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Clinical Trials/NCT06568835
NCT06568835
Recruiting
Not Applicable

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

Yunfeng Xia1 site in 1 country200 target enrollmentJanuary 1, 2024
ConditionsRenal Dialysis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Renal Dialysis
Sponsor
Yunfeng Xia
Enrollment
200
Locations
1
Primary Endpoint
Mid-upper arm circumference of the non-internal fistula side(AC)
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2024
End Date
July 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Yunfeng Xia
Responsible Party
Sponsor Investigator
Principal Investigator

Yunfeng Xia

Doctor

First Affiliated Hospital of Chongqing Medical University

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

Outcomes

Primary Outcomes

Mid-upper arm circumference of the non-internal fistula side(AC)

Time Frame: Baseline and half year, 1 year

Measure the circumference of the non-internal fistula at the midpoint of the upper arm using a soft tape measure, in centimetres

upper arm muscle circumference of the non-internal fistula side(AMC)

Time Frame: Baseline and half year, 1 year

AMC(cm)= AC(cm) - 3.14 x TSF(cm)

grip strength

Time Frame: Baseline and half year, 1 year

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

triceps skin-fold thickness of the non-internal fistula side(TSF)

Time Frame: Baseline and half year, 1 year

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

Incidence of cardiovascular and cerebrovascular events

Time Frame: 1 year

Cardiovascular events include: heart failure episodes, sustained arrhythmias, myocardial infarction, and cerebrovascular events include: cerebral haemorrhage, cerebral infarction, transient ischaemic attack.

calf circumference

Time Frame: Baseline and half year, 1 year

Measure the calf circumference using a soft tape measure, in centimetres

Secondary Outcomes

  • albumin(Baseline and half year, 1 year)
  • c-reactive protein(Baseline and half year, 1 year)
  • haemoglobin(Baseline and half year, 1 year)
  • blood lipids(Baseline and half year, 1 year)
  • prealbumin(Baseline and half year, 1 year)

Study Sites (1)

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