A Comparison of Physical Activity Levels With and Without Feedback Via Fitbit® Flex™ in Hemodialysis Patients

NCT ID: NCT02320513

Last Updated: 2015-10-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 33 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-06-30

Brief Summary

This is a pilot study intended to gather data in order to inform future studies about the role of feedback as an incentive for increasing levels of physical activity which could improve health in hemodialysis patients.

Detailed Description

In prior studies that have analyzed physical activity in dialysis patients, three-dimensional accelerometers, physical performance tasks or self-reporting physical activity questionnaires have been used to measure levels of activity. This proposed study differs in that it will determine the effectiveness of providing "feedback" to dialysis patients using a fitness tracking bracelet. For the purpose of this study, the word 'feedback' is used to refer to the information provided to the subject that demonstrates the number of steps taken since the previous dialysis session as displayed by the Fitbit® application. This 'feedback' will allow subjects to be more aware of their overall physical activity on a quantitative level.

The study will seek to explore an association between feedback and physical activity. Improved physical activity could improve indicators of subjects' health status such as blood pressure, inflammatory markers, and pre-albumin levels, which will also be monitored and recorded.

While informing subjects quantitatively about their levels of physical activity could be a promising method to encourage them to be more active, it is unclear at this point if that strategy actually works. This is an important practical question though, because actually informing subjects on a regular basis about their activity level may pose substantial operative challenges and result in additional costs.

The importance of encouraging subjects to be more physically active should not be underestimated. Studying the physical activity of dialysis patients is important because it allows researchers to consider the long-term effects that may influence the subject's well-being. Johansen et al. showed that there was a direct relationship between the inactivity of dialysis patients and susceptibility to hypertension, diabetes, cardiovascular disease and even mortality. Additionally, the study demonstrated the importance of implementing programs to promote physical activity [1]. If feedback does indeed increase physical activity, then it will be substantially beneficial for this program to be implemented.

Conditions

End Stage Renal Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Control Group

Subjects will wear the activity monitoring device to track their activity between dialysis treatments, however, the feedback from the device will not be shared with them.

Wearing activty monitoring device (Fitbit Flex)

Intervention Type: OTHER

Fitbit Flex

Intervention Type: DEVICE

Feedback Group

The feedback from the activity monitoring device will be shared with subjects at each visit.

Wearing activty monitoring device (Fitbit Flex)

Intervention Type: OTHER

Fitbit Flex

Intervention Type: DEVICE

Interventions

Wearing activty monitoring device (Fitbit Flex)

Intervention Type: OTHER

Fitbit Flex

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Receiving hemodialysis three times a week
• On hemodialysis for more than 3 months
• Between the ages of 18 and 75 years
• Able to walk without assistance or assistive devices
• Able to read and understand the English language

Exclusion Criteria

• Patient already uses an activity tracker
• Unstable health: acute infections, congestive heart failure NYHA class 4 and/or unstable angina
• Hospitalization within the past 3 months for non-access related reasons
• Known allergies to nickel
• Unable to physically grip the handheld dynamometer in order to complete the Hand Grip Strength Test
• Cognitive impairment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Renal Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Kotanko, MD

Role: PRINCIPAL_INVESTIGATOR

Renal Research Institute

Locations

Avantua Upper East Side Dialysis Center

New York, New York, United States

Countries

United States

Other Identifiers

20141534

Identifier Type: -

Identifier Source: org_study_id