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The Effect of Active Exercise on Maintenance Haemodialysis Patients

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06568835
Enrollment
200
Registered
2024-08-23
Start date
2024-01-01
Completion date
2025-07-01
Last updated
2024-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Dialysis

Keywords

Exercise, Inflammation, Nutrition, Muscular Atrophy

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.

Interventions

BEHAVIORALexercise

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

Sponsors

Yunfeng Xia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of cardiovascular and cerebrovascular events1 yearCardiovascular events include: heart failure episodes, sustained arrhythmias, myocardial infarction, and cerebrovascular events include: cerebral haemorrhage, cerebral infarction, transient ischaemic attack.
Mid-upper arm circumference of the non-internal fistula side(AC)Baseline and half year, 1 yearMeasure the circumference of the non-internal fistula at the midpoint of the upper arm using a soft tape measure, in centimetres
triceps skin-fold thickness of the non-internal fistula side(TSF)Baseline and half year, 1 yearMeasurement of the skinfold at the midpoint of the upper arm on the non-internal fistula side by using a skinfold thickness gauge, in centimetres
upper arm muscle circumference of the non-internal fistula side(AMC)Baseline and half year, 1 yearAMC(cm)= AC(cm) - 3.14 x TSF(cm)
calf circumferenceBaseline and half year, 1 yearMeasure the calf circumference using a soft tape measure, in centimetres
grip strengthBaseline and half year, 1 yearUsing 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

Secondary

MeasureTime frameDescription
albuminBaseline and half year, 1 yearlaboratory measurement indicators:albumin(g/L)
haemoglobinBaseline and half year, 1 yearlaboratory measurement indicators:haemoglobin(g/L)
blood lipidsBaseline and half year, 1 yearlaboratory measurement indicators:triglycerides, cholesterol, low-density lipoprotein, high-density lipoprotein
c-reactive proteinBaseline and half year, 1 yearlaboratory measurement indicators:c-reactive protein(mg/L)
prealbuminBaseline and half year, 1 yearlaboratory measurement indicators:prealbumin(g/L)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026