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

NCT ID: NCT06704048

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-22
• Study Completion Date: 2035-08-31

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.

Conditions

Infective Endocarditis; Bacterial Infections; Cardiac Rehabilitation; Patient Participation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cardiac rehabilitation

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Halland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ingrid Larsson, PhD,Prof

Role: STUDY_DIRECTOR

Department of Health and Nursing, School of Health and Welfare, Halmstad, Sweden

Magnus Rasmussen, MD,PhD,Prof

Role: STUDY_DIRECTOR

Department of Clinical Sciences Lund, Division of Infection Medicine, Lund University, Lund, Sweden

Locations

Helena Lindberg

Halmstad, Halland County, Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Helena Lindberg, MD

Role: CONTACT

helena.lindberg@regionhalland.se

+4635131000 ext. +4635131611

Ingrid Larsson, professor

Role: CONTACT

ingrid.larsson@hh.se

+46729773722

Facility Contacts

Helena Lindberg, MD

Role: primary

helena.lindberg@regionhalland.se

+46702941930

Ingrid Larsson, PhD, Prof

Role: backup

ingrid.larsson@hh.se

+46703501749

Magnus Rasmussen, MD,PhD,Prof

Role: backup

References

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.

Reference Type: BACKGROUND

PMID: 34089600 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33962483 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30695817 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31349776 (View on PubMed)

Other Identifiers

2024-03596-01 v

Identifier Type: -

Identifier Source: org_study_id