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

Not Applicable

Completed

• Conditions: End-stage Renal Disease
• Interventions: Behavioral: pedometer

• Registration Number: NCT02623348
• Lead Sponsor: University of California, San Francisco

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-01
• Study First Submitted QC: 2015-12-02
• Study First Posted: 2015-12-07
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Results First Submitted: 2019-02-22
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-10
• Last Update Submitted: 2019-09-10
• Results First Posted: 2019-10-02
• Last Update Posted: 2019-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Physical Activity	Baseline and 12 weeks	change in steps per day from pedometer

Secondary Outcome Measures

Name	Time	Method
Self-reported Physical Functioning	Baseline and 12 weeks	Change in score on the Physical Function scale of the Short-Form 36 Health Survey (scale from 0-100, higher numbers indicate better physical functioning)
Physical Performance	Baseline and 12 weeks	change in score on the Short Physical Performance Battery (0-12), higher scores indicate greater physical performance
Change in Total Body Muscle Mass (Adjusted by Height Squared)	Baseline and 12 weeks	(TBMM calculated from measurements of intracellular water from bioimpedance spectrometry)
Change in Symptom Burden on the Dialysis Symptoms Index	Baseline and 12 weeks	Dialysis symptom index (symptom burden ranges from 0 - 29 symptoms experienced)
Change in the Short From 36 Vitality Scale	Baseline and 12 weeks	Short Form 36 Vitality Scale (0-100, greater values indicate increased levels of energy/decreased levels of fatigue)
Change in SDNN (ms)	12 weeks	Standard deviation of N-N intervals as recorded on electrocardiography waveform (ms)
Change in Symptom Severity on Dialysis Symptoms Index	Baseline and 12 weeks	Symptoms range from score of 0 (Not at all bothersome) to 5 (Very Bothersome) over 29 symptoms. Score ranges from 0 - 145
Change in Activities of Daily Living Score	Baseline and 12 weeks	Barthel's Index of Daily Activities (Index range 0-20, higher scores indicate greater functional independence)
Change in Endothelial Function	12 weeks	Reactive hyperemia index (RHI) using peripheral arterial tonometry. RHI is a non-invasive measure of endothelial function, measured using the EndoPAT 2000 (Itamar Medical). The pulse amplitude in the middle fingers of both hands was recorded for five minutes. A blood pressure cuff was then inflated in one arm (which did not have a vascular access in place) to at least 60 mmHg above systolic blood pressure to achieve full occlusion (minimum 200 mmHg, maximum 300 mmHg). After occlusion for 5 minutes, the cuff was deflated, and the device recorded changes in pulse amplitude for an additional 5 minutes and calculated RHI as the ratio of the post to pre occlusion amplitude of the occluded arm relative to the post to pre occlusion amplitude of the control arm, corrected for baseline vascular tone.

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States