Early Exercise Training in Patients Following Heart Valve Surgery for Infective Endocarditis.

University Hospital of North Norway

Status: Completed

Conditions: Heart Valve Diseases; Endocarditis

Treatments: Other: Aerobic interval training

Study type: Interventional

Funder types: Other

Identifiers

NCT05703022

Interventional (Other Identifier)

Details and patient eligibility

About

A prospective, interventional, single-group, single centre study to evaluate the feasibility of early aerobic exercise training in patients following heart valve surgery for infective endocarditis.

Full description

Infective endocarditis (IE)is uncommon, but people with some heart conditions have a greater risk of developing it. Well designed studies have shown that the majority of the IE population have low physical function and many are inactive. This is negative for their health and well-being. High-intensity aerobic interval training has shown to be beneficial in patients with other cardiovascular disorders. Presumably, patients with IE also benefit from such treatment, but the optimal training mode,intensity, frequency and duration to improve aerobic capacity are not clear. This study will explore how aerobic interval training supported by smartwatch may contribute to the physical activity after infective endocarditis . Throughout the project, investigators will explore opportunities and barriers for supervised individualised exercise training for IE patients that has been treated with heart valve surgery.

The primary objective is to explore how early aerobic interval training can be safely performed and accepted in patients with infective endocarditis after heart valve surgery. The two main research questions are:

1. How is aerobic interval training experienced by patients with IE after heart-valve surgery?
2. Can aerobic interval training with smartwatch support be accepted and safely performed by patients who have undergone endocarditis and left-sided heart-valve surgery?

The study is a single centre feasibility study, at the University Hospital of North Norway in Tromsø .The study duration from the first assessment of the first patient to the last assesment of the last patient: 24 months. The in-hospital training intervention for each patient will start between 7 and 21 days after the heart valve surgery and continue in university or local hospital for 3 months.

Investigators will recruit between 10 and 20 participants from the University Hospital of North Norway.

Enrollment: 15 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• (1)patients presenting with confirmed infectious endocarditis, with left-sided heart valve surgery and without arterial embolus,
• (2)being residents of Northern Norway,
• (3)willing and able to give informed consent 4-21 days after the heart valve surgery.

Exclusion criteria

• (1)patients who are hemodynamically or respiratory unstable, have temperature > 38 or positive blood cultures
• (2)clinically significant serious concurrents medical condition such as premorbid illnesses and other concurrens serious infection which could affect the safety or tolerability of the intervention
• (3)clinically significant concurrens musculoskeletal disorder or other concurrent disease or injury that may inhibit physical activity.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Early exercise training

Experimental group

Description:

Supervised aerobic interval training (uphill treadmill walking or cycling on an exercise bike 4x4 min at 65-85% of peak heart rate) 3 times weekly.

Treatment:

Other: Aerobic interval training