An interventional study of Aerobic interval training in Endocarditis and Heart Valve Diseases, sponsored by University Hospital of North Norway. Completed at 1 site in Norway. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-04-03.
Sponsored by University Hospital of North Norway · Not applicable, Interventional, and Treatment
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.
173 studies on the registry are indexed under Endocarditis; 57 are open to participants now.
This study's enrollment of 15 is below the median of 92 across 86 interventional studies indexed under Endocarditis.
Browse Endocarditis studies →University Hospital of North Norway is the lead sponsor of 152 studies on the registry; 24 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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
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
Time frame: During intervention
Patient related endpoints 2
Atrial fibrillation episodes will be measured with Apple Watch
Time frame: During intervention
Patient related endpoints 3
Blood pressure wil be measured before and after training sessions
Time frame: During intervention
Patient related endpoints 4
Borg RPE-Scale
Time frame: During intervention
Sub-maximal oxygen uptake
A graded treadmill test of sub-maximal oxygen uptake using a breath by breath ergospirometer
Time frame: 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
Time frame: Sub-maximal oxygen uptake at 3 months
6 minute walk test
Walking distance (in meters) will be measured with the 6 minute walk test
Time frame: 6 minute walk test at 2 weeks
6 minute walk test
Walking distance (in meters) will be measured with the 6 minute walk test
Time frame: 6 minute walk test at 3 months
Physical Activity
Axivity AX3 Accelerometers
Time frame: Physical activity 2 weeks
Physical Activity
Axivity AX3 Accelerometers
Time frame: 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.
Time frame: 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.
Time frame: 3 months.
Physical Activity
Apple Watch
Time frame: Physical activity at 2 weeks
Physical Activity
Apple Watch
Time frame: Physical activity at 3 months
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
Time frame: Changes from baseline in heart /health-related quality of life at 3 months
EQ5D-5L
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
Time frame: 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
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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