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Completed

NCT Number: NCT02832466

Quantifying the Deterioration of Physical Function in Renal Patients

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.

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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

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 Test

Other

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

Primary outcomes

  1. Change from Baseline Short Physical Performance Battery at 6 months

    Time frame: At the beginning of the study and after 6 months

    Assess 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).

  2. Change from Baseline One Leg Standing Test at 6 months

    Time frame: At the beginning of the study and after 6 months

    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.

  3. Change from Baseline Timed Up and Go at 6 months

    Time frame: At the beginning of the study and after 6 months

    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.

  4. Change from Baseline Sit to Stand to Sit 10 and 60 at 6 months

    Time frame: At the beginning of the study and after 6 months

    For 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

  5. Change from Baseline On leg heel rise at 6 months

    Time frame: At the beginning of the study and after 6 months

    It 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

  6. Change from Baseline Handgrip strength at 6 months

    Time frame: At the beginning of the study and after 6 months

    To measure the amount of strength developed by each hand in kg

  7. Change from Baseline Six Minutes Walking Time at 6 months

    Time frame: At the beginning of the study and after 6 months

    To 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

Sponsors and collaborators

Lead sponsor

Cardenal Herrera University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jul 14, 2016
Registry last updated
Apr 5, 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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