Clinical trial NCT05703022: Early Exercise Training in Patients Following Heart Valve Surgery for Infective Endocarditis.
Official title: Early Exercise Training in Patients Following Heart Valve Surgery for Infective Endocarditis. A Feasibility Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endocarditis
Heart Valve Diseases
Keywords: Training
Heart valve surgery
Infective endocarditic
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: UiT The Arctic University of Norway
name: Herlev and Gentofte Hospital
name: Norwegian University of Science and Technology
First posted: 2023-01-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single centre feasibility study to assess acceptability, compliance, delivery of the intervention and expected effect sizes.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* (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.

Exclusion Criteria:

* (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.

Primary outcomes:
measure: Feasibility of inhospital aerobic interval training
timeFrame: 3 months
measure: Experience with inhospital aerobic inetrval training assessed by semi structured interviews
timeFrame: Before discharge
measure: Experience with inhospital aerobic inetrval training assessed by semi structured interviews
timeFrame: 3 months
Secondary outcomes:
measure: Intervention related endpoints 1
timeFrame: During intervention
measure: Intervention related endpoints 2
timeFrame: During intervention
measure: Intervention related endpoints 3
timeFrame: During intervention
measure: Intervention related endpoints 4
timeFrame: During intervention
measure: Patient related endpoints 1
timeFrame: During intervention
measure: Patient related endpoints 2
timeFrame: During intervention
measure: Patient related endpoints 3
timeFrame: During intervention
measure: Patient related endpoints 4
timeFrame: During intervention
measure: Sub-maximal oxygen uptake
timeFrame: Sub-maximal oxygen uptake at 2 weeks
measure: Sub-maximal oxygen uptake
timeFrame: Sub-maximal oxygen uptake at 3 months
measure: 6 minute walk test
timeFrame: 6 minute walk test at 2 weeks
measure: 6 minute walk test
timeFrame: 6 minute walk test at 3 months
measure: Physical Activity
timeFrame: Physical activity 2 weeks
measure: Physical Activity
timeFrame: Physical activity 3 months.
measure: Experience with inhospital aerobic - Questionaire
timeFrame: Before discharge
measure: Experience with inhospital aerobic - Questionaire
timeFrame: 3 months.
measure: Physical Activity
timeFrame: Physical activity at 2 weeks
measure: Physical Activity
timeFrame: Physical activity at 3 months
Other outcomes:
measure: HeartQOL
timeFrame: Changes from baseline in heart /health-related quality of life at 3 months
measure: EQ5D-5L
timeFrame: Changes from baseline in health-related quality of life at 3 months
measure: New cardiovascular or cerebrovascular incidents.
timeFrame: 3 months
Locations:
city: Tromsø
country: Norway
facility: University Hospital of North Norway
Study officials:
affiliation: UiT The Arctic University of Norway
name: Gyrd Thrane, PhD
role: STUDY_CHAIR
References: