CKD (Chronic Kidney Disease) Stage 5DNCT07098923
The Effect of Exercise on Blood Pressure Variability on Peritoneal Dialysis Patients
A study testing combination of aerobic and resistance exercise in people with CKD (Chronic Kidney Disease) Stage 5D and Peritoneal Dialysis (PD), run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- CKD (Chronic Kidney Disease) Stage 5D, Peritoneal Dialysis (PD)
- What is being tested?
- combination of aerobic and resistance exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 2 Feb 2024to 16 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The affiliated hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
About this study
Official title: The Effect of Combined Aerobic and Resistance Exercise on Blood Pressure Variability on Peritoneal Dialysis Patients
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.
- Being tested
- combination of aerobic and resistance exercise
- Keywords
- exercise, resistance, peritoneal dialysis, blood pressure, cardiovascular system, Blood Pressure Variability
- Medical subject headings
- Renal Insufficiency, Chronic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combination of aerobic and resistance exerciseBehavioural
Also called Aerobic exercise, 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: combination of aerobic and resistance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Change in the Coefficient of Variation of 24 Hours Systolic Blood Pressure as assessed by Ambulatory Blood Pressure Monitoring.
Measured: Baseline/12Weeks
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.
Measured: Baseline/12Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start2 Feb 2024
- Primary completion30 Jul 2024
- Study completion16 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CKD (Chronic Kidney Disease) Stage 5DStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Sun, The Affiliated Hospital of Xuzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07098923
- Sponsor's protocol ID
- XWRCHT20210038
- Status last verified
- Jul 2025
- First submitted
- 23 Jul 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Combined Aerobic and Resistance Exercise on Blood Pressure Variability on Peritoneal Dialysis Patients
- ClinicalTrials.gov ID
- NCT07098923
- Acronym / sponsor ID
- XWRCHT20210038
- Keywords
- exercise, resistance, peritoneal dialysis, blood pressure, cardiovascular system, Blood Pressure Variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 16 Oct 2024 (actual)
- First posted
- 1 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: combination of aerobic and resistance exerciseRoutine 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| combination of aerobic and resistance exerciseAlso: Aerobic exercise, resistance exerciseAerobic 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. | Behavioural | Exercise group |
Primary outcome
Difference between the coefficient of variation of mean daytime Systolic Blood Pressure from the baseline to the end of the study
Time frame: Baseline/12Weeks
Change in the coefficient of variation of mean daytime Systolic Blood Pressure as assessed by Ambulatory Blood Pressure Monitoring.
Difference between the Coefficient of variation of mean daytime Diastolic Blood Pressure from the baseline to the end of the study
Time frame: Baseline/12Weeks
Change in the Coefficient of variation of mean daytime Diastolic Blood Pressure as assessed by Ambulatory Blood Pressure Monitoring
Difference between the Coefficient of Variation of mean nighttime Systolic Blood Pressure from the baseline to the end of the study
Time frame: Baseline/12Weeks
Change in the Coefficient of Variation of mean nighttime Systolic Blood Pressure as assessed by Ambulatory Blood Pressure Monitoring
Difference between the Coefficient of Variation of mean nighttime Diastolic Blood Pressure from the baseline to the end of the study
Time frame: Baseline/12Weeks
Change in the Coefficient of Variation of mean nighttime Diastolic Blood Pressure as assessed by Ambulatory Blood Pressure Monitoring.
2 secondary outcomes
Difference between the Coefficient of Variation of 24 Hours Systolic Blood Pressure from the baseline to the end of the study
Time frame: Baseline/12Weeks
Difference between the Coefficient of Variation of 24 Hours Diastolic Blood Pressure from the baseline to the end of the study
Time frame: Baseline/12Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combination of aerobic and resistance exercise in people with CKD (Chronic Kidney Disease) Stage 5D and Peritoneal Dialysis (PD), run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between the coefficient of variation of mean daytime Systolic Blood Pressure from the baseline to the end of the study (time frame: Baseline/12Weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025; AzTrials last refreshed its copy on 6 Nov 2026.