Physiotherapist-led Exercise Within Cardiac Rehabilitation and Paroxysmal Atrial Fibrillation and COVID-19.
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|ClinicalTrials.gov Identifier: NCT04600713|
Recruitment Status : Not yet recruiting
First Posted : October 23, 2020
Last Update Posted : April 1, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Paroxysmal||Other: PT-X and IMT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized controlled multicenter study|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Physiotherapist Led Exercise Within Cardiac Rehabilitation and Inspiratory Muscle Training and Patients With Paroxysmal Atrial Fibrillation - a Randomized Controlled Trial|
|Estimated Study Start Date :||September 2021|
|Estimated Primary Completion Date :||August 2025|
|Estimated Study Completion Date :||October 2025|
Experimental: PT-X and IMT
Physiotherapist-led exercise-based cardiac rehabilitation (PT-X) and inspiratory muscle training (IMT).
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.
No Intervention: Control
The participants in the control group will be offered PT-X at the end of the control period.
- 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.
- N-terminal pro-B type natriuretic peptide (NT-proBNP) [ Time Frame: At baseline ]Venous blood samples will be obtained according to the European accreditation system.
- Antibodies for SARS-CoV-2 [ Time Frame: At baseline ]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.
- Inspiratory and expiratory muscle strength [ Time Frame: Change from baseline at 12 weeks ]will be measured with MicroRPM (Micro Medical/Care Fusion, Kent, United Kingdom). The respiratory pressure measures inspiratory and expiratory muscle strength.
- Exercise capacity [ Time Frame: Change from baseline at 12 weeks ]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.
- Muscle function [ Time Frame: Change from baseline at 12 weeks ]
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.
- Physical activity [ Time Frame: Change from baseline at 12 weeks ]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.
- Self reported physical activity [ Time Frame: Change from baseline at 12 weeks ]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.
- Self-reported anxiently and depression [ Time Frame: Change from baseline at 12 weeks ]will be measured by the Hospital Axiently and Depression Scale (HADS ).
- Handheld ECG heart rhythm [ Time Frame: Through the study completion, an avarage of 12 weeks ]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.
- Direct hospital costs related to AF [ Time Frame: Through the study completion, an avarage of 12 weeks ]are calculated as total costs per patient and the patients medical journal in hospital and primary care.
- Ejection fraction [ Time Frame: At baseline ]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).
- Left ventricular function [ Time Frame: At baseline ]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).
- Diastolic function [ Time Frame: At baseline ]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).
- Valvular screening [ Time Frame: At baseline ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04600713
|Contact: Maria Borland, PhD RPTfirstname.lastname@example.org|
|Contact: Åsa Cider, PhD RPTemail@example.com|
|Principal Investigator:||Maria Borland, PhD RPT||SV Hospital Group, Alingsås hospital Sweden|