Skip to main content
OpenTrials
Completed

NCT Number: NCT05703022

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of North Norway

Tromsø, Norway

About this study

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:

  • How is aerobic interval training experienced by patients with IE after heart-valve surgery?
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aerobic interval training

Other

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.

Primary outcomes

  1. Feasibility of inhospital aerobic interval training

    Time frame: 3 months

    Number of completely finished training sessions will be record.

  2. Experience with inhospital aerobic inetrval training assessed by semi structured interviews

    Time frame: Before discharge

    Semi structured interviews will involve patients opinions on the strengths and weaknesses of the inhospital training intervention.

  3. Experience with inhospital aerobic inetrval training assessed by semi structured interviews

    Time frame: 3 months

    Semi structured interviews will involve patients experiences of adopting and following the trainings program at home.

Secondary outcomes

  1. Intervention related endpoints 1

    Time frame: During intervention

    Number of training sessions

  2. Intervention related endpoints 2

    Time frame: During intervention

    Duration of training sessions

  3. Intervention related endpoints 3

    Time frame: During intervention

    Intensity of training sessions: Speed on the treadmill, bicycel or step box

  4. Intervention related endpoints 4

    Time frame: During intervention

    Exercise method.

  5. Patient related endpoints 1

    Time frame: During intervention

    Peak heart rate measured with Apple Watch

  6. Patient related endpoints 2

    Time frame: During intervention

    Atrial fibrillation episodes will be measured with Apple Watch

  7. Patient related endpoints 3

    Time frame: During intervention

    Blood pressure wil be measured before and after training sessions

  8. Patient related endpoints 4

    Time frame: During intervention

    Borg RPE-Scale

  9. Sub-maximal oxygen uptake

    Time frame: Sub-maximal oxygen uptake at 2 weeks

    A graded treadmill test of sub-maximal oxygen uptake using a breath by breath ergospirometer

  10. Sub-maximal oxygen uptake

    Time frame: Sub-maximal oxygen uptake at 3 months

    A graded treadmill test of sub-maximal oxygen uptake using a breath by breath ergospirometer

  11. 6 minute walk test

    Time frame: 6 minute walk test at 2 weeks

    Walking distance (in meters) will be measured with the 6 minute walk test

  12. 6 minute walk test

    Time frame: 6 minute walk test at 3 months

    Walking distance (in meters) will be measured with the 6 minute walk test

  13. Physical Activity

    Time frame: Physical activity 2 weeks

    Axivity AX3 Accelerometers

  14. Physical Activity

    Time frame: Physical activity 3 months.

    Axivity AX3 Accelerometers

  15. Experience with inhospital aerobic - Questionaire

    Time frame: Before discharge

    The questionnaire will contain validated questions from the PasOpp questionnaire along with questions specifically prepared for this study on process and experience outcomes.

  16. Experience with inhospital aerobic - Questionaire

    Time frame: 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.

  17. Physical Activity

    Time frame: Physical activity at 2 weeks

    Apple Watch

  18. Physical Activity

    Time frame: Physical activity at 3 months

    Apple Watch

Other outcomes

  1. HeartQOL

    Time frame: Changes from baseline in heart /health-related quality of life at 3 months

    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

  2. EQ5D-5L

    Time frame: Changes from baseline in health-related quality of life at 3 months

    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

  3. New cardiovascular or cerebrovascular incidents.

    Time frame: 3 months

    Gathered from participants and their electronic journal system

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Collaborators

  • Herlev and Gentofte Hospital
  • Norwegian University of Science and Technology
  • UiT The Arctic University of Norway

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2025
First posted
Jan 27, 2023
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.