Clinical trial NCT06704048: Healthrelated Quality of Life and Experiences of a Heart Rehabilitation Programme After Care for Infective Endocarditis.
Official 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infective Endocarditis
Bacterial Infections
Cardiac Rehabilitation
Patient Participation
Keywords: Infective Endocarditis
Bacterial Infections
Patient Participation
Interview
Qualitative Research
Cardiac rehabilitation
Lead sponsor: Region Halland
Sponsor class: OTHER
First posted: 2024-11-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Mixed method
Primary purpose: TREATMENT

Brief summary: Can the health of patients with Infective endocarditis (IE) be improved by participation in the physical exercise training within cardiac rehabilitation program?

Participants will:

* 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.
* 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.

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.

The hypothesis is that physical exercise training within cardiac rehabilitation can improve physical capacity and reduce symptoms of fatigue. Other aspects of quality of life, mental health, self-rated health and the impact on anxiety and depression will also be studied.

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).

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. 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.

Both the patients' physical improvements for 1 year after IE ( by physiotherapeutic testing) as well as the self-reported experiences of symptoms of fatigue and other aspects of health-related quality of life by surveys 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.

50 patients treated for IE will be included in the study.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 18 months
measure: 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.
timeFrame: 18 months
measure: 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.
timeFrame: 18 months
measure: Quantitative - Degree of patient adherence to the program
timeFrame: 16 weeks
measure: Qualitative - Patients's experiences on cardiac rehabilitation
timeFrame: 0, 3 months, 6-12 months
measure: Qualitative - Patients's experiences on post-infection health restoration
timeFrame: 6-12 months
measure: Mixed method - Hindrances and possibilities for patients in participating after IE in physical exercise training within cardiac rehabilitation program
timeFrame: 12 months
measure: Mixed method - Description and explanation on the health evolution the first year after IE among patients offered physical exercise training within cardiac rehabilitation program
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
measure: Quantitative - HADS (Hospital Anxiety and Depression Scale) as a screening tool for mental malaise
timeFrame: 1 year
measure: Quantitative - OBQ-11 (Occupational Balance Questionnaire) as a screening tool for fatigue
timeFrame: 1 year
measure: Quantitative - MFI-20 (Multidimensional Fatigue Inventory) as a screening tool for fatigue
timeFrame: 1 year
Locations:
city: Halmstad
country: Sweden
facility: Helena Lindberg
state: Halland
Study officials:
affiliation: Department of Health and Nursing, School of Health and Welfare, Halmstad, Sweden
name: Ingrid Larsson, PhD,Prof
role: STUDY_DIRECTOR
affiliation: Department of Clinical Sciences Lund, Division of Infection Medicine, Lund University, Lund, Sweden
name: Magnus Rasmussen, MD,PhD,Prof
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.