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Clinical Trials/NCT05703022
NCT05703022
Completed
Not Applicable

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

University Hospital of North Norway1 site in 1 country15 target enrollmentNovember 30, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endocarditis
Sponsor
University Hospital of North Norway
Enrollment
15
Locations
1
Primary Endpoint
Feasibility of inhospital aerobic interval training
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 30, 2021
End Date
March 27, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University Hospital of North Norway
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Feasibility of inhospital aerobic interval training

Time Frame: 3 months

Number of completely finished training sessions will be record.

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

  • Intervention related endpoints 2(During intervention)
  • Patient related endpoints 3(During intervention)
  • Intervention related endpoints 1(During intervention)
  • Intervention related endpoints 4(During intervention)
  • Patient related endpoints 1(During intervention)
  • 6 minute walk test(6 minute walk test at 3 months)
  • Patient related endpoints 4(During intervention)
  • Sub-maximal oxygen uptake(Sub-maximal oxygen uptake at 3 months)
  • Intervention related endpoints 3(During intervention)
  • Patient related endpoints 2(During intervention)
  • Physical Activity(Physical activity at 3 months)
  • Experience with inhospital aerobic - Questionaire(3 months.)

Study Sites (1)

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