBorg scale.
Measured: Post-test questionnaire completed by the participant 30-90 min after the exercise test.
Predicted future exercise capacity
Predicted future exercise capacity (7-20 Borg scale).
Measured: Post-test questionnaire completed by the participant 30-90 min after the exercise test.
Recalled peak breathlessness intensity during the exercise test
Recalled peak intensity of breathlessness (0-10 mBorg scale).
Measured: Post-test questionnaire is completed by the participant 30-90 min after the exercise test.
Factors influencing the difference between experienced and recalled breathlessness of the exercise test
Recalled descriptors
Measured: Post-test questionnaire is completed by the participant 30-90 min after the exercise test.
Recalled descriptors of breathlessness and their intensity
Recalled descriptors of breathlessness and their intensity
Measured: Post-test questionnaire is completed by the participant 30-90 min after the exercise test.
Recalled overall and peak level of exertion during the exercise test
Recalled overall and peak level of exertion (7-20 mBorg scale).
Measured: Post-test questionnaire is completed by the participant 30-90 min after the exercise test.
Overall perception of the exercise test
Recalled descriptors
Measured: Post-test questionnaire is completed by the participant 30-90 min after the exercise test.
Diagnoses (IHD; heart failure; pulmonary disease; other) during 10 years follow-up
Swedish National Patient Register
Measured: 10 year follow-up
Rate of revascularization and coronary bypass operation during 10 years follow-up
Swedish National Patient Register
Measured: 10 year follow-up
Rate of hospitalization (overall and as for diagnosis) during 10 years follow-up
Swedish National Patient Register
Measured: 10 year follow-up
Rate of mortality and causes of death (overall and as for diagnosis) during 10 years follow-up
Swedish Causes of Death Register
Measured: 10 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start1 Mar 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for DyspneaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Magnus Ekström
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Magnus Ekström, Skane University Hospital
- Investigators
- Magnus Ekström, MD,PhD, Study director, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03458182
- Sponsor's protocol ID
- RECALL18
- Status last verified
- Sep 2019
- First submitted
- 1 Mar 2018
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Parshall MB, Schwartzstein RM, Adams L, Banzett RB, Manning HL, Bourbeau J, Calverley PM, Gift AG, Harver A, Lareau SC, Mahler DA, Meek PM, O'Donnell DE; American Thoracic Society Committee on Dyspnea. An official American Thoracic Society statement: update on the mechanisms, assessment, and management of dyspnea. Am J Respir Crit Care Med. 2012 Feb 15;185(4):435-52. doi: 10.1164/rccm.201111-2042ST.
PubMed 22336677Redelmeier DA, Katz J, Kahneman D. Memories of colonoscopy: a randomized trial. Pain. 2003 Jul;104(1-2):187-94. doi: 10.1016/s0304-3959(03)00003-4.
PubMed 12855328Kahneman D. Experienced Utility and Objective Happiness: A Moment-Based Approach. In: D. Kahneman and A. Tversky (Eds.) Choices, Values and Frames. New York: Cambridge University Press and the Russell Sage Foundation 2000.
Meek PM, Lareau SC, Anderson D. Memory for symptoms in COPD patients: how accurate are their reports? Eur Respir J. 2001 Sep;18(3):474-81. doi: 10.1183/09031936.01.00083501.
PubMed 11589344Stulbarg MS, Carrieri-Kohlman V, Gormley JM, Tsang A, Paul S. Accuracy of recall of dyspnea after exercise training sessions. J Cardiopulm Rehabil. 1999 Jul-Aug;19(4):242-8. doi: 10.1097/00008483-199907000-00005.
PubMed 10453431Bolton CE, Bevan-Smith EF, Blakey JD, Crowe P, Elkin SL, Garrod R, Greening NJ, Heslop K, Hull JH, Man WD, Morgan MD, Proud D, Roberts CM, Sewell L, Singh SJ, Walker PP, Walmsley S; British Thoracic Society Pulmonary Rehabilitation Guideline Development Group; British Thoracic Society Standards of Care Committee. British Thoracic Society guideline on pulmonary rehabilitation in adults. Thorax. 2013 Sep;68 Suppl 2:ii1-30. doi: 10.1136/thoraxjnl-2013-203808. No abstract available.
PubMed 23880483Puente-Maestu L, Palange P, Casaburi R, Laveneziana P, Maltais F, Neder JA, O'Donnell DE, Onorati P, Porszasz J, Rabinovich R, Rossiter HB, Singh S, Troosters T, Ward S. Use of exercise testing in the evaluation of interventional efficacy: an official ERS statement. Eur Respir J. 2016 Feb;47(2):429-60. doi: 10.1183/13993003.00745-2015. Epub 2016 Jan 21.
PubMed 26797036American Thoracic Society; American College of Chest Physicians. ATS/ACCP Statement on cardiopulmonary exercise testing. Am J Respir Crit Care Med. 2003 Jan 15;167(2):211-77. doi: 10.1164/rccm.167.2.211. No abstract available.
PubMed 12524257Brudin L, Jorfeldt L, Pahlm O. Comparison of two commonly used reference materials for exercise bicycle tests with a Swedish clinical database of patients with normal outcome. Clin Physiol Funct Imaging. 2014 Jul;34(4):297-307. doi: 10.1111/cpf.12097. Epub 2013 Oct 31.
PubMed 24171936Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
PubMed 7154893Hareendran A, Leidy NK, Monz BU, Winnette R, Becker K, Mahler DA. Proposing a standardized method for evaluating patient report of the intensity of dyspnea during exercise testing in COPD. Int J Chron Obstruct Pulmon Dis. 2012;7:345-55. doi: 10.2147/COPD.S29571. Epub 2012 May 28.
PubMed 22745534Bestall JC, Paul EA, Garrod R, Garnham R, Jones PW, Wedzicha JA. Usefulness of the Medical Research Council (MRC) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease. Thorax. 1999 Jul;54(7):581-6. doi: 10.1136/thx.54.7.581.
PubMed 10377201Williams M, Garrard A, Cafarella P, Petkov J, Frith P. Quality of recalled dyspnoea is different from exercise-induced dyspnoea: an experimental study. Aust J Physiother. 2009;55(3):177-83. doi: 10.1016/s0004-9514(09)70078-9.
PubMed 19681739Banzett RB, O'Donnell CR, Guilfoyle TE, Parshall MB, Schwartzstein RM, Meek PM, Gracely RH, Lansing RW. Multidimensional Dyspnea Profile: an instrument for clinical and laboratory research. Eur Respir J. 2015 Jun;45(6):1681-91. doi: 10.1183/09031936.00038914. Epub 2015 Mar 18.
PubMed 25792641Kroenke K, Spitzer RL, Williams JB. The PHQ-15: validity of a new measure for evaluating the severity of somatic symptoms. Psychosom Med. 2002 Mar-Apr;64(2):258-66. doi: 10.1097/00006842-200203000-00008.
PubMed 11914441
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recalled Exertional Breathlessness and Improved Predicted Exercise Capacity: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03458182
- Acronym / sponsor ID
- RECALL18
- Conditions
- Dyspnea, Breathlessness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Magnus EkströmUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 8 Mar 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Added exercise | Experimental | Other: Added exerciseAfter completion of the standard exercise test, an intervention period of 2 minutes of low intensity exercise is added. |
| No intervention | No intervention | –No added exercise period (normal exercise test). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Persons referred and eligible for standard exercise stress testing
- Able to read, write and understand sufficient Swedish to participate
Key exclusion criteria (3 listed)
- Duration of exercise test ≤ 3 minutes
- Maximal breathlessness intensity ≤ 3/10 during the test
- Clinical or cardiovascular instability during the exercise test before randomization as judged by the investigator
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 |
|---|---|---|
| Added exerciseAfter completion of the standard exercise test, an intervention period of 2 minutes of low intensity exercise is added. | Other | Added exercise |
Primary outcome
Recalled breathlessness
Time frame: Post-test questionnaire completed by the participant 30-90 min after the exercise test.
Recalled overall intensity of breathlessness (0-10 mBorg scale) during the exercise test.
11 secondary outcomes
Predicted future exertional breathlessness
Time frame: Post-test questionnaire completed by the participant 30-90 min after the exercise test.
Predicted future exercise capacity
Time frame: Post-test questionnaire completed by the participant 30-90 min after the exercise test.
Recalled peak breathlessness intensity during the exercise test
Time frame: Post-test questionnaire is completed by the participant 30-90 min after the exercise test.
Factors influencing the difference between experienced and recalled breathlessness of the exercise test
Time frame: Post-test questionnaire is completed by the participant 30-90 min after the exercise test.
Recalled descriptors of breathlessness and their intensity
Time frame: Post-test questionnaire is completed by the participant 30-90 min after the exercise test.
Recalled overall and peak level of exertion during the exercise test
Time frame: Post-test questionnaire is completed by the participant 30-90 min after the exercise test.
Overall perception of the exercise test
Time frame: Post-test questionnaire is completed by the participant 30-90 min after the exercise test.
Diagnoses (IHD; heart failure; pulmonary disease; other) during 10 years follow-up
Time frame: 10 year follow-up
Rate of revascularization and coronary bypass operation during 10 years follow-up
Time frame: 10 year follow-up
Rate of hospitalization (overall and as for diagnosis) during 10 years follow-up
Time frame: 10 year follow-up
Rate of mortality and causes of death (overall and as for diagnosis) during 10 years follow-up
Time frame: 10 year follow-up
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 Sep 2019.
- Background: PubMed 22336677Parshall MB, Schwartzstein RM, Adams L, Banzett RB, Manning HL, Bourbeau J, Calverley PM, Gift AG, Harver A, Lareau SC, Mahler DA, Meek PM, O'Donnell DE; American Thoracic Society Committee on Dyspnea. An official American Thoracic Society statement: update on the mechanisms, assessment, and management of dyspnea. Am J Respir Crit Care Med. 2012 Feb 15;185(4):435-52. doi: 10.1164/rccm.201111-2042ST.
- Background: PubMed 12855328Redelmeier DA, Katz J, Kahneman D. Memories of colonoscopy: a randomized trial. Pain. 2003 Jul;104(1-2):187-94. doi: 10.1016/s0304-3959(03)00003-4.
- BackgroundKahneman D. Experienced Utility and Objective Happiness: A Moment-Based Approach. In: D. Kahneman and A. Tversky (Eds.) Choices, Values and Frames. New York: Cambridge University Press and the Russell Sage Foundation 2000.
- Background: PubMed 11589344Meek PM, Lareau SC, Anderson D. Memory for symptoms in COPD patients: how accurate are their reports? Eur Respir J. 2001 Sep;18(3):474-81. doi: 10.1183/09031936.01.00083501.
- Background: PubMed 10453431Stulbarg MS, Carrieri-Kohlman V, Gormley JM, Tsang A, Paul S. Accuracy of recall of dyspnea after exercise training sessions. J Cardiopulm Rehabil. 1999 Jul-Aug;19(4):242-8. doi: 10.1097/00008483-199907000-00005.
- Background: PubMed 23880483Bolton CE, Bevan-Smith EF, Blakey JD, Crowe P, Elkin SL, Garrod R, Greening NJ, Heslop K, Hull JH, Man WD, Morgan MD, Proud D, Roberts CM, Sewell L, Singh SJ, Walker PP, Walmsley S; British Thoracic Society Pulmonary Rehabilitation Guideline Development Group; British Thoracic Society Standards of Care Committee. British Thoracic Society guideline on pulmonary rehabilitation in adults. Thorax. 2013 Sep;68 Suppl 2:ii1-30. doi: 10.1136/thoraxjnl-2013-203808. No abstract available.
- Background: PubMed 26797036Puente-Maestu L, Palange P, Casaburi R, Laveneziana P, Maltais F, Neder JA, O'Donnell DE, Onorati P, Porszasz J, Rabinovich R, Rossiter HB, Singh S, Troosters T, Ward S. Use of exercise testing in the evaluation of interventional efficacy: an official ERS statement. Eur Respir J. 2016 Feb;47(2):429-60. doi: 10.1183/13993003.00745-2015. Epub 2016 Jan 21.
- Background: PubMed 12524257American Thoracic Society; American College of Chest Physicians. ATS/ACCP Statement on cardiopulmonary exercise testing. Am J Respir Crit Care Med. 2003 Jan 15;167(2):211-77. doi: 10.1164/rccm.167.2.211. No abstract available.
- Background: PubMed 24171936Brudin L, Jorfeldt L, Pahlm O. Comparison of two commonly used reference materials for exercise bicycle tests with a Swedish clinical database of patients with normal outcome. Clin Physiol Funct Imaging. 2014 Jul;34(4):297-307. doi: 10.1111/cpf.12097. Epub 2013 Oct 31.
- Background: PubMed 7154893Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
- Background: PubMed 22745534Hareendran A, Leidy NK, Monz BU, Winnette R, Becker K, Mahler DA. Proposing a standardized method for evaluating patient report of the intensity of dyspnea during exercise testing in COPD. Int J Chron Obstruct Pulmon Dis. 2012;7:345-55. doi: 10.2147/COPD.S29571. Epub 2012 May 28.
- Background: PubMed 10377201Bestall JC, Paul EA, Garrod R, Garnham R, Jones PW, Wedzicha JA. Usefulness of the Medical Research Council (MRC) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease. Thorax. 1999 Jul;54(7):581-6. doi: 10.1136/thx.54.7.581.
- Individual participant dataSharing planned: Undecided
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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.
Magnus Ekström, MD,PhD study director
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Added exercise in people with Dyspnea and Breathlessness, run by Magnus Ekström at 1 site in Sweden.
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 3 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 Sep 2019. 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 Sweden. 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?
Recalled breathlessness (time frame: Post-test questionnaire completed by the participant 30-90 min after the exercise test.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03458182, which also lists 15 linked publications.
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 Sep 2019.