University of California San Francisco
San Francisco, California, 94114, United States
NCT Number: NCT02623348
Randomized controlled trial using pedometers to increase physical activity among patients on dialysis.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
San Francisco, California, 94114, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
pedometer-based physical activity recommendations
Time frame: Baseline and 12 weeks
change in steps per day from pedometer
Time frame: Baseline and 12 weeks
change in score on the Short Physical Performance Battery (0-12), higher scores indicate greater physical performance
Time frame: 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)
Time frame: Baseline and 12 weeks
Barthel's Index of Daily Activities (Index range 0-20, higher scores indicate greater functional independence)
Time frame: Baseline and 12 weeks
Dialysis symptom index (symptom burden ranges from 0 - 29 symptoms experienced)
Time frame: Baseline and 12 weeks
(TBMM calculated from measurements of intracellular water from bioimpedance spectrometry)
Time frame: 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.
Time frame: Baseline and 12 weeks
Short Form 36 Vitality Scale (0-100, greater values indicate increased levels of energy/decreased levels of fatigue)
Time frame: 12 weeks
Standard deviation of N-N intervals as recorded on electrocardiography waveform (ms)
Time frame: 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
University of California, San Francisco
Other
Acronym: PED
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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