Data Test Trial 2 - v7.2 (Do not make changes)

  • STATUS
    Recruiting
  • participants needed
    170
  • sponsor
    TrialX
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Updated on 29 May 2025
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Summary

<p>Can the health of patients with Infective endocarditis (IE) be improved by participation in the physical exercise training within cardiac rehabilitation program?</p><p>Participants will:</p><ul><li>Be physically evaluated by a physiotherapist before and after the progam of physical exercise training within cardiac rehabilitation.</li><li>Do individual exercises in a group led by a physiotherapist 2 times weekly during 12 weeks.</li><li>Answer digitally surveys on the perceived health for 4 times during 1 year</li><li>Participate in interviews on patient&#x27;s experiences of health and rehabilitation 1 time before and 2 times after the training program during I year.</li></ul>

Description

<p>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&x27;s health can be promoted by rehabilitation since no studies have been able to evaluate the effect of interventions aimed at relieving these problems.</p><p>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.</p><p>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).</p><p>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.</p><p>Both the patients&x27; 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.</p><p>50 patients treated for IE will be included in the study.</p>

Details
Condition Acne
Age 12years - 86years
Clinical Study IdentifierTX13983
SponsorTrialX
Last Modified on29 May 2025

Eligibility

 Yes No Not Sure

Inclusion Criteria

</p><p>Patients with pathological diagnosis of PCD
[e.g.: symptomatic&#x2F;asymptomatic multiple myeloma, monoclonal gammopathy
of undetermined significance (MGUS), POEMS syndrome, light chain (AL)
amyloidosis) from 2007 to 2027 in Zhonshan Hospital.</p><p>Patients who had
complete diagnostic, treatment and follow-up records. With fully comprehension
and signature of the informed consent form (ICF) for

Exclusion Criteria

</p><p>Patients who refused to use
reliable methods of contraception during pregnancy, lactation or age-
appropriate period.</p><p>Patients who suffered from severe mental illness
Patients who were deemed unsuitable for inclusion by the investigator.</p>
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