The "Step4Life" Randomized Control Trial in Hemodialysis

The Impact of Use of a Wearable Pedometer and Structured Feedback Program on Physical Activity in Hemodialysis Patients: The "Step4Life" Randomized Control Trial

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.

Study Overview

• Status: Completed
• Conditions: Physical Activity; Hemodialysis; End Stage Kidney Disease
• Intervention / Treatment: Device: Fitbit

Detailed Description

Physical activity is an important modifiable behavior that is known to impact morbidity and mortality. The patients with advance kidney disease especially those on chronic hemodialysis are deconditioned with decreased muscle mass, and have co-morbidities such as anemia, malnutrition, and depression. These factors may explain why hemodialysis patients are known to have very low physical activity relative to healthy populations. We have recently demonstrated that hemodialysis patients are frequently sedentary, walk less with lower levels of physical activity. Thus, this provides an opportunity to design interventions to improve and sustain physical activity levels in hemodialysis patients.

There is a growing experience of digital technology and intervention delivery modalities to promote physical activity in chronic comorbid conditions, but little is known in hemodialysis patients. We set forward to test a weekly coaching intervention guided by a wearable pedometer to determine whether it would be feasible, promote physical activity, and be sustained for 12 weeks in hemodialysis patients. Equipped with pedometer data, informing subjects quantitatively about their levels of physical activity relative to other hemodialysis patients, might promote physical activity in this high-risk population.

We conduct a 12-week, open label, randomized controlled trial to determine the feasibility and effectiveness of providing structured feedback instruction (e.g., behavioral feedback, goal setting) along with a wearable pedometer (FitBit ®) in sustaining or improving physical activity levels in chronic hemodialysis patients as compared to the wearable pedometer (automated self-managed) alone. I hypothesized that the structured feedback intervention coupled with the wearable pedometer would be feasible, would improve physical activity, and would be sustainable for 12 weeks in hemodialysis patients.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92101
      • University of California San Diego

Participation Criteria

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:

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

Exclusion Criteria:

1) 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fitbit plus Feedback Intervention; Participants who were randomized to the provider-feedback intervention arm received goal setting, and feedback graphs and charts,	Device: Fitbit; The study participants in intervention group received feedback based on steps achieved every week (converted to average steps per day) after randomization.
Active Comparator: Fitbit alone; 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; The study participants in intervention group received feedback based on steps achieved every week (converted to average steps per day) after randomization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Investigators: Principal Investigator: Rakesh Malhotra, MD, MPH, University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): April 30, 2020
• Study Completion (Actual): May 30, 2020

Study Registration Dates

• First Submitted: February 4, 2022
• First Submitted That Met QC Criteria: February 4, 2022
• First Posted (Actual): February 15, 2022

Study Record Updates

• Last Update Posted (Actual): February 15, 2022
• Last Update Submitted That Met QC Criteria: February 4, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: P171917

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No