- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02623348
Use of Pedometers to Measure and Increase Walking Among Patients With ESRD (PED)
September 10, 2019 updated by: University of California, San Francisco
Randomized controlled trial using pedometers to increase physical activity among patients on dialysis.
Study Overview
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Francisco, California, United States, 94114
- University of California San Francisco
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: pedometer
Patients will be given pedometers and instructions to increase physical activity based on pedometer output
|
pedometer-based physical activity recommendations
|
No Intervention: usual care
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical Activity
Time Frame: Baseline and 12 weeks
|
change in steps per day from pedometer
|
Baseline and 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline and 12 weeks
|
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)
|
Baseline and 12 weeks
|
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)
|
Baseline and 12 weeks
|
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)
|
Baseline and 12 weeks
|
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)
|
Baseline and 12 weeks
|
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.
|
12 weeks
|
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)
|
Baseline and 12 weeks
|
Change in SDNN (ms)
Time Frame: 12 weeks
|
Standard deviation of N-N intervals as recorded on electrocardiography waveform (ms)
|
12 weeks
|
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
|
Baseline and 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2015
Primary Completion (Actual)
June 1, 2018
Study Completion (Actual)
June 1, 2018
Study Registration Dates
First Submitted
December 1, 2015
First Submitted That Met QC Criteria
December 2, 2015
First Posted (Estimate)
December 7, 2015
Study Record Updates
Last Update Posted (Actual)
October 2, 2019
Last Update Submitted That Met QC Criteria
September 10, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-02719
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on End-stage Renal Disease
-
Outset MedicalCompletedAcute Kidney Injury | End Stage Renal Disease (ESRD) | End Stage Renal Disease on DialysisUnited States
-
University of Illinois at ChicagoWithdrawnObesity | End-Stage Renal Disease | Renal Disease, End-Stage | Renal Failure, End-StageUnited States
-
Bioconnect Systems, IncCompletedEnd-stage Renal Disease | End-stage Kidney DiseaseUnited States
-
Iperboreal Pharma SrlWithdrawnEnd-Stage Renal Disease
-
Cubist Pharmaceuticals LLCCompleted
-
Medical University of GrazWithdrawnEnd-stage Renal DiseaseAustria
-
Janssen Research & Development, LLCBayerCompleted
-
Chulalongkorn UniversityCompletedEnd-stage Renal DiseaseThailand
-
University of KansasCompletedEnd-Stage Renal Disease
-
Eisai Co., Ltd.CompletedEnd-Stage Renal DiseaseJapan
Clinical Trials on pedometer
-
Meir Medical CenterTerminated
-
University of FloridaCompletedAmbulation | Wearable DevicesUnited States
-
Charles University, Czech RepublicCompletedPhysical Activity | General Practice | Primary Care
-
Rigshospitalet, DenmarkNovo Nordisk A/S; Copenhagen University Hospital at Herlev; Danish Cancer Society and other collaboratorsCompleted
-
Ege UniversityRecruitingCardiac Disease | Kidney Transplant; ComplicationsTurkey
-
Hospital for Special Surgery, New YorkMemorial Sloan Kettering Cancer CenterCompletedChronic Low Back PainUnited States
-
Sheba Medical CenterUnknown
-
University of Alberta, Physical EducationCompleted
-
Mansoura UniversityRecruitingFatigue | Physical InactivityEgypt
-
Yusup subagio sutantoCompletedChronic Obstructive Pulmonary Disease (COPD)Indonesia