NCT02830490

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2015

Completed
8 months until next milestone

First Posted

Study publicly available on registry

July 13, 2016

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 4, 2017

Status Verified

April 1, 2017

Enrollment Period

1.9 years

First QC Date

December 1, 2015

Last Update Submit

April 3, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • One Leg Standing Test

    It will perform the test twice with one to two weeks interval between the testing session

  • Timed Up and Go

    It will perform the test twice with one to two weeks interval between the testing session

Interventions

Test-retest reliability of physical function in hemodialysis patients

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People with Chronic Kidney Diseases undergoing hemodialysis treatment

You may qualify if:

  • people under hemodialysis treatment at least 3 months
  • be medicable stable
  • complete all the physical tests

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad CEU Cardenal Herrera

Moncada, Valencia, 46113, Spain

Location

Related Publications (1)

  • Segura-Orti E, Martinez-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.

    PMID: 21719637BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Eva Segura-Ortí, PhD

    Professor at Universidad CEU Cardenal Herrera

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 1, 2015

First Posted

July 13, 2016

Study Start

September 1, 2014

Primary Completion

August 1, 2016

Study Completion

December 1, 2016

Last Updated

April 4, 2017

Record last verified: 2017-04

Locations