Exercise Improves Gastrointestinal Function in Peritoneal Dialysis Patients

April 11, 2024 updated by: Jin Chen, Sichuan Academy of Medical Sciences

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Recruiting
        • Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital,School of Medicine, University of Electronic Science and Technology of China
        • Contact:
          • Jin Chen, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise intervention group
The exercise intervention group will receive guidance for exercises and participate in remote exercise sessions monitored.
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.
No Intervention: Control group
The control group will not receive exercise intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
Change in 6-MWT
Time Frame: 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.
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.
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.
Change in measured Gastrointestinal Hormones
Time Frame: 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.
Blood samples will be collected at the baseline and and 3 months the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sichuan Academy of Medical Sciences

Investigators

  • Principal Investigator: Jin Chen, Doctor, Sichuan Academy of Medical Sciences , University of Electronic Science and Technology of China,

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

April 7, 2024

First Submitted That Met QC Criteria

April 11, 2024

First Posted (Actual)

April 16, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PD-GIEX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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