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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac rehabilitation | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac rehabilitation | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Helena Lindberg, MD | Contact | +4635131000 | +4635131611 | helena.lindberg@regionhalland.se |
| Ingrid Larsson, professor | Contact | +46729773722 | ingrid.larsson@hh.se |
| Name | Affiliation | Role |
|---|---|---|
| Ingrid Larsson, PhD,Prof | Department of Health and Nursing, School of Health and Welfare, Halmstad, Sweden | Study Director |
| Magnus Rasmussen, MD,PhD,Prof | Department of Clinical Sciences Lund, Division of Infection Medicine, Lund University, Lund, Sweden |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helena Lindberg | Recruiting | Halmstad | Halland County | S-301 85 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34089600 | Background | Rasmussen TB, Zwisler AD, Risom SS, Sibilitz KL, Christensen J, Bundgaard H, Moons P, Thygesen LC, Lindschou J, Norekval TM, Berg SK. Comprehensive cardiac rehabilitation for patients following infective endocarditis: results of the randomized CopenHeartIE trial. Eur J Cardiovasc Nurs. 2022 Apr 9;21(3):261-270. doi: 10.1093/eurjcn/zvab047. | |
| 33962483 |
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Quantitative data can be pseudonymized and shared with other researchers upon request.
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Mixed method
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| 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. | 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. | 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. | 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. | 12 months |
| 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. | 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. | 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. | 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. | 18 months |
| Abraham LN, Sibilitz KL, Berg SK, Tang LH, Risom SS, Lindschou J, Taylor RS, Borregaard B, Zwisler AD. Exercise-based cardiac rehabilitation for adults after heart valve surgery. Cochrane Database Syst Rev. 2021 May 7;5(5):CD010876. doi: 10.1002/14651858.CD010876.pub3. |
| 30695817 | Background | Long L, Mordi IR, Bridges C, Sagar VA, Davies EJ, Coats AJ, Dalal H, Rees K, Singh SJ, Taylor RS. Exercise-based cardiac rehabilitation for adults with heart failure. Cochrane Database Syst Rev. 2019 Jan 29;1(1):CD003331. doi: 10.1002/14651858.CD003331.pub5. |
| 31349776 | Background | Ogmundsdottir Michelsen H, Sjolin I, Schlyter M, Hagstrom E, Kiessling A, Henriksson P, Held C, Hag E, Nilsson L, Back M, Schiopu A, Zaman MJ, Leosdottir M. Cardiac rehabilitation after acute myocardial infarction in Sweden - evaluation of programme characteristics and adherence to European guidelines: The Perfect Cardiac Rehabilitation (Perfect-CR) study. Eur J Prev Cardiol. 2020 Jan;27(1):18-27. doi: 10.1177/2047487319865729. Epub 2019 Jul 26. |
| ID | Term |
|---|---|
| D004696 | Endocarditis |
| D001424 | Bacterial Infections |
| D010358 | Patient Participation |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000072038 | Cardiac Rehabilitation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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