Back to resultsEffectiveness Chronic Kidney Disease & Therapeutic Exercise
Primary Purpose
Kidney Diseases, Exercise
Status
Withdrawn
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Therapeutic Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Diseases
Eligibility Criteria
Inclusion Criteria:
- Patients with chronic kidney disease
Exclusion Criteria:
- Cognitive impairment and non signed consent inform form
Sites / Locations
- Pierre Neyra Bohórquez
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Therapeutic exercise
Control
Arm Description
Outcomes
Primary Outcome Measures
Kidney function
Creatinine clearance
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03416140
Brief Title
Effectiveness Chronic Kidney Disease & Therapeutic Exercise
Official Title
Effectiveness and Safety of the Therapeutic Exercise in Patients With Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Withdrawn
Why Stopped
No participants enrolled
Study Start Date
February 15, 2018 (Actual)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
June 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de León
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Diseases, Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Therapeutic exercise
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Therapeutic Exercise
Intervention Description
30 minutes per day of therapeutic exercise
Primary Outcome Measure Information:
Title
Kidney function
Description
Creatinine clearance
Time Frame
Change from Baseline creatinine clearance at 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with chronic kidney disease
Exclusion Criteria:
Cognitive impairment and non signed consent inform form
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Neyra Bohórquez, MD
Organizational Affiliation
Nephrology Unit, Galdakao Hospital, Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pierre Neyra Bohórquez
City
Galdakao
State/Province
Bizkaia
ZIP/Postal Code
48960
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Effectiveness Chronic Kidney Disease & Therapeutic Exercise
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