Clinical trial NCT03397602: Exercise Training in Patients With Persistent or Permanent Atrial Fibrillation
Official title: Exercise Training in Patients With Persistent or Permanent Atrial Fibrillation - a Multi-centre Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
exercise
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2018-01-12
Enrollment: 132
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. persistent or permanent atrial fibrillation;
2. rate controlled with a resting ventricular rate of equal to or less than 100 bpm;
3. able to perform a symptom-limited exercise test;
4. at least 40 years of age (i.e. participants must be 40 years or older);

Exclusion Criteria:

1. currently participating in routine exercise training (more than two times per week);
2. unstable angina;
3. diagnosed severe mitral or aortic stenosis;
4. diagnosed hypertrophic obstructive cardiomyopathy with significant obstruction;
5. pregnant, lactating or planning to become pregnant during the study period;
6. unable to provide written, informed consent, or
7. unwilling or unable to return for follow up at week 12.

Primary outcomes:
measure: Changes in quality of life measured by the physical component summary (PCS) measure of the Short Form 36 Health Survey Questionnaire (SF-36).
timeFrame: baseline to 12 weeks
measure: Changes in exercise capacity measured by VO2peak on a symptom-limited cardiopulmonary exercise test (CPET).
timeFrame: baseline to 12 weeks
Secondary outcomes:
measure: Changes atrial fibrillation specific quality of life measured by the Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT).
timeFrame: baseline to 12 weeks
measure: Changes atrial fibrillation specific quality of life measured by the University of Toronto Atrial Fibrillation Severity Scale (AFSS).
timeFrame: baseline to 12 weeks
measure: Changes in symptom burden measured by the Canadian Cardiovascular Society Severity of Atrial Fibrillation Scale.
timeFrame: baseline to 12 weeks
measure: Changes in quality of life measured by the mental component summary (MCS) measure of the Short Form 36 Health Survey Questionnaire (SF-36).
timeFrame: baseline to 12 weeks
measure: Changes in heart rate control measured by 24-hour Holter ECG recordings and ECG recordings at each CPET.
timeFrame: baseline to 12 weeks
measure: Changes in lower body muscular fitness measured by standard load tests.
timeFrame: baseline to 12 weeks
measure: Changes in volume and intensity of exercise measured directly by accelerometer.
timeFrame: baseline to 12 weeks
measure: Changes in volume and intensity of exercise measured by self-report (exercise logs).
timeFrame: baseline to 12 weeks
measure: Changes in self-reported symptom frequency and severity measured by the 7-day symptom diary.
timeFrame: baseline to 12 weeks
measure: Changes in self reported sleep patterns measured by the 7-day sleep diary.
timeFrame: baseline to 12 weeks
measure: Changes in blood biomarker concentrations (participants at the University of Ottawa Heart Institute site only).
timeFrame: baseline to 12 weeks
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Network
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Heart Insititue
state: Ontario
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Jennifer L Reed, PhD
role: PRINCIPAL_INVESTIGATOR
References: