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

NCT07098923 | Completed

• 1 other identifier: XWRCHT20210038
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

exercise; resistance; peritoneal dialysis; blood pressure; cardiovascular system; Blood Pressure Variability

Outcome Measures

Primary Outcomes (4)

• 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.

  Baseline/12Weeks

• 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

  Baseline/12Weeks

• 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

  Baseline/12Weeks

• 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.

  Baseline/12Weeks

Secondary Outcomes (2)

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

  Baseline/12Weeks

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

  Baseline/12Weeks

Study Arms (2)

control group

NO INTERVENTION

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

Exercise group

EXPERIMENTAL

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

combination of aerobic and resistance exercise 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.

Also known as: Aerobic exercise, resistance exercise

Exercise group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Hospital of Xuzhou Medical University: lead

Study Sites (1)

The affiliated hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Motor Activity

Interventions

Exercise; Resistance Training

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: August 1, 2025
• Study Start: February 2, 2024
• Primary Completion: July 30, 2024
• Study Completion: October 16, 2024
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

CN (1)