End-stage Renal DiseasePEDNCT02623348

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

A study testing pedometer in people with End-stage Renal Disease, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Randomized controlled trial using pedometers to increase physical activity among patients on dialysis. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: End-stage Renal Disease
What is being tested?: pedometer
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: Dec 2015to Jun 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

on hemodialysis for ≥ 3 months
able to walk
able to give informed consent and willing to participate

Who cannot join

unable to walk
unable to understand directions or give informed consent

Trial locations and contacts

1 site in 1 country.

United States1 site

University of California San Francisco
San Francisco, California, 94114

Other trials in United States

About this study

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

Conditions: End-stage Renal Disease
Being tested: pedometer
Keywords: dialysis, end-stage renal disease
Medical subject headings: Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

pedometerBehavioural
pedometer-based physical activity recommendations

Study groups in NCT02623348
Study group	Role	What they receive
pedometer	Experimental	Patients will be given pedometers and instructions to increase physical activity based on pedometer output Receives: Behavioral: pedometer
usual care	No intervention	No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Physical Activity
change in steps per day from pedometer
Measured: Baseline and 12 weeks

Secondary outcomes (9)

Physical Performance
change in score on the Short Physical Performance Battery (0-12), higher scores indicate greater physical performance
Measured: 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)
Measured: 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)
Measured: Baseline and 12 weeks
Change in Symptom Burden on the Dialysis Symptoms Index
Dialysis symptom index (symptom burden ranges from 0 - 29 symptoms experienced)
Measured: Baseline and 12 weeks
Change in Total Body Muscle Mass (Adjusted by Height Squared)
(TBMM calculated from measurements of intracellular water from bioimpedance spectrometry)
Measured: 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.
Measured: 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)
Measured: Baseline and 12 weeks
Change in SDNN (ms)
Standard deviation of N-N intervals as recorded on electrocardiography waveform (ms)
Measured: 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
Measured: Baseline and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2015Jun 2018

First posted7 Dec 2015 (estimated)
Study startDec 2015
Primary completionJun 2018
Study completionJun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
More trials run by University of California, San FranciscoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02623348
Sponsor's protocol ID: 10-02719
Acronym: PED
Status last verified: Sep 2019
First submitted: 1 Dec 2015
Last updated: 2 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 35018639
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.
PubMed 33979802
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.
PubMed 32437568
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.
PubMed 32178648
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.
PubMed 31679747

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
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All End-stage Renal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Use of Pedometers to Measure and Increase Walking Among Patients With ESRD
ClinicalTrials.gov ID: NCT02623348
Acronym / sponsor ID: PED / 10-02719
Conditions: End-stage Renal Disease
Keywords: dialysis, end-stage renal disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: University of California, San FranciscoUniversity, hospital or other
Study start: Dec 2015 (actual)
Primary completion: Jun 2018 (actual)
Study completion: Jun 2018 (actual)
First posted: 7 Dec 2015 (estimated)
Results: Posted 2 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
pedometer	Experimental	Behavioral: pedometerPatients will be given pedometers and instructions to increase physical activity based on pedometer output
usual care	No intervention	–No intervention

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

on hemodialysis for ≥ 3 months
able to walk
able to give informed consent and willing to participate

Key exclusion criteria (2 listed)

unable to walk
unable to understand directions or give informed consent

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
pedometerpedometer-based physical activity recommendations	Behavioural	pedometer

Primary outcome

Physical Activity
Time frame: Baseline and 12 weeks
change in steps per day from pedometer

9 secondary outcomes

Physical Performance
Time frame: Baseline and 12 weeks
Self-reported Physical Functioning
Time frame: Baseline and 12 weeks
Change in Activities of Daily Living Score
Time frame: Baseline and 12 weeks
Change in Symptom Burden on the Dialysis Symptoms Index
Time frame: Baseline and 12 weeks
Change in Total Body Muscle Mass (Adjusted by Height Squared)
Time frame: Baseline and 12 weeks
Change in Endothelial Function
Time frame: 12 weeks
Change in the Short From 36 Vitality Scale
Time frame: Baseline and 12 weeks
Change in SDNN (ms)
Time frame: 12 weeks
Change in Symptom Severity on Dialysis Symptoms Index
Time frame: Baseline and 12 weeks

Results and safety

Results posted to the registry on 2 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pedometer	30	27
Usual Care	30	28

Primary outcome: Physical Activity

Time frame: Baseline and 12 weeks. Median (95% Confidence Interval). Unit: steps/day

Measure	Pedometer n = 27	Usual Care n = 26
Value	1474 (40 to 3538)	180 (-650 to 1040)

Usual Care: p <0.01, linear mixed modeling

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 months total, 6 months per patient. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pedometer	0 of 30 (0%)	6 of 30 (20%)	1 of 30
Usual Care	0 of 30 (0%)	2 of 30 (6.7%)	0 of 30

Limitations and caveats (from the sponsor): Outcomes reported are median change within groups with 95% confidence interval. Primary analysis is difference in change between groups using linear mixed modeling. Participants were selected only from dialysis clinics in Northern California.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35018639Bernier-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.
Derived from this study: PubMed 33979802Sheshadri 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.
Derived from this study: PubMed 32437568Sheshadri 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.
Derived from this study: PubMed 32178648Sheshadri 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.
Derived from this study: PubMed 31679747Sheshadri 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.

Related trials for End-stage Renal Disease

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
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RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing pedometer in people with End-stage Renal Disease, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical Activity (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02623348, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2019.