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Effects of a Walking Intervention in Older Patients With Chronic Kidney Disease: Feasibility Study

NCT ID: NCT02155127

Last Updated: 2016-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-10-31

Brief Summary

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Chronic kidney disease (CKD) affects more than 26 million individuals (13 percent) of the U.S. population, with a projected 70 percent increase by the year 2015 to over 40 million individuals. Impairments in physical function and mobility limitations have been reported in older Chronic Kidney Disease patients, however the consequences of impaired functioning on participation in daily life and quality of life have not been studied. Early identification and interventions to mitigate deterioration in physical function and mobility should lead to improved health and quality of life outcomes in older patients with Chronic Kidney Disease. Although older individuals with Chronic Kidney Disease have reduced survival expectancy, maintaining physical function and mobility may contribute to longer active life expectancy, and higher quality of life despite their diagnosis.

Detailed Description

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Conditions

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Chronic Kidney Disease

Keywords

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chronic kidney disease physical function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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walking intervention

Subjects are randomized to walking/functional strength program with weekly coaching or usual care. The program is for 12 weeks. The intervention includes 3 lower extremity strengthening exercises, and progressive walking.

Group Type EXPERIMENTAL

walking

Intervention Type BEHAVIORAL

usual care

these subjects receive information on walking program, however do not receive any coaching over 12 weeks

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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walking

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Male and female patients over the age of 60 years
* Diagnosed with moderate to severe CKD (stage 2-4)
* Ambulatory (with or without use of an assistive device such as a cane or walker)
* Living in the community, cognitively able to provide consent and understand directions for the tests
* Cognitive ability to understand and carry out an independent home walking program
* Access and ability to communicate with study staff on a weekly basis and available for follow-up testing.

Exclusion Criteria

* Inability to carry out a program of walking independently at home
* Unavailable for follow-up testing, estimated GFR \>60 ml/minx1.73m2 and \< 15 ml/minx1.73 m2
* Recent cardiac event (within the past 6 months)
* Uncontrolled hypertension
* Uncontrolled diabetes
* Pulmonary disease that may limit the ability to progress with walking
* Progressive neuromuscular disease
* Any orthopedic or neuromuscular condition that may be exacerbated by increased walking activity
* diabetic foot ulcer.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Patricia Painter

Associate Research Faculty

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patricia L Painter, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

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University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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IRB_00064407

Identifier Type: -

Identifier Source: org_study_id