There is one clinical 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.
Description: The Swedish version of short form 36 (SF-36) will be used for self-reported HR-QoL.Measure: Health-related quality of life Time: Change from baseline at 12 weeks
Description: Venous blood samples will be obtained according to the European accreditation system.Measure: N-terminal pro-B type natriuretic peptide (NT-proBNP) Time: At baseline
Description: 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.Measure: Antibodies for SARS-CoV-2 Time: At baseline
Description: will be measured with MicroRPM (Micro Medical/Care Fusion, Kent, United Kingdom). The respiratory pressure measures inspiratory and expiratory muscle strength.Measure: Inspiratory and expiratory muscle strength Time: Change from baseline at 12 weeks
Description: 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.Measure: Exercise capacity Time: Change from baseline at 12 weeks
Description: 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.Measure: Muscle function Time: Change from baseline at 12 weeks
Description: 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.Measure: Physical activity Time: Change from baseline at 12 weeks
Description: 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.Measure: Self reported physical activity Time: Change from baseline at 12 weeks
Description: will be measured by the Hospital Axiently and Depression Scale (HADS ).Measure: Self-reported anxiently and depression Time: Change from baseline at 12 weeks
Description: 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.Measure: Handheld ECG heart rhythm Time: Through the study completion, an avarage of 12 weeks
Description: are calculated as total costs per patient and the patients medical journal in hospital and primary care.Measure: Direct hospital costs related to AF Time: Through the study completion, an avarage of 12 weeks
Description: 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).Measure: Ejection fraction Time: At baseline
Description: 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).Measure: Left ventricular function Time: At baseline
Description: 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).Measure: Diastolic function Time: At baseline
Data processed on January 01, 2021.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports