Exercise Improves Gastrointestinal Function in Peritoneal Dialysis Patients

NCT06368713 | Recruiting DMC

• 1 other identifier: PD-GIEX
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Peritoneal Dialysis; Exercise; Gastrointestinal Function; Quality of Life; Chronic Kidney Diseases

Keywords

Peritoneal Dialysis; Exercise intervention; Gastrointestinal function; Telehealth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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.

• 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.

• Change in 6-MWT

  Measurements are taken before the start of the intervention, 2 weeks and 3 months after the intervention.

• Change in SGA

  Patients are required to complete the SGA scale at the baseline and 3 months after the intervention.

• Change in measured Gastrointestinal Hormones

  Blood samples will be collected at the baseline and and 3 months the intervention.

Study Arms (2)

Exercise intervention group

EXPERIMENTAL

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

Behavioral: Exercise

Control group

NO INTERVENTION

The control group will not receive exercise intervention.

Interventions

Exercise BEHAVIORAL

* 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.

Exercise intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have undergone peritoneal dialysis for more than 3 months.
• Age between 18 and 65 years.
• Possession of a smartphone and proficiency in its usage.
• Willingness to provide voluntary informed consent by signing the consent form.

You may not qualify if:

• 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.
• 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.
• Severe pulmonary diseases, including but not limited to:
• Severe chronic obstructive pulmonary disease (COPD).
• Pulmonary embolism.
• Lung cancer.
• Severe pulmonary infection.
• Presence of deep venous thrombosis.
• Severe neurological, muscular, bone, or joint diseases that hinder compliance with exercise.
• Participation in other concurrent exercise programs.

Sponsors & Collaborators

• Sichuan Academy of Medical Sciences: lead

Study Sites (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, 610000, China

RECRUITING

Related Publications (30)

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MeSH Terms

Conditions

Motor Activity; Renal Insufficiency, Chronic

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jin Chen, Doctor

  Sichuan Academy of Medical Sciences , University of Electronic Science and Technology of China,

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Chen, Doctor

CONTACT

86-28-87393195; jessicakxcj@uestc.edu.cn

Renjing Yang, Master

CONTACT

86-28-87393195; 2048323530@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: April 7, 2024
• First Posted: April 16, 2024
• Study Start: March 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)