Reliability of Functional Measures in Hemodialysis Patient.

Completed

• Conditions: End Stage Renal Disease

• Registration Number: NCT02830490
• Lead Sponsor: Cardenal Herrera University

Brief Summary

The investigators pretend to calculate values absolute and relative reliability that have not been yet reported (Short Physical Performance Battery, one-leg balance and Timed Up and go).

Detailed Description

Patients suffering from End Stage Renal Disease are commonly involved in haemodialysis treatment, which is the most common treatment at this stage. Haemodialysis substitutes the renal function but is associated with several alterations that lead to decrease in functional capacity and health related quality of life (HRQoL). Many studies show that functional capacity, physical activity level and HRQoL is significantly worse than their healthy sedentary age - matched counterparts. It is unknown if low physical activity, uraemia or anaemia are responsible for the decreased functional capacity of this cohort. Physical performance tests are frequently used to assess haemodialysis patients since is a feasible and low-cost evaluation. The purpose of the present study is quantified how the functional capacity changes over a -6 months period in a group of haemodialysis patients. Additionally the investigators pretend to calculate values absolute and relative reliability that have not been yet reported (Short Physical Performance Battery, one-leg balance and Timed Up and go).

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-12-01
• Study First Submitted QC: 2016-07-08
• Study First Posted: 2016-07-13
• Primary Completion: 2016-08
• Study Completion: 2016-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-03
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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
Short Physical Performance Battery	It will perform the test twice with one to two weeks interval between the testing session	Assess lower extremity, which includes objective performance-based measure of balance (side-by-side, semitanden and tandem), endurance (4m gait speed) and strength (five chair stands). Each component was scored from 0 to 4 and when summed yielded SPPB scores between 0 (poor) and 12 (best).

Secondary Outcome Measures

Name	Time	Method
One Leg Standing Test	It will perform the test twice with one to two weeks interval between the testing session	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.
Timed Up and Go	It will perform the test twice with one to two weeks interval between the testing session	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.

Trial Locations

Locations (1)

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