Quantifying the Deterioration of Physical Function in Renal Patients

Completed

• Conditions: End Stage Renal Disease

• Registration Number: NCT02832466
• Lead Sponsor: Cardenal Herrera University

Brief Summary

Patients undergoing haemodialysis present a decrease in physical function, but little is known about the rate at which function decreases.

The purpose of this study is quantifying the nature and degree of functional deterioration experienced by stage 5 chronic kidney disease patients during a six month period of maintenance haemodialysis therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2016-07-08
• Study First Submitted QC: 2016-07-11
• Study First Posted: 2016-07-14
• Primary Completion: 2016-12
• Study Completion: 2017-01
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-04
• Last Update Posted: 2017-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• people under hemodialysis treatment at least 3 months
• be medicable stable
• complete all the physical tests

Exclusion Criteria

• heart stroke in the previous 6 weeks of the study
• inferior limb amputation without artificial aids
• cerebral vascular disease (ictus, ischemic)
• disability to complete functional tests

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from Baseline Short Physical Performance Battery at 6 months	At the beginning of the study and after 6 months	Assess lower extremity, which includes objective performance-based measure of balance (side-by-side, semi-tanden and tandem), endurance (4m gait speed) and strength (five chair stands). Each component was scored from 0 to 4 and when summed yielded Short Physical Performance Battery scores between 0 (poor) and 12 (best).
Change from Baseline Sit to Stand to Sit 10 and 60 at 6 months	At the beginning of the study and after 6 months	For the Sit To Stand 10 participant has to stand up and sit down 10 times and the time needed is record; while for the Sit to stand to sit 60 the participant consist in measures how many repetition the participant can to stand up and sit down during 60 seconds
Change from Baseline Timed Up and Go at 6 months	At the beginning of the study and after 6 months	To stand up from a standard arms chair, walk 3 meters, turn back the cone walk back and sit down to the chair. The time in seconds is record.
Change from Baseline Handgrip strength at 6 months	At the beginning of the study and after 6 months	To measure the amount of strength developed by each hand in kg
Change from Baseline Six Minutes Walking Time at 6 months	At the beginning of the study and after 6 months	To walk the longest distance possible in 6 minutes by walking continuously the 20 or 30 metres indicated on the floor. It measures the distance in meters
Change from Baseline One Leg Standing Test at 6 months	At the beginning of the study and after 6 months	Consist in maintain one leg stance for as long as possible. The test was considered normal if the one leg standing time reached 45 seconds.
Change from Baseline On leg heel rise at 6 months	At the beginning of the study and after 6 months	It measures the strength in the triceps surae in the one leg standing position and has to rise the heel. It measures how many repetitions the participants is can do

Trial Locations

Locations (1)

Universidad CEU Cardenal Herrera; 🇪🇸 Moncada, Valencia, Spain