Endocarditis, Heart Valve Diseases
Conditions
Keywords
Training, Heart valve surgery, Infective endocarditic
Brief summary
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
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.
Interventions
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.
Sponsors
UiT The Arctic University of Norway
Herlev and Gentofte Hospital
Norwegian University of Science and Technology
University Hospital of North Norway
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single centre feasibility study to assess acceptability, compliance, delivery of the intervention and expected effect sizes.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of inhospital aerobic interval training | 3 months | Number of completely finished training sessions will be record. |
| Experience with inhospital aerobic inetrval training assessed by semi structured interviews | Before discharge | Semi structured interviews will involve patients opinions on the strengths and weaknesses of the inhospital training intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intervention related endpoints 2 | During intervention | Duration of training sessions |
| Intervention related endpoints 3 | During intervention | Intensity of training sessions: Speed on the treadmill, bicycel or step box |
| Intervention related endpoints 4 | During intervention | Exercise method. |
| Patient related endpoints 1 | During intervention | Peak heart rate measured with Apple Watch |
| Patient related endpoints 2 | During intervention | Atrial fibrillation episodes will be measured with Apple Watch |
| Intervention related endpoints 1 | During intervention | Number of training sessions |
| 6 minute walk test | 6 minute walk test at 2 weeks | Walking distance (in meters) will be measured with the 6 minute walk test |
| Physical Activity | Physical activity 2 weeks | Axivity AX3 Accelerometers |
| Experience with inhospital aerobic - Questionaire | Before discharge | The questionnaire will contain validated questions from the PasOpp questionnaire along with questions specifically prepared for this study on process and experience outcomes. |
| Patient related endpoints 3 | During intervention | Blood pressure wil be measured before and after training sessions |
| Patient related endpoints 4 | During intervention | Borg RPE-Scale |
| Sub-maximal oxygen uptake | Sub-maximal oxygen uptake at 2 weeks | A graded treadmill test of sub-maximal oxygen uptake using a breath by breath ergospirometer |
Other
| Measure | Time frame | Description |
|---|---|---|
| HeartQOL | Changes from baseline in heart /health-related quality of life at 3 months | Health-related quality of life assessed by The Norwegian version of Heart QOl for patients with coronary heart disease with scale 0-3, where 3= A lot heart problems and 0=No problems |
| New cardiovascular or cerebrovascular incidents. | 3 months | Gathered from participants and their electronic journal system |
| EQ5D-5L | Changes from baseline in health-related quality of life at 3 months | Health status assessed by The Norwegian version of EQ-5D-5L with EQ Visual Analogue scale (EQ VAS) 0-100, where 0=worst health and 100=best health |
Countries
Norway
Outcome results
None listed