Healthrelated Quality of Life and Experiences of a Heart Rehabilitation Programme After Care for Infective Endocarditis.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorRegion Halland
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Not able to do a bicycle ergometer test or training.
Trial design
Design model
Single group
Treatments tested in this trial
Cardiac rehabilitation
Other interventionStandard 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Cardiac rehabilitationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
18 months2
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.
Time frame
18 months3
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)). The scale is 4-20 points, lower points are better. Pre-exercise screening test is compared to the post-exercise tests.
Time frame
18 months4
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
Time frame
16 weeksOther outcomes
1
Quantitative - HADS (Hospital Anxiety and Depression Scale) as a screening tool for mental malaise
Evaluation and interpretation of HADS as a screening tool to find patients that benefit from intervention physically or mentally. Maximum points 21 for depression and 21 points for anxiety. 0-7 points represents normal values and higher values than 11 correlates with clinical significant depression or anxiety.
Time frame
1 year2
Quantitative - OBQ-11 (Occupational Balance Questionnaire) as a screening tool for fatigue
Evaluation and interpretation of OBQ-11 as a screening tool to find patients that benefit from intervention physically or mentally. The higher points, the better occupational balance of the patient, maximum points 33.
Time frame
1 year3
Quantitative - MFI-20 (Multidimensional Fatigue Inventory) as a screening tool for fatigue
Evaluation and interpretation of MFI-20 as a screening tool to find patients that benefit from intervention physically or mentally. The scale is 4-20 points, lower points are better.
Time frame
1 year4
Quantitative - SF-36 (Short Form-36) as a screening tool for Health Related Quality of Life
Evaluation and interpretation of SF-36 as a screening tool to evaluate the health development after IE. Maximum points of SF-36 is 100 and higher points represents favorable health situation.
Time frame
18 monthsSponsors and contacts
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Source ClinicalTrials.gov