Atrial Fibrillation ParoxysmalNCT04600713
Physiotherapist-led Exercise Within Cardiac Rehabilitation and Paroxysmal Atrial Fibrillation and COVID-19.
A study testing PT-X and IMT in people with Atrial Fibrillation Paroxysmal, run by Vastra Gotaland Region.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Atrial Fibrillation Paroxysmal
- What is being tested?
- PT-X and IMT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Oct 2028
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Paroxysmal atrial fibrillation verified with electrocardiogram (ECG)
- Left ventricular ejection fraction (EF) ≥ 45% verified by Echocardiography
Who cannot join
- 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.
- Coronary event or angina pectoris within 3 months prior to inclusion
- stroke with residual symptoms
- presence of pacemaker
- No significant valvular lesions verified by Echocardiography.
About this study
Official title: Physiotherapist Led Exercise Within Cardiac Rehabilitation and Inspiratory Muscle Training and Patients With Paroxysmal Atrial Fibrillation - a Randomized Controlled Trial
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.
Read the detailed description
Introduction Paroxysmal atrial fibrillation (AF) induce, in the affected patient an increased risk of stroke and heart failure. The corner stone in the medical treatment for AF is anticoagulants and heartrate regulators which affect the physical fitness. Other interventions available for rhythm regulation such as antiarrhythmic drugs, cardioversion and catheter ablation are alternatives aimed to be relief the symptoms of AF and increase the health-related quality of life (HR-QoL). Despite this advanced pharmacologic- and electrotherapy studies evaluating Patient Related Outcomes measures (PROMs) have shown that the symptoms persist and the HR-QoL is still reduced after treatment. Furthermore, Gleason et al, have recently shown that women have a comparatively higher frequency of symptoms, anxiety and depression despite type of intervention. The majority > 90 %, of the patients with paroxysmal AF have symptoms such as palpitations, chest pain, reduced physical fitness and breathlessness. The unpredictability regarding the source of an AF attack, duration and frequencies causes the patient suffering, high healthcare utilization and increased sick leave, this result in high expenditures for AF related causes both for the patient and society. To avoid physical activity and exercise due to fear of an AF attack is not unusual, which may further lead to a reduced physical fitness i.e maximal oxygen capacity (VO2max) and an increased risk of stroke and mortality. This may lead to an evil circle with additional reduced physical fitness, possibly an increase in symptoms and a more reduced HR-QoL. The underlying causes of reduced physical fitness and breathlessness associated with AF is probably multifactorial. One reason could be skeletal muscle abnormities as in heart failure, which often coexists with AF. An increased mortality in the novel Coronavirus (COVID-19) caused by the SARS-CoV-2 is seen in individuals with older age, cardiovascular disease and in men, and the most usual complication is arrythmia such as AF. COVID-19 is a disease that affect the persons lungs and it is not uncommon with pulmonary complications. This can lead to an increased demand for exercise-based rehabilitation in patients with AF and reduced inspiratory muscle strength. One study has shown that a reduced respiratory muscle function can positively be affected with inspiratory muscle training in patients with permanent AF. Furthermore, a Cochrane report have shown that exercise can improve physical fitness in patients with AF, however, no effect was seen in HR-QoL. However, patients with paroxysmal AF, were underrepresented and additional studies concerning patients with paroxysmal AF are requested. Whether physiotherapist-led exercise-based cardiac rehabilitation (PT-X) and inspiratory muscle training (IMT) can improve physical fitness and positively affect symptoms and consequently improve HR-QoL is to our knowledge not studied.
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. Further to investigate the prevalence of antibodies for SARS-CoV-2, and the patient's own experience of how COVID-19 has affected their incidence and symptoms of paroxysmal AF.
Question formulations:
Primary question How will participation in PT-X and IMT impact the short form SF-36 general health score compared to the control group that is allowed to continue with their usual life? Secondary questions How will participation in PT-X and IMT impact the exercise capacity compared to the control group that is allowed to continue with their usual life? How will participation in PT-X and IMT affect symptoms of AF and fatigue compared to the control group that is allowed to continue with their usual life? How will participation in PT-X and IMT affect the muscle function compared to the control group that is allowed to continue with their usual life? How will participation in PT-X and IMT affect the frequency, duration and number of AF attacks compared to the control group that is allowed to continue with their usual life? How is the incidence of depression among the participants in the study, and is it possible to impact the prevalence of AF with participation in PT-X and IMT compared to the control group that is allowed to continue with their usual life? How has the COVID-19 affected the patient's own experience of number of attacks, symptoms and duration of AF? How is the prevalence of antibodies for SARs-CoV-2 among the participants in the present study? Method Study design A multi-centre randomised controlled trial Patients A total of 180 patients with paroxysmal AF, age 40 - 85 years, visiting the cardiology clinic at SV Hospital group Alingsås Hospital, Sahlgrenska University Hospital and primary care will be asked to participate in the study. Advertising in the daily press will be made for participants with paroxysmal AF. The patients will be informed both verbal and in written information, and a written informed consent will be obtained.
Statistics and power calculation The patients will be randomised stratified after sex, age and exercise capacity measured by the symptom-limited ergometer cycle test. Ratio and interval data will be presented as mean (± 1 SD), ordinal data will be presented as median (range) and nominal data in absolute and relative numbers. Depending on if the data are normal distributed or not the Student T-Test or the Mann-Whitney U- test will be used for evaluation of differences between the groups. Chi2 test will be used for evaluation of differences between the nominal data.
The sample size was calculated using a power (β) of 80% and a significance level of (α) 5%. Based on the assumption of a mean (SD) significant (p=0.05) difference in the PT-X group compared to the control group regarding improvement of SF-36 General Health score of 7.5 ± 15 points a total of 76 patients are needed in each group. Based on the assumption of a calculated withdraw of approximately 20% a total of 180 participants are needed to be included in this study.
- Conditions
- Atrial Fibrillation Paroxysmal
- Being tested
- PT-X and IMT
- Keywords
- Health Related Quality of Life, Exercise, Physiotherapy, Physical Activity
- Medical subject headings
- Atrial Fibrillation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PT-X and IMTOther
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.
| Study group | Role | What they receive |
|---|---|---|
| PT-X and IMT | Experimental | Physiotherapist-led exercise-based cardiac rehabilitation (PT-X) and inspiratory muscle training (IMT). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life
The Swedish version of short form 36 (SF-36) will be used for self-reported HR-QoL.
Measured: Change from baseline at 12 weeks
Secondary outcomes (10)
N-terminal pro-B type natriuretic peptide (NT-proBNP)
Venous blood samples will be obtained according to the European accreditation system.
Measured: At baseline
Antibodies for SARS-CoV-2
Venous blood samples will be obtained investigated with a laboratory method Enzyme- Linked Immunosorbent Assey (ELISA) where antibodies Ig A, Ig G, Ig M will be detected. Due to the fact that the reliability for the laboratory tests to detect antibodies for SARS-CoV-2 is still changing the final decision regarding on which test to use will be made at the start of the study.
Measured: At baseline
Inspiratory and expiratory muscle strength
will be measured with MicroRPM (Micro Medical/Care Fusion, Kent, United Kingdom). The respiratory pressure measures inspiratory and expiratory muscle strength.
Measured: Change from baseline at 12 weeks
Exercise capacity
will be measured by a symptom-limited ergometer cycle test based on World Health Organization (WHO) protocol. The workload begins at 25 W or 50 W depending on the anamnesis. The Watts increase every 4.5 min by 25 W until the patient's rates perceived exertion (RPE) 17 (Very Heavy) on the Borg scale. Unless the patient shows any symptoms or signs that demands an earlier stop at the test. Heart rate and blood pressure are assessed at rest and during the test. If the patient do not surpass the last 4.5 minute the watt will be estimated according to Strandells formula.
Measured: Change from baseline at 12 weeks
Muscle function
will be measured by a muscle endurance test, including the following: A unilateral isoinertial shoulder flexion test assessed with the patient sitting on a stool with their back touching the wall holding a dumbbell in their hand, 2 kg for women and 3 kg for men. The tested arm is elevated to 90º flexion and the arm not tested is placed in the patient's knee. A pace of 40 beats per min is kept by a digital metronome.
Bilateral isometric shoulder abduction is assessed with the patient holding a 1 kg dumbbell in each hand using the same body position as above. The patient is asked to elevate both arms to 90°of shoulder abduction and to maintain this position as long as possible (measured in s).
Unilateral isoinertial heel-lift is assessed with the patients performing as many unilateral heel-lifts as possible, with a straight knee, on a 10° tilted wedge, with shoes on. A pace of 60 beats per minutes is kept is kept by a metronome.
Measured: Change from baseline at 12 weeks
Physical activity
will be measured by an accelerometer (Actigraph® GT3x+, Actigraph, Pensacola, Florida, USA). The accelerometer will be worn throughout the whole day during seven days except when taking a bath or a shower. The accelerometer has showed to be valid and reliable in the adult population.
Measured: Change from baseline at 12 weeks
Self reported physical activity
will be measured by short form International Physical Activity Questionnaire (IPAQ). IPAQ measures physical activity during seven days and total time spent sitting a day. IPAQ is validity and reliability tested in several countries.
Measured: Change from baseline at 12 weeks
Self-reported anxiently and depression
will be measured by the Hospital Axiently and Depression Scale (HADS ).
Measured: Change from baseline at 12 weeks
Handheld ECG heart rhythm
will be measured with a handheld ECG monitor Zenicor-EKG ® (Zenicor Medical Systems AB, Stockholm, Sverige). Zenicor ® has high specificity and sensitivity for detection of sinus rhythm compared to a 24- Holter ECG. Self- reported AF attacks will be logged in a diary.
Measured: Through the study completion, an avarage of 12 weeks
Direct hospital costs related to AF
are calculated as total costs per patient and the patients medical journal in hospital and primary care.
Measured: Through the study completion, an avarage of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study startOct 2024 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionOct 2028 (estimated)
Why it stopped: Due to logistical problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation ParoxysmalStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- 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
- Model description
- Randomized controlled multicenter study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Maria Borland, PhD RPT, Principal investigator, SV Hospital Group, Alingsås hospital Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600713
- Sponsor's protocol ID
- 273293
- Status last verified
- Oct 2023
- First submitted
- 9 Oct 2020
- Last updated
- 6 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27567465Hobbs 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.
PubMed 12445536Zhang 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.
PubMed 24924742Gleason 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.
PubMed 31118198Dorian 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.
PubMed 11028487Hansson 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.
PubMed 15291967Ericson 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.
PubMed 20593297Rohrbacker 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.
PubMed 20357675Rienstra 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.
PubMed 22689930Hussain 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.
PubMed 29221502Ueshima 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.
PubMed 7728799Okita 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.
PubMed 23337207Santhanakrishnan 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.
PubMed 26746177Guzik 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.
PubMed 32352535Ariansen 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.
PubMed 21925054
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiotherapist Led Exercise Within Cardiac Rehabilitation and Inspiratory Muscle Training and Patients With Paroxysmal Atrial Fibrillation - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04600713
- Acronym / sponsor ID
- 273293
- Conditions
- Atrial Fibrillation Paroxysmal
- Keywords
- Health Related Quality of Life, Exercise, Physiotherapy, Physical Activity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to logistical problems
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- Oct 2024 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 23 Oct 2020 (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.
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.
Detailed description
Introduction Paroxysmal atrial fibrillation (AF) induce, in the affected patient an increased risk of stroke and heart failure. The corner stone in the medical treatment for AF is anticoagulants and heartrate regulators which affect the physical fitness. Other interventions available for rhythm regulation such as antiarrhythmic drugs, cardioversion and catheter ablation are alternatives aimed to be relief the symptoms of AF and increase the health-related quality of life (HR-QoL). Despite this advanced pharmacologic- and electrotherapy studies evaluating Patient Related Outcomes measures (PROMs) have shown that the symptoms persist and the HR-QoL is still reduced after treatment. Furthermore, Gleason et al, have recently shown that women have a comparatively higher frequency of symptoms, anxiety and depression despite type of intervention. The majority > 90 %, of the patients with paroxysmal AF have symptoms such as palpitations, chest pain, reduced physical fitness and breathlessness. The unpredictability regarding the source of an AF attack, duration and frequencies causes the patient suffering, high healthcare utilization and increased sick leave, this result in high expenditures for AF related causes both for the patient and society. To avoid physical activity and exercise due to fear of an AF attack is not unusual, which may further lead to a reduced physical fitness i.e maximal oxygen capacity (VO2max) and an increased risk of stroke and mortality. This may lead to an evil circle with additional reduced physical fitness, possibly an increase in symptoms and a more reduced HR-QoL. The underlying causes of reduced physical fitness and breathlessness associated with AF is probably multifactorial. One reason could be skeletal muscle abnormities as in heart failure, which often coexists with AF. An increased mortality in the novel Coronavirus (COVID-19) caused by the SARS-CoV-2 is seen in individuals with older age, cardiovascular disease and in men, and the most usual complication is arrythmia such as AF. COVID-19 is a disease that affect the persons lungs and it is not uncommon with pulmonary complications. This can lead to an increased demand for exercise-based rehabilitation in patients with AF and reduced inspiratory muscle strength. One study has shown that a reduced respiratory muscle function can positively be affected with inspiratory muscle training in patients with permanent AF. Furthermore, a Cochrane report have shown that exercise can improve physical fitness in patients with AF, however, no effect was seen in HR-QoL. However, patients with paroxysmal AF, were underrepresented and additional studies concerning patients with paroxysmal AF are requested. Whether physiotherapist-led exercise-based cardiac rehabilitation (PT-X) and inspiratory muscle training (IMT) can improve physical fitness and positively affect symptoms and consequently improve HR-QoL is to our knowledge not studied.
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. Further to investigate the prevalence of antibodies for SARS-CoV-2, and the patient's own experience of how COVID-19 has affected their incidence and symptoms of paroxysmal AF.
Question formulations:
Primary question How will participation in PT-X and IMT impact the short form SF-36 general health score compared to the control group that is allowed to continue with their usual life? Secondary questions How will participation in PT-X and IMT impact the exercise capacity compared to the control group that is allowed to continue with their usual life? How will participation in PT-X and IMT affect symptoms of AF and fatigue compared to the control group that is allowed to continue with their usual life? How will participation in PT-X and IMT affect the muscle function compared to the control group that is allowed to continue with their usual life? How will participation in PT-X and IMT affect the frequency, duration and number of AF attacks compared to the control group that is allowed to continue with their usual life? How is the incidence of depression among the participants in the study, and is it possible to impact the prevalence of AF with participation in PT-X and IMT compared to the control group that is allowed to continue with their usual life? How has the COVID-19 affected the patient's own experience of number of attacks, symptoms and duration of AF? How is the prevalence of antibodies for SARs-CoV-2 among the participants in the present study? Method Study design A multi-centre randomised controlled trial Patients A total of 180 patients with paroxysmal AF, age 40 - 85 years, visiting the cardiology clinic at SV Hospital group Alingsås Hospital, Sahlgrenska University Hospital and primary care will be asked to participate in the study. Advertising in the daily press will be made for participants with paroxysmal AF. The patients will be informed both verbal and in written information, and a written informed consent will be obtained.
Statistics and power calculation The patients will be randomised stratified after sex, age and exercise capacity measured by the symptom-limited ergometer cycle test. Ratio and interval data will be presented as mean (± 1 SD), ordinal data will be presented as median (range) and nominal data in absolute and relative numbers. Depending on if the data are normal distributed or not the Student T-Test or the Mann-Whitney U- test will be used for evaluation of differences between the groups. Chi2 test will be used for evaluation of differences between the nominal data.
The sample size was calculated using a power (β) of 80% and a significance level of (α) 5%. Based on the assumption of a mean (SD) significant (p=0.05) difference in the PT-X group compared to the control group regarding improvement of SF-36 General Health score of 7.5 ± 15 points a total of 76 patients are needed in each group. Based on the assumption of a calculated withdraw of approximately 20% a total of 180 participants are needed to be included in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled multicenter study
| Arm | Type | Receives |
|---|---|---|
| PT-X and IMT | Experimental | Other: PT-X and IMTPhysiotherapist-led exercise-based cardiac rehabilitation (PT-X) and inspiratory muscle training (IMT). |
| Control | No intervention | –The participants in the control group will be offered PT-X at the end of the control period. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Paroxysmal atrial fibrillation verified with electrocardiogram (ECG)
- Left ventricular ejection fraction (EF) ≥ 45% verified by Echocardiography
Key exclusion criteria (8 listed)
- 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.
- Coronary event or angina pectoris within 3 months prior to inclusion
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 |
|---|---|---|
| PT-X and IMTThe 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. | Other | PT-X and IMT |
Primary outcome
Health-related quality of life
Time frame: Change from baseline at 12 weeks
The Swedish version of short form 36 (SF-36) will be used for self-reported HR-QoL.
10 secondary outcomes
N-terminal pro-B type natriuretic peptide (NT-proBNP)
Time frame: At baseline
Antibodies for SARS-CoV-2
Time frame: At baseline
Inspiratory and expiratory muscle strength
Time frame: Change from baseline at 12 weeks
Exercise capacity
Time frame: Change from baseline at 12 weeks
Muscle function
Time frame: Change from baseline at 12 weeks
Physical activity
Time frame: Change from baseline at 12 weeks
Self reported physical activity
Time frame: Change from baseline at 12 weeks
Self-reported anxiently and depression
Time frame: Change from baseline at 12 weeks
Handheld ECG heart rhythm
Time frame: Through the study completion, an avarage of 12 weeks
Direct hospital costs related to AF
Time frame: Through the study completion, an avarage of 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Background: PubMed 27567465Kirchhof 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.
- Background: PubMed 12445536Hobbs 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.
- Background: PubMed 24924742Zhang 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.
- Background: PubMed 31118198Gleason 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.
- Background: PubMed 11028487Dorian 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.
- Background: PubMed 15291967Hansson 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.
- Background: PubMed 20593297Ericson 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.
- Background: PubMed 20357675Rohrbacker 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.
- Background: PubMed 22689930Rienstra 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.
- Background: PubMed 29221502Hussain 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.
- Background: PubMed 7728799Ueshima 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.
- Background: PubMed 23337207Okita 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.
- World Health Organization. WHO guidelines on drawing bloodLink provided by the sponsor.
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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.
Maria Borland, PhD RPT principal investigator
SV Hospital Group, Alingsås hospital Sweden
Questions about this trial
What is this clinical trial studying?
A study testing PT-X and IMT in people with Atrial Fibrillation Paroxysmal, run by Vastra Gotaland Region.
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 8 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: withdrawn, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Health-related quality of life (time frame: Change from baseline at 12 weeks). 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 NCT04600713, which also lists 27 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 6 Jan 2025.