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

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02155127
• Other study ID #: IRB_00064407
• Status: Completed
• Phase: N/A
• First received: June 2, 2014
• Last updated: November 16, 2016
• Start date: October 2014
• Est. completion date: October 2016

Study information

• Verified date: November 2016
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• walking

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	walking speed		baseline to 3 months	No