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

Study Overview
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Brief Summary
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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.

Detailed Description
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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: How is aerobic interval training experienced by patients with IE after heart-valve surgery? 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.

Official Title
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Early Exercise Training in Patients Following Heart Valve Surgery for Infective Endocarditis. A Feasibility Study.

Conditions
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Heart Valve Diseases, Endocarditis

Intervention / Treatment
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* Other: Aerobic interval training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single centre feasibility study to assess acceptability, compliance, delivery of the intervention and expected effect sizes.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early exercise training<br>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. | Other: Aerobic interval training<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of inhospital aerobic interval training | Number of completely finished training sessions will be record. | 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. | 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention related endpoints 1 | Number of training sessions | During intervention | 
| Intervention related endpoints 2 | Duration of training sessions | During intervention | 
| Intervention related endpoints 3 | Intensity of training sessions: Speed on the treadmill, bicycel or step box | During intervention | 
| Intervention related endpoints 4 | Exercise method. | During intervention | 
| Patient related endpoints 1 | Peak heart rate measured with Apple Watch | During intervention | 
| Patient related endpoints 2 | Atrial fibrillation episodes will be measured with Apple Watch | During intervention | 
| Patient related endpoints 3 | Blood pressure wil be measured before and after training sessions | During intervention | 
| Patient related endpoints 4 | Borg RPE-Scale | During intervention | 
| Sub-maximal oxygen uptake | A graded treadmill test of sub-maximal oxygen uptake using a breath by breath ergospirometer | Sub-maximal oxygen uptake at 2 weeks | 
| Sub-maximal oxygen uptake | A graded treadmill test of sub-maximal oxygen uptake using a breath by breath ergospirometer | Sub-maximal oxygen uptake at 3 months | 
| 6 minute walk test | Walking distance (in meters) will be measured with the 6 minute walk test | 6 minute walk test at 2 weeks | 
| 6 minute walk test | Walking distance (in meters) will be measured with the 6 minute walk test | 6 minute walk test at 3 months | 
| Physical Activity | Axivity AX3 Accelerometers | Physical activity 2 weeks | 
| Physical Activity | Axivity AX3 Accelerometers | Physical activity 3 months. | 
| Experience with inhospital aerobic - Questionaire | The questionnaire will contain validated questions from the PasOpp questionnaire along with questions specifically prepared for this study on process and experience outcomes. | Before discharge | 
| Experience with inhospital aerobic - Questionaire | The questionnaire will contain validated questions from the PasOpp questionnaire along with questions specifically prepared for this study on process and experience outcomes. | 3 months. | 
| Physical Activity | Apple Watch | Physical activity at 2 weeks | 
| Physical Activity | Apple Watch | Physical activity at 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Training, Heart valve surgery, Infective endocarditic