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Completed

NCT Number: NCT02830490

Reliability of Functional Measures in Hemodialysis Patient.

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).

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universidad CEU Cardenal Herrera

Moncada, Valencia, 46113, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

functional tests

Other

Test-retest reliability of physical function in hemodialysis patients

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Cardenal Herrera University

Other

Registry information

Official study title

Test-retest Reliability and Minimal Detectable Change Scores for the Short Physical Performance Battery (SPPB), One Leg Balance and Timed up and go.

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 13, 2016
Registry last updated
Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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