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RecruitingNCT06568835Updated Aug 23, 2024

The Effect of Active Exercise on Maintenance Haemodialysis Patients

An interventional study of exercise in Renal Dialysis, sponsored by Yunfeng Xia. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-08-23.

Primary conditionMotor Activity(the registry's first term)UnverifiedIs this wrong?Motor Activity is a broad heading, used only when no more specific condition is named. No better condition is named, so the registry's term is kept.

Sponsored by Yunfeng Xia · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 4 months ago, but the record still lists the study as recruiting.
  • Registered 6 months after the study started (first participant enrolled Jan 2024, registered Jul 2024).
  • Started Jan 2024; still recruiting 2 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Renal Dialysis

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Keywords

  • Exercise
  • Inflammation
  • Nutrition
  • Muscular Atrophy
03

In context

Motor Activity Unverified

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

This study's planned enrollment of 200 is above the median of 60 across 8,388 interventional studies indexed under Motor Activity.

Browse Motor Activity studies →

Lead sponsor

Yunfeng Xia is the lead sponsor of 4 studies on the registry; 3 are open to participants now.

Compared within Motor Activity, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form.

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    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).

    Behavioral: exercise

  • No intervention
    Control group

    only receive conventional MHD treatment, no requirement for exercise.

Interventions

  • Behavioralexercise

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline and half year, 1 year

  2. 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

    Time frame: Baseline and half year, 1 year

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

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

    Time frame: Baseline and half year, 1 year

  4. calf circumference

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

    Time frame: Baseline and half year, 1 year

  5. 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

    Time frame: Baseline and half year, 1 year

  6. 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.

    Time frame: 1 year

Secondary outcomes

  1. prealbumin

    laboratory measurement indicators:prealbumin(g/L)

    Time frame: Baseline and half year, 1 year

  2. albumin

    laboratory measurement indicators:albumin(g/L)

    Time frame: Baseline and half year, 1 year

  3. haemoglobin

    laboratory measurement indicators:haemoglobin(g/L)

    Time frame: Baseline and half year, 1 year

  4. blood lipids

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

    Time frame: Baseline and half year, 1 year

  5. c-reactive protein

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

    Time frame: Baseline and half year, 1 year

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06568835
Lead sponsor
Yunfeng Xia
Responsible party
Yunfeng Xia (Doctor, First Affiliated Hospital of Chongqing Medical University) — Sponsor-investigator
First posted
Aug 23, 2024
Start date
Jan 1, 2024
Primary completion
Jul 1, 2025 (estimated)
Completion
Jul 1, 2025 (estimated)
Last update
Aug 23, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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