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Comparison of Two Exercise Programmes in Patients Undergoing Hemodialysis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02832440
First Posted: July 14, 2016
Last Update Posted: April 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eva Segura Ortí, Cardenal Herrera University
  Purpose
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.

Condition Intervention
End Stage Renal Disease Other: Exercise programmes

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Intradialytic Versus Home-based Programmes on Adherence and Strength of Stage 5 Chronic Kidney Disease Patients

Resource links provided by NLM:


Further study details as provided by Eva Segura Ortí, Cardenal Herrera University:

Primary Outcome Measures:
  • 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).

  • 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.

  • 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.

  • 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

  • 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

  • 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

  • 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


Enrollment: 60
Study Start Date: September 2014
Study Completion Date: January 2017
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Intradialytic exercise
Exercise during hemodialysis
Other: Exercise programmes
Home-based exercise
Exercise at home
Other: Exercise programmes

  Eligibility

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02832440


Locations
Spain
Universidad CEU Cardenal Herrera
Moncada, Valencia, Spain, 46113
Sponsors and Collaborators
Cardenal Herrera University
Investigators
Principal Investigator: Eva Segura Ortí Lecturer in the Cardenal Herrera University
  More Information

Responsible Party: Eva Segura Ortí, Professor, Cardenal Herrera University
ClinicalTrials.gov Identifier: NCT02832440     History of Changes
Other Study ID Numbers: CEU Card Herrera
First Submitted: July 8, 2016
First Posted: July 14, 2016
Last Update Posted: April 5, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases