NCT05241171

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Physical Activity
• End Stage Kidney Disease
• Hemodialysis

Interventions

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

Timeline

• Start date: 2019-01-01
• Primary completion: 2020-04-30
• Completion: 2020-05-30
• First posted: 2022-02-15
• Last updated: 2022-02-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study