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

NCT02155127 | Completed DMC

• 1 other identifier: IRB_00064407
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Keywords

chronic kidney disease; physical function

Outcome Measures

Primary Outcomes (1)

• walking speed

  baseline to 3 months

Study Arms (2)

walking intervention

EXPERIMENTAL

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.

Behavioral: walking

usual care

NO INTERVENTION

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

Interventions

walking BEHAVIORAL

walking intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Walking

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Patricia L Painter, Ph.D.

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Research Faculty

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: June 4, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 18, 2016

Record last verified: 2016-11

Locations

US (1)