University Hospital of North Norway
Tromsø, Norway
NCT Number: NCT05703022
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.
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Notify Me18 year–99 year
All sexes
Interventional
Not applicable
Tromsø, Norway
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 3 months
Number of completely finished training sessions will be record.
Time frame: Before discharge
Semi structured interviews will involve patients opinions on the strengths and weaknesses of the inhospital training intervention.
Time frame: 3 months
Semi structured interviews will involve patients experiences of adopting and following the trainings program at home.
Time frame: During intervention
Number of training sessions
Time frame: During intervention
Duration of training sessions
Time frame: During intervention
Intensity of training sessions: Speed on the treadmill, bicycel or step box
Time frame: During intervention
Exercise method.
Time frame: During intervention
Peak heart rate measured with Apple Watch
Time frame: During intervention
Atrial fibrillation episodes will be measured with Apple Watch
Time frame: During intervention
Blood pressure wil be measured before and after training sessions
Time frame: During intervention
Borg RPE-Scale
Time frame: Sub-maximal oxygen uptake at 2 weeks
A graded treadmill test of sub-maximal oxygen uptake using a breath by breath ergospirometer
Time frame: Sub-maximal oxygen uptake at 3 months
A graded treadmill test of sub-maximal oxygen uptake using a breath by breath ergospirometer
Time frame: 6 minute walk test at 2 weeks
Walking distance (in meters) will be measured with the 6 minute walk test
Time frame: 6 minute walk test at 3 months
Walking distance (in meters) will be measured with the 6 minute walk test
Time frame: Physical activity 2 weeks
Axivity AX3 Accelerometers
Time frame: Physical activity 3 months.
Axivity AX3 Accelerometers
Time frame: 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.
Time frame: 3 months.
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: Physical activity at 2 weeks
Apple Watch
Time frame: Physical activity at 3 months
Apple Watch
Time frame: 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
Time frame: 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
Time frame: 3 months
Gathered from participants and their electronic journal system
University Hospital of North Norway
Other
Early Exercise Training in Patients Following Heart Valve Surgery for Infective Endocarditis. A Feasibility Study.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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