Healthrelated Quality of Life and Experiences of a Heart Rehabilitation Programme After Care for Infective Endocarditis.
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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.
Eligibility
Primary outcome measure(s)
- 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. — 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. - 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. — 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. - 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. — 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. - Quantitative - Degree of patient adherence to the program — 16 weeks
Number of times in physical exercise-training within cardiac rehabilitation. Full adherence is set to 12 times during 16 weeks - Qualitative - Patients's experiences on cardiac rehabilitation — 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. - Qualitative - Patients's experiences on post-infection health restoration — 6-12 months
Qualitative content analysis of interviews 6-12 months after the end of the physical exercise training period. Descriptive. - Mixed method - Hindrances and possibilities for patients in participating after IE in physical exercise training within cardiac rehabilitation program — 12 months
Qualitative interviews will be compared with quantitative data of participation and test result to describe and explain the findings. - Mixed method - Description and explanation on the health evolution the first year after IE among patients offered physical exercise training within cardiac rehabilitation program — 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Helena Lindberg | Halmstad | Halland County | Recruiting |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06704048 on ClinicalTrials.gov ↗ ← All trials in Sweden