Exercise Improves Gastrointestinal Function in Peritoneal Dialysis Patients

Not Applicable

Recruiting

• Conditions: Gastrointestinal Function; Peritoneal Dialysis; Quality of Life; Chronic Kidney Diseases; Exercise
• Interventions: Behavioral: Exercise

• Registration Number: NCT06368713
• Lead Sponsor: Sichuan Academy of Medical Sciences

Brief Summary

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 Timeline

• Study Start: 2024-03-01
• Status Verified: 2024-04
• Study First Submitted: 2024-04-07
• Study First Submitted QC: 2024-04-11
• Last Update Submitted: 2024-04-11
• Study First Posted: 2024-04-16
• Last Update Posted: 2024-04-16
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 132

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise intervention group	Exercise	The exercise intervention group will receive guidance for exercises and participate in remote exercise sessions monitored.

Primary Outcome Measures

Name	Time	Method
Change in GIQLI	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.

Secondary Outcome Measures

Name	Time	Method
Change in 6-MWT	Measurements are taken before the start of the intervention, 2 weeks and 3 months after the intervention.	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.
Change in GSRS	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.	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.
Change in SGA	Patients are required to complete the SGA scale at the baseline and 3 months after the intervention.	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.
Change in PAC-SYM	Patients are required to complete the questionnaire at baseline, 2 weeks, 4 weeks, 2 months, and 3 months after the start of the intervention.	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.
Change in measured Gastrointestinal Hormones	Blood samples will be collected at the baseline and and 3 months the intervention.	The assessment includes the measurement of Ghrelin, Pancreatic polypeptide, and peotideYY, which are gastrointestinal hormones involved in regulating appetite and digestion.

Trial Locations

Locations (1)

Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital,School of Medicine, University of Electronic Science and Technology of China; 🇨🇳 Chengdu, Sichuan, China