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The effect of combined exercise training on exercise intolerance and cardiovascular health outcomes in adults living with atrial fibrillation.

Thinking beyond cardiac limitations: determining role of combined exercise training as a treatment option for novel markers of exercise intolerance in adults living with atrial fibrillation.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000922774
Enrollment
38
Registered
2022-06-28
Start date
2022-08-30
Completion date
2025-01-30
Last updated
2022-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to investigate the effect of a combined exercise training program, compared to a sham-placebo control group on skeletal muscle microvascular blood flow and exercise intolerance in adults living with atrial fibrillation. Secondary to this, the study aims to determine the effect of combined exercise training on quality of life, symptom severity and traditional cardiovascular risk factors. It is hypothesised that participants in the combined exercise training group will have an increase in skeletal muscle microvascular blood flow and exercise tolerance when compared to the sham-placebo control. Additionally, those randomised to the combined exercise training group will have an improvement in quality of life, lower symptom severity and improved cardiovascular risk factors.

Interventions

Combined exercise training (CT): For participants randomised to the CT group, exercise training will be completed 3 days per week for 12 weeks (36 sessions), with 2 sessions per week to be completed as group sessions (no more than 4-5 participants per group) face-to-face supervised sessions with an Accredited Exercise Physiologist in the Institute for Physical Activity and Nutrition's (IPAN) exercise lab and gym and 1 session to be performed as an individual unsupervised session at home. The 2 f

Combined exercise training (CT): For participants randomised to the CT group, exercise training will be completed 3 days per week for 12 weeks (36 sessions), with 2 sessions per week to be completed as group sessions (no more than 4-5 participants per group) face-to-face supervised sessions with an Accredited Exercise Physiologist in the Institute for Physical Activity and Nutrition's (IPAN) exercise lab and gym and 1 session to be performed as an individual unsupervised session at home. The 2 face-to-face supervised sessions per week will incorporate both aerobic and resistance training components and the 1 unsupervised session per week will be aerobic training only. Session 18 will involve supervised retesting of cardiorespiratory fitness and muscular strength to modify individual exercise prescriptions due to any changes in fitness levels. All supervised exercise sessions will take 45-60 mins, with all unsupervised MIIT sessions taking 20-30 mins in duration. Moderate-intensity interval training (aerobic training): For the aerobic training component, participants will complete moderate intensity-interval training (MIIT), with a 3 minute warm-up and cool-down to be performed at each session at a light- to moderate-intensity (45-50% HRR, or Borg’s Rating of Perceived Exertion [RPE] of 10-11/20) prior to and immediately following MIIT, respectively. This will involve a gradual increase in intensity during the warm-up and a gradual reduction in intensity during the cool-down to avoid vasovagal events or syncope This will be completed on an aerobic exercise mode of the participant’s choice (e.g. walking, cycling, aerobic stepping, rowing etc.) during supervised and unsupervised sessions. Sessions 1-5: 4x4 minute moderate-intensity intervals (70-75% heart rate reserve [HRR], RPE: “somewhat hard”, 13-14/20), interspersed with 2-minute active recoveries ( or 50-55% HRR or an RPE at “light” exertion, 11-12/20). Sessions 6-11: MIIT will be progressed to 4x5 minute MIIT with 2 minutes of active recoveries at the same prescribed intensities in Sessions 1-5. Sessions 12-17: MIIT will be progressed to 4x5 minute MIIT with 1 minute of active recovery at the same prescribed intensities in Sessions 1-5. Sessions 19-23: will repeat the same exercise prescription of Sessions 1-5, with exercise intensity to be prescribed based off retesting results obtained from Session 18. Sessions 24-29: will repeat the same exercise prescription from Sessions 6-11, with exercise intensity to be prescribed based off retesting results obtained from Session 18. Sessions 30-36: will repeat the same exercise prescription from Sessions 12-17, with exercise intensity to be prescribed based off retesting results obtained from Session 18. Resistance Training: For the resistance training component of the exercise session exercise prescription will follow a “cluster sets” training model which can be defined as a pre-planned rest period between a single or groups (“cluster”) of repetitions within a set. This is in contrast to traditional resistance training whereby all repetitions within a set are completed in succession without a rest period. Participants will complete 6 resistance training exercises: chest press, seated row, leg press, knee extension, shoulder press and biceps curl. All exercises will be performed 3 sets of 8 repetitions at 70% 1RM or an RPE of 13-14/20 with 1 minute of passive recovery between sets. Each cluster will be performed as 2x4 repetitions with 30 seconds passive recovery in-between. Previous research in cardiac population groups like atrial fibrillation have shown that hemodynamic responses (blood pressure responses) to resistance training are significantly lower and within a safe range when performed at lower repetition ranges, than high repetition ranges (>11 repetitions performed consecutively), regardless of the intensity prescribed. The intensity of the exercises will increase every 2 weeks: Week 3-4, 75% 1RM; Week 5-6 80% 1RM; Week 7-8: retested 70% 1RM; Week 9-10: retested 75% 1RM; Week 11-12: retested 80% 1RM. Adherence and compliance to exercise training will be determined by: (i) the completion of number of scheduled sessions attended at the gym as well as Polar HR monitoring data entry for the unsupervised MIIT session; (ii) completing the full duration and intensity of the MIIT component as recorded by HR and RPE; (iii) the number of sets and repetitions completed at the prescribed intensity during the resistance training component.

Sponsors

Deakin University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator)

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

Inclusion criteria: (i) clinical diagnosis of atrial fibrillation as confirmed by a physician with supporting electrocardiogram; (ii) physically inactive (<150 mins exercise per week); (iii) 40-80 years old.

Exclusion criteria

Exclusion criteria: (i) uncontrolled AF (resting heart rate greater than or equal to 110 bpm); (ii) other cardiovascular disease including coronary artery disease or heart valve disease; (iii) pulmonary hypertension; (iv) heart failure or poor ejection fraction ( less than or equal to 50%); (v) critical limb ischemia including peripheral artery disease or previous revascularisation or other surgical treatment for peripheral artery disease; (vi) history of malignancy within past 5 years (except for non-melanoma skin cancers); (vii) uncontrolled hypertension (resting brachial blood pressure greater than or equal to 160/100 mmHg); (viii) Other musculoskeletal conditions and non-cardiovascular barriers to exercise/physical activity; (ix) currently engages in structured exercise or physical activity greater than or equal to 150 minutes per week; (x) successful ablation; (xi) pregnancy/lactation.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026