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

Atrial Fibrillation Paroxysmal Clinical Trial

Official title:

Physiotherapist Led Exercise Within Cardiac Rehabilitation and Inspiratory Muscle Training and Patients With Paroxysmal Atrial Fibrillation - a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04600713
• Other study ID #: 273293
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2024
• Est. completion date: October 2028

Study information

• Verified date: October 2023
• Source: Vastra Gotaland Region
• Contact: Maria Borland, PhD RPT
• Phone: +46700816894
• Email: maria.borland[@]vgregion.se
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: October 2028
• Est. primary completion date: August 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• Paroxysmal atrial fibrillation verified with electrocardiogram (ECG)

• Left ventricular ejection fraction (EF) = 45% verified by Echocardiography

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation Paroxysmal

Intervention

Other:
• PT-X and IMT
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

References & Publications (27)

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* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ejection fraction	Will be investigated will be examined during sinus rhythm with a two -dimensional, Doppler echocardiography (Vidid 7 and Vivid E9, GE Medical systems, Horten, Norway).	At baseline
Other	Left ventricular function	Will be investigated will be examined during sinus rhythm with a two -dimensional, Doppler echocardiography (Vidid 7 and Vivid E9, GE Medical systems, Horten, Norway).	At baseline
Other	Diastolic function	Will be investigated will be examined during sinus rhythm with a two -dimensional, Doppler echocardiography (Vidid 7 and Vivid E9, GE Medical systems, Horten, Norway).	At baseline
Other	Valvular screening	Will be investigated will be examined during sinus rhythm with a two -dimensional, Doppler echocardiography (Vidid 7 and Vivid E9, GE Medical systems, Horten, Norway).	At baseline
Primary	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	N-terminal pro-B type natriuretic peptide (NT-proBNP)	Venous blood samples will be obtained according to the European accreditation system.	At baseline
Secondary	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.	At baseline
Secondary	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.	Change from baseline at 12 weeks
Secondary	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.	Change from baseline at 12 weeks
Secondary	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.	Change from baseline at 12 weeks
Secondary	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.	Change from baseline at 12 weeks
Secondary	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.	Change from baseline at 12 weeks
Secondary	Self-reported anxiently and depression	will be measured by the Hospital Axiently and Depression Scale (HADS ).	Change from baseline at 12 weeks
Secondary	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.	Through the study completion, an avarage of 12 weeks
Secondary	Direct hospital costs related to AF	are calculated as total costs per patient and the patients medical journal in hospital and primary care.	Through the study completion, an avarage of 12 weeks

External Links

•   World Health Organization. WHO guidelines on drawing blood