Reliability of Functional Measures in Hemodialysis Patient.

Overview

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).

Full Title of Study: “Test-retest Reliability and Minimal Detectable Change Scores for the Short Physical Performance Battery (SPPB), One Leg Balance and Timed up and go.”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 2016

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).

Interventions

  • Other: functional tests
    • Test-retest reliability of physical function in hemodialysis patients

Clinical Trial Outcome Measures

Primary Measures

  • Short Physical Performance Battery
    • Time Frame: 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 Measures

  • One Leg Standing Test
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cardenal Herrera University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Eva Segura Ortí, PhD – Cardenal Herrera University
  • Overall Official(s)
    • Eva Segura-Ortí, PhD, Principal Investigator, Professor at Universidad CEU Cardenal Herrera

References

Segura-Ortí E, Martínez-Olmos FJ. Test-retest reliability and minimal detectable change scores for sit-to-stand-to-sit tests, the six-minute walk test, the one-leg heel-rise test, and handgrip strength in people undergoing hemodialysis. Phys Ther. 2011 Aug;91(8):1244-52. doi: 10.2522/ptj.20100141. Epub 2011 Jun 30.

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