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

Quality of Life Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01982344
• Other study ID #: mini-exchange-room
• Status: Completed
• Phase: N/A
• First received: October 29, 2013
• Last updated: October 27, 2016
• Start date: October 2013
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: October 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Physical Activity
• Quality of Life

Intervention

Device:
• mini-exchange-room

Locations

Country	Name	City	State
China	Jie Dong	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the improvement in physical activity		6 months	No
Primary	the improvement in quality of life		6 months	No
Secondary	times of bag exchanges outside patients' home		6 months	No
Secondary	peritonitis rate		6 months	No