Exercise Improves Gastrointestinal Function in Peritoneal Dialysis Patients

Quality of Life Clinical Trial

Official title:

Exercise Improves Gastrointestinal Function in Peritoneal Dialysis Patients: A Single Center Prospective Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06368713
• Other study ID #: PD-GIEX
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Sichuan Academy of Medical Sciences
• Contact: Jin Chen, Doctor
• Phone: 86-28-87393195
• Email: jessicakxcj[@]uestc.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will investigate the impact of exercise on gastrointestinal function in peritoneal dialysis patients.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Patients must have undergone peritoneal dialysis for more than 3 months.

2. Age between 18 and 65 years.

3. Possession of a smartphone and proficiency in its usage.

4. Willingness to provide voluntary informed consent by signing the consent form.

Exclusion Criteria:

1. 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.

2. 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.
• Severe pericardial effusion, valve stenosis, hypertrophic cardiomyopathy, or aortic dissection.

3. Severe pulmonary diseases, including but not limited to:

• Severe chronic obstructive pulmonary disease (COPD).
• Pulmonary embolism.
• Lung cancer.
• Severe pulmonary infection.

4. Presence of deep venous thrombosis.

5. Severe neurological, muscular, bone, or joint diseases that hinder compliance with exercise.

6. Participation in other concurrent exercise programs.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Exercise
• Gastrointestinal Function
• Kidney Diseases
• Peritoneal Dialysis
• Quality of Life
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
China	Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital,School of Medicine, University of Electronic Science and Technology of China	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan Academy of Medical Sciences

Country where clinical trial is conducted

China, 

References & Publications (30)

Abdelbasset WK, Ibrahim AA, Althomali OW, Hussein HM, Alrawaili SM, Alsubaie SF. Effect of twelve-week concurrent aerobic and resisted exercise training in non-dialysis day on functional capacity and quality of life in chronic kidney disease patients. Eur Rev Med Pharmacol Sci. 2022 Sep;26(17):6098-6106. doi: 10.26355/eurrev_202209_29626. — View Citation

Aya V, Jimenez P, Munoz E, Ramirez JD. Effects of exercise and physical activity on gut microbiota composition and function in older adults: a systematic review. BMC Geriatr. 2023 Jun 12;23(1):364. doi: 10.1186/s12877-023-04066-y. — View Citation

Bennett PN, Bohm C, Harasemiw O, Brown L, Gabrys I, Jegatheesan D, Johnson DW, Lambert K, Lightfoot CJ, MacRae J, Meade A, Parker K, Scholes-Robertson N, Stewart K, Tarca B, Verdin N, Wang AY, Warren M, West M, Zimmerman D, Li PK, Thompson S. Physical activity and exercise in peritoneal dialysis: International Society for Peritoneal Dialysis and the Global Renal Exercise Network practice recommendations. Perit Dial Int. 2022 Jan;42(1):8-24. doi: 10.1177/08968608211055290. Epub 2021 Nov 7. — View Citation

Bennett PN, Bohm C, Yee-Moon Wang A, Kanjanabuch T, Figueiredo AE, Harasemiw O, Brown L, Gabrys I, Jegatheesan D, Lambert K, Lightfoot CJ, MacRae J, Scholes-Robertson N, Stewart K, Tarca B, Verdin N, Warren M, West M, Zimmerman D, Finderup J, Ford E, Ribeiro HS, Xu Q, Thompson S. An International Survey of Peritoneal Dialysis Exercise Practices and Perceptions. Kidney Int Rep. 2023 May 3;8(7):1389-1398. doi: 10.1016/j.ekir.2023.04.024. eCollection 2023 Jul. — View Citation

Bianco 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. — View Citation

Biruete 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. 2021 Oct 27:10.1111/sdi.13030. doi: 10.1111/sdi.13030. Online ahead of print. — View Citation

Boytar AN, Skinner TL, Wallen RE, Jenkins DG, Dekker Nitert M. The Effect of Exercise Prescription on the Human Gut Microbiota and Comparison between Clinical and Apparently Healthy Populations: A Systematic Review. Nutrients. 2023 Mar 22;15(6):1534. doi: 10.3390/nu15061534. — View Citation

Cha 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. — View Citation

Deus LA, Correa HL, Neves RVP, Reis AL, Honorato FS, Araujo TB, Souza MK, Haro AS, Silva VL, Barbosa JMDS, Padula IA, Andrade RV, Simoes HG, Prestes J, Stone WJ, Melo GF, Rosa TS. Metabolic and hormonal responses to chronic blood-flow restricted resistance training in chronic kidney disease: a randomized trial. Appl Physiol Nutr Metab. 2022 Feb;47(2):183-194. doi: 10.1139/apnm-2021-0409. Epub 2022 Jan 21. — View Citation

Duncanson 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. — View Citation

Eypasch E, Williams JI, Wood-Dauphinee S, Ure BM, Schmulling C, Neugebauer E, Troidl H. Gastrointestinal Quality of Life Index: development, validation and application of a new instrument. Br J Surg. 1995 Feb;82(2):216-22. doi: 10.1002/bjs.1800820229. — View Citation

Frank L, Kleinman L, Farup C, Taylor L, Miner P Jr. Psychometric validation of a constipation symptom assessment questionnaire. Scand J Gastroenterol. 1999 Sep;34(9):870-7. doi: 10.1080/003655299750025327. — View Citation

Gravina EPL, Pinheiro BV, da Silva Jesus LA, da Silva LP, da Silva RN, Silva K, de Paula RB, Reboredo MM. Effects of long-term aerobic training and detraining on functional capacity and quality of life in hemodialysis patients: A pilot study. Int J Artif Organs. 2020 Jun;43(6):411-415. doi: 10.1177/0391398819890622. Epub 2019 Nov 27. — View Citation

Hamaguchi 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. Erratum In: PLoS One. 2020 Dec 17;15(12):e0244465. — View Citation

Heine GH, Kastner CY, Jahnke T, Kohler H, Kuhlmann MK. Does a history of peritoneal dialysis result in an impaired gastrointestinal life quality? Hemodial Int. 2007 Oct;11(4):461-7. doi: 10.1111/j.1542-4758.2007.00218.x. — View Citation

Hirako 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. — View Citation

Jiang 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. — View Citation

Kosmadakis 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. — View Citation

Li WY, Chiu FC, Zeng JK, Li YW, Huang SH, Yeh HC, Cheng BW, Yang FJ. Mobile Health App With Social Media to Support Self-Management for Patients With Chronic Kidney Disease: Prospective Randomized Controlled Study. J Med Internet Res. 2020 Dec 15;22(12):e19452. doi: 10.2196/19452. — View Citation

Revicki DA, Wood M, Wiklund I, Crawley J. Reliability and validity of the Gastrointestinal Symptom Rating Scale in patients with gastroesophageal reflux disease. Qual Life Res. 1998 Jan;7(1):75-83. doi: 10.1023/a:1008841022998. — View Citation

Riezzo 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. — View Citation

ROB CG, RICHARDSON JS. Peritoneal dialysis. Lancet. 1947 Feb 1;1(6440):195. doi: 10.1016/s0140-6736(47)91172-0. No abstract available. — View Citation

Setyapranata 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. — View Citation

Strid 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. — View Citation

Tian 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. — View Citation

Weiner DE, Liu CK, Miao S, Fielding R, Katzel LI, Giffuni J, Well A, Seliger SL. Effect of Long-term Exercise Training on Physical Performance and Cardiorespiratory Function in Adults With CKD: A Randomized Controlled Trial. Am J Kidney Dis. 2023 Jan;81(1):59-66. doi: 10.1053/j.ajkd.2022.06.008. Epub 2022 Aug 6. — View Citation

Wu HHL, Poulikakos D, Hurst H, Lewis D, Chinnadurai R. Delivering Personalized, Goal-Directed Care to Older Patients Receiving Peritoneal Dialysis. Kidney Dis (Basel). 2023 Jun 23;9(5):358-370. doi: 10.1159/000531367. eCollection 2023 Oct. — View Citation

Yi 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. — View Citation

Zhang F, Liao J, Zhang W, Wang H, Huang L, Shen Q, Zhang H. Effects of Baduanjin Exercise on Physical Function and Health-Related Quality of Life in Peritoneal Dialysis Patients: A Randomized Trial. Front Med (Lausanne). 2021 Nov 29;8:789521. doi: 10.3389/fmed.2021.789521. eCollection 2021. — View Citation

Zhang 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. — View Citation

* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	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.	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.
Secondary	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.	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	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.	Measurements are taken before the start of the intervention, 2 weeks and 3 months after the intervention.
Secondary	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.	Patients are required to complete the SGA scale at the baseline and 3 months after the intervention.
Secondary	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.	Blood samples will be collected at the baseline and and 3 months the intervention.