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Clinical Trials/NCT02623348
NCT02623348CompletedNot Applicable

Use of Pedometers to Measure and Increase Walking Among Patients With ESRD

University of California, San Francisco2 sites in 1 country60 target enrollmentStarted: December 2015Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
2
Primary Endpoint
Physical Activity
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Randomized controlled trial using pedometers to increase physical activity among patients on dialysis.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •on hemodialysis for ≥ 3 months
  • •able to walk
  • •able to give informed consent and willing to participate

Exclusion Criteria

  • •unable to walk
  • •unable to understand directions or give informed consent

Arms & Interventions

pedometer

Experimental

Patients will be given pedometers and instructions to increase physical activity based on pedometer output

Intervention: pedometer (Behavioral)

usual care

No Intervention

No intervention

Outcomes

Primary Outcomes

Physical Activity

Time Frame: Baseline and 12 weeks

change in steps per day from pedometer

Secondary Outcomes

  • Self-reported Physical Functioning(Baseline and 12 weeks)
  • Physical Performance(Baseline and 12 weeks)
  • Change in Total Body Muscle Mass (Adjusted by Height Squared)(Baseline and 12 weeks)
  • Change in Symptom Burden on the Dialysis Symptoms Index(Baseline and 12 weeks)
  • Change in the Short From 36 Vitality Scale(Baseline and 12 weeks)
  • Change in SDNN (ms)(12 weeks)
  • Change in Symptom Severity on Dialysis Symptoms Index(Baseline and 12 weeks)
  • Change in Activities of Daily Living Score(Baseline and 12 weeks)
  • Change in Endothelial Function(12 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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