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CompletedNCT07098923Updated Aug 1, 2025

The Effect of Exercise on Blood Pressure Variability on Peritoneal Dialysis Patients

An interventional study of combination of aerobic and resistance exercise in CKD (Chronic Kidney Disease) Stage 5D and Peritoneal Dialysis (PD), sponsored by The Affiliated Hospital of Xuzhou Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-08-01.

Sponsored by The Affiliated Hospital of Xuzhou Medical University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Feb 2024, registered Jul 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
55
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

In China, the chronic kidney disease (CKD) incidence rate is as high as 10.8%. Renal replacement therapy plays an critical role in the later stage of CKD and becomes mandatory, as end-stage renal disease (ESRD) is unavoidable in progressive CKD. Peritoneal dialysis (PD) has becoming an essential alternative treatment for patient with end-stage renal disease (ESRD). Hypertension is common among ESRD patients receiving PD treatment, with a prevalence rate of 80% -90%, It is major cause for cardiovascular related complications and deaths among ESRD patients. Therefore hypertension increases the cardiovascular disease risk among the patients of ESRD and at the same time plays an independent risk for the progression of ESRD. Most studies uses average blood pressure as a risk indicator, but in recent years, more evidence has shown that blood pressure variability (BPV), the degree of fluctuation of blood pressure for a long period, is an additional risk factors for cardiovascular events.

Read the detailed description

Cardiovascular events can be well predicted by Blood pressure variability (BPV) and is positively correlated with cardiovascular mortality, making it more informative than average blood pressure. BPV is also an excellent predictor of renal dysfunction and is significantly linked with the advancing renal insufficiency in CKD patients. Therefore, reducing BPV has important clinical significance for PD patients. At present, the research studies on impact of BPV in PD patients is very much limited, especially on the exercise impact on BPV in PD patients. Generally speaking the average physical activity in PD patients are well decreased. Low amount of exercise is correlated to high incidence rate and mortality of cardiovascular complication, depression, muscle atrophy, and eventually decreased quality of life. Relevant guidelines recommend that PD patients should engage in appropriate physical exercise to improve the outcome. Therefore, the purpose of this study is to investigate the effect of 12 week combined aerobic and resistance exercise on BPV in PD patients, in order to provide reference point for clinical practice.

02

Conditions studied

  • CKD (Chronic Kidney Disease) Stage 5D
  • Peritoneal Dialysis (PD)

Keywords

  • exercise
  • resistance
  • peritoneal dialysis
  • blood pressure
  • cardiovascular system
  • Blood Pressure Variability
03

In context

Renal Insufficiency, Chronic

3,144 studies on the registry are indexed under Renal Insufficiency, Chronic; 704 are open to participants now.

This study's enrollment of 55 is below the median of 74 across 2,176 interventional studies indexed under Renal Insufficiency, Chronic.

Browse Renal Insufficiency, Chronic studies →

Lead sponsor

The Affiliated Hospital of Xuzhou Medical University is the lead sponsor of 66 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Inclusion criteria

  • Dialysis time ≥ 3 months, a stable condition;
  • Age ≥ 18 years old;
  • Hypertension (blood pressure>140 and/or 90 mmHg or currently under antihypertensive drugs), antihypertensive drugs was not changed or replaced during the complete trial;
  • Patients with regular and sufficient peritoneal dialysis with kt/v>1.7, high compliance, and voluntary participation.

Exclusion criteria

Exclusion Criteria:

  • Blood pressure more than - systolic blood pressure ≥ 180mmHg, diastolic blood pressure ≥ 110mmHg;
  • Severe anaemia Hb ≤ 60g;
  • Cardiac function Class IV - In accordance with The New York Heart Association classification system, patients with severe cardiac disease resulting in inability to perform any physical activity without discomfort (If any physical activity is undertaken, discomfort is increased) or symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest.
  • Using erythropoietin;
  • There have been recent acute cardiovascular and cerebrovascular events, including vascular embolism, surgery, trauma, etc.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Investigator)
Enrollment
55 participants (actual)

Study arms

  • No intervention
    control group

    Routine peritoneal dialysis care, health education, daily activity guidance, and dietary counseling were provided in accordance with the dietary guidelines for chronic kidney disease

  • Experimental
    Exercise group

    Routine peritoneal dialysis care, health education, daily activity guidance, and dietary counseling were provided in a manner consistent with the care given to the control group-to avoid performance bias. In addition to routine basic care and treatment, the exercise group performed a combination of aerobic and resistance exercise

    Behavioral: combination of aerobic and resistance exercise

Interventions

  • Behavioralcombination of aerobic and resistance exercise

    Aerobic exercise: The main form is walking(gait), which includes three parts: warm-up, walking, and relaxation. Exercise time and frequency: 30-60 minutes of exercise per day, 3-5 times per week. Resistance exercise: Mainly uses elastic bands to enhance resistance exercise, since the risks of increased intra-abdominal pressure and fluid leakage in peritoneal dialysis patients is high, Investigator considered selective resistance exercise especially for limb and shoulder joint exercises. Patients can choose 3-5 muscle groups based on individual conditions, with each action 10-15 times and maintained for 10 seconds. Start with 2 sets of resistance exercise and then gradually increase to 3-5 sets, with 2-3 minutes of rest between each sets. Exercise frequency and duration: 2 times a week (non-consecutive days), 20 minutes each time.

    Also known as: Aerobic exercise, resistance exercise

06

What researchers measure

Primary outcomes

  1. Difference between the coefficient of variation of mean daytime Systolic Blood Pressure from the baseline to the end of the study

    Change in the coefficient of variation of mean daytime Systolic Blood Pressure as assessed by Ambulatory Blood Pressure Monitoring.

    Time frame: Baseline/12Weeks

  2. Difference between the Coefficient of variation of mean daytime Diastolic Blood Pressure from the baseline to the end of the study

    Change in the Coefficient of variation of mean daytime Diastolic Blood Pressure as assessed by Ambulatory Blood Pressure Monitoring

    Time frame: Baseline/12Weeks

  3. Difference between the Coefficient of Variation of mean nighttime Systolic Blood Pressure from the baseline to the end of the study

    Change in the Coefficient of Variation of mean nighttime Systolic Blood Pressure as assessed by Ambulatory Blood Pressure Monitoring

    Time frame: Baseline/12Weeks

  4. Difference between the Coefficient of Variation of mean nighttime Diastolic Blood Pressure from the baseline to the end of the study

    Change in the Coefficient of Variation of mean nighttime Diastolic Blood Pressure as assessed by Ambulatory Blood Pressure Monitoring.

    Time frame: Baseline/12Weeks

Secondary outcomes

  1. Difference between the Coefficient of Variation of 24 Hours Systolic Blood Pressure from the baseline to the end of the study

    Change in the Coefficient of Variation of 24 Hours Systolic Blood Pressure as assessed by Ambulatory Blood Pressure Monitoring.

    Time frame: Baseline/12Weeks

  2. Difference between the Coefficient of Variation of 24 Hours Diastolic Blood Pressure from the baseline to the end of the study

    Change in the Coefficient of Variation of 24 Hours Diastolic Blood Pressure as assessed by Ambulatory Blood Pressure Monitoring.

    Time frame: Baseline/12Weeks

07

Study locations

1 site
  • The affiliated hospital of Xuzhou Medical University
    Xuzhou, Jiangsu 221000, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07098923
Lead sponsor
The Affiliated Hospital of Xuzhou Medical University
Responsible party
Dong Sun (Clinical Professor, The Affiliated Hospital of Xuzhou Medical University) — Principal investigator
First posted
Aug 1, 2025
Start date
Feb 2, 2024
Primary completion
Jul 30, 2024
Completion
Oct 16, 2024
Last update
Aug 1, 2025

Oversight

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

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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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