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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01982344

Enrollment

Registered

2013-11-13

Start date

2013-10-31

Completion date

2016-10-31

Last updated

2016-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physical Activity, Quality of Life

Keywords

mini-exchange-room, physical activity, quality of life, peritoneal dialysis

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.

Interventions

DEVICEmini-exchange-room

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
the improvement in physical activity	6 months
the improvement in quality of life	6 months

Secondary

Measure	Time frame
times of bag exchanges outside patients' home	6 months
peritonitis rate	6 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026