Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000734561
Ethics application status
Approved
Date submitted
3/07/2015
Date registered
16/07/2015
Date last updated
25/10/2021
Date data sharing statement initially provided
19/09/2019
Date results information initially provided
25/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A Lifestyle-based, PhysiCal AcTIVity IntErvention for Patients With Symptomatic Atrial Fibrillation (the ACTIVE-AF Study).
Scientific title
A comparison of a lifestyle-based physical activity intervention with usual care on arrhythmia burden and symptom severity in patients with atrial fibrillation.
Secondary ID [1] 287040 0
None
Universal Trial Number (UTN)
Trial acronym
ACTIVE-AF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 295510 0
Condition category
Condition code
Cardiovascular 295772 295772 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The physical activity intervention is designed to increase physical activity towards a weekly target of 210 minutes of moderate-intensity (Rating of Perceived Exertion <14 or <75% Heart rate reserve) physical activity. Vigorous activity (Rating of Perceived Exertion >14 or >75% Heart rate reserve), such as running may be used to substitute moderate activity at a ratio of 1:2 (i.e. 10 minutes of vigorous activity would equate to 20 minutes of moderate activity). This level of activity exceeds the American Heart Association Physical Activity guidelines (Haskell et al., 2007). The rationale for this intervention is based on the LOOK AHEAD study in which a target of 200 minutes per week was used, resulting in significant weight loss and improvements in cardiorespiratory fitness and traditional cardiovascular risk factors (Jakicic et al., 2009; Wing et al., 2013). The incremental benefit on health with a higher exercise dose is also supported by large epidemiological studies (Wen et al., 2012, Lancet).
The program includes a weekly, 45-minute individual session (0-3 months) with an exercise physiologist (Dr Elliott), decreasing to fortnightly from 3-6 months. Within each session, participants will undertake supervised exercise training, discuss strategies to improve weekly PA and goal setting will be agreed between the health professional and the patient. Patients will maintain a journal detailing their physical activity and exercise habits. If required, additional sessions will be scheduled. 24-hour telephone and email support will be accessible to the patient. Participants will be asked to maintain a food diary and to adopt a diet consisting of high protein, low glycemic index foods.
Intervention code [1] 292251 0
Lifestyle
Intervention code [2] 292304 0
Treatment: Other
Intervention code [3] 292305 0
Behaviour
Comparator / control treatment
A usual care control group will be issued with written advice regarding physical activity and nutrition at commencement of their participation in the study. Patients in the usual care group will receive risk factor management at the discretion of their treating physician. All other medical care will continue as per best-practice guidelines
Control group
Active

Outcomes
Primary outcome [1] 295479 0
AF Burden determined by 12-lead ECG, 48-hour Holter monitoring and a smartphone ECG device for home use. Episodes of AF lasting >30s will be classified as an AF occurrence. The number of patients free from arrhythmia at follow-up will be recorded.
Timepoint [1] 295479 0
Baseline, Post-intervention, 3, 6, and 12 months post intervention
Primary outcome [2] 295530 0
AF Symptom Burden & Severity: The University of Toronto Atrial Fibrillation Severity Scale (AFSS) used previously by our group (Abed et al., 2013; Pathak et al., 2014) will be used to determine symptom burden (episode frequency, duration) and severity at baseline and throughout follow-up. This questionnaire also provides an index of quality of life.
Timepoint [2] 295530 0
Baseline, Post-intervention, 3, 6, and 12 months post intervention
Secondary outcome [1] 315665 0
Cardiorespiratory Fitness (CRF): Cardiorespiratory fitness will be determined using cardiopulmonary exercise testing on a treadmill using the Balke protocol. Patients will breathe through a facemask connected to an Oxycon Mobile CPX for the determination of oxygen consumption, carbon dioxide production and minute ventilation. Cardiorespiratory fitness will be quantified by the peak oxygen consumption achieved during a maximal stress test. Heart rate and blood pressure will be recorded throughout the test.
Timepoint [1] 315665 0
Baseline, Post-intervention, 3, 6, and 12 months post intervention
Secondary outcome [2] 315666 0
Cardiac Structure & Function: Composite outcome assessed using transthoracic echocardiographic measures of left and right atrial size, ventricular dimensions, ventricular hypertrophy, systolic function and diastolic function, including measurements of strain and torsion.
Timepoint [2] 315666 0
Baseline, Post-intervention, 3, 6, and 12 months post intervention
Secondary outcome [3] 315667 0
Cardiovascular Risk Factors: Composite outcome of blood pressure, blood lipids (triglycerides, LDL-C, HDL-C) and glycated haemoglobin (HbA1c) will be quantified by venous sampling. Body mass and height will be measured to determine body mass index. Waist circumference will be measured according to standardised methods.
Timepoint [3] 315667 0
Baseline, Post-intervention, 3, 6, and 12 months post intervention
Secondary outcome [4] 315668 0
Inflammation, assessed by composite outcome of of high-sensitivity C-reactive protein (hs-CRP) and Tumour Necrosis Factor Alpha (TNF-a) from venous blood.
Timepoint [4] 315668 0
Baseline, Post-intervention, 3, 6, and 12 months post intervention
Secondary outcome [5] 315669 0
Composite outcome of platelet aggregation & thrombotic markers: Given the relationship between AF and embolic stroke, we will quantify circulating thrombotic (fibrinogen, plasminogen activator inhibitor 1) and fibrinolytic markers (tissue-plasminogen activator) and 2) platelet aggregation from venous blood samples collected at specified timepoints.
Timepoint [5] 315669 0
Baseline, Post-intervention, 3, 6, and 12 months post intervention
Secondary outcome [6] 315785 0
Profibrotic Markers: Composite outcome of Tissue Growth Factor (TGF-ß) and matrix metalloproteinase-9 (MMP-9) will be quantified as markers of fibrosis.
Timepoint [6] 315785 0
Baseline, Post-intervention, 3, 6 and 12 months post-intervention

Eligibility
Key inclusion criteria
- Symptomatic Paroxysmal or Persistent AF
- Aged >18 years and <80 years
- Current physical activity levels <60 minutes per week.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Previous AF ablation
- Permanent AF
- History of myocardial infarction or cardiac surgery in past 12 months.
- Autoimmune or systemic inflammatory disease.
- Decompensated heart failure.
- Unable to exercise due to an existing musculoskeletal disorder.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/08/2015
Actual
4/11/2015
Date of last participant enrolment
Anticipated
20/12/2019
Actual
20/12/2019
Date of last data collection
Anticipated
Actual
20/12/2020
Sample size
Target
120
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 291594 0
University
Name [1] 291594 0
Centre for Heart Rhythm Disorders
Country [1] 291594 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
University of Adelaide
North Terrace
Adelaide
South Australia, 5005
Country
Australia
Secondary sponsor category [1] 290266 0
Hospital
Name [1] 290266 0
Royal Adelaide Hospital
Address [1] 290266 0
North Terrace
Adelaide
South Australia
5000
Country [1] 290266 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293125 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 293125 0
Research Governance Office
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Ethics committee country [1] 293125 0
Australia
Date submitted for ethics approval [1] 293125 0
Approval date [1] 293125 0
02/07/2015
Ethics approval number [1] 293125 0
HREC/15/RAH/227

Summary
Brief summary
We have recently shown that increasing fitness improves arrhythmia outcomes in patients with atrial fibrillation, a common heart rhythm disorder. In this study, we intend to evaluate a goal-directed, lifestyle based physical activity intervention for the reduction of AF burden and symptom severity. We hypothesise that our physical activity intervention will lower arrhythmia burden and improve symptom severity when compared to standard medical care alone.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58582 0
Prof Prashanthan Sanders
Address 58582 0
Centre for Heart Rhythm Disorders, Cardiovascular Investigation Unit, Royal Adelaide Hospital, North Terrace, Adelaide
South Australia, 5000
Country 58582 0
Australia
Phone 58582 0
+61 8 8222 2723
Fax 58582 0
Email 58582 0
prash.sanders@adelaide.edu.au
Contact person for public queries
Name 58583 0
Dr Adrian Elliott
Address 58583 0
Centre for Heart Rhythm Disorders, Cardiovascular Investigation Unit, Royal Adelaide Hospital, North Terrace, Adelaide
South Australia, 5000
Country 58583 0
Australia
Phone 58583 0
+61 8 8222 2723
Fax 58583 0
Email 58583 0
adrian.elliott@adelaide.edu.au
Contact person for scientific queries
Name 58584 0
Dr Adrian Elliott
Address 58584 0
Centre for Heart Rhythm Disorders, Cardiovascular Investigation Unit, Royal Adelaide Hospital, North Terrace, Adelaide
South Australia, 5000
Country 58584 0
Australia
Phone 58584 0
+61 8 8222 2723
Fax 58584 0
Email 58584 0
adrian.elliott@adelaide.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseInfluence of sex on efficacy of exercise training for patients with symptomatic atrial fibrillation: insights from the ACTIVE-AF randomized controlled trial.2023https://dx.doi.org/10.1093/eurjpc/zwad242
EmbaseAn Exercise and Physical Activity Program in Patients With Atrial Fibrillation: The ACTIVE-AF Randomized Controlled Trial.2023https://dx.doi.org/10.1016/j.jacep.2022.12.002
N.B. These documents automatically identified may not have been verified by the study sponsor.