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The effects of different intensity exercise training in patients with ventricular assist devices

The effects of different intensity exercise training on peak oxygen consumption in patients with left ventricular assist devices: a multicentre, randomized, control trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001596493
Acronym
Exercise Training in Ventricular Assist Devices (ETVAD)
Enrollment
21
Registered
2016-11-18
Start date
2016-12-12
Completion date
2020-04-27
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Many heart conditions impair the heart's ability to pump blood. This is known as heart failure. Exercise training is an important component in the management of heart failure, but in severe cases, symptoms such as breathlessness and fatigue limit patients' ability to undertake and benefit from exercise. Left ventricular assist devices (LVADs) are small pumps implanted into the heart of patients with severe heart failure to assist the heart in pumping blood around the body. LVADs reduce symptoms of heart failure, enabling patients to undertake exercise that wasn't previously possible. However, little is known about the most effective form of exercise training in patients with LVADs. This research project will involve an international multicentre randomised controlled trial investigating the effects of a new approach of exercise training in patients with LVADs, involving alternating bouts of moderate and high-intensity exercise. Six weeks after being implanted with a LVAD, participants will be randomised to either 12 weeks of high-intensity interval exercise or 12 weeks of moderate intensity exercise. Before and after the exercise programs, participants will undergo tests to compare the effects of the two exercise programs on fitness, heart and blood vessel function and quality of life. We anticipate the findings of this project will help optimise exercise rehabilitation for people with LVADs and provide information that will help inform exercise prescription in people with cardiovascular disease more generally.

Interventions

High-intensity Interval Training (HIT): This is an intervention of 12-week exercise training program involving high-intensity interval training three times per week. The total duration of each session will be 60 minutes. - The intervention will be delivered by an Exercise Physiologist with minimum 3 years' experience and will be supervised by a multidisciplinary team composed of Senior Exercise Physiologists, Senior Physiotherapists and a Registered Nurse in a hospital-based cardiac rehabilitati

High-intensity Interval Training (HIT): This is an intervention of 12-week exercise training program involving high-intensity interval training three times per week. The total duration of each session will be 60 minutes. - The intervention will be delivered by an Exercise Physiologist with minimum 3 years' experience and will be supervised by a multidisciplinary team composed of Senior Exercise Physiologists, Senior Physiotherapists and a Registered Nurse in a hospital-based cardiac rehabilitation gymnasium. - Sessions in both groups will commence/conclude with a warm-up/cool-down involving 5 minutes of low-intensity aerobic exercise, followed by 5 minutes of stretching. -Following warm up, 4 sets of 4-minute of aerobic exercise on a treadmill at 80-90% of VO2 reserve, interspersed with 3-minute intervals of active recovery at 50-60% of VO2 reserve. -Resistance exercises, involving one set of 3 lower body (dual leg press, dual seated hamstring curl, dual leg extension) and 3 upper body exercises (incline press, lat pull down and biceps curl) at 50-75% of one-repetition maximum.. -The exercise training program will be reviewed every fortnight during the course of the intervention to adapt the exercise prescription for cardiopulmonary and strength changes. - Adherence to exercise training program will be monitored at the cardiac rehabilitation gym on a daily basis, with exercise attendance log and mobile call for follow up in case of non-attendance. Compliance will be set as 90% adherence to the established exercise training program.

Sponsors

Curtin University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

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

Inclusion criteria

- New York Heart Association (NYHA) Class III-IV chronic heart failure with left ventricular systolic dysfunction. - At least 6 weeks post implantation with a continuous-flow LVAD (Heartware, HeartMate II/III) - Haemodynamic stability.

Exclusion criteria

- Any major co-morbidities that preclude exercise testing or training. - Ventricular assist device complications including clotting, serious drive-line or systemic infections or mechanical problems.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 26, 2026