A Study Comparing the Impact of Mini-exchange-room and Usual Care on Physical Activity and Quality of Life in Peritoneal Dialysis Patients

October 27, 2016 updated by: Dong Jie, Peking University First Hospital
To compare the effect of mini-exchange-room and usual care on physical activity and quality of life in peritoneal dialysis (PD) patients through a randomized controlled study. A total of 80 incident CAPD patients with age of 18~80 years old will be enrolled, who are medically stable and regularly followed up. The one group perform traditional PD procedure (G1), and the other group will utilize disposable mini-exchange-room group (G2). Two groups will be followed for 6 months. Biochemistry data, types of space for bag exchange, physical activity and quality of life will also be collected for all subjects at the 3rd and 6th month. During the study period, peritonitis episode, acute comorbidity and hospitalization will be recorded. The change of physical activity, quality of life and peritonitis rate will be compared between the two groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

77

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 Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Jie Dong

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The study will be conducted in the Division of Nephrology, Beijing University First Hospital. A total of 80 incident CAPD patients with age of 18~80 years old will be enrolled, who are medically stable and regularly followed up. Informed consent is required for each patient.

Exclusion Criteria:

  • Those who have (1) intolerance to the study protocols, (2) severe and unstable conditions within one month, acute or chronic inflammation disease, (3) high probability (assessed by the recruiting physician) of receiving a kidney transplant or transferring to HD or drop-out due to socioeconomic causes within 6 months, (4) cognitive or psychological dysfunction, communication barrier, and (5) bag exchange by unfixed manipulator, are excluded.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mini-exchange-room (G2)
the other group will utilize disposable mini-exchange-room group
Device: mini-exchange-room
No Intervention: usual care (G1)
The one group perform traditional PD procedure (G1)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the improvement in physical activity
Time Frame: 6 months
6 months
the improvement in quality of life
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
times of bag exchanges outside patients' home
Time Frame: 6 months
6 months
peritonitis rate
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Peking University First Hospital

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

October 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

October 29, 2013

First Submitted That Met QC Criteria

November 5, 2013

First Posted (Estimate)

November 13, 2013

Study Record Updates

Last Update Posted (Estimate)

October 28, 2016

Last Update Submitted That Met QC Criteria

October 27, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • mini-exchange-room

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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