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

Primary Purpose

End-stage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
pedometer
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End-stage Renal Disease focused on measuring dialysis, end-stage renal disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

pedometer

usual care

Arm Description

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

No intervention

Outcomes

Primary Outcome Measures

Physical Activity
change in steps per day from pedometer

Secondary Outcome Measures

Physical Performance
change in score on the Short Physical Performance Battery (0-12), higher scores indicate greater physical performance
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)
Change in Activities of Daily Living Score
Barthel's Index of Daily Activities (Index range 0-20, higher scores indicate greater functional independence)
Change in Symptom Burden on the Dialysis Symptoms Index
Dialysis symptom index (symptom burden ranges from 0 - 29 symptoms experienced)
Change in Total Body Muscle Mass (Adjusted by Height Squared)
(TBMM calculated from measurements of intracellular water from bioimpedance spectrometry)
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.
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)
Change in SDNN (ms)
Standard deviation of N-N intervals as recorded on electrocardiography waveform (ms)
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

Full Information

First Posted
December 1, 2015
Last Updated
September 10, 2019
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT02623348
Brief Title
Use of Pedometers to Measure and Increase Walking Among Patients With ESRD
Acronym
PED
Official Title
Use of Pedometers to Measure and Increase Walking Among Patients With ESRD
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-stage Renal Disease
Keywords
dialysis, end-stage renal disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pedometer
Arm Type
Experimental
Arm Description
Patients will be given pedometers and instructions to increase physical activity based on pedometer output
Arm Title
usual care
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Behavioral
Intervention Name(s)
pedometer
Intervention Description
pedometer-based physical activity recommendations
Primary Outcome Measure Information:
Title
Physical Activity
Description
change in steps per day from pedometer
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Physical Performance
Description
change in score on the Short Physical Performance Battery (0-12), higher scores indicate greater physical performance
Time Frame
Baseline and 12 weeks
Title
Self-reported Physical Functioning
Description
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
Title
Change in Activities of Daily Living Score
Description
Barthel's Index of Daily Activities (Index range 0-20, higher scores indicate greater functional independence)
Time Frame
Baseline and 12 weeks
Title
Change in Symptom Burden on the Dialysis Symptoms Index
Description
Dialysis symptom index (symptom burden ranges from 0 - 29 symptoms experienced)
Time Frame
Baseline and 12 weeks
Title
Change in Total Body Muscle Mass (Adjusted by Height Squared)
Description
(TBMM calculated from measurements of intracellular water from bioimpedance spectrometry)
Time Frame
Baseline and 12 weeks
Title
Change in Endothelial Function
Description
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
Title
Change in the Short From 36 Vitality Scale
Description
Short Form 36 Vitality Scale (0-100, greater values indicate increased levels of energy/decreased levels of fatigue)
Time Frame
Baseline and 12 weeks
Title
Change in SDNN (ms)
Description
Standard deviation of N-N intervals as recorded on electrocardiography waveform (ms)
Time Frame
12 weeks
Title
Change in Symptom Severity on Dialysis Symptoms Index
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35018639
Citation
Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.
Results Reference
derived
PubMed Identifier
33979802
Citation
Sheshadri A, Kittiskulnam P, Delgado C, Sudore RL, Lai JC, Johansen KL. Association of Cognitive Function Screening Results with Adherence and Performance in a Pedometer-Based Intervention. Am J Nephrol. 2021;52(5):420-428. doi: 10.1159/000516130. Epub 2021 May 12.
Results Reference
derived
PubMed Identifier
32437568
Citation
Sheshadri A, Kittiskulnam P, Delgado C, Sudore R, Lai JC, Johansen KL. Association of motivations and barriers with participation and performance in a pedometer-based intervention. Nephrol Dial Transplant. 2020 Aug 1;35(8):1405-1411. doi: 10.1093/ndt/gfaa047.
Results Reference
derived
PubMed Identifier
32178648
Citation
Sheshadri A, Kittiskulnam P, Lai JC, Johansen KL. Effect of a pedometer-based walking intervention on body composition in patients with ESRD: a randomized controlled trial. BMC Nephrol. 2020 Mar 16;21(1):100. doi: 10.1186/s12882-020-01753-5.
Results Reference
derived
PubMed Identifier
31679747
Citation
Sheshadri A, Kittiskulnam P, Lazar AA, Johansen KL. A Walking Intervention to Increase Weekly Steps in Dialysis Patients: A Pilot Randomized Controlled Trial. Am J Kidney Dis. 2020 Apr;75(4):488-496. doi: 10.1053/j.ajkd.2019.07.026. Epub 2019 Nov 1.
Results Reference
derived

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

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