The "Step4Life" Randomized Control Trial in Hemodialysis

NCT05241171 | Completed FDA Device

• 1 other identifier: P171917
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Persons with end-stage kidney disease (ESKD) have very low physical activity, and among ESKD patients, the level of inactivity is strongly associated with morbidity and mortality. This study aimed to assess the feasibility and effectiveness of a 12-week intervention coupling use of wearable pedometers (FitBit ®) and feedback coaching to increase physical activity in hemodialysis patients.

Conditions

Physical Activity; End Stage Kidney Disease; Hemodialysis

Outcome Measures

Primary Outcomes (1)

• the absolute change from baseline in step counts per week from baseline to 12-weeks between randomized groups.

  weekly step counts measured with Fitbit

  12 weeks

Study Arms (2)

Fitbit plus Feedback Intervention

EXPERIMENTAL

Participants who were randomized to the provider-feedback intervention arm received goal setting, and feedback graphs and charts,

Device: Fitbit

Fitbit alone

ACTIVE COMPARATOR

Participants in self-managed control group were provided access to the Fitbit website or app but did not receive any feedback on their activity level from the study team.

Device: Fitbit

Interventions

Fitbit DEVICE

The study participants in intervention group received feedback based on steps achieved every week (converted to average steps per day) after randomization.

Fitbit alone; Fitbit plus Feedback Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) HD for ≥3 months, 2) age ≥18 years, and 3) ability to walk with or without assistive devices,

You may not qualify if:

• \) wheelchair bound, 2) unstable severe health conditions (e.g., acute infections, heart failure (HF) NYHA class 4 and/or unstable angina), 3) hospitalization within 3 months before enrollment for non-access related reasons, or 4) clinically recognized cognitive impairment including dementia or psychosis.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San Diego

San Diego, California, 92101, United States

Location

Related Publications (1)

• Malhotra R, Rahimi S, Agarwal U, Katz R, Kumar U, Garimella PS, Gupta V, Chopra T, Kotanko P, Ikizler TA, Larsen B, Cadmus-Bertram L, Ix JH. The Impact of a Wearable Activity Tracker and Structured Feedback Program on Physical Activity in Hemodialysis Patients: The Step4Life Pilot Randomized Controlled Trial. Am J Kidney Dis. 2023 Jul;82(1):75-83. doi: 10.1053/j.ajkd.2022.12.011. Epub 2023 Feb 17.

  PMID: 36801430 DERIVED

MeSH Terms

Conditions

Motor Activity; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Behavior; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rakesh Malhotra, MD, MPH

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical medicine

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: February 15, 2022
• Study Start: January 1, 2019
• Primary Completion: April 30, 2020
• Study Completion: May 30, 2020
• Last Updated: February 15, 2022

Record last verified: 2022-02

Locations

US (1)