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Comparison of Two Exercise Programmes in Patients Undergoing Hemodialysis

Primary Purpose

End Stage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Exercise programmes
Sponsored by
Cardenal Herrera University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universidad CEU Cardenal Herrera

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Intradialytic exercise

Home-based exercise

Arm Description

Exercise during hemodialysis

Exercise at home

Outcomes

Primary Outcome Measures

Change from Baseline Short Physical Performance Battery at 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
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
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
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
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
To measure the amount of strength developed by each hand in kg
Change from Baseline Six minutes walking test at 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

Secondary Outcome Measures

Full Information

First Posted
July 8, 2016
Last Updated
April 4, 2017
Sponsor
Cardenal Herrera University
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1. Study Identification

Unique Protocol Identification Number
NCT02832440
Brief Title
Comparison of Two Exercise Programmes in Patients Undergoing Hemodialysis
Official Title
Comparison of Intradialytic Versus Home-based Programmes on Adherence and Strength of Stage 5 Chronic Kidney Disease Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardenal Herrera University

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intradialytic exercise
Arm Type
Other
Arm Description
Exercise during hemodialysis
Arm Title
Home-based exercise
Arm Type
Other
Arm Description
Exercise at home
Intervention Type
Other
Intervention Name(s)
Exercise programmes
Primary Outcome Measure Information:
Title
Change from Baseline Short Physical Performance Battery at 4 months
Description
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).
Time Frame
At the beginning and after 4 months
Title
Change from Baseline One leg standing test at 4 months
Description
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.
Time Frame
At the beginning and after 4 months
Title
Change from Baseline Timed Up and Go test at 4 months
Description
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.
Time Frame
At the beginning and after 4 months
Title
Change from Baseline Sit to stand to sit 10 and 60 at 4 months
Description
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
Time Frame
At the beginning and after 4 months
Title
Change from Baseline One leg heel rise at 4 months
Description
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
Time Frame
At the beginning and after 4 months
Title
Change from Baseline Handgrip Strength at 4 months
Description
To measure the amount of strength developed by each hand in kg
Time Frame
At the beginning and after 4 months
Title
Change from Baseline Six minutes walking test at 4 months
Description
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
Time Frame
At the beginning and after 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Segura Ortí
Organizational Affiliation
Lecturer in the Cardenal Herrera University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad CEU Cardenal Herrera
City
Moncada
State/Province
Valencia
ZIP/Postal Code
46113
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Comparison of Two Exercise Programmes in Patients Undergoing Hemodialysis

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