Clinical trial NCT02623348: Use of Pedometers to Measure and Increase Walking Among Patients With ESRD
Official title: Use of Pedometers to Measure and Increase Walking Among Patients With ESRD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End-stage Renal Disease
Keywords: dialysis
end-stage renal disease
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2015-12-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Physical Activity
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Physical Performance
timeFrame: Baseline and 12 weeks
measure: Self-reported Physical Functioning
timeFrame: Baseline and 12 weeks
measure: Change in Activities of Daily Living Score
timeFrame: Baseline and 12 weeks
measure: Change in Symptom Burden on the Dialysis Symptoms Index
timeFrame: Baseline and 12 weeks
measure: Change in Total Body Muscle Mass (Adjusted by Height Squared)
timeFrame: Baseline and 12 weeks
measure: Change in Endothelial Function
timeFrame: 12 weeks
measure: Change in the Short From 36 Vitality Scale
timeFrame: Baseline and 12 weeks
measure: Change in SDNN (ms)
timeFrame: 12 weeks
measure: Change in Symptom Severity on Dialysis Symptoms Index
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
References:
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.
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.
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.
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.
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.