Precision Exercise to Improve Outcomes in Sepsis

Официальное название

Precision Exercise to Improve Patient Outcomes in Sepsis Survivors: PRECISE Study

Обзор

The goal of this interventional clinical research study is to assess the efficacy of a 12-week precision exercise training intervention to improve exercise tolerance in sepsis survivors. The main question it aims to answer is does a 12-week precision exercise training program improve constant load exercise time in sepsis survivors? Participants will: * Answer questionnaires related to patient reported outcomes and give a blood sample * Perform a constant load exercise test * Complete 12-weeks (3 x per week, 36 session in total) of precision exercise training consisting of individualized, nonlinear periodized strength and aerobic exercise training. Researchers will compare the exercise group to an attention control group of sepsis survivors who do not receive exercise training but instead undergo usual care procedures and receive general lifestyle advice 1x per week.

Подробное описание

Sepsis is a life threatening condition that results in multi-organ system dysfunction. In those who survive sepsis, many patients present with chronic immune dysregulation (i.e., paradoxical hyperinflammation and immune suppression), leading to high rates of re-hospitalization. In addition, exercise tolerance is significantly reduced both acutely post hospital discharge and long term (\~5 years post initial infection). Exercise training is a pleiotropic intervention that has been demonstrated to improve exercise tolerance in a multitude of clinical populations. Aerobic exercise training is also associated with anti-inflammatory and immune-enhancing effects; however, the magnitude of these immunological adaptations is largely dependent on the exercise prescription used. To date, exercise training studies in sepsis have used a more traditional generic linear exercise training approach, which has resulted in minimal or no effect on exercise tolerance. This is in contrast to other clinical populations wherein precision exercise training (e.g., individualized, nonlinear periodized, combined aerobic and strength training) has resulted in greater improvements in exercise tolerance compared to non-specific linear exercise programs, and is considered safe and tolerable. To date, no study has sought to investigate the effects of a precision exercise training intervention on exercise tolerance and immune function in sepsis survivors.

Вмешательства

• Другое 12-week precision exercise training
  The 12-week exercise intervention will consist of both aerobic and strength exercise training performed 3x per week using an individualized and nonlinear periodized approach.

Первичные конечные точки

• Change in constant load exercise time [Срок оценки: 12-weeks]

Вторичные конечные точки (1)

• Change in health related quality of life (SF-36) [Срок оценки: 12-weeks]

Критерии участия

Критерии включения

• Signed informed consent
• At least 19 years of age
• ≥60 days prior to study enrollment, known or suspected infection that includes at least two of the following clinical criteria that together constitute a new bedside clinical score termed quickSOFA (qSOFA): respiratory rate >22breaths/min, altered mentation, or systolic blood pressure <100mmHg.
• Cardiorespiratory fitness <80% of age and sex-predicted norms
• Can commit to attending 3 exercise sessions a week for 12-weeks

Критерии исключения

• Unable to provide informed consent
• On supplemental oxygen
• Known previous cardiac or cerebral vascular events in the past 90 days
• Diabetes
• Autoimmune diseases or on daily immunomodulatory drugs
• Obstructive sleep apnea
• Uncontrolled hypertension
• Known pregnancy/ intending to get pregnant within 28 days of enrolling in the study or breastfeeding
• Desaturation during exercise SpO2<85%
• Cardiovascular contraindication or musculoskeletal limitations to exercise as assessed during the cardiopulmonary exercise test

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Канада · 1 центр

• St. Paul's Hospital - Centre for Heart Lung Innovation — Vancouver

Идентификаторы

NCT: NCT05784740 · H22-02879

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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