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

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
walking
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring chronic kidney disease, physical function

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

walking intervention

usual care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

walking speed

Secondary Outcome Measures

Full Information

First Posted
June 2, 2014
Last Updated
November 16, 2016
Sponsor
University of Utah
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT02155127
Brief Title
Effects of a Walking Intervention in Older Patients With Chronic Kidney Disease: Feasibility Study
Official Title
Effects of a Walking Intervention in Older Patients With Chronic Kidney Disease: Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
chronic kidney disease, physical function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
walking intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
usual care
Arm Type
No Intervention
Arm Description
these subjects receive information on walking program, however do not receive any coaching over 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
walking
Primary Outcome Measure Information:
Title
walking speed
Time Frame
baseline to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia L Painter, Ph.D.
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States

12. IPD Sharing Statement

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

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