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

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* 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.