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NCT Number: NCT06704048

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

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.

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Key information

Conditions

Infective Endocarditis Bacterial Infections Bacterial Infections and Mycoses Behavior Cardiac Rehabilitation Cardiovascular Diseases Endocarditis Health Behavior Heart Diseases Infections Patient Acceptance of Health Care Patient Participation Treatment Adherence and Compliance

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

    Time frame: 18 months

    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.

  2. 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.

    Time frame: 18 months

    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.

  3. 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.

    Time frame: 18 months

    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.

  4. Quantitative - Degree of patient adherence to the program

    Time frame: 16 weeks

    Number of times in physical exercise-training within cardiac rehabilitation. Full adherence is set to 12 times during 16 weeks

  5. Qualitative - Patients's experiences on cardiac rehabilitation

    Time frame: 0, 3 months, 6-12 months

    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.

  6. Qualitative - Patients's experiences on post-infection health restoration

    Time frame: 6-12 months

    Qualitative content analysis of interviews 6-12 months after the end of the physical exercise training period.

    Descriptive.

  7. Mixed method - Hindrances and possibilities for patients in participating after IE in physical exercise training within cardiac rehabilitation program

    Time frame: 12 months

    Qualitative interviews will be compared with quantitative data of participation and test result to describe and explain the findings.

  8. Mixed method - Description and explanation on the health evolution the first year after IE among patients offered physical exercise training within cardiac rehabilitation program

    Time frame: 12 months

    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.

Other outcomes

  1. Quantitative - HADS (Hospital Anxiety and Depression Scale) as a screening tool for mental malaise

    Time frame: 1 year

    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.

  2. Quantitative - OBQ-11 (Occupational Balance Questionnaire) as a screening tool for fatigue

    Time frame: 1 year

    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.

  3. Quantitative - MFI-20 (Multidimensional Fatigue Inventory) as a screening tool for fatigue

    Time frame: 1 year

    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.

  4. Quantitative - SF-36 (Short Form-36) as a screening tool for Health Related Quality of Life

    Time frame: 18 months

    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.

  5. Quantitative - EQ-5D-5L (EuroQoL) as a screening tool for Health Related Quality of Life.

    Time frame: 18 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Helena Lindberg, MD

CONTACT

[email protected]

+4635131000 ext. +4635131611

Ingrid Larsson, professor

CONTACT

[email protected]

+46729773722

Sponsors and collaborators

Lead sponsor

Region Halland

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2035
First posted
Nov 25, 2024
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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