Quantifying the Deterioration of Physical Function in Renal Patients

End Stage Renal Disease Clinical Trial

Official title:

Quantifying the Deterioration of Physical Function Along 6 Months in Patients in End Stage Renal Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02832466
• Other study ID #: Cardenal Herrera Univeristy
• Status: Completed
• Phase: N/A
• First received: July 8, 2016
• Last updated: April 4, 2017
• Start date: September 2014
• Est. completion date: January 2017

Study information

• Verified date: April 2017
• Source: Cardenal Herrera University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Other:
• Functional Test
Observation of physical function in hemodialysis patients during a period of 6 months

Locations

Country	Name	City	State
Spain	Universidad CEU Cardenal Herrera	Moncada	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Cardenal Herrera University

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Short Physical Performance Battery at 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).	At the beginning of the study and after 6 months
Primary	Change from Baseline One Leg Standing Test at 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.	At the beginning of the study and after 6 months
Primary	Change from Baseline Timed Up and Go at 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.	At the beginning of the study and after 6 months
Primary	Change from Baseline Sit to Stand to Sit 10 and 60 at 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	At the beginning of the study and after 6 months
Primary	Change from Baseline On leg heel rise at 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	At the beginning of the study and after 6 months
Primary	Change from Baseline Handgrip strength at 6 months	To measure the amount of strength developed by each hand in kg	At the beginning of the study and after 6 months
Primary	Change from Baseline Six Minutes Walking Time at 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	At the beginning of the study and after 6 months