An interventional study of Cardiac rehabilitation in Infective Endocarditis, Bacterial Infections and Cardiac Rehabilitation, sponsored by Region Halland. Recruiting at 1 site in Sweden. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-04-07.
Sponsored by Region Halland · Not applicable, Interventional, and Treatment
How does health develop after Infective endocarditis (IE)? Can the health of patients with IE be improved by participation in the physical exercise training within cardiac rehabilitation program?
Participants will:
Infective endocarditis (IE) is a rare but severe infectious disease of the heart. Patients with IE are treated for weeks in the hospital and have profound impairments of health for a long time after the treatment. Patients experience a delayed recovery after discharge both physically, with wasting and fatigue; and mentally, with anxiety and depression. Patients suffer from a diminished quality of life and have difficulties returning to work, up to a year post-discharge. Little is known about how patients perceive the IE disease after discharge and if patient's health can be promoted by rehabilitation since no studies have been able to evaluate the effect of interventions aimed at relieving these problems.
Aspects of quality of life, mental health, self-rated health and the impact on anxiety and depression will be studied.The hypothesis is that physical exercise training within cardiac rehabilitation can improve physical capacity and reduce symptoms of fatigue.
Both the patients' self-reported experiences of symptoms of fatigue and other aspects of health-related quality of life by surveys, as well as the physical improvements for 1 year after IE ( by physiotherapeutic testing) will be studied. The patients are also interviewed on expectations and experiences of the intervention and what the patients think is the optimal strategy to regain health. A mixed methods design is chosen to include both quantitative and qualitative data to evaluate the intervention.
Surveys on health-related quality of life, symptoms of fatigue, anxiety, depression, and occupational balance are digitally distributed at 4 occasions during 1 year after IE. Qualitative interviews will be used 3 times the first year to evaluate the effect and meaning of the program on health and well-being.
Individualized center-based evaluations according to the protocols are performed before and after the rehabilitation period. Exercises and training are performed in groups led by specialized physiotherapists 2 times per week for 12 weeks.
The investigators aim to study the intervention of physical exercise training within cardiac rehabilitation on the group of patients with IE. The patients with IE will be offered physical exercise training within cardiac rehabilitation according to the protocols of SEPHIA (Secondary Prevention after Heart Intensive Care Admission), as documented in SWEDEHEART(Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies).
50 patients treated for IE will be included in the study.
173 studies on the registry are indexed under Endocarditis; 57 are open to participants now.
This study's planned enrollment of 50 is below the median of 92 across 86 interventional studies indexed under Endocarditis.
Browse Endocarditis studies →Region Halland is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
An intervention with physical exercise training within cardiac rehabilitation according to the SEPHIA and SWEDEHEART protocols is offered to a new group of patients, patients with infective endocarditis. The intervention is studied with qualitative and quantitative methods on regard of the physical and health-related effects of rehabilitation, the adherence to the intervention and the health restoration in general. Patient's perspectives on rehabilitation and health restoration are given in interviews.
Other: Cardiac rehabilitation
Standard hospital-based cardiac rehabilitation according to SEPHIA and SWEDEHEART protocols 2 times a week for 12 weeks with individualized physical evaluation before and after the intervention.
Quantitative - 1. Changes from test 1 before start of physical exercise training within cardiac rehabilitation to test 2 at the end of the physical exercise training period and test 3 6-12 months after the end of the physical exercise training period.
1 Test of maximal workload (in Watt) and time (in minutes and seconds). Submaximal exercise capacity on a symptom-limited bicycle ergometer test with an increased workload of 25W every 4.5 minutes. The exercise test is discontinued at Borg rating of perceived exertion (RPE) scale 17 and/or dyspnea 7 at Borg´s CR-10 scale. Pre-exercise screening test is compared to the post-exercise tests.
Time frame: 18 months
Quantitative - 2. Changes from test 1 before start of physical exercise training within cardiac rehabilitation to test 2 at the end of the physical exercise training period and test 3 6-12 months after the end of the physical exercise training period.
2 Muscular endurance tests with a unilateral isotonic shoulder flexion and a unilateral isotonic heel lift(maximum number of repetitions). Pre-exercise screening test is compared to the post-exercise tests.
Time frame: 18 months
Quantitative - 3. Changes from test 1 before start of physical exercise training within cardiac rehabilitation to test 2 at the end of the physical exercise training period and test 3 6-12 months after the end of the physical exercise training period.
3 Changes in symptoms of fatigue assessed by the questionnaire Mental Fatigue Inventory (MFI-20) survey. The MFI is a self-report instrument designed to measure symptoms of fatigue which consists of 20 items and, by which 5 dimensions can be calculated (General Fatigue (GF), Physical Fatigue (PF), Reduced Motivation (RM), Reduced Activity (RA) and Mental Fatigue (MF)). The scale is 4-20 points, lower points are better. Pre-exercise screening test is compared to the post-exercise tests.
Time frame: 18 months
Quantitative - Degree of patient adherence to the program
Number of times in physical exercise-training within cardiac rehabilitation. Full adherence is set to 12 times during 16 weeks
Time frame: 16 weeks
Qualitative - Patients's experiences on cardiac rehabilitation
Qualitative content analysis of interviews before start of physical exercise training within cardiac rehabilitation, at the end of the physical exercise training period and 6-12 months after the end of the physical exercise training period. Descriptive.
Time frame: 0, 3 months, 6-12 months
Qualitative - Patients's experiences on post-infection health restoration
Qualitative content analysis of interviews 6-12 months after the end of the physical exercise training period. Descriptive.
Time frame: 6-12 months
Mixed method - Hindrances and possibilities for patients in participating after IE in physical exercise training within cardiac rehabilitation program
Qualitative interviews will be compared with quantitative data of participation and test result to describe and explain the findings.
Time frame: 12 months
Mixed method - Description and explanation on the health evolution the first year after IE among patients offered physical exercise training within cardiac rehabilitation program
Qualitative interviews will be compared with quantitative data of test results on physical capacity and health-related quality of life to describe and explain the findings.
Time frame: 12 months
Quantitative - HADS (Hospital Anxiety and Depression Scale) as a screening tool for mental malaise
Evaluation and interpretation of HADS as a screening tool to find patients that benefit from intervention physically or mentally. Maximum points 21 for depression and 21 points for anxiety. 0-7 points represents normal values and higher values than 11 correlates with clinical significant depression or anxiety.
Time frame: 1 year
Quantitative - OBQ-11 (Occupational Balance Questionnaire) as a screening tool for fatigue
Evaluation and interpretation of OBQ-11 as a screening tool to find patients that benefit from intervention physically or mentally. The higher points, the better occupational balance of the patient, maximum points 33.
Time frame: 1 year
Quantitative - MFI-20 (Multidimensional Fatigue Inventory) as a screening tool for fatigue
Evaluation and interpretation of MFI-20 as a screening tool to find patients that benefit from intervention physically or mentally. The scale is 4-20 points, lower points are better.
Time frame: 1 year
Quantitative - SF-36 (Short Form-36) as a screening tool for Health Related Quality of Life
Evaluation and interpretation of SF-36 as a screening tool to evaluate the health development after IE. Maximum points of SF-36 is 100 and higher points represents favorable health situation.
Time frame: 18 months
Quantitative - EQ-5D-5L (EuroQoL) as a screening tool for Health Related Quality of Life.
Evaluation and interpretation of EQ-5D as a screening tool to evaluate the health development after IE. The highest score is index score of 1.0 representing " no problem" on the 5 dimensions and 0-100 on Visual Analog Scale VAS representing full health.
Time frame: 18 months
Plan to share: No — Quantitative data can be pseudonymized and shared with other researchers upon request.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Region Halland