NCT02623348

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 7, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

October 2, 2019

Completed
Last Updated

October 2, 2019

Status Verified

September 1, 2019

Enrollment Period

2.5 years

First QC Date

December 1, 2015

Results QC Date

February 22, 2019

Last Update Submit

September 10, 2019

Conditions

End-stage Renal Disease

Keywords

dialysisend-stage renal disease

Outcome Measures

Primary Outcomes (1)

  • Physical Activity

    change in steps per day from pedometer

    Baseline and 12 weeks

Secondary Outcomes (9)

  • Physical Performance

    Baseline and 12 weeks

  • Self-reported Physical Functioning

    Baseline and 12 weeks

  • Change in Activities of Daily Living Score

    Baseline and 12 weeks

  • Change in Symptom Burden on the Dialysis Symptoms Index

    Baseline and 12 weeks

  • Change in Total Body Muscle Mass (Adjusted by Height Squared)

    Baseline and 12 weeks

  • +4 more secondary outcomes

Study Arms (2)

pedometer

EXPERIMENTAL

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

Behavioral: pedometer

usual care

NO INTERVENTION

No intervention

Interventions

pedometerBEHAVIORAL

pedometer-based physical activity recommendations

pedometer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • unable to walk
  • unable to understand directions or give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco

San Francisco, California, 94114, United States

Location

Related Publications (5)

  • 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.

    PMID: 35018639DERIVED

  • 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.

    PMID: 33979802DERIVED

  • 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.

    PMID: 32437568DERIVED

  • 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.

    PMID: 32178648DERIVED

  • 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.

    PMID: 31679747DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

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.

Results Point of Contact

Title
Anoop Sheshadri
Organization
University of California, San Francisco
anoop.sheshadri@ucsf.edu
415-221-4810

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2015

First Posted

December 7, 2015

Study Start

December 1, 2015

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

October 2, 2019

Results First Posted

October 2, 2019

Record last verified: 2019-09

Locations

US(1)