- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03416140
Effectiveness Chronic Kidney Disease & Therapeutic Exercise
March 23, 2020 updated by: César Calvo Lobo, Universidad de León
Effectiveness and Safety of the Therapeutic Exercise in Patients With Chronic Kidney Disease
The purpose of this study is to assess the effectiveness and safety of the therapeutic exercise effects in patients with chronic kidney disease.
An randomized clinical trial is carried out.
A total sample of 70 patients with chronic kidney disease is recruited and divided into a therapeutic exercise group and a control group.
The kidney function (creatinine clearance as main outcome) is measured at baseline and 1 month after treatment start.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bizkaia
-
Galdakao, Bizkaia, Spain, 48960
- Pierre Neyra Bohórquez
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with chronic kidney disease
Exclusion Criteria:
- Cognitive impairment and non signed consent inform form
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
NO_INTERVENTION: Control
|
|
|
EXPERIMENTAL: Therapeutic exercise
|
30 minutes per day of therapeutic exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Kidney function
Time Frame: Change from Baseline creatinine clearance at 1 month
|
Creatinine clearance
|
Change from Baseline creatinine clearance at 1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Pierre Neyra Bohórquez, MD, Nephrology Unit, Galdakao Hospital, Spain
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 15, 2018
Primary Completion (ANTICIPATED)
June 1, 2021
Study Completion (ANTICIPATED)
June 15, 2021
Study Registration Dates
First Submitted
January 23, 2018
First Submitted That Met QC Criteria
January 23, 2018
First Posted (ACTUAL)
January 30, 2018
Study Record Updates
Last Update Posted (ACTUAL)
March 25, 2020
Last Update Submitted That Met QC Criteria
March 23, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ERC_ULE_II
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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