Peritoneal DialysisNCT06368713
Exercise Improves Gastrointestinal Function in Peritoneal Dialysis Patients
A study testing Exercise in people with Peritoneal Dialysis and Exercise, run by Sichuan Academy of Medical Sciences at 1 site in China.
Trial summary
This study will investigate the impact of exercise on gastrointestinal function in peritoneal dialysis patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Peritoneal Dialysis, Exercise, Gastrointestinal Function
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 31 Dec 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have undergone peritoneal dialysis for more than 3 months.
- Age between 18 and 65 years.
- Possession of a smartphone and proficiency in its usage.
- Willingness to provide voluntary informed consent by signing the consent form.
Who cannot join
- Recent systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg, or systolic blood pressure ≤90 mmHg or diastolic blood pressure ≤60 mmHg within the past week.
- Presence of severe cardiovascular diseases, including but not limited to:
- Heart failure classified as New York Heart Association (NYHA) functional grade IV-V.
- Severe arrhythmias such as third-degree atrioventricular block, sick sinus syndrome, paroxysmal supraventricular tachycardia, or ventricular tachycardia.
- Unstable angina.
- Pulmonary arterial hypertension with pulmonary arterial pressure ≥25 mmHg.
Show all 15Show fewer
- Severe pericardial effusion, valve stenosis, hypertrophic cardiomyopathy, or aortic dissection.
- Severe pulmonary diseases, including but not limited to:
- Severe chronic obstructive pulmonary disease (COPD).
- Pulmonary embolism.
- Lung cancer.
- Severe pulmonary infection.
- Presence of deep venous thrombosis.
- Severe neurological, muscular, bone, or joint diseases that hinder compliance with exercise.
- Participation in other concurrent exercise programs.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital,School of Medicine, University of Electronic Science and Technology of China
Chengdu, Sichuan, 610000
Jin Chen, Doctor
About this study
Official title: Exercise Improves Gastrointestinal Function in Peritoneal Dialysis Patients: A Single Center Prospective Randomized Controlled Study
This study will investigate the impact of exercise on gastrointestinal function in peritoneal dialysis patients.
Read the detailed description
Maintaining gastrointestinal health is paramount for individuals on peritoneal dialysis, yet it frequently goes unnoticed within the broader scope of their health management. The effectiveness of dialysis treatments, along with aspects such as nutrient uptake and life quality, can be adversely affected by gastrointestinal disturbances. The volume of fluid within the peritoneal space, medications associated with dialysis, and the procedure of dialysis itself are all known to play roles in modulating gastrointestinal health.
The role of physical activity in enhancing gastrointestinal wellness among those with chronic conditions has gained acknowledgment over time. Customized exercise regimes have been shown to markedly better gastrointestinal symptoms, the efficiency of nutrient absorption, and overall life satisfaction among these patients. Notably, the specific influence of exercise on the gastrointestinal functions of individuals undergoing peritoneal dialysis has yet to be explored.
This investigation aims to assess the effects of exercise on the gastrointestinal health of peritoneal dialysis patients. Participants will be divided equally into an exercise group and a control group, following a randomized selection process. After collecting data throughout a four-month period, an analysis will be conducted to ascertain the benefits of physical activity for enhancing the gastrointestinal function of those on peritoneal dialysis. The outcomes of this study are anticipated to guide clinicians in recommending strategies to improve gastrointestinal health in this patient population.
- Conditions
- Peritoneal Dialysis, Exercise, Gastrointestinal Function, Quality of Life, Chronic Kidney Diseases
- Being tested
- Exercise
- Keywords
- Peritoneal Dialysis, Exercise intervention, Gastrointestinal function, Telehealth
- Medical subject headings
- Motor Activity, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
- Frequency: Exercise sessions will occur no less than three times per week.
- Intensity: The intensity will be based on a rating of perceived exertion score ranging from 12 to 16 on a scale of 6 to 20.
- Exercise duration: Each exercise session will last approximately 30 minutes.
- Exercise Type:The exercise regimen will include aerobic exercise, resistance exercise, and flexibility training.
| Study group | Role | What they receive |
|---|---|---|
| Exercise intervention group | Experimental | The exercise intervention group will receive guidance for exercises and participate in remote exercise sessions monitored. Receives: Behavioral: Exercise |
| Control group | No intervention | The control group will not receive exercise intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in GIQLI
The Gastrointestinal Quality of Life Index is a 36-item questionnaire assessing the impact of gastrointestinal symptoms and diseases on daily life. The GIQLI includes five domains: gastrointestinal symptoms (19 items), emotional status (5 items), physical function (7 items), social function (4 items), and medical inconvenience (1 item). Each item is scored from 0 to 4, with a total score ranging from 0 to 144. Higher scores indicate better quality of life.
Measured: Patients are required to complete the questionnaire at baseline, 2 weeks, 4 weeks, 2 months, and 3 months after the start of the intervention.
Secondary outcomes (5)
Change in GSRS
Gastrointestinal Symptom Rating Scale (GSRS)consists of 15 questions aimed at assessing the impact of upper and lower gastrointestinal symptoms. It includes five dimensions (symptoms of gastroesophageal reflux, diarrhea, constipation, abdominal pain, and indigestion), with each question scored from 0 (no discomfort) to 6 (very severe discomfort). A GSRS score of ≥1 defines the presence of gastrointestinal symptoms A higher score indicates more severe gastrointestinal symptoms.
Measured: Patients are also required to complete the questionnaire at baseline, 2 weeks, 4 weeks, 2 months, and 3 months after the start of the intervention.
Change in PAC-SYM
Patient Assessment of Constipation Symptom (PAC-SYM) comprises 12 questions designed to evaluate the impact of upper and lower gastrointestinal symptoms. It assesses five dimensions, including symptoms of gastroesophageal reflux, diarrhea, constipation, abdominal pain, and indigestion. Each question is scored from 0 (no discomfort) to 6 (very severe discomfort). A GSRS score of ≥1 indicates the presence of gastrointestinal symptoms, with higher scores indicating more severe symptoms.
Measured: Patients are required to complete the questionnaire at baseline, 2 weeks, 4 weeks, 2 months, and 3 months after the start of the intervention.
Change in 6-MWT
The 6-Minute Walk Test (6-MWT) is conducted along a 10-meter path marked with two turning points. Patients are instructed to walk back and forth along the path for 6 minutes, and the total walking distance is measured. The test duration is monitored using a stopwatch. Based on the walking distance achieved, patients' heart failure severity is categorized as follows: <150m indicates severe heart failure; 150-425m indicates moderate heart failure; 426-550m indicates mild heart failure.
Measured: Measurements are taken before the start of the intervention, 2 weeks and 3 months after the intervention.
Change in SGA
The Subjective Global Assessment (SGA) is a tool utilized to assess the nutritional status of patients. It involves a comprehensive evaluation of various factors such as weight change, dietary intake, gastrointestinal symptoms, and functional capacity.
Measured: Patients are required to complete the SGA scale at the baseline and 3 months after the intervention.
Change in measured Gastrointestinal Hormones
The assessment includes the measurement of Ghrelin, Pancreatic polypeptide, and peotideYY, which are gastrointestinal hormones involved in regulating appetite and digestion.
Measured: Blood samples will be collected at the baseline and and 3 months the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start1 Mar 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Peritoneal DialysisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Chen, Sichuan Academy of Medical Sciences
- Investigators
- Jin Chen, Doctor, Principal investigator, Sichuan Academy of Medical Sciences , University of Electronic Science and Technology of China,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368713
- Sponsor's protocol ID
- PD-GIEX
- Status last verified
- Apr 2024
- First submitted
- 7 Apr 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
ROB CG, RICHARDSON JS. Peritoneal dialysis. Lancet. 1947 Feb 1;1(6440):195. doi: 10.1016/s0140-6736(47)91172-0. No abstract available.
PubMed 20341549Zhang P, Wang X, Li S, Cao X, Zou J, Fang Y, Shi Y, Xiang F, Shen B, Li Y, Fang B, Zhang Y, Guo R, Lv Q, Zhang L, Lu Y, Wang Y, Yu J, Xie Y, Wang R, Chen X, Yu J, Zhang Z, He J, Zhan J, Lv W, Nie Y, Cai J, Xu X, Hu J, Zhang Q, Gao T, Jiang X, Tan X, Xue N, Wang Y, Ren Y, Wang L, Zhang H, Ning Y, Chen J, Zhang L, Jin S, Ren F, Ehrlich SD, Zhao L, Ding X. Metagenome-wide analysis uncovers gut microbial signatures and implicates taxon-specific functions in end-stage renal disease. Genome Biol. 2023 Oct 12;24(1):226. doi: 10.1186/s13059-023-03056-y.
PubMed 37828586Jiang S, Xie S, Lv D, Wang P, He H, Zhang T, Zhou Y, Lin Q, Zhou H, Jiang J, Nie J, Hou F, Chen Y. Alteration of the gut microbiota in Chinese population with chronic kidney disease. Sci Rep. 2017 Jun 6;7(1):2870. doi: 10.1038/s41598-017-02989-2.
PubMed 28588309Hirako M, Kamiya T, Misu N, Kobayashi Y, Adachi H, Shikano M, Matsuhisa E, Kimura G. Impaired gastric motility and its relationship to gastrointestinal symptoms in patients with chronic renal failure. J Gastroenterol. 2005 Dec;40(12):1116-22. doi: 10.1007/s00535-005-1709-6.
PubMed 16378175Yi C, Wang X, Ye H, Lin J, Yang X. Patient-reported gastrointestinal symptoms in patients with peritoneal dialysis: the prevalence, influence factors and association with quality of life. BMC Nephrol. 2022 Mar 9;23(1):99. doi: 10.1186/s12882-022-02723-9.
PubMed 35264119Duncanson E, Chur-Hansen A, Jesudason S. Psychosocial consequences of gastrointestinal symptoms and dietary changes in people receiving automated peritoneal dialysis. J Ren Care. 2019 Mar;45(1):41-50. doi: 10.1111/jorc.12265. Epub 2018 Dec 25.
PubMed 30585418Strid H, Simren M, Johansson AC, Svedlund J, Samuelsson O, Bjornsson ES. The prevalence of gastrointestinal symptoms in patients with chronic renal failure is increased and associated with impaired psychological general well-being. Nephrol Dial Transplant. 2002 Aug;17(8):1434-9. doi: 10.1093/ndt/17.8.1434.
PubMed 12147791Setyapranata S, Holt SG. The Gut in Older Patients on Peritoneal Dialysis. Perit Dial Int. 2015 Nov;35(6):650-4. doi: 10.3747/pdi.2014.00341.
PubMed 26702007Kosmadakis G, Albaret J, da Costa Correia E, Somda F, Aguilera D. Gastrointestinal Disorders in Peritoneal Dialysis Patients. Am J Nephrol. 2018;48(5):319-325. doi: 10.1159/000494145. Epub 2018 Oct 19.
PubMed 30343294Cha RR, Park SY, Camilleri M; Constipation Research Group of Korean Society of Neurogastroenterology and Motility. Constipation in Patients With Chronic Kidney Disease. J Neurogastroenterol Motil. 2023 Oct 30;29(4):428-435. doi: 10.5056/jnm23133.
PubMed 37814433Tian N, Li L, Ng JK, Li PK. The Potential Benefits and Controversies of Probiotics Use in Patients at Different Stages of Chronic Kidney Disease. Nutrients. 2022 Sep 29;14(19):4044. doi: 10.3390/nu14194044.
PubMed 36235699Biruete A, Shin A, Kistler BM, Moe SM. Feeling gutted in chronic kidney disease (CKD): Gastrointestinal disorders and therapies to improve gastrointestinal health in individuals CKD, including those undergoing dialysis. Semin Dial. 2024 Jul-Aug;37(4):334-349. doi: 10.1111/sdi.13030. Epub 2021 Oct 27.
PubMed 34708456Hamaguchi T, Tayama J, Suzuki M, Nakaya N, Takizawa H, Koizumi K, Amano Y, Kanazawa M, Fukudo S. The effects of locomotor activity on gastrointestinal symptoms of irritable bowel syndrome among younger people: An observational study. PLoS One. 2020 May 29;15(5):e0234089. doi: 10.1371/journal.pone.0234089. eCollection 2020.
PubMed 32470098Bianco A, Russo F, Franco I, Riezzo G, Donghia R, Curci R, Bonfiglio C, Prospero L, D'Attoma B, Ignazzi A, Campanella A, Osella AR. Enhanced Physical Capacity and Gastrointestinal Symptom Improvement in Southern Italian IBS Patients following Three Months of Moderate Aerobic Exercise. J Clin Med. 2023 Oct 26;12(21):6786. doi: 10.3390/jcm12216786.
PubMed 37959251Riezzo G, Prospero L, D'Attoma B, Ignazzi A, Bianco A, Franco I, Curci R, Campanella A, Bonfiglio C, Osella AR, Russo F. The Impact of a Twelve-Week Moderate Aerobic Exercise Program on Gastrointestinal Symptom Profile and Psychological Well-Being of Irritable Bowel Syndrome Patients: Preliminary Data from a Southern Italy Cohort. J Clin Med. 2023 Aug 17;12(16):5359. doi: 10.3390/jcm12165359.
PubMed 37629401
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Improves Gastrointestinal Function in Peritoneal Dialysis Patients: A Single Center Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06368713
- Acronym / sponsor ID
- PD-GIEX
- Conditions
- Peritoneal Dialysis, Exercise, Gastrointestinal Function, Quality of Life, Chronic Kidney Diseases
- Keywords
- Peritoneal Dialysis, Exercise intervention, Gastrointestinal function, Telehealth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Sichuan Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Apr 2024 (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.
This study will investigate the impact of exercise on gastrointestinal function in peritoneal dialysis patients.
Detailed description
Maintaining gastrointestinal health is paramount for individuals on peritoneal dialysis, yet it frequently goes unnoticed within the broader scope of their health management. The effectiveness of dialysis treatments, along with aspects such as nutrient uptake and life quality, can be adversely affected by gastrointestinal disturbances. The volume of fluid within the peritoneal space, medications associated with dialysis, and the procedure of dialysis itself are all known to play roles in modulating gastrointestinal health.
The role of physical activity in enhancing gastrointestinal wellness among those with chronic conditions has gained acknowledgment over time. Customized exercise regimes have been shown to markedly better gastrointestinal symptoms, the efficiency of nutrient absorption, and overall life satisfaction among these patients. Notably, the specific influence of exercise on the gastrointestinal functions of individuals undergoing peritoneal dialysis has yet to be explored.
This investigation aims to assess the effects of exercise on the gastrointestinal health of peritoneal dialysis patients. Participants will be divided equally into an exercise group and a control group, following a randomized selection process. After collecting data throughout a four-month period, an analysis will be conducted to ascertain the benefits of physical activity for enhancing the gastrointestinal function of those on peritoneal dialysis. The outcomes of this study are anticipated to guide clinicians in recommending strategies to improve gastrointestinal health in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise intervention group | Experimental | Behavioral: ExerciseThe exercise intervention group will receive guidance for exercises and participate in remote exercise sessions monitored. |
| Control group | No intervention | –The control group will not receive exercise intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients must have undergone peritoneal dialysis for more than 3 months.
- Age between 18 and 65 years.
- Possession of a smartphone and proficiency in its usage.
- Willingness to provide voluntary informed consent by signing the consent form.
Key exclusion criteria (15 listed)
- Recent systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg, or systolic blood pressure ≤90 mmHg or diastolic blood pressure ≤60 mmHg within the past week.
- Presence of severe cardiovascular diseases, including but not limited to:
- Severe pulmonary diseases, including but not limited to:
- Presence of deep venous thrombosis.
- Severe neurological, muscular, bone, or joint diseases that hinder compliance with exercise.
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 |
|---|---|---|
| Exercise* Frequency: Exercise sessions will occur no less than three times per week. * Intensity: The intensity will be based on a rating of perceived exertion score ranging from 12 to 16 on a scale of 6 to 20. * Exercise duration: Each exercise session will last approximately 30 minutes. * Exercise Type:The exercise regimen will include aerobic exercise, resistance exercise, and flexibility training. | Behavioural | Exercise intervention group |
Primary outcome
Change in GIQLI
Time frame: Patients are required to complete the questionnaire at baseline, 2 weeks, 4 weeks, 2 months, and 3 months after the start of the intervention.
The Gastrointestinal Quality of Life Index is a 36-item questionnaire assessing the impact of gastrointestinal symptoms and diseases on daily life. The GIQLI includes five domains: gastrointestinal symptoms (19 items), emotional status (5 items), physical function (7 items), social function (4 items), and medical inconvenience (1 item). Each item is scored from 0 to 4, with a total score ranging from 0 to 144. Higher scores indicate better quality of life.
5 secondary outcomes
Change in GSRS
Time frame: Patients are also required to complete the questionnaire at baseline, 2 weeks, 4 weeks, 2 months, and 3 months after the start of the intervention.
Change in PAC-SYM
Time frame: Patients are required to complete the questionnaire at baseline, 2 weeks, 4 weeks, 2 months, and 3 months after the start of the intervention.
Change in 6-MWT
Time frame: Measurements are taken before the start of the intervention, 2 weeks and 3 months after the intervention.
Change in SGA
Time frame: Patients are required to complete the SGA scale at the baseline and 3 months after the intervention.
Change in measured Gastrointestinal Hormones
Time frame: Blood samples will be collected at the baseline and and 3 months the intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Background: PubMed 20341549ROB CG, RICHARDSON JS. Peritoneal dialysis. Lancet. 1947 Feb 1;1(6440):195. doi: 10.1016/s0140-6736(47)91172-0. No abstract available.
- Background: PubMed 37828586Zhang P, Wang X, Li S, Cao X, Zou J, Fang Y, Shi Y, Xiang F, Shen B, Li Y, Fang B, Zhang Y, Guo R, Lv Q, Zhang L, Lu Y, Wang Y, Yu J, Xie Y, Wang R, Chen X, Yu J, Zhang Z, He J, Zhan J, Lv W, Nie Y, Cai J, Xu X, Hu J, Zhang Q, Gao T, Jiang X, Tan X, Xue N, Wang Y, Ren Y, Wang L, Zhang H, Ning Y, Chen J, Zhang L, Jin S, Ren F, Ehrlich SD, Zhao L, Ding X. Metagenome-wide analysis uncovers gut microbial signatures and implicates taxon-specific functions in end-stage renal disease. Genome Biol. 2023 Oct 12;24(1):226. doi: 10.1186/s13059-023-03056-y.
- Background: PubMed 28588309Jiang S, Xie S, Lv D, Wang P, He H, Zhang T, Zhou Y, Lin Q, Zhou H, Jiang J, Nie J, Hou F, Chen Y. Alteration of the gut microbiota in Chinese population with chronic kidney disease. Sci Rep. 2017 Jun 6;7(1):2870. doi: 10.1038/s41598-017-02989-2.
- Background: PubMed 16378175Hirako M, Kamiya T, Misu N, Kobayashi Y, Adachi H, Shikano M, Matsuhisa E, Kimura G. Impaired gastric motility and its relationship to gastrointestinal symptoms in patients with chronic renal failure. J Gastroenterol. 2005 Dec;40(12):1116-22. doi: 10.1007/s00535-005-1709-6.
- Background: PubMed 35264119Yi C, Wang X, Ye H, Lin J, Yang X. Patient-reported gastrointestinal symptoms in patients with peritoneal dialysis: the prevalence, influence factors and association with quality of life. BMC Nephrol. 2022 Mar 9;23(1):99. doi: 10.1186/s12882-022-02723-9.
- Background: PubMed 30585418Duncanson E, Chur-Hansen A, Jesudason S. Psychosocial consequences of gastrointestinal symptoms and dietary changes in people receiving automated peritoneal dialysis. J Ren Care. 2019 Mar;45(1):41-50. doi: 10.1111/jorc.12265. Epub 2018 Dec 25.
- Background: PubMed 12147791Strid H, Simren M, Johansson AC, Svedlund J, Samuelsson O, Bjornsson ES. The prevalence of gastrointestinal symptoms in patients with chronic renal failure is increased and associated with impaired psychological general well-being. Nephrol Dial Transplant. 2002 Aug;17(8):1434-9. doi: 10.1093/ndt/17.8.1434.
- Background: PubMed 26702007Setyapranata S, Holt SG. The Gut in Older Patients on Peritoneal Dialysis. Perit Dial Int. 2015 Nov;35(6):650-4. doi: 10.3747/pdi.2014.00341.
- Background: PubMed 30343294Kosmadakis G, Albaret J, da Costa Correia E, Somda F, Aguilera D. Gastrointestinal Disorders in Peritoneal Dialysis Patients. Am J Nephrol. 2018;48(5):319-325. doi: 10.1159/000494145. Epub 2018 Oct 19.
- Background: PubMed 37814433Cha RR, Park SY, Camilleri M; Constipation Research Group of Korean Society of Neurogastroenterology and Motility. Constipation in Patients With Chronic Kidney Disease. J Neurogastroenterol Motil. 2023 Oct 30;29(4):428-435. doi: 10.5056/jnm23133.
- Background: PubMed 36235699Tian N, Li L, Ng JK, Li PK. The Potential Benefits and Controversies of Probiotics Use in Patients at Different Stages of Chronic Kidney Disease. Nutrients. 2022 Sep 29;14(19):4044. doi: 10.3390/nu14194044.
- Background: PubMed 34708456Biruete A, Shin A, Kistler BM, Moe SM. Feeling gutted in chronic kidney disease (CKD): Gastrointestinal disorders and therapies to improve gastrointestinal health in individuals CKD, including those undergoing dialysis. Semin Dial. 2024 Jul-Aug;37(4):334-349. doi: 10.1111/sdi.13030. Epub 2021 Oct 27.
- Individual participant dataSharing planned: No
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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.
Jin Chen, Doctor principal investigator
Sichuan Academy of Medical Sciences , University of Electronic Science and Technology of China,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Peritoneal Dialysis and Exercise, run by Sichuan Academy of Medical Sciences 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 15 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: status not confirmed, as of the sponsor's last update on 16 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin Chen, Doctor (86-28-87393195, jessicakxcj@uestc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in GIQLI (time frame: Patients are required to complete the questionnaire at baseline, 2 weeks, 4 weeks, 2 months, and 3 months after the start of the intervention.). 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 NCT06368713, which also lists 30 linked publications.
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 16 Apr 2024.