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.

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.

Study Overview

• Status: Completed
• Conditions: Heart Valve Diseases; Endocarditis
• Intervention / Treatment: Other: Aerobic interval training

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Tromsø, Norway
    • University Hospital of North Norway

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Early exercise 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of inhospital aerobic interval training	Number of completely finished training sessions will be record.	3 months
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention related endpoints 1	Number of training sessions	During intervention
Intervention related endpoints 2	Duration of training sessions	During intervention
Intervention related endpoints 3	Intensity of training sessions: Speed on the treadmill, bicycel or step box	During intervention
Intervention related endpoints 4	Exercise method.	During intervention
Patient related endpoints 1	Peak heart rate measured with Apple Watch	During intervention
Patient related endpoints 2	Atrial fibrillation episodes will be measured with Apple Watch	During intervention
Patient related endpoints 3	Blood pressure wil be measured before and after training sessions	During intervention
Patient related endpoints 4	Borg RPE-Scale	During intervention
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
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
6 minute walk test	Walking distance (in meters) will be measured with the 6 minute walk test	6 minute walk test at 2 weeks
6 minute walk test	Walking distance (in meters) will be measured with the 6 minute walk test	6 minute walk test at 3 months
Physical Activity	Axivity AX3 Accelerometers	Physical activity 2 weeks
Physical Activity	Axivity AX3 Accelerometers	Physical activity 3 months.
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
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.
Physical Activity	Apple Watch	Physical activity at 2 weeks
Physical Activity	Apple Watch	Physical activity at 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
New cardiovascular or cerebrovascular incidents.	Gathered from participants and their electronic journal system	3 months

Collaborators and Investigators

• Sponsor: University Hospital of North Norway
• Collaborators: Norwegian University of Science and Technology; Herlev and Gentofte Hospital; UiT The Arctic University of Norway
• Investigators: Study Chair: Gyrd Thrane, PhD, UiT The Arctic University of Norway

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2021
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): March 27, 2025

Study Registration Dates

• First Submitted: October 12, 2021
• First Submitted That Met QC Criteria: January 18, 2023
• First Posted (Actual): January 27, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: March 31, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Training; Heart valve surgery; Infective endocarditic
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Cardiovascular Infections; Endocarditis; Heart Valve Diseases; Endocarditis, Bacterial
• Other Study ID Numbers: Interventional (Oncolys BioPharma Inc)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No