The Effect of Active Exercise on Maintenance Haemodialysis Patients

Официальное название

Effect of Active Exercise on Nutritional and Inflammatory Status, Muscle Metabolism and Cardiovascular Events in Maintenance Haemodialysis Patients

Обзор

The goal of this clinical trial is to discuss the effects of physical activity on nutrition, inflammation, muscle metabolism, and the occurrence of cardiovascular and cerebrovascular events in patients with maintenance haemodialysis. The main question it aims to answer is: can exercise improve nutritional and inflammatory status, enhance muscle strength, and reduce the incidence of cardiovascular and cerebrovascular events in patients with maintenance haemodialysis. Researchers will compared active exercise group to conventional treatment group to see the impact of exercise on maintenance haemodialysis patients. Participants will: Choose low-intensity aerobic exercise workouts such as walking (no less than 8,000 steps per day) or jogging, swimming, Tai Chi, etc., according to their individual conditions, for no less than 30 minutes at a time, at least 3 times per week, and the intensity of the exercise should be based on an RPE score of 12 to 16.

Подробное описание

RPE: Rating of Perceived Exertion. RPE scores of 12 to 16 indicate the need for increased respiratory rate and depth during exercise, the ability to engage in conversational exchanges, light sweating, and a feeling of slight fatigue without reaching a state of exhaustion.

Вмешательства

• Поведенческое exercise
  such as walking, jogging, swimming, Tai Chi, etc. It needs to be at a certain frequency and intensity

Первичные конечные точки

• Mid-upper arm circumference of the non-internal fistula side（AC） [Срок оценки: Baseline and half year, 1 year]
• triceps skin-fold thickness of the non-internal fistula side（TSF） [Срок оценки: Baseline and half year, 1 year]
• upper arm muscle circumference of the non-internal fistula side（AMC） [Срок оценки: Baseline and half year, 1 year]
• calf circumference [Срок оценки: Baseline and half year, 1 year]
• grip strength [Срок оценки: Baseline and half year, 1 year]
• Incidence of cardiovascular and cerebrovascular events [Срок оценки: 1 year]

Вторичные конечные точки (5)

• prealbumin [Срок оценки: Baseline and half year, 1 year]
• albumin [Срок оценки: Baseline and half year, 1 year]
• haemoglobin [Срок оценки: Baseline and half year, 1 year]
• blood lipids [Срок оценки: Baseline and half year, 1 year]
• c-reactive protein [Срок оценки: Baseline and half year, 1 year]

Критерии участия

Критерии включения

• MHD more than 3 months, 3 times per week, 3-4h each time;
• Urea clearance index (Kt/V) >1.2;
• Stable condition, no serious infection, tumour and cardiovascular disease;
• Willing to join the study and sign the informed consent form.

Критерии исключения

• Combined with serious heart and lung disease: such as repeated heart failure, severe arrhythmia, unstable angina pectoris, severe pericardial effusion, severe heart valve disease, hypertrophic cardiomyopathy, aortic coarctation, severe emphysema, pulmonary heart disease, severe pulmonary hypertension (average pressure of the pulmonary artery > 55mmHg), etc.;
• Combined with chronic joints, muscles, or vascular disease can not be or is not suitable for regular exercise, such as cerebrovascular disease; combined chronic joint, muscle or vascular disease can not or are not suitable for regular exercise, such as cerebrovascular disease sequelae, serious lower limb joint damage, severe myopathy, deep vein thrombosis, etc.;
• unwilling to cooperate with the movement of people

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

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Chongqing Medical University — Чунцин

Идентификаторы

NCT: NCT06568835 · First ChongQing MU

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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