RecruitingACTRN12618000347268

RehaSep: health status and quality of life monitored during different rehabilitation procedures in post-sepsis patients

Selected indicators of health status and quality of life monitored during different rehabilitation procedures in post-sepsis patients


Sponsor

University of Physical Education in Krakow

Enrollment

60 participants

Start Date

Mar 15, 2018

Study Type

Interventional

Conditions

Summary

The aim of the planned study is to evaluate the effect of two different rehabilitation treatments on physiological, hematological and biochemical diagnostic indices and the quality of life of sepsis survivors. The study will be conducted with 60 patients with a history of hospitalizations for sepsis. They will be assigned to three groups: control group - with no rehabilitation (which reflects the present medical practice), and two experimental groups of patients participating in 3-month diagnostically monitored rehabilitation programs - either as the aerobic training on cycloergometer in a reclining position or in the form of the hyperbaric oxygen therapy. Physiological, hematological and biochemical parameters which indicate the state and function of the immune system, oxidative stress level and degree of post-sepsis organ damage/recovery will be assessed in each patient after completion of clinical therapy of sepsis and in the following three months. In all of the patients respiratory function tests (spirometry) and regular ECG cycloergometer exercise testing will be carried out in order to assess their physical capacity and/or the results of rehabilitation. In addition, when leaving hospital and after 3 months, each patient will be surveyed with the specialized quality of life questionnaire "Life after Sepsis Survey". In spite of the enormous achievements of modern medicine neither the specific diagnostic methods, nor the standards for rehabilitation of the patients have been introduced yet. As a result, high mortality, frequent hospital readmissions and a profound reduction in the quality of life occur in sepsis survivors. The significance of rehabilitation for post-sepsis patients as the key to their recovery is strongly expressed as well as the need of new research to elucidate long-term functional impairments is highly encouraged. The results of this study will be probably the first-of-its kind in science. A comparison of two distinct forms of intervention used as rehabilitation treatments will allow for better understanding of the changes in patients' organisms during recovery after sepsis. The new knowledge gained will constitute the starting point for the next stage - the applied research aimed at selection of the most effective rehabilitation methods. They prepare the ground for the future implementation of the appropriate procedures into the medical practice that will bring the diverse economic and social benefits.


Eligibility

Sex: Both males and femalesMin Age: 35 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at how two different rehabilitation approaches — cycling exercise on a recumbent bike or hyperbaric oxygen therapy (breathing pure oxygen in a pressurised chamber) — can help people recover after surviving sepsis (a life-threatening response to infection). Sepsis survivors often experience long-term physical weakness, reduced immune function, and poor quality of life. This study will follow 60 participants over 3 months and measure immune function, organ recovery, exercise capacity, and quality of life to find out which rehabilitation approach is more effective. You may be eligible if: - You are aged 35 to 75 years - You have a documented history of sepsis (according to current SEPSIS-3 criteria) - You have been discharged from hospital after being treated for sepsis You may NOT be eligible if: - Your sepsis was caused by trauma, cancer, or a burn injury - You require palliative care - You have a psychiatric illness or intellectual disability that would prevent cooperation Talk to your doctor about whether this trial might be right for you.

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Interventions

All the rehabilitation and routine diagnostic procedures will be performed by experienced medical specialists at the Ludwik Rydygier Specialist Hospital in Krakow and the specialized microscopy and bi

All the rehabilitation and routine diagnostic procedures will be performed by experienced medical specialists at the Ludwik Rydygier Specialist Hospital in Krakow and the specialized microscopy and biochemistry examinations will be done by scientists of the University of Physical Education in Krakow, Poland. To evaluate the effect of two different rehabilitation treatments on physiological, hematological and biochemical diagnostic indices and the quality of life of sepsis survivors, at the hospital discharge each patient will be qualified for the study by ward physicians after detailed examinations and individually assigned to one of two experimental groups (C, H) of patients participating in different rehabilitation programs or the control group (K) – with no rehabilitation (which reflects the present medical practice). Rehabilitation treatment - 36 sessions (3 times a week for 12 weeks): Arm C: Rehabilitation by cycloergometer training plus diagnostic monitoring; Rehabilitation training administered by physiotherapist face-to-face will be performed three times a week for 1 h; comprising 15 min warm-up, 30 min cycling in a reclining position and 15 min calming down phase. The exercise intensity will be selected individually according to the result of the initial ECG cycloergometer exercise test supervised by clinical cardiologist. Arm H: Rehabilitation by Hyperbaric Oxygen Therapy plus diagnostic monitoring: The patients assigned to group H will be qualified by a experienced HBOT physician after a detailed examination and will undergo 36 sessions of breathing 100% oxygen at 2.5 atm for 90 min seated in a multiplace hyperbaric chamber under medical supervision. All the participants will be monitored at monthly intervals by multiparameter diagnostic measurements: routine blood tests and specialized hematological and biochemical tests. At the discharge and after 3 months spirometry and ECG cycloergometer exercise test will be also performed as well as the specialized "Life after Sepsis Survey" questionnaire filled by the patients. In order to monitor adherence to the interventions the session attendance lists checked by the study personnel will be implemented. All the data acquired from measurements, observations, medical documentation etc. will be stored in the dedicated data base managed by the project team.


Locations(1)

Malopolska, Poland

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ACTRN12618000347268