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
Verified date | April 2017 |
Source | Cardenal Herrera University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Universidad CEU Cardenal Herrera | Moncada | Valencia |
Lead Sponsor | Collaborator |
---|---|
Cardenal Herrera University |
Spain,
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 |
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