Physiotherapist-led Exercise Within Cardiac Rehabilitation and Paroxysmal Atrial Fibrillation and COVID-19.

NCT04600713 | Withdrawn

• 1 other identifier: 273293
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Paroxysmal atrial fibrillation (AF) induce, in the affected patient, a prominent negative effect on health-related quality of life (HR-QoL) and physical fitness. The health care utilisation is high and the patient does never know when the next attack of atrial fibrillation occurs. Therefore, is physical exertion often avoided due to fear of new attacks. Further, are shortness of breath and fatigue often present despite of prescribed modern drugs. Paroxysmal AF per se enhance markedly the risk to develop stroke and heart failure, which both are syndromes that cause further negative effect on the patient´s HR-QoL and physical fitness. Altogether, cause the symptoms in paroxysmal AF a vicious spiral where both VO2max and muscle function deteriorate. The problems with shortness of breath might be due to dysfunction in respiratory muscles. Physiotherapy led exercise within cardiac rehabilitation (PT-X) in combination with inspiratory muscle training (IMT) has shown positive effects in patients with permanent atrial fibrillation. However, to our knowledge, not yet investigated in patients with paroxysmal AF. Aim: Primary to investigate, in a multicentre randomised controlled trial, if PT-X in combination with IMT can impact HR-QoL in patients with paroxysmal AF. Secondary to investigate the effect of PT-X in combination with IMT regarding symptoms, physical fitness, physical activity and the number of atrial fibrillation attacks and health care costs compared to the control group, asked to live their usual life, during the study period. Expected outcome: PTX in combination with IMT can improve HR-QoL, respiratory muscle function, level of symptoms, physical fitness and physical activity in patients with paroxysmal AF. In addition, a reduced number of atrial fibrillation attacks could decrease the direct cost of health care.

Conditions

Atrial Fibrillation Paroxysmal

Keywords

Health Related Quality of Life; Exercise; Physiotherapy; Physical Activity

Outcome Measures

Primary Outcomes (1)

• Health-related quality of life

  The Swedish version of short form 36 (SF-36) will be used for self-reported HR-QoL.

  Change from baseline at 12 weeks

Secondary Outcomes (10)

• N-terminal pro-B type natriuretic peptide (NT-proBNP)

  At baseline

• Antibodies for SARS-CoV-2

  At baseline

• Inspiratory and expiratory muscle strength

  Change from baseline at 12 weeks

• Exercise capacity

  Change from baseline at 12 weeks

• Muscle function

  Change from baseline at 12 weeks

Other Outcomes (4)

• Ejection fraction

  At baseline

• Left ventricular function

  At baseline

• Diastolic function

  At baseline

Study Arms (2)

PT-X and IMT

EXPERIMENTAL

Physiotherapist-led exercise-based cardiac rehabilitation (PT-X) and inspiratory muscle training (IMT).

Other: PT-X and IMT

Control

NO INTERVENTION

The participants in the control group will be offered PT-X at the end of the control period.

Interventions

PT-X and IMT OTHER

The intervention consists of PT-X, including central circulatory exercise and muscle exercises, 2 times/week, 60 min/session for 12 weeks, and homebased exercises 2 times/week logged in an exercise diary. For IMT the Threshold Inspiratory Muscle Trainer (Threshold IMT) (Respironics Inc., Murrysville, PA, USA) will be used at 30 % of maximal expiratory pressure in 15 minutes 2 times a day during 12 weeks.

PT-X and IMT

Eligibility Criteria

• Age: 40 Years - 85 Years
• Gender Eligibility Details: The patients are randomized stratified to age, gender and exercise capacity measured by the symptom-limited ergometer cycle test.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Paroxysmal atrial fibrillation verified with electrocardiogram (ECG)
• Left ventricular ejection fraction (EF) ≥ 45% verified by Echocardiography

You may not qualify if:

• Ongoing participation in regular aerobic and muscular endurance exercises more than 1 time per week.
• Participation in a weight reduction program.
• Smoking cessation program
• Treatment for sleep apnoea.
• stroke with residual symptoms
• presence of pacemaker
• No significant valvular lesions verified by Echocardiography.

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Related Publications (27)

• Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Popescu BA, Schotten U, Van Putte B, Vardas P, Agewall S, Camm J, Baron Esquivias G, Budts W, Carerj S, Casselman F, Coca A, De Caterina R, Deftereos S, Dobrev D, Ferro JM, Filippatos G, Fitzsimons D, Gorenek B, Guenoun M, Hohnloser SH, Kolh P, Lip GY, Manolis A, McMurray J, Ponikowski P, Rosenhek R, Ruschitzka F, Savelieva I, Sharma S, Suwalski P, Tamargo JL, Taylor CJ, Van Gelder IC, Voors AA, Windecker S, Zamorano JL, Zeppenfeld K. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Europace. 2016 Nov;18(11):1609-1678. doi: 10.1093/europace/euw295. Epub 2016 Aug 27. No abstract available.

  PMID: 27567465 BACKGROUND

• Hobbs FD, Kenkre JE, Roalfe AK, Davis RC, Hare R, Davies MK. Impact of heart failure and left ventricular systolic dysfunction on quality of life: a cross-sectional study comparing common chronic cardiac and medical disorders and a representative adult population. Eur Heart J. 2002 Dec;23(23):1867-76. doi: 10.1053/euhj.2002.3255.

  PMID: 12445536 BACKGROUND

• Zhang L, Gallagher R, Neubeck L. Health-related quality of life in atrial fibrillation patients over 65 years: A review. Eur J Prev Cardiol. 2015 Aug;22(8):987-1002. doi: 10.1177/2047487314538855. Epub 2014 Jun 12.

  PMID: 24924742 BACKGROUND

• Gleason KT, Dennison Himmelfarb CR, Ford DE, Lehmann H, Samuel L, Jain S, Naccarelli G, Aggarwal V, Nazarian S. Association of sex and atrial fibrillation therapies with patient-reported outcomes. Heart. 2019 Nov;105(21):1642-1648. doi: 10.1136/heartjnl-2019-314881. Epub 2019 May 22.

  PMID: 31118198 BACKGROUND

• Dorian P, Jung W, Newman D, Paquette M, Wood K, Ayers GM, Camm J, Akhtar M, Luderitz B. The impairment of health-related quality of life in patients with intermittent atrial fibrillation: implications for the assessment of investigational therapy. J Am Coll Cardiol. 2000 Oct;36(4):1303-9. doi: 10.1016/s0735-1097(00)00886-x.

  PMID: 11028487 BACKGROUND

• Hansson A, Madsen-Hardig B, Olsson SB. Arrhythmia-provoking factors and symptoms at the onset of paroxysmal atrial fibrillation: a study based on interviews with 100 patients seeking hospital assistance. BMC Cardiovasc Disord. 2004 Aug 3;4:13. doi: 10.1186/1471-2261-4-13.

  PMID: 15291967 BACKGROUND

• Ericson L, Bergfeldt L, Bjorholt I. Atrial fibrillation: the cost of illness in Sweden. Eur J Health Econ. 2011 Oct;12(5):479-87. doi: 10.1007/s10198-010-0261-3. Epub 2010 Jul 1.

  PMID: 20593297 BACKGROUND

• Rohrbacker NJ, Kleinman NL, White SA, March JL, Reynolds MR. The burden of atrial fibrillation and other cardiac arrhythmias in an employed population: associated costs, absences, and objective productivity loss. J Occup Environ Med. 2010 Apr;52(4):383-91. doi: 10.1097/JOM.0b013e3181d967bc.

  PMID: 20357675 BACKGROUND

• Rienstra M, Lubitz SA, Mahida S, Magnani JW, Fontes JD, Sinner MF, Van Gelder IC, Ellinor PT, Benjamin EJ. Symptoms and functional status of patients with atrial fibrillation: state of the art and future research opportunities. Circulation. 2012 Jun 12;125(23):2933-43. doi: 10.1161/CIRCULATIONAHA.111.069450. No abstract available.

  PMID: 22689930 BACKGROUND

• Hussain N, Gersh BJ, Gonzalez Carta K, Sydo N, Lopez-Jimenez F, Kopecky SL, Thomas RJ, Asirvatham SJ, Allison TG. Impact of Cardiorespiratory Fitness on Frequency of Atrial Fibrillation, Stroke, and All-Cause Mortality. Am J Cardiol. 2018 Jan 1;121(1):41-49. doi: 10.1016/j.amjcard.2017.09.021. Epub 2017 Nov 13.

  PMID: 29221502 BACKGROUND

• Ueshima K, Myers J, Ribisl PM, Morris CK, Kawaguchi T, Liu J, Froelicher VF. Exercise capacity and prognosis in patients with chronic atrial fibrillation. Cardiology. 1995;86(2):108-13. doi: 10.1159/000176850.

  PMID: 7728799 BACKGROUND

• Okita K, Kinugawa S, Tsutsui H. Exercise intolerance in chronic heart failure--skeletal muscle dysfunction and potential therapies. Circ J. 2013;77(2):293-300. doi: 10.1253/circj.cj-12-1235. Epub 2013 Jan 19.

  PMID: 23337207 BACKGROUND

• Santhanakrishnan R, Wang N, Larson MG, Magnani JW, McManus DD, Lubitz SA, Ellinor PT, Cheng S, Vasan RS, Lee DS, Wang TJ, Levy D, Benjamin EJ, Ho JE. Atrial Fibrillation Begets Heart Failure and Vice Versa: Temporal Associations and Differences in Preserved Versus Reduced Ejection Fraction. Circulation. 2016 Feb 2;133(5):484-92. doi: 10.1161/CIRCULATIONAHA.115.018614. Epub 2016 Jan 8.

  PMID: 26746177 BACKGROUND

• Guzik TJ, Mohiddin SA, Dimarco A, Patel V, Savvatis K, Marelli-Berg FM, Madhur MS, Tomaszewski M, Maffia P, D'Acquisto F, Nicklin SA, Marian AJ, Nosalski R, Murray EC, Guzik B, Berry C, Touyz RM, Kreutz R, Wang DW, Bhella D, Sagliocco O, Crea F, Thomson EC, McInnes IB. COVID-19 and the cardiovascular system: implications for risk assessment, diagnosis, and treatment options. Cardiovasc Res. 2020 Aug 1;116(10):1666-1687. doi: 10.1093/cvr/cvaa106.

  PMID: 32352535 BACKGROUND

• Ariansen I, Edvardsen E, Borchsenius F, Abdelnoor M, Tveit A, Gjesdal K. Lung function and dyspnea in patients with permanent atrial fibrillation. Eur J Intern Med. 2011 Oct;22(5):466-70. doi: 10.1016/j.ejim.2011.06.010. Epub 2011 Jul 12.

  PMID: 21925054 BACKGROUND

• Risom SS, Zwisler AD, Johansen PP, Sibilitz KL, Lindschou J, Gluud C, Taylor RS, Svendsen JH, Berg SK. Exercise-based cardiac rehabilitation for adults with atrial fibrillation. Cochrane Database Syst Rev. 2017 Feb 9;2(2):CD011197. doi: 10.1002/14651858.CD011197.pub2.

  PMID: 28181684 BACKGROUND

• Sullivan M, Karlsson J, Ware JE Jr. The Swedish SF-36 Health Survey--I. Evaluation of data quality, scaling assumptions, reliability and construct validity across general populations in Sweden. Soc Sci Med. 1995 Nov;41(10):1349-58. doi: 10.1016/0277-9536(95)00125-q.

  PMID: 8560302 BACKGROUND

• Exercise tests in relation to cardiovascular function. Report of a WHO meeting. World Health Organ Tech Rep Ser. 1968;388:1-30. No abstract available.

  PMID: 4968942 BACKGROUND

• STRANDELL T. CIRCULATORY STUDIES ON HEALTHY OLD MEN. WITH SPECIAL REFERENCE TO THE LIMITATION OF THE MAXIMAL PHYSICAL WORKING CAPACITY. Acta Med Scand Suppl. 1964;414:SUPPL 414:1-44. No abstract available.

  PMID: 14161322 BACKGROUND

• Borg G. Borg's perceived exertion and pain scales. Leeds: Human Kinetics; 1998.

  BACKGROUND

• Cider A, Carlsson S, Arvidsson C, Andersson B, Sunnerhagen KS. Reliability of clinical muscular endurance tests in patients with chronic heart failure. Eur J Cardiovasc Nurs. 2006 Jun;5(2):122-6. doi: 10.1016/j.ejcnurse.2005.10.001. Epub 2005 Oct 28.

  PMID: 16257580 BACKGROUND

• Doliwa PS, Frykman V, Rosenqvist M. Short-term ECG for out of hospital detection of silent atrial fibrillation episodes. Scand Cardiovasc J. 2009 Jun;43(3):163-8. doi: 10.1080/14017430802593435.

  PMID: 19096977 BACKGROUND

• Hendrikx T, Rosenqvist M, Wester P, Sandstrom H, Hornsten R. Intermittent short ECG recording is more effective than 24-hour Holter ECG in detection of arrhythmias. BMC Cardiovasc Disord. 2014 Apr 1;14:41. doi: 10.1186/1471-2261-14-41.

  PMID: 24690488 BACKGROUND

• Aadland E, Ylvisaker E. Reliability of the Actigraph GT3X+ Accelerometer in Adults under Free-Living Conditions. PLoS One. 2015 Aug 14;10(8):e0134606. doi: 10.1371/journal.pone.0134606. eCollection 2015.

  PMID: 26274586 BACKGROUND

• Van Remoortel H, Giavedoni S, Raste Y, Burtin C, Louvaris Z, Gimeno-Santos E, Langer D, Glendenning A, Hopkinson NS, Vogiatzis I, Peterson BT, Wilson F, Mann B, Rabinovich R, Puhan MA, Troosters T; PROactive consortium. Validity of activity monitors in health and chronic disease: a systematic review. Int J Behav Nutr Phys Act. 2012 Jul 9;9:84. doi: 10.1186/1479-5868-9-84.

  PMID: 22776399 BACKGROUND

• Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

  PMID: 12900694 BACKGROUND

• Polikandrioti M, Koutelekos I, Vasilopoulos G, Gerogianni G, Gourni M, Zyga S, Panoutsopoulos G. Anxiety and Depression in Patients with Permanent Atrial Fibrillation: Prevalence and Associated Factors. Cardiol Res Pract. 2018 Feb 19;2018:7408129. doi: 10.1155/2018/7408129. eCollection 2018.

  PMID: 29670767 BACKGROUND

Related Links

• World Health Organization. WHO guidelines on drawing blood

MeSH Terms

Conditions

Atrial Fibrillation; Motor Activity

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Maria Borland, PhD RPT

  SV Hospital Group, Alingsås hospital Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Randomized controlled multicenter study

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 23, 2020
• Study Start: October 1, 2024
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: January 6, 2025

Record last verified: 2023-10