Early Exercise Training in Patients Following Heart Valve Surgery for Infective Endocarditis.

Heart Valve Diseases Clinical Trial

Official title:

Early Exercise Training in Patients Following Heart Valve Surgery for Infective Endocarditis. A Feasibility Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05703022
• Other study ID #: Interventional
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: January 2023
• Source: University Hospital of North Norway
• Contact: Margrethe Müller, MSc
• Phone: 004777655893
• Email: margrethemuller[@]unn.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 30, 2025
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endocarditis
• Endocarditis, Bacterial
• Heart Valve Diseases

Intervention

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.

Locations

Country	Name	City	State
Norway	University Hospital of North Norway	Tromsø

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital of North Norway	Herlev and Gentofte Hospital, Norwegian University of Science and Technology, UiT The Arctic University of Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Changes from baseline in heart /health-related quality of life at 3 months
Other	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	Changes from baseline in health-related quality of life at 3 months
Other	New cardiovascular or cerebrovascular incidents.	Gathered from participants and their electronic journal system	3 months
Primary	Feasibility of inhospital aerobic interval training	Number of completely finished training sessions will be record.	3 months
Primary	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.	Before discharge
Primary	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.	3 months
Secondary	Intervention related endpoints 1	Number of training sessions	During intervention
Secondary	Intervention related endpoints 2	Duration of training sessions	During intervention
Secondary	Intervention related endpoints 3	Intensity of training sessions: Speed on the treadmill, bicycel or step box	During intervention
Secondary	Intervention related endpoints 4	Exercise method.	During intervention
Secondary	Patient related endpoints 1	Peak heart rate measured with Apple Watch	During intervention
Secondary	Patient related endpoints 2	Atrial fibrillation episodes will be measured with Apple Watch	During intervention
Secondary	Patient related endpoints 3	Blood pressure wil be measured before and after training sessions	During intervention
Secondary	Patient related endpoints 4	Borg RPE-Scale	During intervention
Secondary	Sub-maximal oxygen uptake	A graded treadmill test of sub-maximal oxygen uptake using a breath by breath ergospirometer	Sub-maximal oxygen uptake at 2 weeks
Secondary	Sub-maximal oxygen uptake	A graded treadmill test of sub-maximal oxygen uptake using a breath by breath ergospirometer	Sub-maximal oxygen uptake at 3 months
Secondary	6 minute walk test	Walking distance (in meters) will be measured with the 6 minute walk test	6 minute walk test at 2 weeks
Secondary	6 minute walk test	Walking distance (in meters) will be measured with the 6 minute walk test	6 minute walk test at 3 months
Secondary	Physical Activity	Axivity AX3 Accelerometers	Physical activity 2 weeks
Secondary	Physical Activity	Axivity AX3 Accelerometers	Physical activity 3 months.
Secondary	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.	Before discharge
Secondary	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.	3 months.
Secondary	Physical Activity	Apple Watch	Physical activity at 2 weeks
Secondary	Physical Activity	Apple Watch	Physical activity at 3 months