EndocarditisNCT05703022
Early Exercise Training in Patients Following Heart Valve Surgery for Infective Endocarditis.
A study testing Aerobic interval training in people with Endocarditis and Heart Valve Diseases, run by University Hospital of North Norway at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Endocarditis, Heart Valve Diseases
- What is being tested?
- Aerobic interval training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNorway
- Study dates
- 30 Nov 2021to 27 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Endocarditis, Heart Valve Diseases
- Being tested
- Aerobic interval training
- Keywords
- Training, Heart valve surgery, Infective endocarditic
- Medical subject headings
- Endocarditis, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic interval trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Early exercise training | Experimental | 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. Receives: Other: Aerobic interval training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of inhospital aerobic interval training
Number of completely finished training sessions will be record.
Measured: 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.
Measured: 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.
Measured: 3 months
Secondary outcomes (18)
Intervention related endpoints 1
Number of training sessions
Measured: During intervention
Intervention related endpoints 2
Duration of training sessions
Measured: During intervention
Intervention related endpoints 3
Intensity of training sessions: Speed on the treadmill, bicycel or step box
Measured: During intervention
Intervention related endpoints 4
Exercise method.
Measured: During intervention
Patient related endpoints 1
Peak heart rate measured with Apple Watch
Measured: During intervention
Patient related endpoints 2
Atrial fibrillation episodes will be measured with Apple Watch
Measured: During intervention
Patient related endpoints 3
Blood pressure wil be measured before and after training sessions
Measured: During intervention
Patient related endpoints 4
Borg RPE-Scale
Measured: During intervention
Sub-maximal oxygen uptake
A graded treadmill test of sub-maximal oxygen uptake using a breath by breath ergospirometer
Measured: 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
Measured: Sub-maximal oxygen uptake at 3 months
6 minute walk test
Walking distance (in meters) will be measured with the 6 minute walk test
Measured: 6 minute walk test at 2 weeks
6 minute walk test
Walking distance (in meters) will be measured with the 6 minute walk test
Measured: 6 minute walk test at 3 months
Physical Activity
Axivity AX3 Accelerometers
Measured: Physical activity 2 weeks
Physical Activity
Axivity AX3 Accelerometers
Measured: 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.
Measured: 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.
Measured: 3 months.
Physical Activity
Apple Watch
Measured: Physical activity at 2 weeks
Physical Activity
Apple Watch
Measured: Physical activity at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start30 Nov 2021
- Primary completion31 Oct 2023
- Study completion27 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndocarditisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single centre feasibility study to assess acceptability, compliance, delivery of the intervention and expected effect sizes.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- UiT The Arctic University of Norway, Herlev and Gentofte Hospital, Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Gyrd Thrane, PhD, Study chair, UiT The Arctic University of Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05703022
- Sponsor's protocol ID
- Interventional
- Status last verified
- Mar 2025
- First submitted
- 12 Oct 2021
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Muller M, Hanssen TA, Johansen D, Jakobsen O, Pedersen JE, Aksetoy ILA, Rasmussen TB, Hartvigsen G, Skogen V, Henriksen A, Thrane G. Feasibility of early interval training in patients recovering from heart valve surgery due to infective endocarditis. Pilot Feasibility Stud. 2026 May 12;12(1):93. doi: 10.1186/s40814-026-01830-w.
PubMed 42116217
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Exercise Training in Patients Following Heart Valve Surgery for Infective Endocarditis. A Feasibility Study.
- ClinicalTrials.gov ID
- NCT05703022
- Acronym / sponsor ID
- Interventional
- Conditions
- Endocarditis, Heart Valve Diseases
- Keywords
- Training, Heart valve surgery, Infective endocarditic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- UiT The Arctic University of Norway, Herlev and Gentofte Hospital, Norwegian University of Science and Technology
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 27 Mar 2025 (actual)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single centre feasibility study to assess acceptability, compliance, delivery of the intervention and expected effect sizes.
| Arm | Type | Receives |
|---|---|---|
| Early exercise training | Experimental | Other: Aerobic interval trainingSupervised aerobic interval training (uphill treadmill walking or cycling on an exercise bike 4x4 min at 65-85% of peak heart rate) 3 times weekly. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- (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.
Key exclusion criteria (3 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic interval trainingThe 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. | Other | Early exercise training |
Primary outcome
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: Before discharge
Semi structured interviews will involve patients opinions on the strengths and weaknesses of the inhospital training intervention.
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.
18 secondary outcomes
Intervention related endpoints 1
Time frame: During intervention
Intervention related endpoints 2
Time frame: During intervention
Intervention related endpoints 3
Time frame: During intervention
Intervention related endpoints 4
Time frame: During intervention
Patient related endpoints 1
Time frame: During intervention
Patient related endpoints 2
Time frame: During intervention
Patient related endpoints 3
Time frame: During intervention
Patient related endpoints 4
Time frame: During intervention
Sub-maximal oxygen uptake
Time frame: Sub-maximal oxygen uptake at 2 weeks
Sub-maximal oxygen uptake
Time frame: Sub-maximal oxygen uptake at 3 months
6 minute walk test
Time frame: 6 minute walk test at 2 weeks
6 minute walk test
Time frame: 6 minute walk test at 3 months
Physical Activity
Time frame: Physical activity 2 weeks
Physical Activity
Time frame: Physical activity 3 months.
Experience with inhospital aerobic - Questionaire
Time frame: Before discharge
Experience with inhospital aerobic - Questionaire
Time frame: 3 months.
Physical Activity
Time frame: Physical activity at 2 weeks
Physical Activity
Time frame: Physical activity at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Derived from this study: PubMed 42116217Muller M, Hanssen TA, Johansen D, Jakobsen O, Pedersen JE, Aksetoy ILA, Rasmussen TB, Hartvigsen G, Skogen V, Henriksen A, Thrane G. Feasibility of early interval training in patients recovering from heart valve surgery due to infective endocarditis. Pilot Feasibility Stud. 2026 May 12;12(1):93. doi: 10.1186/s40814-026-01830-w.
- Individual participant dataSharing planned: No
Related trials for Endocarditis
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CBCT vs OPT on the Oral Health Status at 12 Months of Patients Hospitalized for Infective Endocarditis.
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Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia
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REVIVE-FR Registry
Bioprosthetic Valve Failure, Prosthetic Heart Valve Dysfunction
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Impact of Preoperative Dental Screening in Reducing Infective Endocarditis Risk in Transcatheter Aortic Valve Implantation Patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gyrd Thrane, PhD study chair
UiT The Arctic University of Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic interval training in people with Endocarditis and Heart Valve Diseases, run by University Hospital of North Norway at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of inhospital aerobic interval training (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05703022, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.