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

NCT ID: NCT07098923

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-02
• Study Completion Date: 2024-10-16

Brief 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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

combination of aerobic and resistance exercise

Intervention Type: BEHAVIORAL

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.

Interventions

combination 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Aerobic exercise; resistance exercise

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Hospital of Xuzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Dong Sun

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The affiliated hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Countries

China

Other Identifiers

XWRCHT20210038

Identifier Type: -

Identifier Source: org_study_id