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NCT Number: NCT06568835

The Effect of Active Exercise on Maintenance Haemodialysis Patients

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location status: Recruiting

Location contact

Yunfeng Xia, Dr.

CONTACT

[email protected]

86-23-89012256

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

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

Primary outcomes

  1. 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

  2. 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

  3. 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)

  4. calf circumference

    Time frame: Baseline and half year, 1 year

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

  5. 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

  6. 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.

Secondary outcomes

  1. prealbumin

    Time frame: Baseline and half year, 1 year

    laboratory measurement indicators:prealbumin(g/L)

  2. albumin

    Time frame: Baseline and half year, 1 year

    laboratory measurement indicators:albumin(g/L)

  3. haemoglobin

    Time frame: Baseline and half year, 1 year

    laboratory measurement indicators:haemoglobin(g/L)

  4. blood lipids

    Time frame: Baseline and half year, 1 year

    laboratory measurement indicators:triglycerides, cholesterol, low-density lipoprotein, high-density lipoprotein

  5. c-reactive protein

    Time frame: Baseline and half year, 1 year

    laboratory measurement indicators:c-reactive protein(mg/L)

Sponsors and collaborators

Lead sponsor

Yunfeng Xia

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 23, 2024
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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