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

Not Applicable

Completed

• Conditions: Physical Activity; Quality of Life
• Interventions: Device: mini-exchange-room

• Registration Number: NCT01982344
• Lead Sponsor: Peking University First Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-29
• Study First Submitted QC: 2013-11-05
• Study First Posted: 2013-11-13
• Primary Completion: 2015-06
• Status Verified: 2016-10
• Study Completion: 2016-10
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mini-exchange-room (G2)	mini-exchange-room	the other group will utilize disposable mini-exchange-room group

Primary Outcome Measures

Name	Time	Method
the improvement in physical activity	6 months
the improvement in quality of life	6 months

Secondary Outcome Measures

Name	Time	Method
times of bag exchanges outside patients' home	6 months
peritonitis rate	6 months

Trial Locations

Locations (1)

Jie Dong; 🇨🇳 Beijing, Beijing, China