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

University Hospital of North Norway15 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Endocarditis Heart Valve Diseases

Interventions

Aerobic interval trainingOTHER

The intervention will start between 7 and 21 days after heart valve surgery. While hospitalized the participants will perform supervised aerobic interval training comprised 4x4 minute, 3 times per week. Intensity will start at 60% of maximum heart rate in the first week, around 13-14 in Borg RPE-Scale. The workload will be gradually increased as the participant tolerance improves, but not above 85% of maximum heart rate or 16-17 in Borg RPE Scale.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (1)

University Hospital of North Norway

Tromsø, Norway

Outcomes

Primary Outcomes

Feasibility of inhospital aerobic interval training

Number of completely finished training sessions will be record.

Time frame: 3 months

Experience with inhospital aerobic inetrval training assessed by semi structured interviews

Semi structured interviews will involve patients opinions on the strengths and weaknesses of the inhospital training intervention.

Time frame: Before discharge

Experience with inhospital aerobic inetrval training assessed by semi structured interviews

Semi structured interviews will involve patients experiences of adopting and following the trainings program at home.

Time frame: 3 months

Secondary Outcomes

Intervention related endpoints 1

Number of training sessions

Time frame: During intervention

Intervention related endpoints 2

Duration of training sessions

Time frame: During intervention

Intervention related endpoints 3

Intensity of training sessions: Speed on the treadmill, bicycel or step box

Time frame: During intervention

Intervention related endpoints 4

Exercise method.

Time frame: During intervention

Patient related endpoints 1

Peak heart rate measured with Apple Watch

Data from ClinicalTrials.gov

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