Reliability of Functional Measures in Hemodialysis Patient.

End Stage Renal Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02830490
• Other study ID #: CardenalHU
• Status: Completed
• Phase: N/A
• First received: December 1, 2015
• Last updated: April 3, 2017
• Start date: September 2014
• Est. completion date: December 2016

Study information

• Verified date: April 2017
• Source: Cardenal Herrera University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

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

Locations

Country	Name	City	State
Spain	Universidad CEU Cardenal Herrera	Moncada	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Cardenal Herrera University

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short Physical Performance Battery	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).	It will perform the test twice with one to two weeks interval between the testing session
Secondary	One Leg Standing Test	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.	It will perform the test twice with one to two weeks interval between the testing session
Secondary	Timed Up and Go	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.	It will perform the test twice with one to two weeks interval between the testing session