Идёт набор NCT06374537

Evaluate the Impact of Targeted Physical Activity on Clinically Debilitated Dialysis Patients.

Без фазы С лечением Frailty Pain, Chronic Dialysis; Complications Kidney Diseases

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: Muscle Therapy.
Кому может быть актуально: Состояния в реестре: Frailty, Pain, Chronic, Dialysis; Complications, Kidney Diseases. 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

Evaluating the Impact of Targeted Physical Activity on Clinically Debilitated Dialysis Patients.

Обзор

This research is being done to better understand the impact of the use of a specific physical activity training program (GH Method) in dialysis/kidney disease patients.

Подробное описание

The 12-Month Randomized Trial Group will include a total of 150 patients from UI Health (≥ 18 years of age), who are on dialysis, or have chronic kidney disease stage 4 (CKD 4 = GFR between 15 and 29) or have chronic kidney disease stage 5 (CKD 5 = GFR below 15) and are considered clinically debilitated by their direct healthcare professional will be enrolled. Randomization will be a 2:1 ratio (100 intervention, 50 control). The intervention arm will perform a 12-month exercise intervention which involves two days a week of personalized exercise rehabilitation. The control arm will receive no exercise intervention. Both arms of patients will be tested on various measures of health and function both at baseline (prior to intervention) at 6 months, and at 12 months (post intervention). This study will also investigate the effects of an exercise intervention on a subgroup of pre- and post- kidney transplant patients (PPKT Subgroup). This subgroup will include a total of 100 patients (≥ 18 years of age), who are on dialysis, or have CKD stage 4 or 5, and are considered clinically debilitated by their direct healthcare professional will be enrolled, or post- renal (kidney) transplant. This subgroup will perform 36 visits of exercise intervention which involves two days a week of personalized exercise rehabilitation. The Investigator will also utilize validated surveys and assessment tools to assess health issue management and depression severity.

Вмешательства

Другое Muscle Therapy
Participants will attend 2 muscle therapy sessions a week for 12 months, for one hour each.

Первичные конечные точки

Rate at which subjects will see changes in their physical abilities. [Срок оценки: 12 months]

Вторичные конечные точки (6)

Rate at which exercise will change body composition [Срок оценки: 12 months]
Rate at which exercise will change handgrip strength. [Срок оценки: 12 months]
Rate at which subjects enrolled in the exercise intervention will have an overall changed sense of well-being. [Срок оценки: 12 months]
Rate at which subjects enrolled in the exercise intervention will have an overall changed in their quality of life. [Срок оценки: 12 months]
Rate at which subjects enrolled in the exercise intervention will have an overall decreased change in depression. [Срок оценки: 12 months]
Rate at which subjects enrolled in the exercise intervention will have an overall change in pain intensity. [Срок оценки: 12 months]

Критерии участия

Критерии включения

Clinically debilitated patients, currently on dialysis, or have CKD 4 (GFR between 15 and 29), or have CKD 5 (GFR below 15), or post- kidney transplant (for PPKT Subgroup only) as stated by patient's health care professional.
Adequate cognitive ability to complete the questionnaires, give consent for the study and follow the physical and diet instructions