Trials / Completed
CompletedNCT05703022
Early Exercise Training in Patients Following Heart Valve Surgery for Infective Endocarditis.
Early Exercise Training in Patients Following Heart Valve Surgery for Infective Endocarditis. A Feasibility Study.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- University Hospital of North Norway · Academic / Other
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-11-30
- Primary completion
- 2023-10-31
- Completion
- 2025-03-27
- First posted
- 2023-01-27
- Last updated
- 2025-04-03
Locations
1 site across 1 country: Norway
Source: ClinicalTrials.gov record NCT05703022. Inclusion in this directory is not an endorsement.