NCT03416140

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 30, 2018

Completed
16 days until next milestone

Study Start

First participant enrolled

February 15, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2021

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

3.3 years

First QC Date

January 23, 2018

Last Update Submit

March 23, 2020

Conditions

Kidney DiseasesExercise

Outcome Measures

Primary Outcomes (1)

  • Kidney function

    Creatinine clearance

    Change from Baseline creatinine clearance at 1 month

Study Arms (2)

Therapeutic exercise

EXPERIMENTAL
Other: Therapeutic Exercise

Control

NO INTERVENTION

Interventions

Therapeutic ExerciseOTHER

30 minutes per day of therapeutic exercise

Therapeutic exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with chronic kidney disease

You may not qualify if:

  • Cognitive impairment and non signed consent inform form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pierre Neyra Bohórquez

Galdakao, Bizkaia, 48960, Spain

Location

MeSH Terms

Conditions

Kidney DiseasesMotor Activity

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesBehavior

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Pierre Neyra Bohórquez, MD

    Nephrology Unit, Galdakao Hospital, Spain

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, MSc, PT

Study Record Dates

First Submitted

January 23, 2018

First Posted

January 30, 2018

Study Start

February 15, 2018

Primary Completion

June 1, 2021

Study Completion

June 15, 2021

Last Updated

March 25, 2020

Record last verified: 2020-03

Locations

ES(1)