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

Study Overview
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Brief Summary
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Randomized controlled trial using pedometers to increase physical activity among patients on dialysis.

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

Conditions
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End-stage Renal Disease

Intervention / Treatment
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* Behavioral: pedometer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pedometer<br>Patients will be given pedometers and instructions to increase physical activity based on pedometer output | Behavioral: pedometer<br>* pedometer-based physical activity recommendations<br>|
| No Intervention: usual care<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity | change in steps per day from pedometer | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Performance | change in score on the Short Physical Performance Battery (0-12), higher scores indicate greater physical performance | Baseline and 12 weeks | 
| Self-reported Physical Functioning | 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) | Baseline and 12 weeks | 
| Change in Activities of Daily Living Score | Barthel's Index of Daily Activities (Index range 0-20, higher scores indicate greater functional independence) | Baseline and 12 weeks | 
| Change in Symptom Burden on the Dialysis Symptoms Index | Dialysis symptom index (symptom burden ranges from 0 - 29 symptoms experienced) | Baseline and 12 weeks | 
| Change in Total Body Muscle Mass (Adjusted by Height Squared) | (TBMM calculated from measurements of intracellular water from bioimpedance spectrometry) | Baseline and 12 weeks | 
| Change in Endothelial Function | 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. | 12 weeks | 
| Change in the Short From 36 Vitality Scale | Short Form 36 Vitality Scale (0-100, greater values indicate increased levels of energy/decreased levels of fatigue) | Baseline and 12 weeks | 
| Change in SDNN (ms) | Standard deviation of N-N intervals as recorded on electrocardiography waveform (ms) | 12 weeks | 
| Change in Symptom Severity on Dialysis Symptoms Index | Symptoms range from score of 0 (Not at all bothersome) to 5 (Very Bothersome) over 29 symptoms. Score ranges from 0 - 145 | Baseline and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dialysis, end-stage renal disease