Early Exercise Training in Patients Following Heart Valve Surgery for Infective Endocarditis.
- Conditions
- EndocarditisHeart Valve Diseases
- Interventions
- Other: Aerobic interval training
- Registration Number
- NCT05703022
- Lead Sponsor
- University Hospital of North Norway
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- (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.
- (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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Early exercise training Aerobic interval training 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.
- Primary Outcome Measures
Name Time Method 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 3 months Semi structured interviews will involve patients experiences of adopting and following the trainings program at home.
- Secondary Outcome Measures
Name Time Method Patient related endpoints 4 During intervention Borg RPE-Scale
Physical Activity Physical activity at 3 months Apple Watch
Intervention related endpoints 2 During intervention Duration of training sessions
Patient related endpoints 3 During intervention Blood pressure wil be measured before and after training sessions
Intervention related endpoints 1 During intervention Number of training sessions
Intervention related endpoints 4 During intervention Exercise method.
Patient related endpoints 1 During intervention Peak heart rate measured with Apple Watch
6 minute walk test 6 minute walk test at 3 months Walking distance (in meters) will be measured with the 6 minute walk test
Sub-maximal oxygen uptake Sub-maximal oxygen uptake at 3 months A graded treadmill test of sub-maximal oxygen uptake using a breath by breath ergospirometer
Intervention related endpoints 3 During intervention Intensity of training sessions: Speed on the treadmill, bicycel or step box
Patient related endpoints 2 During intervention Atrial fibrillation episodes will be measured with Apple Watch
Experience with inhospital aerobic - Questionaire 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.
Trial Locations
- Locations (1)
University Hospital of North Norway
🇳🇴Tromsø, Norway