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

NCT01982344 | Completed

• 1 other identifier: mini-exchange-room
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Activity; Quality of Life

Keywords

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

Outcome Measures

Primary Outcomes (2)

• the improvement in physical activity

  6 months

• the improvement in quality of life

  6 months

Secondary Outcomes (2)

• times of bag exchanges outside patients' home

  6 months

• peritonitis rate

  6 months

Study Arms (2)

mini-exchange-room (G2)

EXPERIMENTAL

the other group will utilize disposable mini-exchange-room group

Device: mini-exchange-room

usual care (G1)

NO INTERVENTION

The one group perform traditional PD procedure (G1)

Interventions

mini-exchange-room DEVICE

mini-exchange-room (G2)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Jie Dong

Beijing, Beijing Municipality, 100034, China

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Institute of Nephrology, Division of Renal

Study Record Dates

• First Submitted: October 29, 2013
• First Posted: November 13, 2013
• Study Start: October 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: October 1, 2016
• Last Updated: October 28, 2016

Record last verified: 2016-10

Locations

CN (1)