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Randomized controlled trial using pedometers to increase physical activity among patients on dialysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pedometer | Experimental | Patients will be given pedometers and instructions to increase physical activity based on pedometer output |
|
| usual care | No Intervention | No intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pedometer | Behavioral | pedometer-based physical activity recommendations |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity | change in steps per day from pedometer | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Performance | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35018639 | Derived | 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. | |
| 33979802 | Derived | 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. |
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Baseline assessment performed prior to random assignment
Patients recruited from 3 local San Francisco dialysis clinics
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| ID | Title | Description |
|---|---|---|
| FG000 | Pedometer | Patients will be given pedometers and weekly instructions to increase physical activity based on pedometer output over the prior week. |
| FG001 | Usual Care | Recommendations for physical activity as determined by American Heart Association and American College of Sports Medicine at time of enrollment only. Otherwise, usual care. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pedometer | Patients will be given pedometers and weekly instructions to increase physical activity based on pedometer output over the prior week. |
| BG001 | Usual Care | Recommendations for physical activity as determined by American Heart Association and American College of Sports Medicine at time of enrollment only. Otherwise, usual care. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Physical Activity | change in steps per day from pedometer | Posted | Median | 95% Confidence Interval | steps/day | Baseline and 12 weeks |
|
24 months total, 6 months per patient
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pedometer | Patients will be given pedometers and weekly instructions to increase physical activity based on pedometer output over the prior week. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Systematic Assessment | Increased fatigue/weariness |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anoop Sheshadri | University of California, San Francisco | 415-221-4810 | 22576 | anoop.sheshadri@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2019 | Aug 1, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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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 | 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 | 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) | (TBMM calculated from measurements of intracellular water from bioimpedance spectrometry) | 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. | 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) | Baseline and 12 weeks |
| Change in SDNN (ms) | Standard deviation of N-N intervals as recorded on electrocardiography waveform (ms) | 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 | Baseline and 12 weeks |
| 32437568 | Derived | 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. |
| 32178648 | Derived | 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. |
| 31679747 | Derived | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| BMI | Median | Inter-Quartile Range | kg/m^2 |
|
| Dialysis Vintage (Years) | Mean | Inter-Quartile Range | years |
|
| Hemoglobin | Median | Inter-Quartile Range | mg/dL |
|
| Serum Albumin | Median | Inter-Quartile Range | g/dL |
|
| Standardized Kt/V | Median | Inter-Quartile Range | unitless, per week |
|
| Currently smoking | Count of Participants | Participants |
|
| Hypertension | Count of Participants | Participants |
|
| Diabetes | Count of Participants | Participants |
|
| Coronary Artery Disease | Count of Participants | Participants |
|
| Congestive Heart Failure | Count of Participants | Participants |
|
| Stroke | Count of Participants | Participants |
|
| Peripheral Vascular Disease | Count of Participants | Participants |
|
| HIV | Count of Participants | Participants |
|
| Arrhythmia | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Secondary | Physical Performance | change in score on the Short Physical Performance Battery (0-12), higher scores indicate greater physical performance | Posted | Median | 95% Confidence Interval | score on a scale | Baseline and 12 weeks |
|
|
|
| Secondary | 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) | Posted | Median | 95% Confidence Interval | score on a scale | Baseline and 12 weeks |
|
|
|
| Secondary | Change in Activities of Daily Living Score | Barthel's Index of Daily Activities (Index range 0-20, higher scores indicate greater functional independence) | Posted | Median | 95% Confidence Interval | score on a scale | Baseline and 12 weeks |
|
|
|
| Secondary | Change in Symptom Burden on the Dialysis Symptoms Index | Dialysis symptom index (symptom burden ranges from 0 - 29 symptoms experienced) | Posted | Median | Inter-Quartile Range | score on a scale | Baseline and 12 weeks |
|
|
|
| Secondary | Change in Total Body Muscle Mass (Adjusted by Height Squared) | (TBMM calculated from measurements of intracellular water from bioimpedance spectrometry) | Note: we were unable to obtain body composition measures from all participants at baseline and 12 weeks (Missing data from: 3 with metal implants, 1 with pacemaker, 2 with poor quality of measurement likely related to fluid shifts) | Posted | Median | Inter-Quartile Range | kg/m2 | Baseline and 12 weeks |
|
|
|
| Secondary | 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. | Posted | Median | 95% Confidence Interval | unitless | 12 weeks |
|
|
|
| Secondary | 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) | Posted | Median | 95% Confidence Interval | score on a scale | Baseline and 12 weeks |
|
|
|
| Secondary | Change in SDNN (ms) | Standard deviation of N-N intervals as recorded on electrocardiography waveform (ms) | Posted | Median | 95% Confidence Interval | ms | 12 weeks |
|
|
|
| Secondary | 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 | Posted | Median | Inter-Quartile Range | score on a scale | Baseline and 12 weeks |
|
|
|
| 1 |
| 30 |
| 0 |
| 30 |
| 6 |
| 30 |
| EG001 | Usual Care | Recommendations for physical activity as determined by American Heart Association and American College of Sports Medicine at time of enrollment only. Otherwise, usual care. | 0 | 30 | 0 | 30 | 2 | 30 |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |