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Completed

NCT Number: NCT02832440

Comparison of Two Exercise Programmes in Patients Undergoing Hemodialysis

Although exercise training of haemodialysis patients is associated with generally positive outcomes few haemodialysis units routinely offer intradialytic exercise therapy. This is often related to financial cost and/or staffing limitations. Home-based programs could be an alternative means of providing exercise benefits without associated implementation costs The aim of this study was to compare the effects of 4 weeks intradialytic versus home based exercise for haemodialysis patients regarding adherence and strength gains.

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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

Interventional

Phase

Not applicable

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

Exercise programmes

Other

Primary outcomes

  1. Change from Baseline Short Physical Performance Battery at 4 months

    Time frame: At the beginning and after 4 months

    Assess lower extremity, which includes objective performance-based measure of balance (side-by-side, semi-tandem 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 4 months

    Time frame: At the beginning and after 4 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 test at 4 months

    Time frame: At the beginning and after 4 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 4 months

    Time frame: At the beginning and after 4 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 One leg heel rise at 4 months

    Time frame: At the beginning and after 4 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 4 months

    Time frame: At the beginning and after 4 months

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

  7. Change from Baseline Six minutes walking test at 4 months

    Time frame: At the beginning and after 4 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

Comparison of Intradialytic Versus Home-based Programmes on Adherence and Strength of Stage 5 Chronic Kidney Disease Patients

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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