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Reliability of Functional Measures in Hemodialysis Patient.

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ClinicalTrials.gov Identifier: NCT02830490
Recruitment Status : Completed
First Posted : July 13, 2016
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Eva Segura Ortí, 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).

Condition or disease Intervention/treatment
End Stage Renal Disease Other: functional tests

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).

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Study Type : Observational
Actual Enrollment : 66 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Test-retest Reliability and Minimal Detectable Change Scores for the Short Physical Performance Battery (SPPB), One Leg Balance and Timed up and go.
Study Start Date : September 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : December 2016

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


Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
People with Chronic Kidney Diseases undergoing hemodialysis treatment
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830490


Locations
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Spain
Universidad CEU Cardenal Herrera
Moncada, Valencia, Spain, 46113
Sponsors and Collaborators
Cardenal Herrera University
Investigators
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Principal Investigator: Eva Segura-Ortí, PhD Professor at Universidad CEU Cardenal Herrera

Publications:
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Responsible Party: Eva Segura Ortí, PhD, Cardenal Herrera University
ClinicalTrials.gov Identifier: NCT02830490    
Other Study ID Numbers: CardenalHU
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency