Exercise Training in Patients With Persistent or Permanent Atrial Fibrillation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: standard care + moderate-intensity continuous exercise training, standard care + high-intensity interval training.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Exercise Training in Patients With Persistent or Permanent Atrial Fibrillation - a Multi-centre Randomized Controlled Trial
Overview
The main purpose of this project is to evaluate the effects of high-intensity interval training (HIIT) compared to moderate-intensity continuous exercise training (MICE) and standard care on exercise capacity and quality of life in patients with persistent or permanent atrial fibrillation. Positive findings are vitally important for these patients, given the condition's substantial morbidity, mortality and high economic costs.
Detailed description
Recommended standards of care do not include the prescription of exercise to target and ameliorate the progressive health decline and overall feeling of well-being in patients with atrial fibrillation. Recent Standards for the Provision of Cardiac Rehabilitation of Ontario are calling for the consideration for referral and enrollment of patients with atrial fibrillation in cardiovascular rehabilitation - evidence is needed to support and confirm these efforts. The main purpose of this project is to evaluate the effects of high-intensity interval training (HIIT) compared to moderate-intensity continuous exercise training (MICE) and standard care on exercise capacity and quality of life in patients with persistent or permanent atrial fibrillation. Positive results from this study will identify a new intervention that: produces important improvements in patient-rated clinical, behavioural and exercise outcomes; provides mechanistic insight into the role of exercise training in the management of atrial fibrillation; requires minimal equipment; and, is appealing to patients with atrial fibrillation.
Interventions
- Behavioral standard care + moderate-intensity continuous exercise training
Participants will attend on-site moderate-intensity continuous exercise training two times weekly for 12 weeks. - Behavioral standard care + high-intensity interval training
Participants will attend on-site high-intensity interval training two times weekly for 12 weeks.
Primary outcome measures
- Changes in quality of life measured by the physical component summary (PCS) measure of the Short Form 36 Health Survey Questionnaire (SF-36). [Time frame: baseline to 12 weeks]
- Changes in exercise capacity measured by VO2peak on a symptom-limited cardiopulmonary exercise test (CPET). [Time frame: baseline to 12 weeks]
Secondary outcome measures (11)
- Changes atrial fibrillation specific quality of life measured by the Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT). [Time frame: baseline to 12 weeks]
- Changes atrial fibrillation specific quality of life measured by the University of Toronto Atrial Fibrillation Severity Scale (AFSS). [Time frame: baseline to 12 weeks]
- Changes in symptom burden measured by the Canadian Cardiovascular Society Severity of Atrial Fibrillation Scale. [Time frame: baseline to 12 weeks]
- Changes in quality of life measured by the mental component summary (MCS) measure of the Short Form 36 Health Survey Questionnaire (SF-36). [Time frame: baseline to 12 weeks]
- Changes in heart rate control measured by 24-hour Holter ECG recordings and ECG recordings at each CPET. [Time frame: baseline to 12 weeks]
- Changes in lower body muscular fitness measured by standard load tests. [Time frame: baseline to 12 weeks]
- Changes in volume and intensity of exercise measured directly by accelerometer. [Time frame: baseline to 12 weeks]
- Changes in volume and intensity of exercise measured by self-report (exercise logs). [Time frame: baseline to 12 weeks]
- Changes in self-reported symptom frequency and severity measured by the 7-day symptom diary. [Time frame: baseline to 12 weeks]
- Changes in self reported sleep patterns measured by the 7-day sleep diary. [Time frame: baseline to 12 weeks]
- Changes in blood biomarker concentrations (participants at the University of Ottawa Heart Institute site only). [Time frame: baseline to 12 weeks]
Eligibility criteria
Inclusion criteria
- persistent or permanent atrial fibrillation;
- rate controlled with a resting ventricular rate of equal to or less than 100 bpm;
- able to perform a symptom-limited exercise test;
- at least 40 years of age (i.e. participants must be 40 years or older);
Exclusion criteria
- currently participating in routine exercise training (more than two times per week);
- unstable angina;
- diagnosed severe mitral or aortic stenosis;
- diagnosed hypertrophic obstructive cardiomyopathy with significant obstruction;
- pregnant, lactating or planning to become pregnant during the study period;
- unable to provide written, informed consent, or
- unwilling or unable to return for follow up at week 12.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
Canada · 2 centers
- London Health Sciences Network — London
- University of Ottawa Heart Insititue — Ottawa
Identifiers
NCT: NCT03397602 · 0906