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OpenTrials
Completed

NCT Number: NCT02623348

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

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Francisco

San Francisco, California, 94114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pedometer

Behavioral

pedometer-based physical activity recommendations

Primary outcomes

  1. Physical Activity

    Time frame: Baseline and 12 weeks

    change in steps per day from pedometer

Secondary outcomes

  1. Physical Performance

    Time frame: Baseline and 12 weeks

    change in score on the Short Physical Performance Battery (0-12), higher scores indicate greater physical performance

  2. Self-reported Physical Functioning

    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)

  3. Change in Activities of Daily Living Score

    Time frame: Baseline and 12 weeks

    Barthel's Index of Daily Activities (Index range 0-20, higher scores indicate greater functional independence)

  4. Change in Symptom Burden on the Dialysis Symptoms Index

    Time frame: Baseline and 12 weeks

    Dialysis symptom index (symptom burden ranges from 0 - 29 symptoms experienced)

  5. Change in Total Body Muscle Mass (Adjusted by Height Squared)

    Time frame: Baseline and 12 weeks

    (TBMM calculated from measurements of intracellular water from bioimpedance spectrometry)

  6. Change in Endothelial Function

    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.

  7. Change in the Short From 36 Vitality Scale

    Time frame: Baseline and 12 weeks

    Short Form 36 Vitality Scale (0-100, greater values indicate increased levels of energy/decreased levels of fatigue)

  8. Change in SDNN (ms)

    Time frame: 12 weeks

    Standard deviation of N-N intervals as recorded on electrocardiography waveform (ms)

  9. Change in Symptom Severity on Dialysis Symptoms Index

    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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Acronym: PED

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Dec 7, 2015
Registry last updated
Oct 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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