Comparison of Two Exercise Programmes in Patients Undergoing Hemodialysis

Not Applicable

Completed

• Conditions: End Stage Renal Disease
• Interventions: Other: Exercise programmes

• Registration Number: NCT02832440
• Lead Sponsor: Cardenal Herrera University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2016-07-08
• Study First Submitted QC: 2016-07-11
• Study First Posted: 2016-07-14
• Primary Completion: 2016-12
• Study Completion: 2017-01
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-04
• Last Update Posted: 2017-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home-based exercise	Exercise programmes	Exercise at home
Intradialytic exercise	Exercise programmes	Exercise during hemodialysis

Primary Outcome Measures

Name	Time	Method
Change from Baseline Handgrip Strength at 4 months	At the beginning and after 4 months	To measure the amount of strength developed by each hand in kg
Change from Baseline Short Physical Performance Battery at 4 months	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 Timed Up and Go test at 4 months	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 Six minutes walking test at 4 months	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
Change from Baseline One leg standing test at 4 months	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 Sit to stand to sit 10 and 60 at 4 months	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	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

Trial Locations

Locations (1)

Universidad CEU Cardenal Herrera; 🇪🇸 Moncada, Valencia, Spain