Comparison of Two Exercise Programmes in Patients Undergoing Hemodialysis

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02832440
• Other study ID #: CEU Card Herrera
• Status: Completed
• Phase: N/A
• First received: July 8, 2016
• Last updated: April 4, 2017
• Start date: September 2014
• Est. completion date: January 2017

Study information

• Verified date: April 2017
• Source: Cardenal Herrera University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Other:
• Exercise programmes

Locations

Country	Name	City	State
Spain	Universidad CEU Cardenal Herrera	Moncada	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Cardenal Herrera University

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	At the beginning and after 4 months
Primary	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.	At the beginning and after 4 months
Primary	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.	At the beginning and after 4 months
Primary	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	At the beginning and after 4 months
Primary	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	At the beginning and after 4 months
Primary	Change from Baseline Handgrip Strength at 4 months	To measure the amount of strength developed by each hand in kg	At the beginning and after 4 months
Primary	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	At the beginning and after 4 months