Quantifying the Deterioration of Physical Function in Renal Patients

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

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.

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease
• Intervention / Treatment: Other: Functional Test

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Spain
  • Valencia
    • Moncada, Valencia, Spain, 46113
      • Universidad CEU Cardenal Herrera

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

People with Chronic Kidney Diseases undergoing hemodialysis treatment

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Cardenal Herrera University
• Investigators: Principal Investigator: Eva Segura Ortí, Lecturer in the Cardenal Herrera University

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: July 8, 2016
• First Submitted That Met QC Criteria: July 11, 2016
• First Posted (Estimate): July 14, 2016

Study Record Updates

• Last Update Posted (Actual): April 5, 2017
• Last Update Submitted That Met QC Criteria: April 4, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: Cardenal Herrera Univeristy