Effectiveness Chronic Kidney Disease & Therapeutic Exercise | NCT03416140

Studies
Effectiveness Chronic Kidney Disease & Therapeutic Exercise

NCT03416140

Sponsor

Universidad de León

Status

Withdrawn

Last Update Posted

Mar 25, 2020Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Kidney Diseases
Exercise

Interventions

Therapeutic Exercise

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No participants enrolled

Expanded Access Info

Start Date

Feb 15, 2018Actual

Primary Completion Date

Jun 1, 2021Estimated

Completion Date

Jun 15, 2021Estimated

First Submitted Date

Jan 23, 2018

First Submission Date that Met QC Criteria

Jan 23, 2018

First Posted Date

Jan 30, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2020

Last Update Posted Date

Mar 25, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Therapeutic exercise	Experimental		Other: Therapeutic Exercise
Control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Therapeutic Exercise	Other	30 minutes per day of therapeutic exercise	Therapeutic exercise

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Kidney function	Creatinine clearance	Change from Baseline creatinine clearance at 1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with chronic kidney disease

Exclusion Criteria:

Cognitive impairment and non signed consent inform form

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pierre Neyra Bohórquez, MD	Nephrology Unit, Galdakao Hospital, Spain	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pierre Neyra Bohórquez		Galdakao	Bizkaia	48960	Spain

Condition Browse Module

MeSH Terms

ID	Term
D007674	Kidney Diseases
D009043	Motor Activity

Ancestor Terms

ID	Term
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005081	Exercise Therapy

Ancestor Terms

ID	Term
D012046	Rehabilitation
D000359	Aftercare
D003266	Continuity of Patient Care
D005791	Patient Care

Browse Leaves

Not provided

Browse Branches

Not provided