Healthrelated Quality of Life and Experiences of a Heart Rehabilitation Programme After Care for Infective Endocarditis. A Quantitave and Qualitative Study With Mixed Methods.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
Aspects of quality of life, mental health, self-rated health and the impact on anxiety and depression will be studied.The hypothesis is that physical exercise training within cardiac rehabilitation can improve physical capacity and reduce symptoms of fatigue.
Both the patients' self-reported experiences of symptoms of fatigue and other aspects of health-related quality of life by surveys, as well as the physical improvements for 1 year after IE ( by physiotherapeutic testing) 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.
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.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Not able to do a bicycle ergometer test or training.
研究组 & 干预措施
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.
干预措施: Cardiac rehabilitation (Other)
结局指标
主要结局
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.
时间窗: 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.
时间窗: 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.
时间窗: 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)). Pre-exercise screening test is compared to the post-exercise tests.
Quantitative - Degree of patient adherence to the program
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点