The Step4Life Randomized Control Trial in Hemodialysis

Study Overview
=================
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.

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.

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

Conditions
-----------------
Physical Activity, End Stage Kidney Disease, Hemodialysis

Intervention / Treatment
-----------------
* Device: Fitbit


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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 |