Healthrelated Quality of Life and Experiences of a Heart Rehabilitation Programme After Care for Infective Endocarditis.

Healthrelated Quality of Life and Experiences of a Heart Rehabilitation Programme After Care for Infective Endocarditis. A Quantitave and Qualitative Study With Mixed Methods.

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:

• Answer digitally surveys on the perceived health for 4 times during 1 year
• Participate in interviews on patient's experiences of health and rehabilitation 1 time before and 2 times after the training program during I year.
• Be physically evaluated by a physiotherapist before and after the progam of physical exercise training within cardiac rehabilitation.
• Do individual exercises in a group led by a physiotherapist 2 times weekly during 12 weeks.

Study Overview

• Status: Recruiting
• Conditions: Bacterial Infections; Patient Participation; Cardiac Rehabilitation; Infective Endocarditis
• Intervention / Treatment: Other: Cardiac rehabilitation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Helena Lindberg, MD; Phone Number: +4635131611 +4635131000; Email: helena.lindberg@regionhalland.se
• Study Contact Backup: Name: Ingrid Larsson, professor; Phone Number: +46729773722; Email: ingrid.larsson@hh.se

Study Locations

• Sweden
  • Halland County
    • Halmstad, Halland County, Sweden, S-301 85
      • Recruiting
      • Helena Lindberg
      • Contact: Helena Lindberg, MD; Phone Number: +46702941930; Email: helena.lindberg@regionhalland.se
      • Contact: Ingrid Larsson, PhD, Prof; Phone Number: +46703501749; Email: ingrid.larsson@hh.se
      • Sub-Investigator: Magnus Rasmussen, MD,PhD,Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of infective endocarditis (IE) based on Dukes ISCVID criteria and discharged after treatment for IE from the Department of Infectious Diseases, Hospital of Halmstad, Region Halland, Sweden.

Exclusion Criteria:

• Not able to do a bicycle ergometer test or training.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Cardiac rehabilitation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 - 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	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
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

Other Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Region Halland
• Investigators: Study Director: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2024
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2035

Study Registration Dates

• First Submitted: November 14, 2024
• First Submitted That Met QC Criteria: November 21, 2024
• First Posted (Actual): November 25, 2024

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Bacterial Infections; Cardiac rehabilitation; Patient Participation; Interview; Qualitative Research; Infective Endocarditis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Infections; Bacterial Infections and Mycoses; Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Acceptance of Health Care; Endocarditis; Bacterial Infections; Patient Participation; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Rehabilitation; Aftercare; Continuity of Patient Care; Cardiac Rehabilitation
• Other Study ID Numbers: 2024-03596-01 v

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Quantitative data can be pseudonymized and shared with other researchers upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No