Breathlessness During Exercise: Experience and Memory

NCT03458182 | Completed

• 1 other identifier: RECALL18
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dyspnea; Breathlessness

Outcome Measures

Primary Outcomes (1)

• Recalled breathlessness

  Recalled overall intensity of breathlessness (0-10 mBorg scale) during the exercise test.

  Post-test questionnaire completed by the participant 30-90 min after the exercise test.

Secondary Outcomes (11)

• Predicted future exertional breathlessness

  Post-test questionnaire completed by the participant 30-90 min after the exercise test.

• Predicted future exercise capacity

  Post-test questionnaire completed by the participant 30-90 min after the exercise test.

• Recalled peak breathlessness intensity during the exercise test

  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

  Post-test questionnaire is completed by the participant 30-90 min after the exercise test.

• Recalled descriptors of breathlessness and their intensity

  Post-test questionnaire is completed by the participant 30-90 min after the exercise test.

Study Arms (2)

Added exercise

EXPERIMENTAL

After completion of the standard exercise test, an intervention period of 2 minutes of low intensity exercise is added.

Other: Added exercise

No intervention

NO INTERVENTION

No added exercise period (normal exercise test).

Interventions

Added exercise OTHER

After completion of the standard exercise test, an intervention period of 2 minutes of low intensity exercise is added.

Added exercise

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Persons referred and eligible for standard exercise stress testing
• Able to read, write and understand sufficient Swedish to participate

You may not qualify if:

• 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

Sponsors & Collaborators

• Magnus Ekström: lead

Study Sites (1)

Blekingesjukhuset

Karlskrona, Blekinge County, 371 41, Sweden

Location

Related Publications (15)

• 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.

  PMID: 22336677 BACKGROUND

• Redelmeier 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.

  PMID: 12855328 BACKGROUND

• Kahneman 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

• 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.

  PMID: 11589344 BACKGROUND

• Stulbarg 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.

  PMID: 10453431 BACKGROUND

• Bolton 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.

  PMID: 23880483 BACKGROUND

• Puente-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.

  PMID: 26797036 BACKGROUND

• American 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.

  PMID: 12524257 BACKGROUND

• Brudin 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.

  PMID: 24171936 BACKGROUND

• Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.

  PMID: 7154893 BACKGROUND

• Hareendran 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.

  PMID: 22745534 BACKGROUND

• Bestall 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.

  PMID: 10377201 BACKGROUND

• Williams 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.

  PMID: 19681739 BACKGROUND

• Banzett 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.

  PMID: 25792641 BACKGROUND

• Kroenke 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.

  PMID: 11914441 BACKGROUND

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Magnus Ekström, MD,PhD

  Lund University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD, Associate Professor

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 8, 2018
• Study Start: March 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: September 18, 2019

Record last verified: 2019-09

Locations

SE (1)