Clinical trial NCT06568835: The Effect of Active Exercise on Maintenance Haemodialysis Patients
Official title: Effect of Active Exercise on Nutritional and Inflammatory Status, Muscle Metabolism and Cardiovascular Events in Maintenance Haemodialysis Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Renal Dialysis
Keywords: Exercise
Inflammation
Nutrition
Muscular Atrophy
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2024-08-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Active exercise group: patients were asked to choose walking (no less than 8000 steps per day) or low-intensity aerobic exercise such as jogging, swimming, Tai Chi, etc., according to their own conditions, for no less than 30 minutes each time, at least 3 times per week, and the intensity of the exercise was determined by the need to increase the frequency and depth of breathing during the exercise, and it was appropriate to feel slightly tired but not exhausted (RPE score 12-16).

Exercise intensity should be at least 3 times a week, and the exercise intensity should be at a level that requires an increase in breathing rate and depth, allowing for dialogue and communication, slight sweating, and a feeling of being slightly tired but not exhausted (RPE score of 12 to 16).

Control group: only receive conventional MHD treatment, no requirement for exercise.
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Mid-upper arm circumference of the non-internal fistula side（AC）
timeFrame: Baseline and half year, 1 year
measure: triceps skin-fold thickness of the non-internal fistula side（TSF）
timeFrame: Baseline and half year, 1 year
measure: upper arm muscle circumference of the non-internal fistula side（AMC）
timeFrame: Baseline and half year, 1 year
measure: calf circumference
timeFrame: Baseline and half year, 1 year
measure: grip strength
timeFrame: Baseline and half year, 1 year
measure: Incidence of cardiovascular and cerebrovascular events
timeFrame: 1 year
Secondary outcomes:
measure: prealbumin
timeFrame: Baseline and half year, 1 year
measure: albumin
timeFrame: Baseline and half year, 1 year
measure: haemoglobin
timeFrame: Baseline and half year, 1 year
measure: blood lipids
timeFrame: Baseline and half year, 1 year
measure: c-reactive protein
timeFrame: Baseline and half year, 1 year
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
References: