Quantifying the Deterioration of Physical Function in Renal Patients

NCT02832466 | Completed

• 1 other identifier: Cardenal Herrera Univeristy
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (7)

• 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

Interventions

Functional Test OTHER

Observation of physical function in hemodialysis patients during a period of 6 months

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with Chronic Kidney Diseases undergoing hemodialysis treatment

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardenal Herrera University: lead

Study Sites (1)

Universidad CEU Cardenal Herrera

Moncada, Valencia, 46113, Spain

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eva Segura Ortí

  Lecturer in the Cardenal Herrera University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 8, 2016
• First Posted: July 14, 2016
• Study Start: September 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: April 5, 2017

Record last verified: 2017-04

Locations

ES (1)