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| Name | Class |
|---|---|
| UiT The Arctic University of Norway | OTHER |
| Herlev and Gentofte Hospital | OTHER |
| Norwegian University of Science and Technology | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early exercise training | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic interval training | Other | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention related endpoints 1 | Number of training sessions | During intervention |
| Intervention related endpoints 2 | Duration of training sessions |
| Measure | Description | Time Frame |
|---|---|---|
| HeartQOL | 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 | Changes from baseline in heart /health-related quality of life at 3 months |
| EQ5D-5L |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gyrd Thrane, PhD | UiT The Arctic University of Norway | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of North Norway | Tromsø | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42116217 | Derived | Muller M, Hanssen TA, Johansen D, Jakobsen O, Pedersen JE, Aksetoy ILA, Rasmussen TB, Hartvigsen G, Skogen V, Henriksen A, Thrane G. Feasibility of early interval training in patients recovering from heart valve surgery due to infective endocarditis. Pilot Feasibility Stud. 2026 May 12;12(1):93. doi: 10.1186/s40814-026-01830-w. |
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| ID | Term |
|---|---|
| D004696 | Endocarditis |
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Single centre feasibility study to assess acceptability, compliance, delivery of the intervention and expected effect sizes.
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| 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 |
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 |
| Changes from baseline in health-related quality of life at 3 months |
| New cardiovascular or cerebrovascular incidents. | Gathered from participants and their electronic journal system | 3 months |