Идёт набор NCT03954678

Exercise in Patients Undergoing Urologic Surgery

Без фазы С лечением Perioperative Complication

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Exercise Group, Nutrition Group.
Кому может быть актуально: Состояния в реестре: Perioperative Complication. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Prospective Randomized Study of Exercise in Patients Undergoing Urologic Surgery

Обзор

Patients who are being scheduled for an operative procedure with an inpatient postoperative stay are eligible for this study. Participants will be selected to start a physical fitness plan or a nutrition plan at the time of surgical scheduling. Each participant will be asked to continue their current lifestyle for two days after their pre-operative appointment to get a baseline of activity (by pedometer and functional tests) and nutritional risk (by questionnaire). After two days, patients in the activity group will start their activity plans. They will be encouraged to get 10,000 steps per day and to perform whole body strength training exercises 3 times a week. Five days before and after surgery, participants in the nutrition group will be asked to consume a standard liquid nutrition supplement (i.e. Boost or Ensure) two times per day. Participants in the activity group will record steps and number of strength training sessions completed, while patients in the nutrition group will record the number of supplements consumed.

Подробное описание

Increases in physical activity and nutritional status are associated with improvements in a number of health conditions, including coronary artery disease, hypertension, stroke, insulin sensitivity, osteoporosis, and depression. Regretfully, despite the evidence supporting the benefits of physical activity, greater than half of adults in the United States do not get adequate activity and approximately one quarter do not get any activity. As such, many people, especially the elderly and those with comorbid diseases, have low levels of physical fitness. Additionally, up to 45% of community dwelling older adults are malnourished. Patients undergoing surgery with poor exercise tolerance and suboptimal nutritional status may be at an increased risk of perioperative complications. Thus, increasing physical activity and dietary intake quality prior to surgery is recommended, to hopefully decrease these risks. The primary objective is to determine if recommended physical activity or dietary intake results in an increase in patient physical function performance and if so, to what extent. The secondary goal is to examine if increased exercise or nutrition reduces perioperative complications.

Вмешательства

Поведенческое Exercise Group
For the first two days after their pre-operative visit, participants will be asked to continue their present level of exercise and activity, which will be monitored by pedometer. Participants will begin the activity intervention on study Day 3. Participants will be instructed to take 10,000 steps per day, recording their daily steps with a pedometer. Participants also will be provided with resistance bands and instructed on how to safely perform 10 whole-body strength training exercises. They wi
Пищевая добавка Nutrition Group
Participants in the nutrition group will be provided with a liquid over-the-counter nutrition supplement (i.e. Boost or Ensure) to consume. Participants will be instructed to consume 1 bottle, 2 times per day, beginning 5 days before surgery and continuing 5 days post-operatively.

Первичные конечные точки

Change in Body Mass Index (BMI) [Срок оценки: Baseline, Day of surgery (up to 50 days after Baseline), Follow-up (30 days after surgery)]
Change in Standing Task Time [Срок оценки: Baseline, Day of surgery (up to 50 days after Baseline), Follow-up (30 days after surgery)]
Change in 6 Minute Walk Test (6MWT) Distance [Срок оценки: Baseline, Day of surgery (up to 50 days after Baseline), Follow-up (30 days after surgery)]
Change in grip strength [Срок оценки: Baseline, Day of surgery (up to 50 days after Baseline), Follow-up (30 days after surgery)]
Change in Timed Up and Go (TUG) Task [Срок оценки: Baseline, Day of surgery (up to 50 days after Baseline), Follow-up (30 days after surgery)]
Change in Short-Length Food Frequency Questionnaire [Срок оценки: Baseline, Day of surgery (up to 50 days after Baseline), Follow-up (30 days after surgery)]

Вторичные конечные точки (1)

Perioperative Complications [Срок оценки: 30 days after surgery]

Критерии участия

Критерии включения

Patients scheduled for operative procedure with an inpatient postoperative stay are eligible for this study
Patients willing and able to give blood sample as part of standard of care labs
Patients willing and able to fill out questionnaire
Patients who will fill out the step log daily
Patients willing and able to sign informed consent