Kidney Failure, ChronicNCT05718765
The Effect of Physical ACtivity Enhancement Scheme (PACES) in Hemodialysis Patients
A study testing PACES intervention in people with Kidney Failure, Chronic and Exercise, run by Xi'an Jiaotong University at 1 site in China.
Trial summary
Hemodialysis is the most commonly used renal replacement therapy for end-stage renal disease (ESRD) patients. At present, more than 553,000 ESRD patients in China are receiving hemodialysis treatment, but the long-term survival rate is low, and the annual mortality rate is as high as 18%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic, Exercise, Physical Activity
- What is being tested?
- PACES intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2022to 10 Jan 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult (age≥18) with stable ESRD;
- receiving≥3 months HD;
- receiving HD more than 5 times every two weeks;
- volunteer for participating in this investigation.
Who cannot join
- are unable to do walk on one's own (severe musculoskeletal pain at rest or with minimal activity precluding walking or stationary cycling; unable to sit, stand or walk unassisted, walking devices such as cane or walker allowed);
- have shortness of breath at rest or with activities of daily living (NYHA Class IV);
- have mental disease, disturbance of consciousness and couldn't cooperate with this investigation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Physical ACtivity Enhancement Scheme (PACES) on Physical Outcomes in Hemodialysis Patients
Hemodialysis is the most commonly used renal replacement therapy for end-stage renal disease (ESRD) patients. At present, more than 553,000 ESRD patients in China are receiving hemodialysis treatment, but the long-term survival rate is low, and the annual mortality rate is as high as 18%. This is significantly related to lower physical activity in hemodialysis patients. Physical inactivity can lead to the decline of cardiopulmonary function and muscle function, the aggravation of daily life restriction and the increased risk of death. The National Kidney Foundation Disease Outcomes Quality Initiative (K/DOQI) recommends physical activity as cornerstone of ESRD rehabilitation. But hemodialysis patients are still living in a physical inactivity state. In the early stage of this study, the Physical Activity Enhancement Scheme (PACES) was developed for hemodialysis patients, that is, taking spaces as the core of physical activity investigation, and encouraging patients to start to improve physical activity. The PACES has been registered on the ClinicalTrials.gov before (number: NCT05189795).
The investigators now plan to evaluate the impact of PACES on physical activity of hemodialysis patients through clinical trials.
- Conditions
- Kidney Failure, Chronic, Exercise, Physical Activity, Renal Dialysis
- Being tested
- PACES intervention, Usual care with sham intervention
- Keywords
- End-Stage Renal Disease, Exercise, Physical Activity, Hemodialysis
- Medical subject headings
- Kidney Failure, Chronic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PACES interventionBehavioural
The exercise perception intervention program is divided into three stage, and every four weeks is a stage. The theme of the first stage is to make the patient have the intention to exercise. The theme of the second stage is to provide effective support for the patient, so that the patient can take the initiative to start exercise. The theme of the third stage is to enable patients to keep exercising.
The exercise intervention is a 12-week progressive intradialytic combined cycling exercise which proceed in the first HD 2 hours for safety. Each session consisted of a 5-minute warm-up, cool-down and 30-minute cycling at a Rating of Perceived Exertion (RPE) of 12-14. The machine has two exercise types including aerobic exercise and resistance exercise. Every four weeks is divided into a stage. And the time of aerobic exercise and resistance exercise were personally adjusted per stage to maintain the personalized target RPE.
Usual care with sham interventionOther
Patients in the control group received usual care and were advised to do sham exercise such as stretch legs and arms about 15 minutes during the first 2 hemodialysis hours.
| Study group | Role | What they receive |
|---|---|---|
| Usual care with sham intervention | Sham comparator | Patients in the control group received usual care with sham exercise. Receives: Other: Usual care with sham intervention |
| PACES intervention | Experimental | PACES includes an exercise perception intervention and an exercise intervention, which lasts for 12 weeks and is carried out simultaneously. Receives: Behavioral: PACES intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
daily steps (paces)
OMRON electronic pedometer (HJ-321) records the participants' daily steps. Participants are instructed to wear the pedometer on their waist for 7 days, and the pedometer is removed only during rest, bathing and swimming.
Measured: Change from daily steps at 12 weeks.
The Human Activity Profile (HAP)
HAP is a questionnaire designed to assess general physical activity. It consists of a list of 94 activities ranked in ascending order of level of energy required to perform each activity. Two scores are available from the HAP: a maximum activity score (MAS), reflective of the most taxing activity a respondent is still performing and an adjusted activity score (AAS), reflective of the respondent's daily activity level. The MAS is the number of the highest ranked activity the respondent is still performing. The AAS is calculated by subtracting from the MAS the number of activities that the respondent has stopped performing that rank below the participants' most metabolically intense activity. The minimum and maximum values of MAS and AAS are 0 and 94 respectively. The higher the score, the stronger the physical activity of the patient.
Measured: Change from HAP 12 weeks.
Secondary outcomes (15)
Dialysis Patient-perceived Exercise Benefits and Barriers Scale (DPEBBS)
The 24-item DPEBBS is used to evaluate participants' perceived benefits and barriers to exercise. The scale consisted of 24 items and 2 open questions, including 12 items of exercise benefits and 12 items of exercise barriers. Total scores ranged from 24 to 96. The higher the score, the more exercise benefits the patients experienced and the fewer factors that prevented them from exercise.
Measured: DPEBBS is measured at baseline (before intervention) and after 12 weeks of intervention.
Self-efficacy for exercise scale (SEE)
SEE is used to identify the participants' confidence in their ability to exercise, which is a major determinant in the success of changing behavior. The score ranges from 0 to 100, and the higher the score, the higher the level of self-efficacy.
Measured: SEE is measured at baseline (before intervention) and after 12 weeks of intervention.
Social support Rating Scale (SSRS)
Participants' social support status is measured by the SSRS. The scale has 10 items, including 3 aspects, objective support, subjective support and utilization of social support. The total score is the sum of points for each item. The higher the score is, the higher the degree of social support is. The scale scores range from 12 to 66, with ≤22 being low, 23 to 44 medium, and 45 to 66 high.
Measured: SSRS is measured at baseline (before intervention) and after 12 weeks of intervention.
Stage of Change Questionnaire
The questionnaire identifies the participants' state of readiness to adopt a more active lifestyle according to the Health Action Process Approach. The higher the stage, the better the readiness of the participants.
Measured: The questionnaire is measured at baseline (before intervention) and after 12 weeks of intervention.
Kidney Disease Quality of Life (KDQOL-36)
KDQOL-36, consisted of the 12-item Short Form Health Survey (SF-12) including the physical component summary (PCS) and the mental component summary (MCS) and 24 disease-specific items which entail 3 subscales: the symptom and problems list, the burden of kidney disease, and the effects of kidney disease, is to evaluate patients' QoL. Scores of each dimension range from 0 to 100 and higher scores represent better QoL.
Measured: KDQOL-36 is measured at baseline (before intervention) and after 12 weeks of intervention.
Glomerular filtration rate (GFR)
GFR is estimated by the using the CKD-EPI creatinine equation.
Measured: GFR is measured at baseline (before intervention) and after 12 weeks of intervention.
Serum levels of IL-6
Serum levels of IL-6 is measured using immunoassay kit (DuoSet ELISA Development, R\&D Systems, Inc., USA). Blood samples are drawn after an overnight fast of at least 12 hour. The last blood collection will be performed 48 h after the last exercise session, to avoid acute effects of the exercise influencing inflammatory and oxidative stress markers. These methods will follow the manufacturer's recommendations.
Measured: Serum levels of IL-6 is measured at baseline (before intervention) and after 12 weeks of intervention.
C-reactive protein (CRP)
CRP is evaluated as an index of catabolism and systemic inflammation using a high-sensitivity assay.
Measured: CRP is measured at baseline (before intervention) and after 12 weeks of intervention.
Serum creatinine
Serum creatinine is evaluated as an index of catabolism and systemic inflammation.
Measured: Serum creatinine is measured at baseline (before intervention) and after 12 weeks of intervention.
sit-to-stand tests 10 (STS-10)
The sit-to-stand tests 10(STS-10) is a test that assesses the capacity to stand up from a chair. The STS-10 is calculated as the total time needed to complete 10 repetitions of standing up and sitting down again.
Measured: STS-10 is measured at baseline (before intervention) and after 12 weeks of intervention.
sit-to-stand tests 60 (STS-60)
The sit-to-stand tests 60 (STS-60) is a test that assesses the capacity to stand up from a chair. The STS-60 registers the repetitions performed in 60 seconds.
Measured: STS-60 is measured at baseline (before intervention) and after 12 weeks of intervention.
Six-minute walk test (6MWT)
6MWT is commonly used to assess walking capacity in patients with chronic diseases, including Chronic Kidney Disease (CKD) patients.
Measured: 6MWT is measured at baseline (before intervention) and after 12 weeks of intervention.
Ejection fraction
Transthoracic echocardiography is performed using a Vivid E95 ultrasound system (General Electric, Frankfurt, Germany) equipped with a multifrequency transducer and 4D imaging analysis software. Normative ultrasound images were obtained by use of a 3.5-MHz phased array probe, placed on the third or fourth left intercostal space and Apical region. Connect electrocardiogram (ECG) for each subject to ensure standardization of image acquisition and data calculation to obtain ejection fraction. Data were analyzed and interpreted by one experienced echocardiographer who was blinded to treatment status and imaging sequence. To minimize the effect of variations in fluid volume in hemodialysis patients, studies were performed 18-24 h after a hemodialysis session.
Measured: Ejection fraction is measured at baseline (before intervention) and after 12 weeks of intervention.
Left ventricular mass index
Left ventricular mass is calculated from M-mode images, according to the guidelines of the American Society of Echocardiography. The left ventricular mass index is obtained by dividing by the formula of body surface area.
Measured: Left ventricular mass index is measured at baseline (before intervention) and after 12 weeks of intervention.
Left ventricular volume index
Left ventricular volume is calculated from M-mode images, according to the guidelines of the American Society of Echocardiography. The left ventricular volume index is obtained by dividing by the formula of body surface area. index is obtained by dividing by the formula of body surface area.
Measured: Left ventricular volume index is measured at baseline (before intervention) and after 12 weeks of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start20 Sep 2022
- Primary completion10 Jan 2023
- Study completion10 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, ChronicStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mei Huang, Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05718765
- Sponsor's protocol ID
- 2022SF-077
- Status last verified
- Jan 2023
- First submitted
- 24 Dec 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Huang M, Zhang X, Kang Y, Lv H, Gao J, Zhang Y, Liu Y, Xu X, Lv A, Ni C. The Physical ACtivity Enhancement Scheme (PACES) improves physical activity level and well-being in persons with hemodialysis: a randomized controlled trial. BMC Nephrol. 2026 Aug 6;27(1):598. doi: 10.1186/s12882-026-05256-7.
PubMed 42855667
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Physical ACtivity Enhancement Scheme (PACES) on Physical Outcomes in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT05718765
- Acronym / sponsor ID
- 2022SF-077
- Conditions
- Kidney Failure, Chronic, Exercise, Physical Activity, Renal Dialysis
- Keywords
- End-Stage Renal Disease, Exercise, Physical Activity, Hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 8 Feb 2023 (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.
Hemodialysis is the most commonly used renal replacement therapy for end-stage renal disease (ESRD) patients. At present, more than 553,000 ESRD patients in China are receiving hemodialysis treatment, but the long-term survival rate is low, and the annual mortality rate is as high as 18%. This is significantly related to lower physical activity in hemodialysis patients. Physical inactivity can lead to the decline of cardiopulmonary function and muscle function, the aggravation of daily life restriction and the increased risk of death. The National Kidney Foundation Disease Outcomes Quality Initiative (K/DOQI) recommends physical activity as cornerstone of ESRD rehabilitation. But hemodialysis patients are still living in a physical inactivity state. In the early stage of this study, the Physical Activity Enhancement Scheme (PACES) was developed for hemodialysis patients, that is, taking spaces as the core of physical activity investigation, and encouraging patients to start to improve physical activity. The PACES has been registered on the ClinicalTrials.gov before (number: NCT05189795).
The investigators now plan to evaluate the impact of PACES on physical activity of hemodialysis patients through clinical trials.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care with sham intervention | Sham comparator | Other: Usual care with sham interventionPatients in the control group received usual care with sham exercise. |
| PACES intervention | Experimental | Behavioral: PACES interventionPACES includes an exercise perception intervention and an exercise intervention, which lasts for 12 weeks and is carried out simultaneously. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult (age≥18) with stable ESRD;
- receiving≥3 months HD;
- receiving HD more than 5 times every two weeks;
- volunteer for participating in this investigation.
Key exclusion criteria (3 listed)
- are unable to do walk on one's own (severe musculoskeletal pain at rest or with minimal activity precluding walking or stationary cycling; unable to sit, stand or walk unassisted, walking devices such as cane or walker allowed);
- have shortness of breath at rest or with activities of daily living (NYHA Class IV);
- have mental disease, disturbance of consciousness and couldn't cooperate with this investigation.
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 |
|---|---|---|
| PACES interventionThe exercise perception intervention program is divided into three stage, and every four weeks is a stage. The theme of the first stage is to make the patient have the intention to exercise. The theme of the second stage is to provide effective support for the patient, so that the patient can take the initiative to start exercise. The theme of the third stage is to enable patients to keep exercising. The exercise intervention is a 12-week progressive intradialytic combined cycling exercise which proceed in the first HD 2 hours for safety. Each session consisted of a 5-minute warm-up, cool-down and 30-minute cycling at a Rating of Perceived Exertion (RPE) of 12-14. The machine has two exercise types including aerobic exercise and resistance exercise. Every four weeks is divided into a stage. And the time of aerobic exercise and resistance exercise were personally adjusted per stage to maintain the personalized target RPE. | Behavioural | PACES intervention |
| Usual care with sham interventionPatients in the control group received usual care and were advised to do sham exercise such as stretch legs and arms about 15 minutes during the first 2 hemodialysis hours. | Other | Usual care with sham intervention |
Primary outcome
daily steps (paces)
Time frame: Change from daily steps at 12 weeks.
OMRON electronic pedometer (HJ-321) records the participants' daily steps. Participants are instructed to wear the pedometer on their waist for 7 days, and the pedometer is removed only during rest, bathing and swimming.
The Human Activity Profile (HAP)
Time frame: Change from HAP 12 weeks.
HAP is a questionnaire designed to assess general physical activity. It consists of a list of 94 activities ranked in ascending order of level of energy required to perform each activity. Two scores are available from the HAP: a maximum activity score (MAS), reflective of the most taxing activity a respondent is still performing and an adjusted activity score (AAS), reflective of the respondent's daily activity level. The MAS is the number of the highest ranked activity the respondent is still performing. The AAS is calculated by subtracting from the MAS the number of activities that the respondent has stopped performing that rank below the participants' most metabolically intense activity. The minimum and maximum values of MAS and AAS are 0 and 94 respectively. The higher the score, the stronger the physical activity of the patient.
15 secondary outcomes
Dialysis Patient-perceived Exercise Benefits and Barriers Scale (DPEBBS)
Time frame: DPEBBS is measured at baseline (before intervention) and after 12 weeks of intervention.
Self-efficacy for exercise scale (SEE)
Time frame: SEE is measured at baseline (before intervention) and after 12 weeks of intervention.
Social support Rating Scale (SSRS)
Time frame: SSRS is measured at baseline (before intervention) and after 12 weeks of intervention.
Stage of Change Questionnaire
Time frame: The questionnaire is measured at baseline (before intervention) and after 12 weeks of intervention.
Kidney Disease Quality of Life (KDQOL-36)
Time frame: KDQOL-36 is measured at baseline (before intervention) and after 12 weeks of intervention.
Glomerular filtration rate (GFR)
Time frame: GFR is measured at baseline (before intervention) and after 12 weeks of intervention.
Serum levels of IL-6
Time frame: Serum levels of IL-6 is measured at baseline (before intervention) and after 12 weeks of intervention.
C-reactive protein (CRP)
Time frame: CRP is measured at baseline (before intervention) and after 12 weeks of intervention.
Serum creatinine
Time frame: Serum creatinine is measured at baseline (before intervention) and after 12 weeks of intervention.
sit-to-stand tests 10 (STS-10)
Time frame: STS-10 is measured at baseline (before intervention) and after 12 weeks of intervention.
sit-to-stand tests 60 (STS-60)
Time frame: STS-60 is measured at baseline (before intervention) and after 12 weeks of intervention.
Six-minute walk test (6MWT)
Time frame: 6MWT is measured at baseline (before intervention) and after 12 weeks of intervention.
Ejection fraction
Time frame: Ejection fraction is measured at baseline (before intervention) and after 12 weeks of intervention.
Left ventricular mass index
Time frame: Left ventricular mass index is measured at baseline (before intervention) and after 12 weeks of intervention.
Left ventricular volume index
Time frame: Left ventricular volume index is measured at baseline (before intervention) and after 12 weeks of intervention.
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 8 Feb 2023.
- Derived from this study: PubMed 42855667Huang M, Zhang X, Kang Y, Lv H, Gao J, Zhang Y, Liu Y, Xu X, Lv A, Ni C. The Physical ACtivity Enhancement Scheme (PACES) improves physical activity level and well-being in persons with hemodialysis: a randomized controlled trial. BMC Nephrol. 2026 Aug 6;27(1):598. doi: 10.1186/s12882-026-05256-7.
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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 PACES intervention in people with Kidney Failure, Chronic and Exercise, run by Xi'an Jiaotong 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 3 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 8 Feb 2023. 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. Some participants in this study may receive a placebo. 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?
daily steps (paces) (time frame: Change from daily steps at 12 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05718765, which also lists 1 linked publication.
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 8 Feb 2023; AzTrials last refreshed its copy on 7 Nov 2026.