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

Region Halland

Status: Enrolling

Conditions: Cardiac Rehabilitation; Patient Participation; Infective Endocarditis; Bacterial Infections

Treatments: Other: Cardiac rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT06704048

2024-03596-01 v

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Cardiac rehabilitation

Experimental group

Description:

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.

Treatment:

Other: Cardiac rehabilitation