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Quantifying the Deterioration of Physical Function in Renal Patients

Quantifying the Deterioration of Physical Function Along 6 Months in Patients in End Stage Renal Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02832466
Enrollment
60
Registered
2016-07-14
Start date
2014-09-30
Completion date
2017-01-31
Last updated
2017-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease

Brief summary

Patients undergoing haemodialysis present a decrease in physical function, but little is known about the rate at which function decreases. The purpose of this study is quantifying the nature and degree of functional deterioration experienced by stage 5 chronic kidney disease patients during a six month period of maintenance haemodialysis therapy.

Interventions

Observation of physical function in hemodialysis patients during a period of 6 months

Sponsors

Cardenal Herrera University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline Short Physical Performance Battery at 6 monthsAt the beginning of the study and after 6 monthsAssess lower extremity, which includes objective performance-based measure of balance (side-by-side, semi-tanden and tandem), endurance (4m gait speed) and strength (five chair stands). Each component was scored from 0 to 4 and when summed yielded Short Physical Performance Battery scores between 0 (poor) and 12 (best).
Change from Baseline One Leg Standing Test at 6 monthsAt the beginning of the study and after 6 monthsConsist in maintain one leg stance for as long as possible. The test was considered normal if the one leg standing time reached 45 seconds.
Change from Baseline Timed Up and Go at 6 monthsAt the beginning of the study and after 6 monthsTo 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.
Change from Baseline Sit to Stand to Sit 10 and 60 at 6 monthsAt the beginning of the study and after 6 monthsFor the Sit To Stand 10 participant has to stand up and sit down 10 times and the time needed is record; while for the Sit to stand to sit 60 the participant consist in measures how many repetition the participant can to stand up and sit down during 60 seconds
Change from Baseline On leg heel rise at 6 monthsAt the beginning of the study and after 6 monthsIt measures the strength in the triceps surae in the one leg standing position and has to rise the heel. It measures how many repetitions the participants is can do
Change from Baseline Handgrip strength at 6 monthsAt the beginning of the study and after 6 monthsTo measure the amount of strength developed by each hand in kg
Change from Baseline Six Minutes Walking Time at 6 monthsAt the beginning of the study and after 6 monthsTo walk the longest distance possible in 6 minutes by walking continuously the 20 or 30 metres indicated on the floor. It measures the distance in meters

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026