Clinical trial NCT06368713: Exercise Improves Gastrointestinal Function in Peritoneal Dialysis Patients
Official title: Exercise Improves Gastrointestinal Function in Peritoneal Dialysis Patients: A Single Center Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peritoneal Dialysis
Exercise
Gastrointestinal Function
Quality of Life
Chronic Kidney Diseases
Keywords: Peritoneal Dialysis
Exercise intervention
Gastrointestinal function
Telehealth
Lead sponsor: Sichuan Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in GIQLI
timeFrame: 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:
measure: Change in GSRS
timeFrame: 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.
measure: Change in PAC-SYM
timeFrame: Patients are required to complete the questionnaire at baseline, 2 weeks, 4 weeks, 2 months, and 3 months after the start of the intervention.
measure: Change in 6-MWT
timeFrame: Measurements are taken before the start of the intervention, 2 weeks and 3 months after the intervention.
measure: Change in SGA
timeFrame: Patients are required to complete the SGA scale at the baseline and 3 months after the intervention.
measure: Change in measured Gastrointestinal Hormones
timeFrame: Blood samples will be collected at the baseline and and 3 months the intervention.
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital,School of Medicine, University of Electronic Science and Technology of China
state: Sichuan
Study officials:
affiliation: Sichuan Academy of Medical Sciences , University of Electronic Science and Technology of China,
name: Jin Chen, Doctor
role: PRINCIPAL_INVESTIGATOR
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