The Effect of Active Exercise on Maintenance Haemodialysis Patients
NCT Number: NCT06568835
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Renal Dialysis
Interventions: BEHAVIORAL: exercise
Sponsor: Yunfeng Xia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-01-01
Completion Date: 2025-07-01
Locations: The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, 400016, China

Summary:
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.

Primary Outcome Measures: Mid-upper arm circumference of the non-internal fistula side（AC）, Measure the circumference of the non-internal fistula at the midpoint of the upper arm using a soft tape measure, in centimetres, Baseline and half year, 1 year|triceps skin-fold thickness of the non-internal fistula side（TSF）, Measurement of the skinfold at the midpoint of the upper arm on the non-internal fistula side by using a skinfold thickness gauge, in centimetres, Baseline and half year, 1 year|upper arm muscle circumference of the non-internal fistula side（AMC）, AMC（cm）= AC(cm) - 3.14 x TSF（cm）, Baseline and half year, 1 year|calf circumference, Measure the calf circumference using a soft tape measure, in centimetres, Baseline and half year, 1 year|grip strength, Using a grip strength meter, with the patient seated and gripping the handle firmly with the palm of the non-internal fistulae side, measure twice and record the maximum grip strength value, Baseline and half year, 1 year|Incidence of cardiovascular and cerebrovascular events, Cardiovascular events include: heart failure episodes, sustained arrhythmias, myocardial infarction, and cerebrovascular events include: cerebral haemorrhage, cerebral infarction, transient ischaemic attack., 1 year
Secondary Outcome Measures: prealbumin, laboratory measurement indicators:prealbumin(g/L), Baseline and half year, 1 year|albumin, laboratory measurement indicators:albumin(g/L), Baseline and half year, 1 year|haemoglobin, laboratory measurement indicators:haemoglobin(g/L), Baseline and half year, 1 year|blood lipids, laboratory measurement indicators:triglycerides, cholesterol, low-density lipoprotein, high-density lipoprotein, Baseline and half year, 1 year|c-reactive protein, laboratory measurement indicators:c-reactive protein(mg/L), Baseline and half year, 1 year