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

NCT06704048 | Recruiting DMC

• 1 other identifier: 2024-03596-01 v
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infective Endocarditis; Bacterial Infections; Cardiac Rehabilitation; Patient Participation

Keywords

Infective Endocarditis; Bacterial Infections; Patient Participation; Interview; Qualitative Research; Cardiac rehabilitation

Outcome Measures

Primary Outcomes (8)

• 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 - 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)). 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

Other Outcomes (5)

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

  1 year

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

  1 year

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

  1 year

Study Arms (1)

Cardiac rehabilitation

EXPERIMENTAL

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

Interventions

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.

Cardiac rehabilitation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Region Halland: lead

Study Sites (1)

Helena Lindberg

Halmstad, Halland County, S-301 85, Sweden

RECRUITING

Related Publications (4)

• 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.

  PMID: 34089600 BACKGROUND

• 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.

  PMID: 33962483 BACKGROUND

• 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.

  PMID: 30695817 BACKGROUND

• 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.

  PMID: 31349776 BACKGROUND

MeSH Terms

Conditions

Endocarditis; Bacterial Infections; Patient Participation

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Bacterial Infections and Mycoses; Infections; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• 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

  STUDY DIRECTOR

Central Study Contacts

Helena Lindberg, MD

CONTACT

+4635131000; helena.lindberg@regionhalland.se

Ingrid Larsson, professor

CONTACT

+46729773722; ingrid.larsson@hh.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Mixed method

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 25, 2024
• Study Start: August 22, 2024
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2035
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)