Chronic Kidney Disease & Therapeutic Exercise | NCT03301987

Studies
Chronic Kidney Disease & Therapeutic Exercise

NCT03301987

Sponsor

Universidad de León

Status

Completed

Last Update Posted

Dec 12, 2017Actual

Enrollment

9Actual

Phase

Not Applicable

Conditions

Kidney
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

Dec 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 14, 2017Actual

Primary Completion Date

Dec 5, 2017Actual

Completion Date

Dec 9, 2017Actual

First Submitted Date

Sep 30, 2017

First Submission Date that Met QC Criteria

Sep 30, 2017

First Posted Date

Oct 4, 2017Actual

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

Dec 9, 2017

Last Update Posted Date

Dec 12, 2017Actual

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 aim of this study is to evaluate the therapeutic exercise effects in patients with chronic kidney disease. An interventional prospective study is carried out. A sample of 9 patients with chronic kidney disease is recruited. 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

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Therapeutic exercise	Experimental		Other: Therapeutic exercise

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

Not provided

Locations

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31166442	Derived	Calvo-Lobo C, Neyra-Bohorquez PP, Seco-Calvo J. Aerobic exercise effects in renal function and quality of life of patients with advanced chronic kidney disease. Rev Assoc Med Bras (1992). 2019 Jun 3;65(5):657-662. doi: 10.1590/1806-9282.65.5.657.

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