An interventional study of pedometer in End-stage Renal Disease, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-02.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment
Randomized controlled trial using pedometers to increase physical activity among patients on dialysis.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 60 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will be given pedometers and instructions to increase physical activity based on pedometer output
Behavioral: pedometer
No intervention
pedometer-based physical activity recommendations
Physical Activity
change in steps per day from pedometer
Time frame: Baseline and 12 weeks
Physical Performance
change in score on the Short Physical Performance Battery (0-12), higher scores indicate greater physical performance
Time frame: 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)
Time frame: 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)
Time frame: Baseline and 12 weeks
Change in Symptom Burden on the Dialysis Symptoms Index
Dialysis symptom index (symptom burden ranges from 0 - 29 symptoms experienced)
Time frame: Baseline and 12 weeks
Change in Total Body Muscle Mass (Adjusted by Height Squared)
(TBMM calculated from measurements of intracellular water from bioimpedance spectrometry)
Time frame: 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.
Time frame: 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)
Time frame: Baseline and 12 weeks
Change in SDNN (ms)
Standard deviation of N-N intervals as recorded on electrocardiography waveform (ms)
Time frame: 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
Time frame: Baseline and 12 weeks
Patients recruited from 3 local San Francisco dialysis clinics
| Milestone | Pedometer | Usual Care |
|---|---|---|
| Started | 30 | 30 |
| 3-month assessment | 27 | 26 |
| Completed | 27 | 28 |
| Not completed | 3 | 2 |
change in steps per day from pedometer
| steps/day | Pedometer | Usual Care |
|---|---|---|
| Physical Activity | 1474 (40 to 3538) | 180 (-650 to 1040) |
change in score on the Short Physical Performance Battery (0-12), higher scores indicate greater physical performance
| score on a scale | Pedometer | Usual Care |
|---|---|---|
| Physical Performance | 0 (0 to 1) | 0 (-1 to 1) |
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)
| score on a scale | Pedometer | Usual Care |
|---|---|---|
| Self-reported Physical Functioning | 0 (-10 to 5) | 5 (-5 to 10) |
Barthel's Index of Daily Activities (Index range 0-20, higher scores indicate greater functional independence)
| score on a scale | Pedometer | Usual Care |
|---|---|---|
| Change in Activities of Daily Living Score | 0 (0 to 0) | 0 (0 to 0) |
Dialysis symptom index (symptom burden ranges from 0 - 29 symptoms experienced)
| score on a scale | Pedometer | Usual Care |
|---|---|---|
| Change in Symptom Burden on the Dialysis Symptoms Index | 1 (-1.5 to 2) | 0 (-2 to 2) |
(TBMM calculated from measurements of intracellular water from bioimpedance spectrometry)
| kg/m2 | Pedometer | Usual Care |
|---|---|---|
| Change in Total Body Muscle Mass (Adjusted by Height Squared) | 0.30 (-0.50 to 0.76) | -0.47 (-0.90 to 0.35) |
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.
| unitless | Pedometer | Usual Care |
|---|---|---|
| Change in Endothelial Function | -0.1 (-0.3 to 0.22) | 0.1 (-0.57 to 0.28) |
Short Form 36 Vitality Scale (0-100, greater values indicate increased levels of energy/decreased levels of fatigue)
| score on a scale | Pedometer | Usual Care |
|---|---|---|
| Change in the Short From 36 Vitality Scale | 0 (-10 to 15) | 5 (-10 to 10) |
Standard deviation of N-N intervals as recorded on electrocardiography waveform (ms)
| ms | Pedometer | Usual Care |
|---|---|---|
| Change in SDNN (ms) | 1.54 (-6.19 to 11.57) | -0.13 (-6.95 to 2.27) |
Symptoms range from score of 0 (Not at all bothersome) to 5 (Very Bothersome) over 29 symptoms. Score ranges from 0 - 145
| score on a scale | Pedometer | Usual Care |
|---|---|---|
| Change in Symptom Severity on Dialysis Symptoms Index | 2 (-3.5 to 13) | -1 (-9 to 9) |
Collected over 24 months total, 6 months per patient. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pedometer | 1/30 (3.3%) | 0/30 (0%) | 6/30 (20%) |
| Usual Care | 0/30 (0%) | 0/30 (0%) | 2/30 (6.7%) |
| Event | Pedometer | Usual Care |
|---|---|---|
| FatigueGeneral disorders | 6/30 | 2/30 |
| Age, Continuous(years) | Pedometer | Usual Care | Total |
|---|---|---|---|
| Median | 60 (53 to 66) | 56 (51 to 65) | 58 (53 to 65.5) |
| Sex: Female, Male(Participants) | Pedometer | Usual Care | Total |
|---|---|---|---|
| Female | 2 | 11 | 13 |
| Male | 28 | 19 | 47 |
| Ethnicity (NIH/OMB)(Participants) | Pedometer | Usual Care | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 5 | 10 |
| Not Hispanic or Latino | 23 | 24 | 47 |
| Unknown or Not Reported | 2 | 1 | 3 |
| Race (NIH/OMB)(Participants) | Pedometer | Usual Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 6 | 6 | 12 |
| Native Hawaiian or Other Pacific Islander | 2 | 3 | 5 |
| Black or African American | 14 | 11 | 25 |
| White | 4 | 5 | 9 |
| More than one race | 2 | 2 | 4 |
| Unknown or Not Reported | 2 | 3 | 5 |
| Region of Enrollment(Participants) | Pedometer | Usual Care | Total |
|---|---|---|---|
| United States | 30 | 30 | 60 |
| BMI(kg/m^2) | Pedometer | Usual Care | Total |
|---|---|---|---|
| Median | 26.9 (25.3 to 32.9) | 31.6 (26.7 to 34.6) | 29 (25.5 to 34.4) |
| Dialysis Vintage (Years)(years) | Pedometer | Usual Care | Total |
|---|---|---|---|
| Mean | 3.7 (1.5 to 7.2) | 1.9 (0.95 to 4.7) | 3.1 (1.1 to 5.8) |
| Hemoglobin(mg/dL) | Pedometer | Usual Care | Total |
|---|---|---|---|
| Median | 10.6 (9.6 to 11.7) | 10.9 (9.8 to 11.7) | 10.7 (9.8 to 11.7) |
11 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco