Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04600713
Recruitment Status : Not yet recruiting
First Posted : October 23, 2020
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Vastra Gotaland Region

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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Paroxysmal Other: PT-X and IMT Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled multicenter study
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


  6. 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.

  7. 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.

  8. Self-reported anxiently and depression [ Time Frame: Change from baseline at 12 weeks ]
    will be measured by the Hospital Axiently and Depression Scale (HADS ).

  9. 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.

  10. 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.


Other Outcome Measures:
  1. 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).

  2. 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).

  3. 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).

  4. Valvular screening [ 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The patients are randomized stratified to age, gender and exercise capacity measured by the symptom-limited ergometer cycle test.
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Maria Borland, PhD RPT +46700816894 maria.borland@vgregion.se
Contact: Åsa Cider, PhD RPT +46722224515 asa.cider@neuro.gu.se

Sponsors and Collaborators
Vastra Gotaland Region
Investigators
Layout table for investigator information
Principal Investigator: Maria Borland, PhD RPT SV Hospital Group, Alingsås hospital Sweden
Additional Information:
Publications:
Borg G. Borg's perceived exertion and pain scales. Leeds: Human Kinetics; 1998.

Layout table for additonal information
Responsible Party: Vastra Gotaland Region
ClinicalTrials.gov Identifier: NCT04600713    
Other Study ID Numbers: 273293
First Posted: October 23, 2020    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: October 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vastra Gotaland Region:
Health Related Quality of Life
Exercise
Physiotherapy
Physical Activity
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes